Philip Katz, MD; Donald O. Castell, MD; Gary W. Falk, MD, MS; Michael Vaezi, MD, PhD, MSc

Supplement to Gastroenterology & Endoscopy News (Special Report), November 15, 2016

Summary and article link available at: http://www.gastroendonews.com/Monographs-and-Whitepapers/Article/11-16/Expert-Consensus-on-the-Benefit-to-Risk-Ratio-of-PPIs-An-Analysis-of-Recent-Observational-Studies/38575/ses=ogst

Due to concerns stemming from observational studies, a PPI roundtable summit was convened in August 2016 to review the articles and put them into context with the following conclusions:

• There is no single mechanism of action that explains the occurrence of such varied types of adverse events.
• The odds ratios reported in the majority of these observational studies were less than two, indicating association but no causality.
• The likelihood that a chronic PPI user would develop any reported serious adverse event is extremely low.

Conclusion: Patients should not take or be prescribed drugs that they do not need; this is appropriate both on the basis of safety and cost. For most patients with an indication for PPI therapy, benefits are likely to outweigh risks to a degree that meets or exceeds the benefit-to-risk calculation. The controlled evidence that PPIs are safe does not preclude a periodic recalculation of benefit-to-risk, which is appropriate in the long-term users.