EFFICACY AND SAFETY OF FLUVASTATIN IN HYPERTENSIVE PATIENTS - AN ANALYSIS OF A CLINICAL-TRIAL DATABASE

The concurrence of hypertension and hypercholesterolemia leads to the clinical need to lower lipids in hypertensive patients. Thus, it is in teresting to evaluate the efficacy and safety of fluvastatin, a new 3- hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA)-reductase inhibitor, in such a patient population. A retrospective analysis of the clinical ef ficacy and safety of fluvastatin was based on the data from 1815 patie nts who received fluvastatin at daily doses of greater-than-or-equal-t o 20 mg compared with 783 patients taking placebo. The results showed that 332 (18.3%) of the fluvastatin-treated and 124 (15.8%) of the pla cebo-treated patients were identified as having hypertension. The perc entage change from baseline of low-density lipoprotein cholesterol (LD L-C) in hypertensive patients taking fluvastatin at doses of 20 and 40 mg/day was -20% and -26%, respectively (placebo: 1.4%), and did not d iffer from the response in non-hypertensive patients. Increases in hig h-density lipoprotein cholesterol (HDL-C) as well as decreases in trig lycerides with fluvastatin were not consistently different between hyp ertensive and non-hypertensive patients. Irrespective of the presence or absence of hypertension, confirmed (measured on two consecutive occ asions) increases > three times the upper limit of normal in aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) were obse rved in three (0.2%) and 12 (0.7%) patients, respectively. With placeb o, ALAT was increased in two patients (0.2%). The incidence of notable increases more than 10 times the upper limit of normal in creatine ki nase was similar with fluvastatin compared with placebo (0.3% in both) . The tolerability of fluvastatin, as assessed by analysis of the adve rse events, was not consistently influenced by the presence of hyperte nsion. In conclusion, the pooling of data from multiple trials, allowi ng the first exploratory assessment of fluvastatin in hypertensive pat ients, suggests that the efficacy and safety profile of this HMG-CoA-r eductase inhibitor is not affected by concomitant hypertension.