The Safety of Appropriate Use of Over-the-Counter Proton Pump Inhibitors: An Evidence-Based Review and Delphi Consensus

Autor: Henry Cohen, David A. Johnson, Philip O. Katz, David Armstrong, Brendan Delaney, Donald O. Castell, Colin W. Howden, Radu Tutuian, Peter H. Katelaris
Rok vydání: 2017
Předmět:
medicine.medical_specialty
Delphi Technique
MEDLINE
Delphi method
GASTROESOPHAGEAL-REFLUX DISEASE
Nonprescription Drugs
Review Article
Pharmacology
Toxicology
CLOSTRIDIUM-DIFFICILE INFECTION
Risk Assessment
03 medical and health sciences
0302 clinical medicine
QUALITY-OF-LIFE
STEADY-STATE PHARMACOKINETICS
medicine
Humans
Pharmacology (medical)
030212 general & internal medicine
Pharmacology & Pharmacy
Medical prescription
Intensive care medicine
Adverse effect
CUTANEOUS LUPUS-ERYTHEMATOSUS
Science & Technology
Evidence-Based Medicine
business.industry
SPONTANEOUS BACTERIAL PERITONITIS
Heartburn
ACID-SUPPRESSIVE DRUGS
COMMUNITY-ACQUIRED PNEUMONIA
UPPER GASTROINTESTINAL MALIGNANCY
Proton Pump Inhibitors
Evidence-based medicine
Gastroesophageal Reflux
030211 gastroenterology & hepatology
Over-the-counter
1115 Pharmacology And Pharmaceutical Sciences
medicine.symptom
BONE-MINERAL DENSITY
Risk assessment
business
Life Sciences & Biomedicine
Zdroj: Drugs
ISSN: 1179-1950
Popis: The availability of over-the-counter (OTC) proton pump inhibitors (PPIs) for the short-term (2 weeks) management of frequent heartburn (≥2 days/week) has increased markedly, yet evidence-based recommendations have not been developed. A panel of nine international experts in gastroesophageal reflux disease developed consensus statements regarding the risks and benefits of OTC PPIs using a modified Delphi process. Consensus (based on ≥80% approval) was reached through multiple rounds of remote voting and a final round of live voting. To identify relevant data, the available literature was searched and summarized. Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system terminology was used to rate the quality of evidence and strength of recommendations; consensus was based on ≥2/3 agreement. After 4 rounds of review, consensus was achieved for 18 statements. Notably, the available data did not directly reflect OTC use, but instead, prescription use; therefore, extrapolations to the OTC setting were often necessary. This limitation is regrettable, but it justifies performing this exercise to provide evidence-based expert opinion on a widely used class of drugs. The panel determined that using OTC PPIs according to label instructions is unlikely to mask the symptoms of esophageal or gastric cancer or adversely impact the natural history of related precursor conditions. OTC PPIs are not expected to substantially affect micronutrient absorption or bone mineral density or cause community-acquired pneumonia, Clostridium difficile infection, or cardiovascular adverse events. However, OTC PPI use may be associated with slightly increased risks for infectious diarrhea, certain idiosyncratic reactions, and cirrhosis-related spontaneous bacterial peritonitis. The available evidence does not suggest that OTC PPI use consistent with label instructions is associated with substantial health risks. To minimize potential risks, healthcare professionals and consumers must actively participate in decision making when managing reflux-related symptoms in the self-care setting. Electronic supplementary material The online version of this article (doi:10.1007/s40265-017-0712-6) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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