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BAYESIAN META-ANALYSIS AND NET CLINICAL BENEFIT OF CLOPIDOGREL AND PROTON PUMP INHIBITORS IN ADVERSE CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
E1763 JACC March 27, 2012 Volume 59, Issue 13
Prevention BAYESIAN META-ANALYSIS AND NET CLINICAL BENEFIT OF CLOPIDOGREL AND PROTON PUMP INHIBITORS IN ADVERSE CARDIOVASCULAR AND GASTROINTESTINAL EVENTS ACC Moderated Poster Contributions McCormick Place South, Hall A Sunday, March 25, 2012, 11:00 a.m.-Noon
Session Title: Prevention: Clinical: Updates in Prevention Abstract Category: 9. Prevention: Clinical Presentation Number: 1187-418 Authors: Christopher Lang, Donald Gullickson, III, Caren Bartosz, Roshin Mathew, Rohit Arora, University of Rochester, Rochester, NY, USA, Chicago Medical School, North Chicago, IL, USA Background: Recent controversy surrounding interaction between proton pump inhibitors and clopidogrel has lead to an FDA warning advising against the simultaneous use of these medications. This warning stems from studies indicating reduced antiplatelet activity in some patients taking clopidogrel. However, the clinical impact of this interaction is unclear with regards to adverse cardiac outcomes, and reduction in bleeding events. To investigate this, we performed a Bayesian meta-analysis of adverse outcomes in patients taking PPIs and clopidogrel, and conducted a net-clinical benefit analysis. Methods: A literature search identified 6 RCTs or matched trials involving patients randomized to aspirin and clopidogrel, plus PPI or placebo. Major endpoints evaluated were MI/ACS, overall mortality, and major adverse cardiovascular events. Seven trials were found that contained either randomized or retrospective data regarding the major GI adverse outcomes of patients on aspirin and clopidogrel, randomized to PPI or placebo groups. A Bayesian meta-analysis was performed on each group, defining probabilities of benefit for the posterior probability. From this data, net clinical benefit calculations were performed and posterior probabilities were obtained. Results: Posterior probabilities for ACS/MI, mortality, and MACE did not indicate significant impact of PPI use on these endpoints, with posterior probabilities of benefit of 45%, 66%, and 53% respectively. Further, adverse GI outcomes were substantially reduced in patients taking PPIs, with a 99% probability of benefit, and a 77% probability of at least a 30% benefit. The net clinical probability of benefit is significant, with a 93% probability of benefit, and a 65% probability of at least a 30% benefit. Conclusions: Despite recent studies prompting an FDA warning regarding an interaction between clopidogrel and proton-pump inhibitors, Bayesian meta-analysis suggests little to no clinical impact of this interaction on major adverse cardiovascular events. Further, there appears to be a strong, beneficial impact of using PPIs with dual-antiplatelet therapy, with significant reductions in adverse GI complications.
Prevention BAYESIAN META-ANALYSIS AND NET CLINICAL BENEFIT OF CLOPIDOGREL AND PROTON PUMP INHIBITORS IN ADVERSE CARDIOVASCULAR AND GASTROINTESTINAL EVENTS ACC Moderated Poster Contributions McCormick Place South, Hall A Sunday, March 25, 2012, 11:00 a.m.-Noon
Session Title: Prevention: Clinical: Updates in Prevention Abstract Category: 9. Prevention: Clinical Presentation Number: 1187-418 Authors: Christopher Lang, Donald Gullickson, III, Caren Bartosz, Roshin Mathew, Rohit Arora, University of Rochester, Rochester, NY, USA, Chicago Medical School, North Chicago, IL, USA Background: Recent controversy surrounding interaction between proton pump inhibitors and clopidogrel has lead to an FDA warning advising against the simultaneous use of these medications. This warning stems from studies indicating reduced antiplatelet activity in some patients taking clopidogrel. However, the clinical impact of this interaction is unclear with regards to adverse cardiac outcomes, and reduction in bleeding events. To investigate this, we performed a Bayesian meta-analysis of adverse outcomes in patients taking PPIs and clopidogrel, and conducted a net-clinical benefit analysis. Methods: A literature search identified 6 RCTs or matched trials involving patients randomized to aspirin and clopidogrel, plus PPI or placebo. Major endpoints evaluated were MI/ACS, overall mortality, and major adverse cardiovascular events. Seven trials were found that contained either randomized or retrospective data regarding the major GI adverse outcomes of patients on aspirin and clopidogrel, randomized to PPI or placebo groups. A Bayesian meta-analysis was performed on each group, defining probabilities of benefit for the posterior probability. From this data, net clinical benefit calculations were performed and posterior probabilities were obtained. Results: Posterior probabilities for ACS/MI, mortality, and MACE did not indicate significant impact of PPI use on these endpoints, with posterior probabilities of benefit of 45%, 66%, and 53% respectively. Further, adverse GI outcomes were substantially reduced in patients taking PPIs, with a 99% probability of benefit, and a 77% probability of at least a 30% benefit. The net clinical probability of benefit is significant, with a 93% probability of benefit, and a 65% probability of at least a 30% benefit. Conclusions: Despite recent studies prompting an FDA warning regarding an interaction between clopidogrel and proton-pump inhibitors, Bayesian meta-analysis suggests little to no clinical impact of this interaction on major adverse cardiovascular events. Further, there appears to be a strong, beneficial impact of using PPIs with dual-antiplatelet therapy, with significant reductions in adverse GI complications.