Gastroenterology Peptic Ulcer Disease Courses in Therapeutics and

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Gastroenterology: Peptic Ulcer Disease Courses in Therapeutics and Disease State Management Author: Monica L.

Gastroenterology: Peptic Ulcer Disease Courses in Therapeutics and Disease State Management Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Learning Objectives • Identify and compare the common forms of peptic ulcer disease (PUD).

Learning Objectives • Identify and compare the common forms of peptic ulcer disease (PUD). • Describe features associated with Helicobactor pyloriassociated and NSAID-induced ulcers. • Discuss the role of Helicobacter pylori (HP) in PUD. • Compare and contrast signs and symptoms of duodenal and gastric ulcers. • Identify, describe, and discuss the utility of laboratory tests used to detect the presence of HP Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Learning Objectives • Discuss pharmacologic treatment options for HPassociated and NSAID-induced PUD. • Given

Learning Objectives • Discuss pharmacologic treatment options for HPassociated and NSAID-induced PUD. • Given a PUD patient history, recommend appropriate pharmacologic therapy and explain the rationale behind your decision • Discuss drug adverse effects and monitoring parameters for drugs and disease states • Construct counseling points for a PUD patient on their disease state and pharmacologic therapy Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Required Reading Love BL, Mohorn PL. Peptic Ulcer Disease and Related Disorders. In: Di.

Required Reading Love BL, Mohorn PL. Peptic Ulcer Disease and Related Disorders. In: Di. Piro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 10 e New York, NY: Mc. Graw. Hill; 2017. Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Overview • Peptic ulcer disease (PUD) refers to ulceration of the mucosa anywhere in

Overview • Peptic ulcer disease (PUD) refers to ulceration of the mucosa anywhere in the GI tract exposed to acid and pepsin • They can range in size from a few millimeters to a few centimeters • Estimated that 10% of Americans will develop PUD in their lifetime • The 2 most common forms/locations of PUD are – Duodenal ulcer – Gastric ulcer Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Duodenal Ulcers • Most common form of PUD – It is 3 times more

Duodenal Ulcers • Most common form of PUD – It is 3 times more common than gastric ulcers • Usually located in the duodenal bulb of the small intestine • Most commonly occurs in people between the ages of 30 and 50 Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Gastric Ulcers • Less common than duodenal ulcers – Especially in the absence of

Gastric Ulcers • Less common than duodenal ulcers – Especially in the absence of chronic NSAID use • Most commonly located in the lesser curvature of the antrum of the stomach • More common in people greater than 60 years old Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Duodenal and Gastric Ulcers Link: Anatomic structure of the stomach and duodenum and most

Duodenal and Gastric Ulcers Link: Anatomic structure of the stomach and duodenum and most common locations of gastric and duodenal ulcers. Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Duodenal and Gastric Ulcers • Link: Figure of a Duodenal Ulcer and a Gastric

Duodenal and Gastric Ulcers • Link: Figure of a Duodenal Ulcer and a Gastric Ulcer Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Etiology and Pathophysiology • Gastric and duodenal ulcers develop because of an imbalance between

Etiology and Pathophysiology • Gastric and duodenal ulcers develop because of an imbalance between aggressive factors and mechanisms that maintain mucosal integrity • There is an increase in mucosal injury and a decrease in mucosal defense – Aggressive factors (H. pylori, NSAIDs) cause mucosal injury and a decrease in mucosal defenses and healing (decreased mucous, decreased bicarbonate, decreased mucosal blood flow) Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Etiology and Pathophysiology • Common causes of PUD – Helicobacter pylori (H. pylori) infection

Etiology and Pathophysiology • Common causes of PUD – Helicobacter pylori (H. pylori) infection – Nonsteroidal Anti-inflammatory Drugs (NSAIDs) – Critical illness (stress-related mucosal damage) • Uncommon causes of PUD – Idiopathic (non-H. pylori, non- NSAID) – Hypersecretion of gastric acid (e. g. Zollinger Ellison syndrome) – Viral infections – Radiation therapy – Chemotherapy Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Helicobacter Pylori (HP)-Associated • Helicobacter pylori (HP) is a spiral shaped, gram negative, flagellated

Helicobacter Pylori (HP)-Associated • Helicobacter pylori (HP) is a spiral shaped, gram negative, flagellated bacteria first associated with PUD in the early 1980’s • Found in most people with duodenal and gastric ulcers – About 95% of those with duodenal ulcers – About 80% of those with gastric ulcers Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Helicobacter Pylori (HP)-Associated • Approximately 30% - 40% of the U. S. population is

