Rana Rajiv, Singh Amarinder
Head Medical Services, Merck Limited, Shiv Sagar Estate A, Dr. Annie Besant Road, Worli, Mumbai 400418, India.
J Assoc Physicians India. 2010 Feb;58:77-83.
OBJECTIVE(S): To assess the efficacy and safety of once daily olmesartan medoxomil 20 mg in Indian patients with stage 1 essential hypertension.
METHOD(S): This was an open label, multicentre, real world observational postmarketing surveillance conducted in male and female patients (N=825), in age group of 18 to 65 yrs who had clinically diagnosed stage 1 hypertension (JNC-7 guidelines) and were prescribed olmesartan medoxomil 20 mg once daily as treatment. There were total of seven study visits, Visit-1 (day 1) and end of study visit-7 (end of week 8). Except for those patients who did not achieve the target BP levels, all the patients continued to receive olmesartan medoxomil 20 mg for 8 weeks, given once a day at 24 hourly intervals. At end of surveillance (EOS; week 8) visit-7 clinical response to treatment was determined by "responder rate" and changes in level of systolic blood pressure (SBP) and diastolic blood pressure (DBP). Responder rate criteria was defined as, SBP and DBP levels of <140 mmHg and <90 mmHg respectively, and for hypertensive patients with diabetes mellitus SBP and DBP levels of < 130 mmHg and < 80 mmHg respectively.
RESULT(S): There were significant changes in mean sitting systolic and diastolic blood pressure, the primary end point of the study. From baseline visit to the end of the surveillance visit-7 (week 8), a mean change of -18.7 (147.86 to 129.16; p < .0001; 95% CI) in sitting SBP and a mean change of -14.47 (95.99 to 81.56; p < .0001; 95% CI) in sitting DBP respectively was observed with olmesartan 20 mg once daily. The response rate at the end of study was 81.82% and 70.18% for SBP and DBP respectively, in stage 1 hypertensive patients without diabetes mellitus. It was 73.38% and 65.47% respectively for SBP and DBP in patients with diabetes. Overall efficacy of Olmesartan medoxomil 20 mg was excellent to very good in 92.5% patients, only 05 (0.6%) of patients, reported of poor efficacy. Tolerability as assessed globally was reported to be excellent to very good by 92.1% of patient, with only one patient (0.1%) reported it to be poor. The most common adverse events reported were dizziness (82.52%), headache (63%), respiratory tract infection (50.40%) and nausea (40.24%); all the AE's were mild-moderate in nature which did not require stoppage of treatment.
CONCLUSION(S): Our findings reiterated that Olmesartan medoxomil 20 mg once daily is not only effective in achieving the desired BP in a significant number of patients, it also shows excellent tolerability and hence compliance. Olmesartan is a valuable option for treatment of essential hypertension in adult Indian patients.
评估每日一次口服20毫克奥美沙坦酯对印度1期原发性高血压患者的疗效和安全性。
这是一项开放标签、多中心、真实世界的上市后观察性监测研究，研究对象为年龄在18至65岁之间、临床诊断为1期高血压（依据美国国家联合委员会第7版指南）且被处方每日一次口服20毫克奥美沙坦酯进行治疗的男性和女性患者（N = 825）。总共进行了7次研究访视，即访视1（第1天）和研究访视7结束时（第8周结束时）。除未达到目标血压水平的患者外，所有患者持续接受每日一次口服20毫克奥美沙坦酯治疗8周，给药间隔为24小时。在监测结束时（第8周）的访视7中，通过“有效率”以及收缩压（SBP）和舒张压（DBP）水平的变化来确定治疗的临床反应。有效率标准定义为，SBP和DBP水平分别<140 mmHg和<90 mmHg，对于糖尿病高血压患者，SBP和DBP水平分别<130 mmHg和<80 mmHg。
研究的主要终点，即平均坐位收缩压和舒张压有显著变化。从基线访视到监测访视7结束时（第8周），每日一次口服20毫克奥美沙坦酯后，坐位SBP平均变化为-18.7（从147.86降至129.16；p <.0001；95%置信区间），坐位DBP平均变化为-14.47（从95.99降至81.56；p <.0001；95%置信区间）。在无糖尿病的1期高血压患者中，研究结束时SBP和DBP的有效率分别为81.82%和70.18%。糖尿病患者中SBP和DBP的有效率分别为73.38%和65.47%。92.5%的患者对20毫克奥美沙坦酯的总体疗效评价为优至良，仅有5名（0.6%）患者报告疗效不佳。据全球评估，92.1%的患者报告耐受性为优至良，仅有1名患者（0.1%）报告耐受性差。报告的最常见不良事件为头晕（82.52%）、头痛（63%）、呼吸道感染（50.40%）和恶心（40.24%）；所有不良事件均为轻至中度，无需停药。
我们的研究结果重申，每日一次口服20毫克奥美沙坦酯不仅能使大量患者有效达到理想血压，还显示出极佳的耐受性及依从性。奥美沙坦是治疗成年印度原发性高血压患者的一个有价值的选择。
