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Low-Dose Perindopril and Indapamide Combination Compared with Losartan in the Treatment of Systemic Hypertension: A Randomized, Double-Blind Study

比較低劑量複方藥物Perindopril/Indapamide與Losartan在高血壓病人治療之隨機雙盲研究

摘要


背景 比較滴劑量複方藥物Perindopril/Indapamine (P/I, 2/0.625mg)與Losartan (50mg),在治療台灣地區輕至中度高血壓病人的效果及安全性。 方法 50位輕至中度高血壓病人,經過2週的評估及非藥物控制後,隨機分配接受P/I及Losartan治療。經過8週治療後,如果在門診測量之血壓仍高於140/90毫米汞柱,則加倍劑量治療。經由分析比較兩組經治療後的反應性,正常血壓的比例,及需要加量治療的比率,以判定其效果。 結果 兩組基本資料無差異,達到正常血壓的比例在P/I組顯著的較Losartan為高(69.2% vs 41.1%)(p值<0.05)。有反應的比例也是P/I組為高(80.8% vs 54.2%)(p值<0.05)。平均坐姿收縮期及舒張期血壓下降的程度在P/I組為15.2±10.0及9.5±4.9mmHg,而Losartan組則為11.6±12.3及6.7±7.4mmHg。但無顯著意義的差別。兩組藥物使用的耐受性及生化檢查方面,皆無顯著差異。 結論 使用低劑量複方藥物P/I較Losartan在治療輕至中度高血壓病人,較為有效且一樣安全,這個結果提示低劑量複方藥物P/I適用於第一線治療輕至中度高血壓病患。

並列摘要


Background and Purpose: We compared the efficacy and safety of a low-dose combination of perindopril and indapamide (P/I, 2/0.625mg) with losartan (50mg) in Taiwanese patients with mild to moderate essential hypertension. Methods: Fifty patients with mild to moderate essential hypertension were randomized to receive either P/I or losartan once daily for a period of 12 weeks after a 2-week run-in phase. After 8 weeks treatment, if the office blood pressure (BP) was 140/9 mmHg or greater, the dose was doubled. Response and normalization rates (systolic blood pressure [SBP] less than 140mmHg and diastolic blood pressure [DBP] less than 90mmHg), extent of BP reduction, and proportion of patients necessitating increase of dose were compared both in full set and per protocol set analyses. Results: The baseline characteristics were comparable between the two patient groups. Normalization rate was significantly higher in the P/I group than in the losartan group (69.2% vs 41.7%) (p<0.05); so was the response rate (80.8% vs 54.2%) (p<0.05). Mean sitting SBP and sitting DBP fell by 15.2±10.0 and 9.5±4.7mmHg, respectively, in the P/I group (p<0.001)and by 11.6±12.3 and 6.7±7.4mmHg, respectively, in the losartan group (p<0.001). The falls were greater with P/I than those with losartan; however, these differences did not reach statistical significance. Both treatments were well tolerated, and laboratory examinations did not show any significant difference between two groups. Conclusions: A low-dose combination of P/I is more effective than losartan in the treatment of mild to moderate essential hypertension, with similar safety profiles. The results suggest that low-dose combination of P/I can be considered as an alternative for the first-line antihypertensive treatment.

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