| Authors |
| Frick MH, Elo O, Haapa K. et al. |
| Title |
| Primary prevention trial with gemfibrozil in middle-aged men with dyslipidemia |
| References |
| N Engl J Med. 1987 Nov 12;317(20):1237-45. |
| Background |
| Lowering LDL cholesterol has been shown to reduce the incidence of coronary heart disease. There has not been conclusive data to suggest changes in serum HDL can affect incidence of coronary heart disease. |
| Purpose |
| To investigate the effect of gemfibrozil (an agent that can lower LDL and triglyceride and also raise HDL) on the incidence of coronary heart disease in middle aged men free of coronary symptoms. |
| Design |
- Randomized, double-blind, placebo-controlled trial
- 4081 pts aged 40-55 yrs
- LDL >5.2 mmol/L
|
| Exclusion Criteria |
- History of coronary heart disease
- History of congestive heart failure
- Any serious medical condition that would prevent study participation
|
| Follow-Up |
| Mean 60.4 months |
| Treatment Regimen |
- Gemfibrozil 600mg BID or placebo
- Follow up every 3 months after enrolment with clinical and lab assessments
|
| Results |
Primary Endpoints Gemfibrozil group had reduction in total cholesterol by (11%), LDL by (10%) and triglycerides by (43%). Gemfibrozil
n=2051
Endpoints per 1000 | Placebo
n=2030
Endpoints per 1000 | p value |
|---|
| Fatal or non-fatal MI |
|---|
| 27.3 | 41.4 | 0.02 | | Death or hospital admission for cardiac reasons |
|---|
| 57% | 56% | 1.01 (0.91-1.11) | |
| Summary |
| Modification of lipoprotein profile with gemfibrozil resulted in marked reduction in coronary heart disease events without any serious side effects and are in keeping with two previous primary prevention trials using lipid modifying agents. |