Patients with dyslipidemia benefit from early gemfibrozil treatment, particularly if they have coronary heart disease (CHD) risk factors related to the metabolic syndrome, long-term follow-up data from a Finnish study indicate.
The original 5-year Helsinki Heart Study was a double-blind, placebo-controlled primary prevention trial involving 4081 dyslipidemic middle-aged men. It was designed to test the effects of gemfibrozil on CHD mortality. At the end of the trial, there was a 34% reduction in cardiac endpoints with gemfibrozil versus placebo, but no reduction in all-cause mortality.
After the trial, participants were notified of their treatment and invited to continue, or start, gemfibrozil therapy. The current study is an 18-year follow-up of 2046 patients from the original gemfibrozil (OG) group who continued with therapy, and 2035 from the original placebo (OP) group who started on the drug.
Comparing CHD, cancer, and all-cause mortality between the two groups, the team, led by Leena Tenkanen from Tampere University in Finland, calculated crude mortality rates, plotted Kaplan-Meier survival curves and estimated relative risks in a series of models.
After 13 years' follow-up, 57 patients in the OG group had died from CHD, compared with 83 in the OP group, giving a relative risk reduction for patients in the OG group of 32%. By 18 years, 99 participants in the OG group had died from CHD versus 128 in the OP group, representing a 23% relative risk reduction for those in the OG group. There were no differences recorded in all-cause or cancer mortality rates.
Interestingly, OG participants who had a body mass index and triglyceride level in the highest tertile at baseline had a 71% relative risk reduction in CHD mortality compared with their counterparts in the OP group, as well as a 33% lower relative risk of all-cause mortality, and a 36% reduced relative risk of cancer mortality.
Writing in the Archives of Internal Medicine, the team notes that participants in the OG group had a longer period of active treatment, and started this treatment at an earlier age. Seeking to explain the benefits that an early start on gemfibrozil could provide, they say: "One reasonable mechanism is drug-related prevention of the conversion of early, clinically innocent coronary lesions (fatty streaks) into clinically significant, more complex lesions.
"This conversion already starts in coronary arteries during the second decade of life and, by the end of the fourth decade, most male subjects have intermediate or advanced lesions in their coronary tree."
In an accompanying commentary, Hanna Bloomfield, from the Center for Chronic Disease Outcomes Research, writes: "Especially for those with features of the metabolic syndrome, gemfibrozil is a very reasonable and less expensive alternative to statins."
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