Argentine multicenter evaluation of fluvastatin in the treatment of patients with hypercholesterolemia

Abstract

An open-label, multicenter, uncontrolled clinical trial was conducted to assess the efficacy and tolerability of fluvastatin, the first hydroxymethylglutaryl-coenzyme A reductase synthetic inhibitor in the treatment of primary hypercholesterolemia in patients with or without coronary artery disease (CAD) risk factors. This trial was conducted in 2566 men and women 18 years of age or older who received the study medication for at least 12 weeks. Following a minimum of 4 weeks on a low-fat diet (National Cholesterol Education Program), eligible patients took one capsule of fluvastatin 20 mg/d orally, in the evening, during the first 6 weeks and 20 or 40 mg/d (1 or 2 20-mg capsules), in the evening, during the remainder of the trial. Overall, patients had the following risk factors: arterial hypertension, 65.4%; family history of CAD, 54.9%; obesity; 47.9%; nicotine addiction, 34.9%; diabetes, 18.1%; total cholesterol (TC) levels ⩾300 mg/dL, 43.2%; CAD, 17.9%; and peripheral vascular disease, 9.4%. Patients were divided into two groups depending on the initial TC levels. The first group was composed of 1451 patients with mild-to-moderate hypercholesterolemia (TC, 200 to 299 mg/dL); the second group included 1115 patients with severe hypercholesterolemia (TC, ⩾300 mg/dL). The results showed a 22.41% decrease in TC levels in the first group and a 30.94% decrease in the second group. At the end of the study, low-density lipoprotein cholesterol levels decreased by 26.15% and 32.63% in the first and second groups, respectively. High-density lipoprotein cholesterol levels increased by 8.94% in the mild-to-moderate hypercholesterolemia group and by 9.22% in the severe hypercholesterolemia group. Only 9.3% of the patients in the first group and 16.4% of the patients in the second group required an increase from 20 mg/d to 40 mg/d of fluvastatin after the first 6 weeks of treatment. Fluvastatin was well tolerated, with gastrointestinal disorders the most frequent adverse event observed (4.68%). No myopathies were reported. These study results, which are similar to those from other international trials with fluvastatin published to date, show that it is an effective and well-tolerated treatment for hypercholesterolemia.