Helicobacter Pylori (HP)-Associated • Approximately 30% - 40% of the U. S. population is infected • About 15% of those infected will develop PUD • HP is primarily spread through the fecal to oral route • People are most often infected during childhood Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Helicobacter Pylori (HP)-Associated • Mechanisms by which HP causes mucosal injury are not entirely

Helicobacter Pylori (HP)-Associated • Mechanisms by which HP causes mucosal injury are not entirely clear but occurs through a combination of the following mechanisms: – HP catalyzes urea ammonia is produced ammonia erodes the mucous barrier and causes epithelial damage – HP produces cytotoxins – HP produces mucolytic enzymes Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Helicobacter pylori (HP)-Associated Link: Schematic of the relationships between colonization with Helicobacter pylori and

Helicobacter pylori (HP)-Associated Link: Schematic of the relationships between colonization with Helicobacter pylori and diseases of the upper gastrointestinal tract Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

NSAID-Induced • In long-term NSAID users, there is a 10% - 20% prevalence of

NSAID-Induced • In long-term NSAID users, there is a 10% - 20% prevalence of gastric ulcers and a 2% - 5% prevalence of duodenal ulcers • Mechanisms for NSAID-induced ulceration – NSAIDs are weak acids and are non-ionized at gastric p. H • Diffuse freely across the mucous barrier into gastric epithelial cells H+ ions are liberated and cause cellular damage Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

NSAID-Induced • Mechanisms for NSAID-induced ulceration (continued) – NSAIDs inhibit cyclooxygenase activity and therefore

NSAID-Induced • Mechanisms for NSAID-induced ulceration (continued) – NSAIDs inhibit cyclooxygenase activity and therefore decrease prostaglandin production which results in a: • Reduction in gastric and mucosal blood flow • Decrease in mucous and bicarbonate secretion • Decrease in cellular repair and replication • Link: Figure showing mechanisms by which nonsteroidal anti-inflammatory drugs may induce mucosal injury Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

NSAID-Induced • 1% - 2% of NSAID users will develop an ulcer or ulcer

NSAID-Induced • 1% - 2% of NSAID users will develop an ulcer or ulcer complications with 1 year • The risk of developing an NSAID-related complication is greater in patients: – Greater than 60 years old – With a prior history of PUD – Taking high dose NSAIDs or multiple NSAIDs, including low dose aspirin Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

NSAID-Induced • The risk of developing an NSAID-related complication is greater in patients (continued):

NSAID-Induced • The risk of developing an NSAID-related complication is greater in patients (continued): – Who are concurrently taking • • • Corticosteroids Anticoagulants Oral bisphonates Anti-platelet agents SSRIs (Selective Serotonin Reuptake Inhibitors) • Aspirin is the most ulcernogenic of all NSAIDs. – Even with low dose aspirin (81 -162 mg/day), ulcers occur in 0. 6% - 1. 2% of patients per year. Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Zollinger-Ellison Syndrome (ZES) • ZES is characterized by gastric acid hypersecretion and recurrent peptic

Zollinger-Ellison Syndrome (ZES) • ZES is characterized by gastric acid hypersecretion and recurrent peptic ulcers that result from a gastrin-producing tumor – More than 50% of gastrinomas are malignant • ZES is suspected for patients with multiple ulcers and recurrent or refractory PUD often accompanied by esophagitis or ulcer complications • Only accounts for 0. 1% to 1% of those with duodenal ulcer Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Other Potential Factors in the Development of PUD • Cigarette smoking – Increases the

Other Potential Factors in the Development of PUD • Cigarette smoking – Increases the risk of developing PUD and its complications – Impairs ulcer healing and increases the risk of recurrence – Ulcer risk is proportional to the number of cigarettes smoked per day • Psychological stress – People who develop PUD tend to be more adversely affected by stress – However, controlled trials are conflicting and have failed to document a direct cause-effect relationship – Stress may induce behavioral risks such as smoking and the use of NSAIDs or may alter the inflammatory response or resistance to HP infection • Dietary factors – Certain foods (e. g. coffee, tea, carbonated beverages, beer, milk, spices) may cause dyspepsia but do not increase the risk of developing PUD Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Signs and Symptoms • Symptoms depend on ulcer location, ulcer etiology, and patient age

Signs and Symptoms • Symptoms depend on ulcer location, ulcer etiology, and patient age • Many patients, particularly the elderly, have few or even no symptoms • NSAID-induced ulcers are often silent – Complications such as bleeding and perforation are often the initial presentation Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Signs and Symptoms • Pain localized to the epigastrium is the most common symptom

