Toggle Main Menu Toggle Search

Open Access padlockePrints

Attaining United States and European guideline LDL-cholesterol levels with simvastatin in patients with coronary heart disease (the GOALLS study)

Lookup NU author(s): Andrew Brown, Dr Philip Adams


Full text for this publication is not currently held within this repository. Alternative links are provided below where available.


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).

Publication metadata

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


PubMed id: 11191012