Epidemiology of hyperlipidemia and the efficacy of pravastatin therapy

• Published in: Current therapeutic research Vol. 54; no. 3; pp. 290 - 299
• Main Author: Steingo, L
• Format: Journal Article
• Language: English
• Published: Belle Mead, NJ EM Inc USA 1993; Excerpta medica
• Subjects: Biological and medical sciences; General and cellular metabolism. Vitamins; Medical sciences; Pharmacology. Drug treatments; Human; Enzyme; Enzyme inhibitor; Metabolic diseases; Lipids; Hyperlipoproteinemia; Cholesterol; Chemotherapy; Hypercholesterolemia; Treatment; Hydroxymethylglutaryl-CoA reductase; Hyperlipemia; Antilipemic agent
• ISSN: 0011-393X; 1879-0313
• DOI: 10.1016/S0011-393X(05)80629-0

To evaluate the effectiveness of pravastatin, a 3-hydroxy, 3-methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitor, as a cholesterol-reducing agent in typical general-practice use, data from 313 patients with primary type-II hyperlipidemia were analyzed in terms of epidemiologic factors, efficacy, and safety. Patients were to have had at least 4 weeks of diet therapy before beginning the study medication. The mean duration of therapy with pravastatin for all patients was 6 weeks. Of the 134 previously untreated patients, 67 received 10 mg of pravastatin daily and 67 received 20 mg. Patients in the 10-mg group showed mean percent changes of −23.1% in total cholesterol (TC) and −27.2% in low-density lipoprotein cholesterol (LDL-C) levels ( P < 0.0001). The corresponding changes in the 32 evaluable patients taking 20 mg of pravastatin daily were −28.1% and −34.9%, respectively ( P < 0.0001). Patients who had been previously treated with other antihyperlipidemic agents also showed significant percent reductions in the various lipid indices, albeit from lower baseline levels. The 13 evaluable patients in the 10-mg group showed reductions of −13.8% in TC and −20.3% in LDL-C, while the 36 evaluable patients taking 20-mg daily doses showed changes of −15.6% for TC and −19.3% for LDL-C ( P < 0.01). All these patients were switched directly to pravastatin with no washout period. The incidence of side effects was low, the most common being gastrointestinal disturbances. There was no significant difference in the incidence or the distribution of adverse effects between the total intent-to-treat patient population and the previously untreated patients. Dosage administered also had no significant bearing on the nature or incidence of adverse effects. Fewer than 50% of reported side effects were evaluated by the investigator as being definitely related to pravastatin therapy. We conclude that pravastatin in “real world” use yields results similar to those of the developmental studies and other HMG-CoA reductase inhibitors.