Signs and Symptoms • Pain localized to the epigastrium is the most common symptom • The pain is described as burning, gnawing, cramping, or hunger • A typical nocturnal pain that wakes the patient from sleep (especially between 12 and 3 am) • The severity of ulcer pain varies from patient to patient and my be seasonal, occurring more often in the spring or fall Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Signs and Symptoms • Episodes of pain usually occur in clusters, lasting up to

Signs and Symptoms • Episodes of pain usually occur in clusters, lasting up to a few weeks followed by a pain-free period or remission lasting weeks to years • Changes in the character of pain may suggest the presence of complications • Pyrosis (heartburn), belching, and bloating may accompany the pain Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Gastric Ulcer • Pain often does not follow a consistent pattern; not predictable •

Gastric Ulcer • Pain often does not follow a consistent pattern; not predictable • Food will sometimes cause or accentuate pain • Nausea, vomiting, anorexia, and weight loss are more common with gastric ulcer than duodenal ulcer Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Duodenal Ulcer • Pain more likely follows a consistent pattern (compared to gastric ulcer)

Duodenal Ulcer • Pain more likely follows a consistent pattern (compared to gastric ulcer) – Epigastric pain occurs in 60% - 90% of patients with duodenal ulcers • Food often relieves pain but the pain usually returns 1 to 3 hours after eating • Nocturnal epigastric pain often occurs • 40% - 70% have additional non-specific dyspeptic complaints (belching, bloating, abdominal distension, food intolerance) Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Clinical Presentation • Link: Table on Comparison of Common Forms of Peptic Ulcer •

Clinical Presentation • Link: Table on Comparison of Common Forms of Peptic Ulcer • Link: Table on Clinical Presentation of Peptic Ulcer Disease Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Complications • Major complications of PUD include: – Bleeding • Occurs in about 15%

Complications • Major complications of PUD include: – Bleeding • Occurs in about 15% of patients with active PUD – Perforation • Occurs in about 7% of patients with active PUD – Mortality • Mortality from acute bleeding is about 6% - 10% Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Bleeding and Hemorrhage in Peptic Ulcers Link: Figure of stigmata of hemorrhage in peptic

Bleeding and Hemorrhage in Peptic Ulcers Link: Figure of stigmata of hemorrhage in peptic ulcers Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Role of Testing • The diagnosis of PUD depends on visualizing the ulcer crater

Role of Testing • The diagnosis of PUD depends on visualizing the ulcer crater by either upper GI radiography or upper endoscopy – Upper GI radiography with barium was the initial diagnostic procedure but has been replaced with upper endoscopy • There are multiple laboratory tests that can be performed to diagnosis an H. pylori infection Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Testing for H. pylori • There are multiple tests that can be performed to

Testing for H. pylori • There are multiple tests that can be performed to test for the presence of H. pylori • Invasive testing (Requires endoscopy with biopsy) – Histology – Culture – Rapid urease testing • Noninvasive testing – Serological test – Urea breath test – Fecal antigen test Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Invasive Testing • All of these tests require biopsy to be acquired via endoscopy

Invasive Testing • All of these tests require biopsy to be acquired via endoscopy • Histology – Microbiologic examination using various stains – Excellent sensitivity and specificity but it is invasive, expensive and requires trained personnel • Culture – Culture of biopsy – Costly, time consuming, and technically difficult Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Invasive Testing • Rapid Urease Testing – Rapid urease tests detect the presence of

Invasive Testing • Rapid Urease Testing – Rapid urease tests detect the presence of ammonia in the biopsy sample – The ammonia is generated by H. pylori urease activity – Test of choice at endoscopy – Greater than 90% sensitive and specific – Easily performed with rapid results – Tests for active HP infection Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Noninvasive Tests (Antibody Detection/Serological Test) • A simple blood test – Laboratory-based (more accurate

Noninvasive Tests (Antibody Detection/Serological Test) • A simple blood test – Laboratory-based (more accurate than office-based tests) – Office-based • Detects Ig. G antibodies to H. pylori in the serum • Quick, noninvasive, inexpensive but has a low positive predictive value in populations where prevalence of HP infection is low. • Can’t be used to distinguish between an active infection or past exposure because antibodies persist for long periods of time – Most patients remain seropositive for 6 months to 1 year after HP eradication Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved • Can’t be used to determine if eradication is successful

Noninvasive Tests (Urea Breath Test) • Detects the exhalation of radioactive CO 2 following

