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.
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.
Authors: D J Moliterno; E V Jokinen; A R Miserez; R A Lange; J E Willard; E Boerwinkle; L D Hillis; H H Hobbs Journal: Arterioscler Thromb Vasc Biol Date: 1995-07 Impact factor: 8.311
Authors: P J Schreiner; G Heiss; H A Tyroler; J D Morrisett; C E Davis; R Smith Journal: Arterioscler Thromb Vasc Biol Date: 1996-03 Impact factor: 8.311