Visco Valeria, Finelli Rosa, Pascale Antonietta Valeria, Giannotti Rocco, Fabbricatore Davide, Ragosa Nicola, Ciccarelli Michele, Iaccarino Guido
Department of Medicine, Surgery and Dentistry, University of Salerno, Italy.
Transl Med UniSa. 2017 Jul 1;16:17-23. eCollection 2017 Jan.
The introduction of fixed combination of ACEi+CCB (Fixed) has significantly increased patients compliance and adherence to therapy. At the moment, however, there are no data suggesting the better control of once-daily fixed (Fixed) over free doses in separate administrations combination therapy in hypertensives. In a population of 39 consecutive outpatient patients referred to the departmental Hypertension clinic of the University Hospital of Salerno Medical School with the first diagnosis of arterial hypertension, we tested the hypothesis that the Fixed achieve a better control of blood pressure than the Free combination. Patients were randomized to either strategy and after 3 months patients underwent a clinical assessment to evaluate the antihypertensive effect. The two groups, matched for anthropometric and clinical parameters, received Amlodipine (5-10 mg/daily) and Perindopril (5-10 mg/daily). Perindopril and Amlodipine doses did not significantly differ between the two groups. After 3 months BP control was improved in both groups and BP targets were similarly reached in both groups (SBP; Fixed: 61.54%; Free 69.23%; n.s. DPB; Fixed: 80.77%; Free 84.62%; n.s.). The reduction in systolic blood pressure was similar in both groups (Fixed:7.64±2.49%; Free: 7.81±4.00%, n.s.), while the reduction of diastolic blood pressure was greater in the Fixed group (Fixed: 14.22±2.03%; Free: 4.92±5.00%, p<0.05). Although both strategies are effective in reducing BP, the use of Fixed dose has an advantage in the reduction of BP. The present study does not allow to identify the mechanisms of this difference, which can be assumed to be due to the pharmacokinetics of the drugs administered in once-daily fixed combination.
血管紧张素转换酶抑制剂(ACEi)与钙通道阻滞剂(CCB)的固定复方制剂(固定剂型)的引入显著提高了患者对治疗的依从性和持续性。然而,目前尚无数据表明,在高血压患者中,每日一次的固定剂型在控制血压方面优于单独给药的自由联合剂型。在萨勒诺医学院大学医院部门高血压门诊首次诊断为动脉高血压的39例连续门诊患者中,我们检验了以下假设:固定剂型在控制血压方面优于自由联合剂型。患者被随机分为两种治疗策略,3个月后对患者进行临床评估以评估降压效果。两组在人体测量和临床参数方面相匹配,均接受氨氯地平(5-10mg/日)和培哚普利(5-10mg/日)治疗。两组之间培哚普利和氨氯地平的剂量无显著差异。3个月后,两组的血压控制均得到改善,且两组均相似地达到了血压目标(收缩压;固定剂型组:61.54%;自由联合剂型组:69.23%;无统计学差异;舒张压;固定剂型组:80.77%;自由联合剂型组:84.62%;无统计学差异)。两组的收缩压降低幅度相似(固定剂型组:7.64±2.49%;自由联合剂型组:7.81±4.00%,无统计学差异),而舒张压降低幅度在固定剂型组更大(固定剂型组:14.22±2.03%;自由联合剂型组:4.92±5.00%,p<0.05)。虽然两种治疗策略在降低血压方面均有效,但使用固定剂型在降低血压方面具有优势。本研究无法确定这种差异的机制,推测可能是由于每日一次固定复方制剂中药物的药代动力学所致。