輕度至中度高血壓患者接受Benidipine治療相對於Lercanidipine治療的隨機臨床試驗研究

Randomized Study of Benidipine Versus Lercanidipine Therapy in Patients with Mild to Moderate Hypertension

吳卓鍇(Cho-Kai Wu) ； 詹鼎正(Ding-Cheng Chan) ； 王岡陵(Kang-Ling Wang) ； 余文鍾(Wen-Chung Yu) ； 張皓翔(Hao-Hsiang Chang) ； 徐國基(Kou-Gi Shyu) ； 陳昱宏(Yu-Hung Chen) ； 曾炳憲(Bing-Hsiean Tzeng) ； 鄭書孟(Shu-Meng Cheng) ； 黃瑞仁(Juey-Jen Hwang)

《內科學誌》 31卷5期 (2020/10) Pp. 333-347

https://doi.org/10.6314/JIMT.202010_31(5).07

摘要

Benidipine是一種鈣離子通道阻斷劑，也是使用於高血壓患者的第一線降血壓藥。這項多中心、隨機、雙盲、雙虛擬、lercanidipine對照試驗的目的為評估178名罹患原發性高血壓的台灣患者接受4毫克benidipine的療效與安全性。經過4週治療後，benidipine組的收縮壓（SBP）平均變化值為-14.07毫米汞柱[95%CI：-17.07～-11.08]，lercanidipine組則為-11.55毫米汞柱[95%CI：-14.24～-8.86]。由於SBP平均變化值在第4週經調整後的組別差異之95%CI上限值（1.59）低於4.5毫米汞柱，根據遵循計劃書族群，benidipine的作用可算是不亞於lercanidipine。經過4週治療後，benidipine組的DBP降低值為-5.81毫米汞柱（95%CI：-7.67～-3.94），lercanidipine組則為-5.56毫米汞柱（95%CI：-7.14～-3.99）；兩組無顯著差異（p值=0.9856）。關於血壓目標（＜140/90毫米汞柱），兩組既未展現出明顯的組別差異（p=0.4087），在療效反應者的比例上亦未顯現介入治療優勢（OR=1.38，95%CI：0.64～2.95）。Benidipine組共有13名受試者、lercanidipine組共有14名受試者發生與研究藥物有關的AEs，並且符合預期產生的副作用。研究期間未發生重大不良事件或死亡案例。總結來說，經過4週高血壓治療後，4毫克benidipine的治療效果可算是不亞於10毫克lercanidipine，並且具備可接受的耐受性。

關鍵字

Benidipine ； 高血壓（Hypertension） ； Lercanidipine

並列摘要

The calcium channel blocker (CCB) benidipine is used as a first-line antihypertensive agent in hypertension. This multicenter, randomized, double-blind, double-dummy, lercanidipine-controlled trial aimed to evaluate the efficacy and safety of benidipine 4 mg in 178 patients with essential hypertension in Taiwan. After a 4-week treatment, mean change in systolic blood pressure (SBP) was -14.07 mmHg [95% confidence interval [CI]: -17.07 to -11.08] and -11.55 mmHg [95% CI: -14.24 to -8.86] in the benidipine and lercanidipine arms, respectively. Since the upper limit of the 95% CI (1.59) of the adjusted group difference in mean change of SBP at week 4 was less than 4.5 mmHg, benidipine could be considered non-inferior to lercanidipine based on the per protocol population. The diastolic BP was reduced by -5.81 mmHg (95% CI: -7.67 to -3.94) and -5.56 mmHg (95% CI: -7.14 to -3.99) in the benidipine and lercanidipine arms, respectively, after a 4-week treatment; no significant difference was noted (p = 0.9856). The BP target (＜ 140/90 mmHg) achievement showed no significant difference (p = 0.4087) or intervention advantage (odds ratio [OR] = 1.38, 95% CI: 0.64-2.95) in proportion of responders between groups. In total, 13 and 14 subjects in the benidipine and lercanidipine groups, respectively, experienced study drug-related adverse events (AEs), consistent with expected side effects. No serious AEs or deaths occurred during the study. In conclusion, benidipine 4 mg could be considered non-inferior to lercanidipine 10 mg after 4 weeks of antihypertensive treatment with an acceptable tolerability profile.