Effectiveness of Levoamlodipine Maleate for Hypertension Compared with Amlodipine Besylate: a Pragmatic Comparative Effe
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ORIGINAL ARTICLE
Effectiveness of Levoamlodipine Maleate for Hypertension Compared with Amlodipine Besylate: a Pragmatic Comparative Effectiveness Study Wei Ma 1 & Ningling Sun 2 & Chongyang Duan 3 & Lianyou Zhao 4 & Qi Hua 5 & Yingxian Sun 6 & Aimin Dang 7 & Pingjin Gao 8 & Peng Qu 9 & Wei Cui 10 & Luosha Zhao 11 & Yugang Dong 12 & Lianqun Cui 13 & Xiaoyong Qi 14 & Yinong Jiang 15 & Jianhong Xie 16 & Jun Li 17 & Gang Wu 18 & Xinping Du 19 & Yong Huo 1 & Pingyan Chen 3 & for LEADER Study Group Accepted: 7 August 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Purpose Antihypertensive treatment is the most important method to reduce the risk of cardiovascular events in hypertensive patients. However, there is scant evidence of the benefits of levoamlodipine maleate for antihypertensive treatment using a headto-head comparison in the real-world. This study aims to examine the effectiveness of levoamlodipine maleate used to treat outpatients with primary hypertension compared with amlodipine besylate in a real-world setting. Methods This was a pragmatic comparative effectiveness study carried out at 110 centers across China in outpatients with primary hypertension treated with levoamlodipine maleate or amlodipine besylate, with 24 months of follow-up. The primary outcomes used for evaluating the effectiveness were composite major cardiovascular and cerebrovascular events (MACCE), adverse reactions, and cost-effectiveness. Results Among the included 10,031 patients, there were 482 MACCE, 223 (4.4%) in the levoamlodipine maleate group (n = 5018) and 259 (5.2%) in the amlodipine besylate group (n = 5013) (adjusted hazard ratio = 0.90, 95%CI: 0.75-1.08, P = 0.252). The levoamlodipine maleate group had lower overall incidences of any adverse reactions (6.0% vs. 8.4%, P < 0.001), lower extremity edema (1.1% vs. 3.0%, P < 0.001) and headache (0.7% vs. 1.1%, P = 0.045). There was a nearly 100% chance of the levoamlodipine maleate being cost-effective at a willingness to pay threshold of 150,000 Yuan per quality-adjusted life years (QALYs) gained, resulting in more QALYs (incremental QALYs: 0.00392) and cost savings (saving 2725 Yuan or 28.8% reduction in overall costs) per patient. Conclusion In conclusion, levoamlodipine maleate could reduce cost by 29% with a similar MACCE incidence rate and lower occurrence of adverse reactions (especially edema and headache) compared with amlodipine besylate. Trial Registration Clinicaltrials.gov NCT01844570 registered at May 1, 2013. Keywords Hypertension . Comparative effectiveness research . Cardiovascular events . Amlodipine besylate . Levoamlodipine maleate . Pragmatic clinical trial
Introduction Wei Ma, Ningling Sun and Chongyang Duan contributed equally to this work. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10557-020-07054-1) contains supplementary material, which is available to authorized users. * Yong Huo [email protected] * Pingyan Chen [email protected] Extended author information avail
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