THE RED-LIP STUDY - PRAVASTATIN IN PRIMARY ISOLATED HYPERCHOLESTEROLEMIA - AN OPEN, PROSPECTIVE, MULTICENTER TRIAL

The therapeutic effects of the HMG-CoA reductase inhibitor pravastatin on plasma lipids were assessed in an open, prospective, multicenter trial over a treatment period of 3 months. Of a total of 1111 patients, the overall results were calculated from 715 evaluable patients (352 men and 363 women, mean age: 56.1 +/- 11.3 years) with primary isolated hypercholesterolemia (hyperlipoproteinemia type IIa according to Fredrickson) being at high risk for cardiovascular disease according to the classification of the national cholesterol consensus, whose guidelines are distinguishing between three risk levels (low, moderate, and high, respectively) of total-cholesterol (total-c) as well as LDL-c. The treatment period was preceded by a 3-month dietary counselling phase. Treatment with pravastatin significantly reduced total-c (23.8%, p < 0.001), LDL-c (31.9%, p < 0.001) and triglyceride (16.9%, p < 0.001) levels, concomitantly those of HDL-c were significantly raised (15%, p < 0.001). Pravastatin lowered the total-c/HDL-c ratio by nearly 36% from a mean of 8.1 +/- 2.5 to a mean of 5.2 +/- 1.6. At the end 476 patients (66.6%) received the standard dosage of 10 mg/day wherease 140 patients (19.6%) were recorded to take a dose of 20 mg/day. When comparing those patients (n = 456) having maintained consistently a dose of 10 mg pravastatin per day from week 0 to week 12 with patients (n = 113) who received 20 mg/day from week 4 to 12 similar efficacy was observed in both groups (reduction of total-c: 24.5% vs. 22.2%, n.s., reduction of LDL-c: 33.0% vs. 30.0%, n.s.). At the end of the treatment period 67.2% of 122 patients with high cardiovascular risk (presence of coronary heart disease, mean total-c 311 mg/dl) could be categorized in a lower risk group according to the national recommendations when treated with 10 mg/day. Safety analysis included the complete study population. Neither liver enzymes nor creatine kinase (CK) were significantly changed after 12 weeks of pharmacological intervention. Adverse reactions were of milder degree, mainly consisting of gastrointestinal discomfort and rarely causing discontinuation of treatment (1.7%). Fourfold elevations of CK were observed in 2 patients, increases of liver enzymes (SGOT, SGPT) exceeding three times the normal range were discovered in 3 patients. In the majority of patients pravastatin effectively lowers total-c and LDL-c and markedly elevates HDL-c even in high risk patients with coronary heart disease. The observed changes of lipid profiles resulted in considerable risk reduction according to national guidelines.