Effects and Safety of Allisartan Isoproxil Combined With Amlodipine or Indapamide in Patients With Hypertension Who Failed Allisartan Monotherapy

Abstract

Abstract Background To primarily evaluate the effects and safety of a selective angiotensin II type 1 (AT1) receptor blocker (ARB) allisartan isoproxil combined with amlodipine or indapamide in the treatment of patients with essential hypertension who failed allisartan monotherapy. Methods Patients aged 18–75 years with mild-to-moderate essential hypertension [office systolic blood pressure (SBP) 140 to <180 and/or office diastolic blood pressure (DBP) 90 to <110 mm Hg] in 44 study centers between 2016 and 2018 were recruited. Allisartan isoproxil tablet 240 mg was administered per day for 4 weeks, and continued for 8 weeks if office blood pressure (BP) achieved the target of SBP/DBP <140/90 mm Hg. The nonachievers were 1:1 randomly divided into allisartan isoproxil 240 mg + indapamide sustained-release tablet 1.5 mg, or allisartan isoproxil 240 mg + amlodipine besylate 5 mg groups for further 8 weeks of combined therapy. The BP target achieving rate, reduction of sitting BP from baseline, safety and compliance were evaluated as the primary efficacy endpoint. Results A total of 2,212 patients were enrolled, among them 2,126 patients were included in the efficacy analysis, with an average age of 55.1 ± 10.2 years. A total of 1,463 cases (68.8%) were effective after 4 weeks allisartan treatment, and the mean SBP and DBP were significantly decreased by 14.7 ± 12.2 and 8.0 ± 8.4 mm Hg compared with the baseline levels (all P < 0.001). In nonachievers, allisartan combined with indapamide for 8 weeks significantly lowered the sitting BP (SBP/DBP) by 14.0 ± 12.2/8.3 ± 9.2 mm Hg, respectively, compared with 4 weeks monotherapy with allisartan with a BP targeting rate of 57.7% (169/293). In the allisartan + amlodipine group, the SBP/DBP were significantly decreased by (14.4 ± 12.1/8.2 ± 8.2) mm Hg, respectively, with a BP targeting rate of 62.8% (181/288). There was no statistical significance in BP reduction, targeting rate, or adverse reactions between the 2 combined therapies. Conclusions Allisartan isoproxil combined with indapamide or amlodipine can further improve the BP targeting rate when allisartan monotherapy failed in essential hypertension. The 2 combined therapies have similar efficacy and safety.