STATT: A titrate-to-goal study of simvastatin in Asian patients with coronary heart disease

Background: Most published studies on the use of lipid-lowering agents to t reat hypercholesterolemia have focused on Western populations, with few dat a on Asian populations. Objective: The Simvastatin Treats Asians to Target (STATT) study used a tit rate-to-goal protocol to evaluate the efficacy and tolerability of simvasta tin 20 to 80 mg/d in the treatment of Asian patients with coronary heart di sease. Methods: This was a multicenter, open-label, uncontrolled, 14-week study in patients with coronary heart disease and serum low-density lipoprotein cho lesterol (LDL-C) levels of 115-180 mg/dL and triglyceride levels of less th an or equal to 400 mg/dL. The dose of simvastatin was titrated from 20 to 8 0 mg/d to achieve the National Cholesterol Education Program (NCEP) LDL-C t arget of less than or equal to 100 mg/dL. The primary efficacy measure was the percentage of patients achieving the NCEP target. Among secondary measu res were the percentage of patients achieving European Society of Cardiolog y/European Atherosclerosis Society/European Society of Hypertension target LDL-C levels of less than or equal to 115 mg/dL and the percentage change f rom baseline in lipid parameters. Tolerability was assessed in terms of the overall incidence of adverse experiences and the incidences of the most co mmonly reported adverse experiences. Results: The intent-to-treat analysis included 133 Asian patients (93 men, 40 women; mean age, 59.5 years), of wh om 125 completed 14 weeks of therapy. Their mean blood pressure was 130.2/7 9.4 mm Hg. Overall, 104 (78.2%) patients treated with simvastatin achieved LDL-C levels less than or equal to 100 mg/dL at week 14, and 125 (94.0%) ac hieved this target at some point during the study. Similarly, 122 (91.7%) p atients achieved an LDL-C level less than or equal to 115 mg/dL at week 14, and 130 (97.7%) achieved this target at some point during the study. Treat ment with simvastatin had favorable effects on the lipid profile, producing significant percentage changes from baseline in all parameters (P < 0.001) . Simvastatin was well tolerated across the dose range. Overall, 40 patient s (30.1%) had greater than or equal to1 clinical adverse experience. Only 1 4 (10.5%) had adverse experiences that were possibly, probably, or definite ly related to study drug; none of these experiences were considered serious . The most common adverse experiences (greater than or equal to3% incidence ) were abdominal pain (6%); chest pain (5%); dizziness (4%); and asthenia/f atigue, fibromyalgia, headache, insomnia, and upper respiratory tract infec tion (3% each). No new or unexpected adverse experiences were seen at the h igher doses. Conclusions: Simvastatin was effective and well tolerated at doses of 20, 4 0, and 80 mg/d ill Asian patients with coronary heart disease. Titration en abled the majority to achieve target LDL-C levels of less than or equal to 100 mg/dL.