A clinical trial for evaluating efficacy and safety of amlodipine besylate / atorvastatin calcium in treating hypertension complicated with hyperlipidemia

Objective: To evaluate the efficacy and safety of amlodipine besylate/atorvastatin calcium in the treatment of hypertension complicated with hyperlipidemia. Methods:In a multicenter,randomized doubleblind and parallel-controlled trial,the patients diagnosed as primary hypertension complicated with primary hyperlipidemia were chosed. The patients were treated by either amlodipine besylate / atorvastatin calcium or amlodipine besylate alone(control). The primary efficacy endpoint were the changes in LDL-C,systolic blood pressure,diastolic blood pressure,as well as safety indicators,at 8 weeks after treatment. Results: Totally 237 patients met the inclusion criteria. The crowd of FAS were 228 patients(117 in combination group and 111 in control group),and the safety population werre 233 patients(118 in combination group and 115 in control group). After 8-week treatment,the reduction in LDL-C,TC and TG in combination group was significantly more natable than in control group(P0.05). Both systolic and diastolic blood pressures decreased after treatment in both groups(P=0.0000, all),but the changes in blood preasures had no significant difference between two groups(P0.05). The incidence of adverse events in two groups had no significant difference. Conclusion: Amlodipine besylate / atorvastatin calcium can effectively reduce the level of LDL-C and blood pressure,and has a good tolerability.