Noninvasive Tests (Urea Breath Test) • Detects the exhalation of radioactive CO 2 following ingestion of 13 C or 14 C radiolabeled urea • H. pylori hydrolysis of the radiolabeled urea results in radiolabeled CO 2 production • 97% sensitivity and 95% specificity Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Noninvasive Tests (Fecal Antigen Test) • Polyclonal antibody test that detects the presence of

Noninvasive Tests (Fecal Antigen Test) • Polyclonal antibody test that detects the presence of H. pylori antigen in the stool • Sensitivity and specificity similar to urea breath test • Patients may have a reluctance to collect stool samples Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Noninvasive Tests • The urea breath and fecal antigen tests may be falsely negative

Noninvasive Tests • The urea breath and fecal antigen tests may be falsely negative in patients who have recently taken – Antibiotics (up to 4 weeks) – Bismuth compounds (up to 4 weeks) – Antisecretory agents (up to 2 weeks) • The urea breath and fecal antigen tests can be used as an initial screen to determine if a patient is infected Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Tests for Confirming Eradication • The urea breath (preferred) and fecal antigen tests can

Tests for Confirming Eradication • The urea breath (preferred) and fecal antigen tests can be used to confirm eradiation of H. pylori in a patient who has been treated • The serological test can not be used to determine eradication because antibodies last for an extended period after the infection has been cleared • However, confirming eradication is not practical or cost effective • Indications for confirming eradication include: – Continued dyspeptic symptoms – H. pylori-associated MALT (mucosal associated lymphoid tissue) lymphoma – Resection for gastric cancer Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Testing for H. pylori Link: Table covering tests for the detection of Helicobacter pylori

Testing for H. pylori Link: Table covering tests for the detection of Helicobacter pylori Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Treatment/Therapy Goals • Choice of treatment depends on etiology (e. g. HP or NSAIDs)

Treatment/Therapy Goals • Choice of treatment depends on etiology (e. g. HP or NSAIDs) and whether treatment is for initial management or prevention of recurrence • Overall goals – Relief of pain – Healing of ulcer – Prevention of recurrence – Prevent or reduce complications Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Nonpharmacologic Therapy • • Eliminate or reduce psychological stress Smoking cessation Eliminate or reduce

Nonpharmacologic Therapy • • Eliminate or reduce psychological stress Smoking cessation Eliminate or reduce NSAID use Avoid foods that cause dyspepsia Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Pharmacologic Therapy Overview • For an active HP positive ulcer, our goals are to

Pharmacologic Therapy Overview • For an active HP positive ulcer, our goals are to eradicate the HP, heal the ulcer, and ultimately cure the disease – Use multi-drug regimens containing antibiotics and anti-secretory agents (usually proton pump inhibitors (PPIs)) and sometimes bismuth preparations • For an NSAID-induced peptic ulcer or a peptic ulcer is not caused by HP, our primary goal is to heal the ulcer as quickly as possible – Can use PPIs, H 2 -receptor antagonists, or sucralfate – Antacids are not used as monotherapy to heal peptic ulcers – Misoprostol can be used to reduce the risk of NSAID-induced PUD Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Proton Pump Inhibitors (PPIs) • MOA – Blocks acid secretion by inhibiting gastric H+/K+

Proton Pump Inhibitors (PPIs) • MOA – Blocks acid secretion by inhibiting gastric H+/K+ adenosine triphosphatase found on the secretory surface of gastric parietal cells – Results in a long-lasting anti-secretory effect that can maintain gastric p. H levels above 4 • Agents – – – – Dexlansoprazole (Dexilant) Esomeprazole (Nexium) Lansoprazole (Prevacid) Omeprazole (Prilosec) Omeprazole/sodium bicarbonate (Zegerid) Pantoprazole (Protonix) Rabeprazole (Aciphex) Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Proton Pump Inhibitors (PPIs) • Common adverse effects – Headache, dizziness, somnolence, diarrhea, constipation,

Proton Pump Inhibitors (PPIs) • Common adverse effects – Headache, dizziness, somnolence, diarrhea, constipation, flatulence, abdominal pain, nausea • Serious adverse effects – Increased risk of Clostridium difficile infections – Increase risk of community-acquired pneumonia • Long-term adverse effects (> 1 year) – Hypomagnesemia – Bone fractures – Vitamin B 12 deficiency Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Proton Pump Inhibitors (PPIs) • Monitoring – Appearance of diarrhea (frequency and type of

Proton Pump Inhibitors (PPIs) • Monitoring – Appearance of diarrhea (frequency and type of diarrhea episodes) – Periodic magnesium levels (if long-term therapy) – Routine bone density studies (DXA scans) • If other risk factors for osteoporosis or bone fractures present • Patient counseling – Preferable to take a PPI 30 to 60 minutes before a meal (mainly breakfast) – If a second dose is needed, take prior to the evening meal – Onset of relief is 2 to 3 hours and the duration of relief is 12 to 24 hours Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Evaluate the Risks versus Benefits of Long-Term PPI Use • Long-term PPI use has

