Abstract 306: China Observational Study on Efficacy and Safety of Valsartan/Amlodipine Single-Pill Combination in Treating Patients with Blood Pressure Uncontrolled by Monotherapy (China STATUS II): Interim Analysis

Abstract

BACKGROUND Single-pill combination (SPC) in hypertension treatment has been recommended in guidelines for its benefits on improving blood pressure (BP) control and reducing adverse events (AEs) by simplifying treatment. OBJECTIVE To evaluate efficacy and safety of valsartan/amlodipine SPC on BP control in Chinese hypertensive patients in a real-life practice setting. METHODS This is a multicenter, open-label, observational study in Chinese hypertensive patients. Adults (18 and older) who were not at BP goal (<140/90 mmHg for uncomplicated patients, and <130/80 mmHg for patients with diabetes and chronic kidney disease) on monotherapy were eligible to the study. Patients were treated with valsartan/amlodipine 80/5 mg SPC and were followed over 8 weeks with approximately monthly intervals between clinic visits. For patients not achieving BP goal at week 4, other antihypertensives might be added. RESULTS A total of 11,879 patients were recruited into the study. In this interim analysis (from October 12, 2010 to October 11, 2011), a total of 4,609 patients were included. Among them, 39 were excluded due to violation of inclusion criteria, 20 discontinued (9 due to AEs). In total, 4,562 were included in the analysis. Mean age was 57.6 years, 7.1% (324 of 4562) of patients aged ≥80. Overall, mean BP was reduced from 159.7/95.6 mmHg at baseline to 132.0/80.3 mmHg at week 8 (-27.7/-15.3 mmHg, P<0.0001). The magnitude of BP reduction increased by severity of baseline BP. Blood pressure goal was achieved in 67.4% (3076 of 4562) of patients. In patients aged 80 or over, 65.1% (211 of 324) achieved BP goal. Add-on antihypertensives were prescribed in 6.2% (283 of 4562) of patients with diuretics the most often used. Adverse events were reported in 2.2% (99 of 4604) of patients. Edema was reported in 12 patients (0.3%). Three patients experienced serious AEs, of which none were trial drug related. In patients aged ≥80, AEs were reported in 1.2% (4 of 327) of patients, with 2 trial drug related AEs (0.61%), 1 of hypotension and 1 of flush. CONCLUSION In this 1 st largest observational study in Chinese hypertensive patients, the interim analysis results showed that valsartan/amlodipine SPC was effective and safe on BP control in Chinese patients, as well as in patients aged 80 and over.