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Efficacy and tolerability of fixed dose combination of metoprolol and amlodipine in Indian patients with essential hypertension

机译:美托洛尔和氨氯地平固定剂量联合治疗对印度原发性高血压患者的疗效和耐受性

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Background:This open-labeled, post-marketing study was conducted to assess the efficacy and tolerability of fixed dose combination of amlodipine and metoprolol extended release capsules in mild to moderate hypertension in adult Indian patients.Materials and Methods:Of 101 enrolled patients, 64 drug na?ve patients were treated with regimen A (amlodipine 5 mg + metoprolol 25 mg) and those with prior history of hypertension (n = 37) were treated with regimen B (amlodipine 5 mg + metoprolol 50 mg) for 8 weeks. Treatment response was assessed at week 4 and 8. Dose up titration to regimen B was carried out for those who failed to achieve the target blood pressure (BP) at week 4 in regimen A and additional antihypertensives were added to those in regimen B. Safety laboratory tests were performed at baseline and end of study.Results:Mean age (±SD) of patients was 53.36 (±11.26) years and body weight (±SD) 63.40 (10.03) kg. Ninety five patients (94.06%) were only hypertensive and 6 (5.94%) had hypertension with history of coronary artery disease; mean duration (±SD) of hypertension was 42.50 (48.07) months. At baseline, patients had a mean (±SD) systolic blood pressure (SBP) and diastolic blood pressure (DBP) of 154.98 (±7.76) mmHg and 95.55 (±5.70) mmHg respectively. There was a statistically significant (P < 0.001) reduction of 12.16% and 14.69% in SBP, 11.49% and 14.65% in DBP at week 4 and week 8 respectively, compared to baseline. Normalization of overall BP was achieved in 49.49% and 70.71% patients at week 4 and 8, respectively. Peripheral edema was reported in 2.97% (3/101) patients.Conclusion:This combination was safe, efficacious, and well-tolerated in study population.
机译:背景:这项公开标签的上市后研究旨在评估固定剂量的氨氯地平联合美托洛尔缓释胶囊在印度成年人中轻度至中度高血压中的疗效和耐受性。材料与方法:纳入101名入选患者中,有64名初次接受药物治疗的患者接受方案A(氨氯地平5 mg +美托洛尔25 mg)治疗,有高血压病史(n = 37)的患者接受方案B(氨氯地平5 mg +美托洛尔50 mg)治疗8周。在治疗的第4周和第8周评估治疗反应。对治疗A的第4周未能达到目标血压(BP)的患者进行剂量B的滴定,并向治疗B的患者添加其他降压药。安全结果:患者的平均年龄(±SD)为53.36(±11.26)岁,体重(±SD)为63.40(10.03)kg。有高血压的95名患者(94.06%)仅患有高血压,有高血压的6名患者(5.94%)有冠心病病史。高血压的平均持续时间(±SD)为42.50(48.07)个月。在基线时,患者的平均收缩压(SBP)和舒张压(DBP)分别为154.98(±7.76)mmHg和95.55(±5.70)mmHg。与基线相比,第4周和第8周,SBP分别降低12.16%和14.69%,DBP分别降低11.49%和14.69%(P <0.001),具有统计学意义(P <0.001)。在第4周和第8周,分别有49.49%和70.71%的患者实现了总BP的正常化。据报道有2.97%(3/101)的患者出现周围性水肿。结论:该组合在研究人群中安全,有效且耐受性良好。

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