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

The effectiveness and safety of simvastatin in reducing low-density lipopro tein cholesterol (LDL-C) to target levels in patients with coronary heart d isease (CHD) were evaluated in the GOALLS (Getting to Appropriate LDL-C Lev els 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 b etween 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 patie nts were started on 20 mg simvastatin with dose titration up to 80 mg if th e LDL-C remained above 100 mg/dl at weeks 6 and 10. The key efficacy parame ters 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 labo ratory tests and recording adverse events. After 14 weeks of simvastatin (20-80 mg) treatment, approximately 90% of th e patients achieved LDL-C goals according to US(87%) and European (94%) gui delines. Most patients (72-93%) achieved target LDL-C levels on 20 Mg simva statin. An estimated 14% of the patients required titration to the 80 mg do se. Treatment with simvastatin (20-80 mg) produced statistically significan t 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 i n TG, were 28%, 41% and 16%, respectively. The increase in high-density lip oprotein cholesterol and apolipoprotein A-1 were 5% and 4%, respectively. S imvastatin 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 goal s were achieved in approximately 90% of the patients. These goals were simi larly achieved for a variety of high-risk sub-groups (hypertensives, diabet ics and elderly patients).