Evaluate the Risks versus Benefits of Long-Term PPI Use • Long-term PPI use has been associated with increased risk of: – Fractures – Infections such as C. Diff and pneumonia (expand) – Hypomagnesemia – Vitamin B 12 deficiency Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Evaluate the Risks versus Benefits of Long-Term PPI Use • Long-term PPI use MAY

Evaluate the Risks versus Benefits of Long-Term PPI Use • Long-term PPI use MAY BE associated with increased risk of: – Dementia – Renal disease – Cardiovascular disease Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

H 2 -Receptor Antagonists • MOA – Competitive inhibition of histamine at H 2

H 2 -Receptor Antagonists • MOA – Competitive inhibition of histamine at H 2 receptors of gastric parietal cells which inhibits gastric acid secretion • Agents – Cimetidine (Tagamet) – Famotidine (Pepcid) – Nizatidine (Axid) – Ranitidine (Zantac) Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

H 2 -Receptor Antagonists • Adverse effects – Headache, somnolence, fatigue, dizziness, constipation, diarrhea

H 2 -Receptor Antagonists • Adverse effects – Headache, somnolence, fatigue, dizziness, constipation, diarrhea • Monitoring – Monitor for CNS effects (rare) in those over 50 years old or in those with renal or hepatic impairment • Patient counseling – If taking once a day, it is preferable to take the dose at bedtime – Onset of relief is 30 to 45 minutes and duration of relief is 4 to 10 hours Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Misoprostol • MOA – A synthetic prostaglandin E 1 analog that replaces the protective

Misoprostol • MOA – A synthetic prostaglandin E 1 analog that replaces the protective prostaglandins that are decreased from prostaglandin inhibiting therapies such as NSAIDs • Enhances natural gastromucosal defense mechanisms and healing by increasing the production of gastric mucous and mucosal secretion of bicarbonate • Inhibits basal and nocturnal acid secretion by direct action on the parietal cells • Agent – Misoprostol (Cytotec) • Adverse effects – Diarrhea, abdominal pain, headache, nausea/vomiting, flatulence, dysmenorrhea, hypophosphatemia Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Misoprostol • Monitoring – Pregnancy test – Serum phosphate • Patient Counseling – Pregnancy

Misoprostol • Monitoring – Pregnancy test – Serum phosphate • Patient Counseling – Pregnancy category X • Is a potential abortifacient Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Bismuth Preparations • MOA – Bismuth exhibits antimicrobial activity against bacterial and viral gastrointestinal

Bismuth Preparations • MOA – Bismuth exhibits antimicrobial activity against bacterial and viral gastrointestinal pathogens • Agents – Bismuth subsalicylate (Pepto-Bismol and others) – Bismuth subcitrate potassium (bismuth salt in Pylera capsules) • Adverse effects – Fecal discoloration, tongue discoloration – Neurotoxicity (rare) Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Bismuth Preparations • Monitoring – No specific monitoring • Patient counseling – May cause

Bismuth Preparations • Monitoring – No specific monitoring • Patient counseling – May cause temporary, harmless darkening of the tongue and/or stool – Avoid bismuth subsalicylate if have an aspirin allergy Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Sucralfate • MOA – Thought to form an ulcer-adherent complex at the ulcer site

Sucralfate • MOA – Thought to form an ulcer-adherent complex at the ulcer site protecting it from further injury from stomach acid • Agent – Sucralfate (Carafate) • Adverse Effects – Constipation, bezoar formation, hyperglycemia in diabetes patients, aluminum toxicity in patients with chronic renal failure or on dialysis Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Sucralfate • Monitoring – Blood glucose in diabetes patients – Renal function in elderly

Sucralfate • Monitoring – Blood glucose in diabetes patients – Renal function in elderly patients • Patient counseling – Take on an empty stomach – Do not take antacids 30 minutes before or after taking sucralfate Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Antacids • MOA – Neutralize hydrochloric acid in the stomach, which results in an

Antacids • MOA – Neutralize hydrochloric acid in the stomach, which results in an increase in gastric p. H • Agents – Magnesium hydroxide – Aluminum hydroxide – Calcium carbonate • Adverse effects – – Diarrhea (magnesium hydroxide) Constipation (aluminum hydroxide and calcium carbonate) Alterations in mineral metabolism Acid-base disturbances Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Antacids • Monitoring – Periodic calcium and phosphate levels if on chronic antacid therapy

