title: Efficacy and safety of fluvastatin in hypertensive patients. An analysis of a clinical trial database.
abstract: The concurrence of hypertension and hypercholesterolemia leads to the clinical need to lower lipids in hypertensive patients. Thus, it is interesting 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 efficacy and safety of fluvastatin was based on the data from 1815 patients who received fluvastatin at daily doses of > or = 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 placebo-treated patients were identified as having hypertension. The percentage change from baseline of low-density lipoprotein cholesterol (LDL-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 differ from the response in non-hypertensive patients. Increases in high-density lipoprotein cholesterol (HDL-C) as well as decreases in triglycerides with fluvastatin were not consistently different between hypertensive and non-hypertensive patients. Irrespective of the presence or absence of hypertension, confirmed (measured on two consecutive occasions) increases > three times the upper limit of normal in aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) were observed in three (0.2%) and 12 (0.7%) patients, respectively. With placebo, ALAT was increased in two patients (0.2%). The incidence of notable increases more than 10 times the upper limit of normal in creatine kinase was similar with fluvastatin compared with placebo (0.3% in both).(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Department of Clinical Research and Development, Sandoz Pharma Ltd, Basel, Switzerland.
authors.forename: T K
authors.initials: TK
authors.lastname: Peters
authors.forename: M
authors.initials: M
authors.lastname: Mehra
authors.forename: E N
authors.initials: EN
authors.lastname: Muratti
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004361:Drug Tolerance / Q000502:physiology; D005229:Fatty Acids, Monounsaturated / Q000009:adverse effects / Q000592:standards* / Q000627:therapeutic use*; D005260:Female; D000077340:Fluvastatin; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D006973:Hypertension / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D007211:Indoles / Q000009:adverse effects / Q000592:standards* / Q000627:therapeutic use*; D007256:Information Systems; D008055:Lipids / Q000097:blood; D008074:Lipoproteins / Q000097:blood; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D013997:Time Factors; D014280:Triglycerides / Q000097:blood
chemical_list: D008078:Cholesterol, LDL; D005229:Fatty Acids, Monounsaturated; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007211:Indoles; D008055:Lipids; D008074:Lipoproteins; D014280:Triglycerides; D000077340:Fluvastatin; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase