Efficacy and Safety of Valsartan/Amlodipine Single-Pill Combination in 11,422 Chinese Patients with Hypertension: an Observational Study

Abstract

IntroductionSingle-pill combination (SPC) therapy of two drugs is recommended by international guidelines, including the Chinese guidelines (2010), for the treatment of hypertension in high-risk patients who require marked blood pressure (BP) reductions. Real-world data on the efficacy and safety of valsartan/amlodipine (Val/Aml) SPC are scarce. The present study is the first observational study in China to evaluate the efficacy (primary endpoint) and safety of Val/Aml (80/5 mg) SPC in Chinese patients with hypertension whose BP was not adequately controlled by monotherapy in a real-world setting.MethodsThis prospective, multicenter, open-label, post-marketing observational study included 11,422 Chinese adults (≥18 years) with essential hypertension from 238 sites of 29 provinces who were prescribed once-daily Val/Aml (80/5 mg) SPC. Patients were treated for 8 weeks. The primary efficacy variable of the study included changes in mean sitting systolic BP (MSSBP) and mean diastolic BP (MSDBP) from baseline to week 8 (end point). The secondary efficacy variable of the study included BP control rate and response rate at week 4 and 8. Safety assessments included recording and measurement of all adverse events (AEs) and vital signs in the safety population.ResultsA significant reduction of 27.1 mmHg in MSSBP (159.6 vs. 132.5 mmHg; P < 0.0001) and 15.2 mmHg in MSDBP (95.6 vs. 80.4 mmHg; P < 0.0001) from baseline was observed at week 8. The BP-lowering efficacy of Val/Aml SPC was independent of age and comorbidities. BP control of <140/90 mmHg was achieved in 76.8% (n = 8,692) of the patients. The most frequently reported AEs were dizziness (0.2%), headache (0.2%), upper respiratory tract infection (0.2%), and edema (0.2%). Only three serious AEs were reported and they were not drug-related.ConclusionThis is the first evidence-based real-world data in Chinese hypertensive patients which demonstrate the efficacy and safety of Val/Aml (80/5 mg) SPC.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-014-0132-x) contains supplementary material, which is available to authorized users.

Effectiveness and safety of valsartan/amlodipine in hypertensive patients with stroke

“…[19] The present analysis of patients from the China Status II study stratified based on 3 stroke subtypes, confirmed the BP-lowering effectiveness and safety of Val/Aml 80/5 mg SPC in Chinese hypertensive patients with hemorrhagic, ischemic, or mixed stroke. The majority of patients achieved BP control, SBP response, and DBP response in all stroke subgroups at the study endpoint at week 8.…”

“…[19] The present study is a subanalysis of China Status II, evaluating the effectiveness and safety of 8-week treatment with Val/Aml SPC in hypertensive patients with stroke.…”

Effectiveness, Safety and Tolerability of Combination of Amlodipine and Valsartan in Hypertensive Patients

“…26 The present study findings of BP reductions with an amlodipine/valsartan in patients previously treated with monotherapy are also similar to those reported in another large observational study in a real-life setting and conducted in Chinese patients. 27 The results of the present study can be used in a generalized large and diverse group of patients suffering from hypertension to whom the drug is prescribed. The results of this study have demonstrated the effectiveness, safety and tolerability of amlodipine/valsartan in patients with hypertension in the general population in a real world settings.…”

Single-pill combinations for hypertension: first line treatment for all?

“…In an observational study in older urban community-dwelling Chinese subjects in Shanghai, the antihypertensive drugs used in combination most often were CCBs and ARBs, and FDCs were only used in 12.4% of the younger (65 to 80 years) and 18.2% of the very old (!80 years) subjects with hypertension 9 . The SPC of valsartan/ amlodipine (80/5 mg) was shown to be very effective in lowering BP in the CHINA STATUS II study, a large observational study in China, where the mean reduction in BP was 27.1/ 15.2 mmHg and the combination showed very good tolerability 10 .…”