Once-daily, extended-release gemfibrozil in patients with dyslipidemia

Antonio M. Gotto, William J. Breen, Clinton N. Corder, J. Kay Dunn, Anne Goldberg, Robert H. Knopp, Helmut Schrott, Dennis Sprecher

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Abstract

This randomized, parallel-group, multicenter clinical trial compared a newly developed, once-daily, extended-release formulation of gemfibrozil (Lopid SR®) and gemfibrozil twice daily (Lopid®) in terms of lipid-regulating effects and toxicity. Patients were men and women with elevations of low-density lipoprotein cholesterol and low levels of high-density lipoprotein cholesterol. The trial consisted of a 1-week screening period, an 8-week diet baseline period (Step One Diet), and a 24-week double-blind treatment period (extended-release gemfibrozil 1,200 mg once daily vs gemfibrozil 600 mg twice daily). At the end of the trial, the 2 treatment groups showed comparable improvements in all primary lipid factors: mean percent changes in triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol were -32, +10 and -10% for extended release (n = 325) and -36, +11 and -10% for twice daily (n = 330). The 90% confidence interval for the relative difference between the treatment means fell within the equivalence bounds of ±35% for all 3 factors, demonstrating equivalence of efficacy. Adverse events were reported at low rates and were similarly distributed in frequency and intensity between treatment groups; they were preponderantly mild or moderate, and gastrointestinal effects were the most frequent. The once-daily formulation of gemfibrozil may afford better control of dyslipidemia through improved compliance by patients who have this asymptomatic disease.

Original languageEnglish
Pages (from-to)1057-1063
Number of pages7
JournalThe American journal of cardiology
Volume71
Issue number12
DOIs
StatePublished - May 1 1993

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    Gotto, A. M., Breen, W. J., Corder, C. N., Dunn, J. K., Goldberg, A., Knopp, R. H., Schrott, H., & Sprecher, D. (1993). Once-daily, extended-release gemfibrozil in patients with dyslipidemia. The American journal of cardiology, 71(12), 1057-1063. https://doi.org/10.1016/0002-9149(93)90573-U