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Lookup NU author(s): Andrew Brown, Dr Philip Adams
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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) less than or equal to 400 mg/dl (4.4 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 [less than or equal to 100 mg/dl (2.6 mmol/l) and less than or equal to 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).
Author(s): Garmendia F, Brown AS, Reiber I, Adams PC
Publication type: Article
Publication status: Published
Journal: Current Medical Research and Opinion
Year: 2000
Volume: 16
Issue: 3
Pages: 208-219
Print publication date: 01/01/2000
ISSN (print): 0300-7995
ISSN (electronic): 1473-4877
Publisher: Informa Healthcare
URL: http://www.ncbi.nlm.nih.gov/pubmed/11191012
PubMed id: 11191012
