Effectiveness and tolerability of a new lipid-altering agent, gemcabene, in patients with low levels of high-density lipoprotein cholesterol☆
Section snippets
Study design
This was a randomized, double-blind, placebo-controlled, parallel group, dose-response multicenter study. The study was conducted at 11 centers in the United States and 1 center in Canada. Institutional review board approval was obtained at each center and every patient was informed of the study, freely consented to participate, and signed an informed consent document. After a 6-week, single-blind placebo, dietary lead-in period conducted according to the National Cholesterol Education Program
Baseline demographics
A total of 161 patients were randomized. Of these patients, 67 had TG levels <200 mg/dl (14 randomized to placebo and 53 to active treatment) and 94 had TG levels ≥200 mg/dl (18 randomized to placebo and 76 to active treatment). Patient characteristics were generally similar across the TG strata (Table 2), with the obvious exception of the lipid parameters (Table 3). The study was completed by 152 patients. Six withdrew due to adverse events and 3 failed to complete the study for administrative
Discussion
This study was conducted to determine the effectiveness and tolerability of a new lipid-altering compound, gemcabene, in a dose-response study, and represents the first published report of the use of gemcabene in human test subjects. The primary efficacy parameter evaluated was the percent change from baseline in serum HDL cholesterol levels, because clinical improvement in HDL cholesterol levels may further reduce coronary heart disease risk above that achieved with LDL cholesterol lowering.5
Acknowledgements
We are indebted to J. Short and B. Shaw for assistance in managing the study and to M. Pressler, J. Nawrocki, and D. Black for their valued contributions to the design, conduct, and interpretation of this trial.
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This study was supported by a grant from Pfizer Global Research and Development, Ann Arbor Laboratories, Ann Arbor, Michigan.