Lancet meta-analysis finds some benefits for fibrates Reply

A new meta-analysis has found evidence that fibrates may have a small beneficial effect on cardiovascular outcomes. The paper by Min Jun and colleagues is published online in the Lancet.

Combining data from 18 clinical trials including over 45,000 subjects, the investigators found that fibrates resulted in a 10% relative risk reduction for major cardiovascular events and a 13% reduction for coronary events. Fibrates had no effect on stroke, cardiovascular mortality, or sudden death.

The authors wrote in their conclusion:

The magnitude of the proportional risk reduction is more modest than that achieved with other vascular preventive therapies targeting lipids, blood pressure, and coagulation, and the clinical relevance of the effect reported here will be debated. As for other drug classes, the real clinical value will depend on both the size of the proportional risk reduction and the absolute level of risk of the population treated. For high-risk populations, a proportional risk reduction of 10–15% would translate into a worthwhile absolute risk reduction and a plausible number needed to treat. The challenge will be to define this group in the clinical setting.

The meta-analysis did not contain, according to the authors, enough data to test the hypothesis proposed by the ACCORD investigators that people with both low HDL levels and high triglyceride levels were likely to achieve the greatest benefits from fibrates. The authors also noted that ACCORD was the only trial included in the meta-analysis in which statins were routinely given.

Here is the Lancet press release:

FIBRATES PREVENT CORONARY EVENTS AND COULD HAVE ROLE IN HEART PROTECTION

A major meta-analysis of fibrate drugs has shown that they reduce the risk of major cardiovascular events, mainly through prevention of coronary artery disease and the need for revascularisation events such as angioplasty or stenting. The  findings are reported in an Article Online First and in an upcoming Lancet, written by Dr Vlado Perkovic, The George Institute for International Health, University of Sydney, NSW, Australia, and colleagues.

Several clinical trials have reported inconsistent findings for the effect of fibrates on cardiovascular risk. To resolve this uncertainty, the authors undertook a systematic review and meta-analysis to investigate the effects of fibrates on major clinical outcomes. The authors searched through trials published between 1950 and March, 2010. They included prospective randomised controlled trials assessing the effects of fibrates on cardiovascular outcomes compared with placebo. Relative risk (RR) reductions were calculated using standard meta-analytic techniques. The outcomes included were major cardiovascular events, coronary events, stroke, heart failure, coronary revascularisation, all-cause mortality, cardiovascular death, non-cardiovascular death, sudden death, new onset albuminuria (excessive protein excretion in urine), and adverse events.

The final analysis included 18 trials and 45 058 participants, including 2870 major cardiovascular events, 4552 coronary events, and 3880 deaths. Fibrate therapy produced a 10% RR reduction for major cardiovascular events  and a 13% RR reduction for coronary events. However fibrate treatment had no statistically significant effect on stroke,  all-cause mortality, cardiovascular mortality, or sudden death. Fibrates reduced the risk of albuminuria progression by 14% (albuminuria is an early marker of kidney disease commonly seen in patients with cardiovascular disease).  Serious adverse events were not significantly increased by fibrates.

The authors point out that the benefit of fibrate treatment on cardiovascular disease occurs mainly through prevention of coronary artery disease and the need for revascularisation events such as angioplasty or stenting.

They conclude: “The magnitude of the proportional risk reduction is more modest than that achieved with other vascular preventive therapies targeting lipids, blood pressure, and coagulation, and the clinical relevance of the effect reported here will be debated. As for other drug classes, the real clinical value will depend on both the size of the proportional risk reduction and the absolute extent of risk of the population treated. For high-risk populations, a proportional risk reduction of 10–15% would translate into a worthwhile absolute risk reduction and a plausible number needed to treat. The challenge will be to define this group in the clinical setting.”

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