We excluded patients who were already receiving statins; those who should have been receiving statins according to the Adult Treatment Panel III risk stratification27; those who were receiving drugs that are contraindicated with statins; those who had active liver disease, alcoholism, or allergy; and those who were unable to take statins. Patients who met the criteria for statin treatment were excluded from the study on the basis of established guidelines.27 Before patients were enrolled, lipid levels were measured after the patient had fasted for 12 hours. After STATCOPE began on March 4, 2010, the Food and Drug Administration (FDA) issued a warning (on June 8, 2011) against the concomitant use of amlodipine or high doses of verapamil with simvastatin.28 This announcement resulted in discontinuation of the study drug in participants from both study groups who were receiving amlodipine or high-dose verapamil (16 patients in the simvastatin group and 20 in the placebo group). The STATCOPE data and safety monitoring board subsequently recommended the exclusion of patients with diabetes, according to the medical history or a glycated hemoglobin level of more than 6.5%, which resulted in discontinuation of the study treatment in 28 participants
We excluded patients who were already receiving statins; those who should have been receiving statins according to the Adult Treatment Panel III risk stratification27; those who were receiving drugs that are contraindicated with statins; those who had active liver disease, alcoholism, or allergy; and those who were unable to take statins. Patients who met the criteria for statin treatment were excluded from the study on the basis of established guidelines.27 Before patients were enrolled, lipid levels were measured after the patient had fasted for 12 hours. After STATCOPE began on March 4, 2010, the Food and Drug Administration (FDA) issued a warning (on June 8, 2011) against the concomitant use of amlodipine or high doses of verapamil with simvastatin.28 This announcement resulted in discontinuation of the study drug in participants from both study groups who were receiving amlodipine or high-dose verapamil (16 patients in the simvastatin group and 20 in the placebo group). The STATCOPE data and safety monitoring board subsequently recommended the exclusion of patients with diabetes, according to the medical history or a glycated hemoglobin level of more than 6.5%, which resulted in discontinuation of the study treatment in 28 participants
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