A randomized, double-blind, placebo-controlled, 8-week study to evaluate the efficacy and safety of once daily atorvastatin (10 mg) in patients with elevated LDL-cholesterol

Japanese Heart Journal
K Y Wang, C T Ting

Abstract

Lowering of serum cholesterol levels by pharmacologic intervention with statins reduces the incidence of cardiovascular events in subjects with and without atherosclerotic manifestations. In an 8-week, randomized, double-blind study we compared the efficacy and safety of the new compound atorvastatin for reducing LDL-cholesterol (LDL-C) with placebo in an Asian patient cohort. Patients with LDL-C between 160 mg/dl and 250 mg/dl were randomly assigned to treatment with 10 mg atorvastatin or placebo once daily for 8 weeks. At the end of weeks 4 and 8 of the randomized phase, the serum concentrations of lipid parameters as well as safety parameters were determined. Fifty-four patients (32 males and 22 females) were enrolled. Twenty-six patients were assigned to the treatment group. The primary end-point, LDL-C, was reduced by 40% and 42% after 4 and 8 weeks of treatment in the atorvastatin treated patients (p<0.001). The reductions in total cholesterol and triglycerides were up to 31% and 23%, respectively. The HDL-C levels increased up to 11% (p=0.043). There were no significant adverse events. Transient increases in CPK levels (10 times) without myalgia were identified in 1 patient. Atorvastatin, 10 mg/day produced significant r...Continue Reading

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Citations

Nov 3, 2011·Pharmacogenomics·Ping Wang
Mar 10, 2016·PloS One·Daniel Q LiAmit X Garg
Mar 12, 2015·The Cochrane Database of Systematic Reviews·Stephen P AdamsJames M Wright
Sep 22, 2017·The Cochrane Database of Systematic Reviews·Hugo A FarneStephen J Milan
Nov 13, 2002·Pharmacoepidemiology and Drug Safety
Jun 21, 2017·The Cochrane Database of Systematic Reviews·Han NiSoe Moe
Aug 16, 2016·Cardiovascular Therapeutics·Juliana C N ChanRachel Laskey
Jan 23, 2021·The Cochrane Database of Systematic Reviews·Muhammad Ismail ShawishJames M Wright
Mar 13, 2021·Clinical Pharmacology : Advances and Applications·Panisa ManasirisukKittisak Sawanyawisuth

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