Antacids • Monitoring – Periodic calcium and phosphate levels if on chronic antacid therapy • Patient counseling – Antacids can decrease the levels of numerous other drugs including tetracyclines, digoxin, iron supplements, fluroquinolones, and ketoconazole. • Patients should separate antacids and other medications by at least 2 hours – Patients with renal impairment should not use aluminum or magnesium containing antacids unless directed by their physician – Onset of relief is less than 5 minutes and duration of relief is 20 to 30 minutes • Link: Table on Composition and Acid Neutralizing Capacities of Popular Antacid Preparations Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Drug Used in PUD Therapy Regimens • Link: Drug Dosing Table • Link: Drug

Drug Used in PUD Therapy Regimens • Link: Drug Dosing Table • Link: Drug Monitoring Table Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Treatment of H. pylori-Positive Ulcers • Multi-drug regimens that include antimicrobials and anti-secretory agents

Treatment of H. pylori-Positive Ulcers • Multi-drug regimens that include antimicrobials and anti-secretory agents are used to eradicate H. pylori infection • H. pylori has been developing resistance to some antibiotics, particularly clarithromycin – First-line therapies should have an eradication rate of greater than 80% – Regional bacterial resistance patterns need to be taken into account when recommending therapy – If a second course of H. pylori eradication therapy is needed, the second regimen should contain different antibiotics • H. pylori eradication regimens – – Triple Therapy Bismuth-based Quadruple Therapy Sequential Therapy Salvage Therapy Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Triple Therapy • Standard triple therapy regimen contains – Amoxicillin 1000 mg twice day

Triple Therapy • Standard triple therapy regimen contains – Amoxicillin 1000 mg twice day PLUS Clarithromycin 500 mg twice a day PLUS a PPI dosed once to twice a day – Given for 10 to 14 days • 14 day regimens are generally preferred as 14 day regimens significantly increases the eradication rate • If the patient is allergic to penicillin, then metronidazole 500 mg twice a day can be substituted for the amoxicillin Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Triple Therapy • Standard triple therapy is considered first-line in areas where the clarithromycin

Triple Therapy • Standard triple therapy is considered first-line in areas where the clarithromycin resistance rate of H. pylori is less than 20% • Adding probiotics (specifically Saccharomyces boulardii and Lactobacillus) to triple therapy has been shown to increase eradication rates and decrease adverse effects of treatment, particularly diarrhea Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Bismuth-based Quadruple Therapy • Bismuth-based quadruple-therapy contains – Tetracycline 500 mg 4 times day

Bismuth-based Quadruple Therapy • Bismuth-based quadruple-therapy contains – Tetracycline 500 mg 4 times day PLUS Metronidazole 250500 mg 4 times a day PLUS Bismuth subsalicylate 525 mg 4 times a day PLUS a PPI once or twice a day OR H 2 -receptor antagonist twice a day – Pylera is a brand name product that is a 3 in 1 capsule • Each capsule contains Tetracycline 125 mg, Metronidazole 125 mg, and Bismuth subcitrate potassium 140 mg • Dose is 3 capsules 4 times a day plus a PPI twice a day – Bismuth-based quadruple regimens are given for 10 to 14 days Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Bismuth-based Quadruple Therapy • May be used as first-line therapy in areas where the

Bismuth-based Quadruple Therapy • May be used as first-line therapy in areas where the clarithromycin resistance rate is ≥ 20% • May also be considered for first-line therapy in those with penicillin allergy or in those who have been previously treated with a macrolide antibiotic • May also be used if first-line standard triple therapy fails (e. g. as second-line therapy or salvage therapy) Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Sequential Therapy • Newer HP eradication therapy where the antibiotics are administered in a

Sequential Therapy • Newer HP eradication therapy where the antibiotics are administered in a sequence rather than at the same time • Sequential therapy contains: – A PPI twice a day for 10 days AND – Amoxicillin 1000 mg twice days 1 – 5, followed by Clarithromycin 500 mg twice day PLUS Tinidazole 500 mg OR Metronidazole 500 mg twice a days 6 – 10. – Given for 10 days total (5 days for each antibiotic regimen) Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Sequential Therapy • Adherence and tolerance rates of sequential therapy are similar to triple

Sequential Therapy • Adherence and tolerance rates of sequential therapy are similar to triple therapy but the cost is lower • The American College of Gastroenterology (ACG) Guidelines state that additional validation of sequential therapy needs to occur in North America before it is recommended as a first-line regimen Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Levofloxacin-Based Triple Therapy • Levofloxacin-based Triple Therapy contains: – Amoxicillin 1000 mg twice a

