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Gemfibrozil treatment in patients with elevated lipoprotein a: a pilot study
A G Fereshetian1, M Davidson, H Haber
1Parke-Davis Pharmaceutical Research, Ann Arbor, Michigan, USA.
Insights
High-dose gemfibrozil did not significantly reduce lipoprotein (a) [Lp(a)] in this pilot study. However, it effectively lowered triglycerides and total cholesterol, warranting further research in coronary heart disease risk.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Elevated lipoprotein (a) [Lp(a)] is an independent risk factor for coronary heart disease (CHD).
- Gemfibrozil is a lipid-lowering medication.
Purpose of the Study:
- To investigate the efficacy of high-dose gemfibrozil (2400 mg/day) in patients with elevated Lp(a).
Main Methods:
- Pilot study with 11 patients having Lp(a) >/=45 mg/dl.
- 12-week treatment with gradually increasing gemfibrozil dosage up to 2400 mg/day.
- Assessed Lp(a), triglyceride, and total cholesterol levels.
Main Results:
- Eight patients completed the study; 3 achieved a 33% Lp(a) reduction (not statistically significant).
- Gemfibrozil significantly decreased plasma triglycerides (-62.5%) and total cholesterol (-12.4%).
- Adverse events were generally mild, with one withdrawal due to dyspepsia.
Conclusions:
- High-dose gemfibrozil did not significantly reduce Lp(a) in this pilot study.
- Gemfibrozil effectively lowered triglycerides and total cholesterol.
- Further randomized studies with larger patient numbers are warranted to confirm effectiveness.
Objective:
This pilot study investigated the efficacy of high-dose gemfibrozil (2400 mg/day) in treating patients with elevated lipoprotein (a) [Lp(a)]. Lp(a) has been shown to be an independent risk factor for the development of coronary heart disease (CHD).
Patients:
Eleven patients with serum Lp(a) >/=45 mg/dl participated in this 12-week study. Initially, all patients received oral gemfibrozil 600mg twice daily. At 4-week intervals, the dose was increased by 600mg for patients able to tolerate the increase up to a maximum of 2400 mg/day.
Results:
Eight patients completed the study. Three of these patients met the predetermined criterion of a clinically meaningful Lp(a) reduction of 33%. The mean percentage change in Lp(a) was not statistically significant with values of -18.3 +/- 15.4% (p = 0.14, 1-tailed). All patients demonstrated a significant decrease in plasma triglycerides. The mean percentage change was -62.5 +/- 1.8% (p < 0.001, 1-tailed). The mean percentage change in total cholesterol was -12.4 +/- 3.8% (p = 0.007, 1-tailed). Gemfibrozil was considered suspect in five of 16 adverse events reported, but only one of these (dyspepsia) caused withdrawal from the study. For all patients participating in the study no adverse event was characterised as severe.
Conclusion:
While the small number of patients does not allow any definitive conclusion on effectiveness to be drawn, the results suggest that further randomised studies utilising larger patient numbers appear warranted.
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