Cardiovascular outcome trial · N Engl J Med 1987
Helsinki Heart Study trial
Helsinki Heart Study: primary-prevention trial with gemfibrozil in middle-aged men with dyslipidemia. Safety of treatment, changes in risk factors, and incidence of coronary heart disease.
The bottom line
In middle-aged men with dyslipidemia, gemfibrozil raised HDL and lowered non-HDL cholesterol and significantly reduced coronary heart disease incidence over five years without affecting total mortality or cancer rates.
BenefitUS status: US-approved
At a glance
- Medicine
- 600 mg of gemfibrozil twice daily (2051 men)
- Compared with
- placebo (2030 men)
- People
- 4,081
- Who took part
- 4081 asymptomatic middle-aged men (40 to 55 years of age) with primary dyslipidemia (non-HDL cholesterol greater than or equal to 200 mg per deciliter [5.2 mmol per liter] in two consecutive pretreatment measurements)
- Design
- randomized, double-blind five-year trial
- Follow-up
- five-year trial
- Main question
- Incidence of coronary heart disease (cumulative rate of cardiac end points)
Main result
The cumulative rate of cardiac end points at five years was 27.3 per 1,000 in the gemfibrozil group and 41.4 per 1,000 in the placebo group--a reduction of 34.0 percent in the incidence of coronary heart disease (95 percent confidence interval, 8.2 to 52.6; P less than 0.02; two-tailed test).
Effect on LDL cholesterol
Gemfibrozil caused a marked increase in HDL cholesterol and persistent reductions in serum levels of total, low-density lipoprotein (LDL), and non-HDL cholesterol and triglycerides.
Other results
There was no difference between the groups in the total death rate, nor did the treatment influence the cancer rates.
Safety
There was no difference between the groups in the total death rate, nor did the treatment influence the cancer rates.
In the trial's own words
“The cumulative rate of cardiac end points at five years was 27.3 per 1,000 in the gemfibrozil group and 41.4 per 1,000 in the placebo group--a reduction of 34.0 percent in the incidence of coronary heart disease (95 percent confidence interval, 8.2 to 52.6; P less than 0.02; two-tailed test).”
Quoted from the abstract of N Engl J Med 1987, checked word for word against PubMed. PubMed 3313041 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Fibrates (fenofibrate)
Common questions
What did the Helsinki Heart Study trial find?
In middle-aged men with dyslipidemia, gemfibrozil raised HDL and lowered non-HDL cholesterol and significantly reduced coronary heart disease incidence over five years without affecting total mortality or cancer rates.
Who was in Helsinki Heart Study?
4,081 people. 4081 asymptomatic middle-aged men (40 to 55 years of age) with primary dyslipidemia (non-HDL cholesterol greater than or equal to 200 mg per deciliter [5.2 mmol per liter] in two consecutive pretreatment measurements).
What was Helsinki Heart Study's main result?
The cumulative rate of cardiac end points at five years was 27.3 per 1,000 in the gemfibrozil group and 41.4 per 1,000 in the placebo group--a reduction of 34.0 percent in the incidence of coronary heart disease (95 percent confidence interval, 8.2 to 52.6; P less than 0.02; two-tailed test).
How much did LDL cholesterol change in Helsinki Heart Study?
Gemfibrozil caused a marked increase in HDL cholesterol and persistent reductions in serum levels of total, low-density lipoprotein (LDL), and non-HDL cholesterol and triglycerides.
Related trials
- VA-HIT (1999)In men with coronary heart disease and low HDL cholesterol but not high LDL, gemfibrozil reduced the risk of major cardiovascular events despite not lowering LDL cholesterol.
- FIELD (2005)In patients with type 2 diabetes not on statins, fenofibrate did not significantly reduce coronary events but did reduce total cardiovascular events, driven by fewer nonfatal heart attacks and revascularizations, with a small increase in pancreatitis and pulmonary embolism.
- JELIS (2007)Adding EPA to statin therapy modestly reduced major coronary events, mainly non-fatal events, in hypercholesterolaemic Japanese patients, without a significant effect on sudden cardiac or coronary death.
- ACCORD Lipid (2010)Adding fenofibrate to simvastatin did not reduce cardiovascular events or death compared with simvastatin alone in high-risk patients with type 2 diabetes, so routine combination therapy is not supported.
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