Levofloxacin-Based Triple Therapy • Levofloxacin-based Triple Therapy contains: – Amoxicillin 1000 mg twice a day PLUS Levofloxacin 500 mg once a day PLUS a PPI twice a day – Given for 10 days • This regimen is an option for salvage therapy in patients who have persistent H. pylori infection – This therapy regimen needs validation in North America Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

PPI after H. pylori Eradication Therapy Completion • When treating an active ulcer, anti-secretory

PPI after H. pylori Eradication Therapy Completion • When treating an active ulcer, anti-secretory therapy with a PPI is usually continued for 2 weeks after completing the eradication therapy regimen • Typically PPI treatment beyond 2 weeks after completion of eradication therapy is not needed for ulcer healing Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Treatment of NSAID-Induced Ulcers • Ideally, discontinue the NSAID and treat with standard healing

Treatment of NSAID-Induced Ulcers • Ideally, discontinue the NSAID and treat with standard healing regimens of a PPI, H 2 -receptor antagonist, or sucralfate – Link: Drug Dosing Table – PPIs are usually preferred because they provide the fastest symptom relief and ulcer healing Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Treatment of NSAID-Induced Ulcers • If the NSAID needs to be continued: – Consider:

Treatment of NSAID-Induced Ulcers • If the NSAID needs to be continued: – Consider: • Reducing the dose of the NSAID OR • Change NSAID to one of the following – Acetaminophen – A nonacetylated salicylate (salsalate, trisalicylate) – A partially selective COX-2 inhibitor (etodalac, nabumetone, meloxicam, diclofenac, celecoxib) – Use a PPI to treat the ulcer • When an NSAID needs to be continued, PPIs are the drugs of choice to treat and heal the ulcer Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Reducing the Risk of NSAID-Induced Ulcer and GI Complications • Strategies to reduce the

Reducing the Risk of NSAID-Induced Ulcer and GI Complications • Strategies to reduce the risk of NSAID-induced ulcers – In GI toxicity high risk patients, use either a PPI or misoprostol as co-therapy along with the NSAID – Use a selective COX-2 inhibitor instead of a nonselective NSAID • When selecting a strategy, cardiovascular risk of the patient must also be considered Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

GI and Cardiovascular Safety Issues with NSAIDs • There is no difference in cardiovascular

GI and Cardiovascular Safety Issues with NSAIDs • There is no difference in cardiovascular risk between the selective COX-2 inhibitors, the partially selective NSAIDs, and the non-selective NSAIDs with the exception of naproxen – When compared with all the other NSAIDs, naproxen has the best cardiovascular safety profile • Link: Table on Risk Factors Associated with NSAIDInduced Ulcers and Upper GI Complications Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

GI and Cardiovascular Safety Issues with NSAIDs • Guidelines for reducing GI risk for

GI and Cardiovascular Safety Issues with NSAIDs • Guidelines for reducing GI risk for patients receiving chronic NSAID therapy – Link: Table on Guidelines for Reducing GI Risk for Patients Receiving Chronic NSAID Therapy • Guidelines take both CV risk and GI toxicity risk into account when recommending a strategy to reduce the risk of developing a peptic ulcer in those who need chronic NSAID therapy Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Treatment of Non-H. pylori, Non-NSAID Ulcers • Very few patients have non-H. pylori, non-NSAID

Treatment of Non-H. pylori, Non-NSAID Ulcers • Very few patients have non-H. pylori, non-NSAID (idiopathic) peptic ulcers • If an idiopathic peptic ulcer is confirmed, treatment with standard ulcer healing therapy should be initiated – Standard H 2 -receptor antagonist or sucralfate dosage regimens heal the majority of gastric and duodenal ulcers in 6 to 8 weeks – Standard PPI dosage regimens heal the majority of gastric and duodenal ulcers in 4 weeks – Link: Drug Dosing Table Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Maintenance Therapy with Anti-Secretory Agents • Maintenance therapy (to maintain ulcer healing, prevent recurrence

Maintenance Therapy with Anti-Secretory Agents • Maintenance therapy (to maintain ulcer healing, prevent recurrence and complications) with anti-secretory agents like PPIs is only indicated in the following groups of high risk patients: – Those who have failed H. pylori eradication – Those who have a history of ulcer related complications – Those who have frequent recurrences of H. pylori-negative ulcers – Those who are heavy smokers – Those who NSAID users • Standard maintenance doses as listed in Drug Dosing Table are appropriate for most of these patients Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Treatment of Gastric Acid Hypersecretion from Zollinger-Ellison Syndrome (ZES) • PPIs are the oral

