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Volume 4, Supplement 4, 2004

Volume 4, Supplement 4, 2004

Table of Contents

Treatment of Gastroesophageal Reflux Disease: Defining Endpoints That Are Important to Patients
Patients with gastroesophageal reflux disease (GERD) seek treatment to obtain relief of their symptoms. Symptoms are important to patients because they interfere with activities of daily living and impair quality of life. Clinical trials in GERD have traditionally focused on the healing of erosive esophagitis, and symptom endpoints have been relegated to a secondary role. In primary care, however, patients typically are treated empirically without definition of the presence or absence of esophagitis. Patient-centered endpoints such as complete symptom resolution, patient satisfaction, and improvement in quality of life therefore provide more meaningful results in the broad population of patients with GERD, provided they are coupled with objective data on mucosal healing. This article reviews the importance of patient-centered endpoints in the assessment of the treatment of GERD and concludes that complete resolution of symptoms is the most rigorous endpoint in clinical trials and provides a meaningful endpoint for therapy in clinical practice. [Rev Gastroenterol Disord. 2004;4(suppl 4):S3-S7]
Effectiveness of Proton Pump Inhibitors: Beyond Cost
As a drug class, proton pump inhibitors are excellent pharmacologic agents for the treatment of gastroesophageal reflux disease. All 5 of the agents discussed here are exceptionally effective, so much so that cost has often superseded other outcome measures as a primary reason for the choice of agent. This article reviews other important outcome measures including control of intragastric pH, healing, symptom relief, improvement in quality of life, sleep, and increase in work productivity in an effort to “move beyond cost” in decision-making related to patient care. [Rev Gastroenterol Disord. 2004;4(suppl 4):S8-S15]
Gastroesophageal Reflux Disease in the Elderly-- A Prevalent and Severe Disease
Gastroesophageal reflux disease (GERD) is a prevalent problem that has particular implications for physicians treating geriatric patients. In elderly patients, there are multiple physiologic changes that occur and influence both the manifestations and severity of GERD. Elderly patients typically have less severe symptoms of GERD, yet they have more severe esophagitis compared to the younger patient population. Physicians treating elderly patients with GERD need to recognize that these patients require more potent and sustained acid inhibition to effectively and consistently achieve optimal clinical outcomes. [Rev Gastroenterol Disord. 2004;4(suppl 4):S16-S24]
Sleep and Gastroesophageal Reflux Disease: A Wake-Up Call
The medical community has mostly ignored the relationship between sleep and gastroesophageal reflux (GER), although recent studies have begun to explore the connection and suggest possible treatments. These studies have found that the relationship is reciprocal; reflux influences sleep and sleep influences reflux. It has been found that nighttime GER can result in a number of complications, and more generally, lower the quality of life for its sufferers, establishing sleep-related GER as a more intolerable form of GER. Though some lifestyle modifications may help reduce the risk of nighttime reflux, the use of a proton pump inhibitor may be a valuable tool in the management of both heartburn and nighttime GER. [Rev Gastroenterol Disord. 2004;4(suppl 4):S25-S32]
Proton Pump Inhibitor Co-Therapy With Nonsteroidal Anti-Inflammatory Drugs-- Nice or Necessary?
Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for their anti-inflammatory, analgesic, and anti-pyretic effects, whereas low-dose aspirin (also an NSAID) is used for cardiovascular prophylaxis. The main concern limiting use of these drugs is their gastrointestinal (GI) toxicity. GI side effects include ulcers (found at endoscopy in 15%-30% of patients using NSAIDs regularly), complications such as upper GI bleeding (annual incidence of 1.0%-1.5%), and development of upper GI symptoms such as dyspepsia (occurring in up to 60% of patients taking NSAIDs). Histamine-2 receptor antagonists are not effective at preventing NSAID-induced gastric ulcers when used at standard doses, although they can decrease upper GI symptoms. Misoprostol effectively decreases NSAID-induced ulcers and GI complications but is used infrequently in the United States—perhaps because of issues of compliance (multiple daily doses) and side effects (eg, diarrhea, dyspepsia). Once-daily proton pump inhibitor (PPI) therapy also decreases the development of NSAID-associated ulcers and recurrent NSAID-related ulcer complications; it also decreases upper GI symptoms in NSAID users. In patients using aspirin, the addition of a cyclooxygenase-2–specific inhibitor appears to significantly increase GI risk to the level of a nonselective NSAID; aspirin plus a nonselective NSAID appears to increase GI risk still higher. Patients taking low-dose aspirin who have risk factors for GI complications (including concomitant nonselective NSAID therapy) should receive medical co-therapy, such as a PPI. [Rev Gastroenterol Disord. 2004;4(suppl 4):S33-S41]