Attaining United States and European guideline LDL-cholesterol levels with simvastatin in patients with coronary heart disease (the GOALLS study).
The effectiveness and safety of simvastatin in reducing low-density lipoprotein cholesterol (LDL-C) to target levels in patients with coronary heart disease (CHD) were evaluated in the GOALLS (Getting to Appropriate LDL-C Levels with Simvastatin) study. This multinational, multicentre, prospective, open-label, study consisted of a six-week diet washout period followed by a 14-week titrate-to-goal treatment period with simvastatin. One hundred and ninety-eight men and women with documented CHD and a fasting LDL-C level between 115 mg/dl (3.0 mmol/l) and 180 mg/dl (4.7 mmol/l) and triglycerides (TGs) < or = 400 mg/dl (4.5 mmol/l) were enrolled. The patients were started on 20 mg simvastatin with dose titration up to 80 mg if the LDL-C remained above 100 mg/dl at weeks 6 and 10. The key efficacy parameters were the percentage of patients achieving US and European LDL-C goals [< or = 100 mg/dl (2.6 mmol/l) and < or = 115 mg/dl (3.0 mmol/l), respectively]. Safety was evaluated by monitoring laboratory tests and recording adverse events. After 14 weeks of simvastatin (20-80 mg) treatment, approximately 90% of the patients achieved LDL-C goals according to US (87%) and European (94%) guidelines. Most patients (72-93%) achieved target LDL-C levels on 20 mg simvastatin. An estimated 14% of the patients required titration to the 80 mg dose. Treatment with simvastatin (20-80 mg) produced statistically significant improvements in all measured lipid variables by the end of the study. The mean reductions in total cholesterol and LDL-C, and the median reduction in TG, were 28%, 41% and 16%, respectively. The increase in high-density lipoprotein cholesterol and apolipoprotein A-1 were 5% and 4%, respectively. Simvastatin was well tolerated across the dosage range. In conclusion, simvastatin, 20-80 mg/day, was safe and highly effective at reducing LDL-C levels. The recommended US and European LDL-C treatment goals were achieved in approximately 90% of the patients. These goals were similarly achieved for a variety of high-risk sub-groups (hypertensives, diabetics and elderly patients).
Garmendia
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F
Universidada Nacional Mayor De San Marcos, Lima, Peru.
Brown
A S
AS
Reiber
I
I
Adams
P C
PC
D000368:Aged; D000924:Anticholesteremic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002784:Cholesterol / Q000097:blood; D008078:Cholesterol, LDL / Q000187:drug effects*; D003257:Consumer Product Safety; D003327:Coronary Disease / Q000097:blood / Q000150:complications; D005060:Europe; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D019821:Simvastatin / Q000494:pharmacology / Q000627:therapeutic use*; D014481:United States
D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; D002784:Cholesterol; D019821:Simvastatin