Jain S D, Biradar Sangram, Periyandavar I, Singh Sodhi Sanjeet, Anwaruddin K, Gawde Ashish, Baliga Vidyagauri, Gandewar Kailas, Desai Anish
Department of Medicine, Yerala Medical College, Mumbai, India.
Mohodevappo Rampure Medical College, Gulbarga, Karnataka, India.
Curr Ther Res Clin Exp. 2005 Nov;66(6):630-42. doi: 10.1016/j.curtheres.2005.12.007.
A new oral fixed-dose combination (FDC) of telmisartan plus ramipril is being introduced in India for the treatment of patients with stage 2 hypertension.
The aim of this study was to compare the effectiveness and tolerability of an oral FDC of telmisartan plus ramipril with those of an oral FDC of losartan plus ramipril in adult Indian patients with stage 2 hypertension.
This multicenter, prospective, randomized, double-blind, Phase III study was conducted at 5 centers in India. Indian patients aged 18 to 65 years with uncomplicated stage 2 essential hypertension (systolic/diastolic blood pressure [SBP/DBP], >160/>100 mm Hg) were enrolled. After a 2-week placebo run-in period, patients were randomly assigned to receive telmisartan 40 mg plus ramipril 5 mg (T + R) or losartan 50 mg plus ramipril 5 mg (L + R), PO (tablet) QD (before the morning meal) for 8 weeks. Supine blood pressure (BP) was measured at 0 (baseline) and 8 weeks of treatment. The primary end point was the mean reduction from baseline in BP. Responders were classified as patients who had a DBP <90 mm Hg at the end of 8 weeks of therapy. Tolerability was assessed using spontaneous reports of adverse events (AEs) during the follow-up visits and laboratory analyses performed at week 8.
A total of 289 patients were enrolled (155 men, 134 women; mean age, 50.74 years). Of these, 8 patients in the T + R group and 7 in the L + R group were lost to follow-up and considered withdrawals. At the end of week 8, the mean percentage reduction in SBP was significantly greater in the T + R group compared with that in the L + R group (24.1% vs 19.4%; P < 0.05). The mean percentage reduction in DBP was also significantly greater in the T + R group compared with that in the L + R group (17.3% vs 12.5%; P < 0.05). The response rates in the T + R and L + R groups were statistically similar (79.1% vs 68.7%). The most common AEs in the T + R and L + R groups were cough (9 [6.1%] and 11 [7.8%] patients, respectively) and headache (7 [4.7%] and 8 [5.7%] patients, respectively).
The results in this study in Indian patients with stage 2 essential hypertension suggest that the FDC of T + R controlled BP more effectively compared with the FDC of L + R over 8 weeks. The response rates were similar between the 2 groups. Both treatments were well tolerated.
一种新型的替米沙坦与雷米普利口服固定剂量复方制剂（FDC）正在印度推出，用于治疗2期高血压患者。
本研究旨在比较替米沙坦与雷米普利口服FDC和氯沙坦与雷米普利口服FDC在成年印度2期高血压患者中的有效性和耐受性。
这项多中心、前瞻性、随机、双盲III期研究在印度的5个中心进行。纳入年龄在18至65岁、无并发症的2期原发性高血压（收缩压/舒张压[SBP/DBP]，>160/>100 mmHg）的印度患者。经过2周的安慰剂导入期后，患者被随机分配接受替米沙坦40 mg加雷米普利5 mg（T + R）或氯沙坦50 mg加雷米普利5 mg（L + R），口服（片剂），每日一次（早餐前），共8周。在治疗0周（基线）和8周时测量仰卧位血压（BP）。主要终点是血压从基线的平均降低值。反应者被定义为在治疗8周结束时舒张压<90 mmHg的患者。使用随访期间不良事件（AE）的自发报告和第8周进行的实验室分析评估耐受性。
共纳入289例患者（155例男性，134例女性；平均年龄50.74岁）。其中，T + R组有8例患者和L + R组有7例患者失访并被视为退出研究。在第8周结束时，T + R组的SBP平均降低百分比显著高于L + R组（24.1%对19.4%；P < 0.05）。T + R组的DBP平均降低百分比也显著高于L + R组（17.3%对12.5%；P < 0.05）。T + R组和L + R组的反应率在统计学上相似（79.1%对68.7%）。T + R组和L + R组最常见的AE分别是咳嗽（分别为9例[6.1%]和11例[7.8%]患者）和头痛（分别为7例[4.7%]和8例[5.7%]患者）。
本研究在印度2期原发性高血压患者中的结果表明，与L + R FDC相比，T + R FDC在8周内更有效地控制血压。两组的反应率相似。两种治疗的耐受性都良好。
