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Purpose: Recent FDA guidance regarding the use of simvastatin in combination with gemfibrozil led to the discontinuation of all fibrates in patients receiving concomitant statin therapy at PVAMC. The objective of this study was to evaluate changes in lipid levels after discontinuation of fibrates.
Methods: Electronic medical records of all patients subject to the universal fibrate discontinuation in June - July 2011 were reviewed. Patient demographics, comorbidities, and medications were extracted two years prior to discontinuation and 6 months after the discontinuation. Lipid levels were recorded from the last test prior to discontinuation and the first test within eight to twenty weeks of discontinuation. Changes in medications and lipid levels were compared before and after discontinuation using the paired t-test and the chi-square test, where appropriate.
Results: Of the 837 patients whose fibrates were discontinued, 398 have been screened to date and 348 met inclusion criteria. The majority of these patients had elevated triglycerides ( >150 mg /dL mean 248 mg/dL ), 68% had diabetes, 32% had CAD, and 11% had a stroke prior to discontinuation. Only 51% had follow-up lipid tests after discontinuation. Among these patients, there was a significant increase in triglycerides, decrease in HDL, and increase in total cholesterol (p<0.05 for all). There was no significant change in LDL or in prescribing rates for adjunctive therapies (i.e., niacin and omega-3 fatty acid preparations) after discontinuation. The proportion of the patients with TG>204mg/dL, HDL<34mg/dL, and DM increased from 18% before discontinuation to 39% afterwards.
Conclusion: Pharmacy-implemented universal discontinuation of fibrates may place patients at increased risk of cardiovascular events. Targeted patient follow-up may be needed to reassess medication therapy, particularly for patients already at high-risk.