Garg Megha, Manik Geetesh, Singhal Alok, Singh V K, Varshney Rohit K, Sethi Aseem
Department of Pharmacy Practice, Teerthanker Mahaveer College of Pharmacy, Teerthanker Mahaveer University, Moradabad, Uttar Pradesh, India.
Department of Cardiology, Teerthanker Mahaveer Hospital, Moradabad, Uttar Pradesh, India.
Saudi J Med Med Sci. 2020 May-Aug;8(2):87-94. doi: 10.4103/sjmms.sjmms_19_19. Epub 2020 Apr 17.
Few studies have compared the safety and efficacy of azilsartan medoxomil (AZL-M) and telmisartan in hypertensive patients, especially using ambulatory blood pressure monitoring (ABPM).
The objective of this study was to compare the efficacy and safety profile of AZL-M and telmisartan in hypertensive patients using ABPM and clinic blood pressure (BP) monitoring.
This prospective, randomized, open-label, blinded endpoint, parallel-arm study included 700 patients, aged 18-70 years, with clinic and 24-h mean ambulatory systolic BP (SBP) of 150-180 mmHg and 130-170 mmHg, respectively. They were randomized equally into two groups: Group A received AZL-M 40 mg and Group T received telmisartan 40 mg; the dose was force titrated to 80 mg after 2 weeks if the response rate was not achieved. BP (clinical and ambulatory) was measured after 12 weeks and compared with baseline measurements.
AZL-M significantly reduced the 24-h mean ambulatory SBP (Group A: 112.74 ± 7.58 mmHg; Group T: 113.96 ± 8.52 mmHg; < 0.0001) and diastolic BP (Group A: 71.39 ± 5.89 mmHg; Group T: 67.29 ± 6.79 mmHg; < 0.0001) compared with telmisartan at week 12. The clinic SBP significantly decreased in Group A at weeks 4 (-30.69± -0.33 mmHg) and 12 (-39.69± -1.09 mmHg) (for both, = 0.0001). Dose titration was done in 99 and 128 patients from Group A and Group T, respectively ( = 0.012). Headache was the most common adverse drug reaction (Group A: 21; Group T: 27) and fatigue the least.
This study found that AZL-M has greater antihypertensive efficacy than telmisartan, with comparable side effects. In addition, ABPM was shown to be a feasible method for such studies.
很少有研究比较阿齐沙坦美索米酯（AZL-M）和替米沙坦在高血压患者中的安全性和疗效，尤其是使用动态血压监测（ABPM）的研究。
本研究的目的是使用ABPM和诊所血压（BP）监测比较AZL-M和替米沙坦在高血压患者中的疗效和安全性。
这项前瞻性、随机、开放标签、盲终点、平行组研究纳入了700名年龄在18至70岁之间的患者，其诊所收缩压和24小时动态平均收缩压（SBP）分别为150至180 mmHg和130至170 mmHg。他们被平均随机分为两组：A组接受40 mg阿齐沙坦美索米酯，T组接受40 mg替米沙坦；如果未达到有效率，2周后剂量强制滴定至80 mg。12周后测量血压（诊所和动态）并与基线测量值进行比较。
在第12周时，与替米沙坦相比，阿齐沙坦美索米酯显著降低了24小时动态平均收缩压（A组：112.74±7.58 mmHg；T组：113.96±8.52 mmHg；<0.0001）和舒张压（A组：71.39±5.89 mmHg；T组：67.29±6.79 mmHg；<0.0001）。A组在第4周（-30.69±-0.33 mmHg）和第12周（-39.69±-1.09 mmHg）时诊所收缩压显著降低（两者均P = 0.0001）。A组和T组分别有99名和128名患者进行了剂量滴定（P = 0.012）。头痛是最常见的药物不良反应（A组：21例；T组：27例），疲劳是最少见的。
本研究发现，阿齐沙坦美索米酯的降压疗效优于替米沙坦，且副作用相当。此外，ABPM被证明是此类研究的一种可行方法。