Treatment of Gastric Acid Hypersecretion from Zollinger-Ellison Syndrome (ZES) • PPIs are the oral drugs of choice for managing gastric acid hypersecretion from ZES • Treatment should be started with omeprazole 60 mg per day or an equivalent dose of another PPI – This PPI daily dose should be divided and the PPI given every 8 to 12 hours • Additional pharmacologic and non-pharmacologic treatments are instituted depending on the gastrinoma itself and any other complications that may be present Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Treatment of Refractory Ulcers • Ulcers are considered refractory to therapy when symptoms, ulcers,

Treatment of Refractory Ulcers • Ulcers are considered refractory to therapy when symptoms, ulcers, or both persist beyond 8 to 12 weeks despite conventional treatment as previously described or when several courses of H. pylori eradication therapy fail • Patient should undergo an upper endoscopy to assess the situation • Treatment depends on cause and may include additional H. pylori eradication attempts, higher PPI dosages, or surgery Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Evaluation and Management of PUD Link: Algorithm for the evaluation and management of PUD

Evaluation and Management of PUD Link: Algorithm for the evaluation and management of PUD Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

Additional Patient Counseling • Discuss with the patient the cause of the ulcer (e.

Additional Patient Counseling • Discuss with the patient the cause of the ulcer (e. g. H. pylori, NSAIDs, etc. ) • Address risk factors (e. g. NSAID use, cigarette smoking, etc. ) • Discuss the rationale behind the multi-drug regimens and the importance of adherence and sticking to the full course of therapy • Caution patient to look out for signs of GI bleeding (e. g. tarry stools, abdominal pain, vomiting with evidence of blood) Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

References • Atherton JC, Blaser MJ. Helicobacter pylori Infections. In: Kasper D, Fauci A,

References • Atherton JC, Blaser MJ. Helicobacter pylori Infections. In: Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J. eds. Harrison’s Principles of Internal Medicine, 19 e. New York, NY; Mc. Graw-Hill; 2015. • Kee Song L, Topazian M. Gastrointestinal Endoscopy. In: Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J. eds. Harrison's Principles of Internal Medicine, 19 e. New York, NY: Mc. Graw-Hill; 2015. • Del Valle J. Peptic Ulcer Disease and Related Disorders. In: Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J. eds. Harrison's Principles of Internal Medicine, 19 e. New York, NY: Mc. Graw-Hill; 2015. Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

References • Love BL, Thoma MN. Chapter 20. Peptic Ulcer Disease. In: Di. Piro

References • Love BL, Thoma MN. Chapter 20. Peptic Ulcer Disease. In: Di. Piro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 9 e. New York, NY: Mc. Graw-Hill; 2014. • Wallace JL, Sharkey KA. Pharmacotherapy of Gastric Acidity, Peptic Ulcers, and Gastroesophageal Reflux Disease. In: Brunton LL, Chabner BA, Knollmann BC. eds. Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 12 e. New York, NY: Mc. Graw-Hill; 2011. • Martin CP, Talbert RL. Section 5. Gastroenterology. In: Martin CP, Talbert RL. eds. Pharmacotherapy Bedside Guide. New York, NY: Mc. Graw-Hill; 2013. Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

References • Chey WD, Wong B, et al. American College of Gastroenterology Guideline on

References • Chey WD, Wong B, et al. American College of Gastroenterology Guideline on the Management of Helicobacter pylori Infection. Am J Gastroenterol 2007; 102: 1808 -1825. • Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut 2010; 59: 11431153. • Rimbara E, Rischbach LA, Graham DY. Optimal therapy for Helicobacter pylori infections. Nat Rev Gastroenterol Hepatol 2011; 8: 78 -88. • Chuah SK, Tsay FW, Hsu PI, Wu DC. A new look at anti. Helicobacter pylori therapy. World J Gastroenterol 2011; 17: 3971 -3975. Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved

References • Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed November 1,

References • Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed November 1, 2016. • Lexicomp Online®, Lexi-Drugs®, Hudson, Ohio: Lexi. Comp, Inc. Accessed November 1, 2016. Author: Monica L. Skomo, B. S. , Pharm. D. , BCACP, CTTS; Assoc. Prof. of Pharmacy Practice; Dir. of Assessment and Educational Strategies; Duquesne University School of Pharmacy http: //accesspharmacy. mhmedical. com/qa. aspx#tab 6 Copyright © 2017 Mc. Graw-Hill Education. All rights reserved