Introduction
Single-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 (80/5ย mg) SPC in Chinese patients with hypertension whose BP was not adequately controlled by monotherapy in a real-world setting.
Methods
This prospective, multicenter, open-label, post-marketing observational study included 11,422 Chinese adults (โฅ18ย years) with essential hypertension from 238 sites of 29 provinces who were prescribed once-daily Val/Aml (80/5ย mg) SPC. Patients were treated for 8ย 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.
Results
A significant reduction of 27.1ย mmHg in MSSBP (159.6 vs. 132.5ย mmHg; Pย <ย 0.0001) and 15.2ย mmHg in MSDBP (95.6 vs. 80.4ย mmHg; Pย <ย 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 <140/90ย mmHg was achieved in 76.8% (nย =ย 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.
Conclusion
This is the first evidence-based real-world data in Chinese hypertensive patients which demonstrate the efficacy and safety of Val/Aml (80/5ย mg) SPC.
Electronic supplementary material
The online version of this article (doi:10.1007/s12325-014-0132-x) contains supplementary material, which is available to authorized users.