Effects Of Valsartan/Amlodipine Single Pill Combination On Hypertensive Patients With Overweight And Obesity Uncontrolled By Mono-therapy:

Objective The efficacy of the single-pill combination of valsartan/amlodipine on the hypertensive patients with overweight and obesity is unknown in China. As a sub-analysis of China observational study on efficacy and safety of valsartan/amlodipine in treating patients with hypertension uncontrolled by mono-therapy (CHINA STATUS II), we aimed to investigate the effects of valsartan/amlodipine on the hypertensive patients with overweight and obesity uncontrolled by mono-therapy according to their body size and waist circumference.Methods A total of11,422patients from238sites of29provinces across China were recruited into the study from October12,2010to February20,2012. The Full analysis set were11,289for body size analysis and11,182for waist circumference analysis. On the basis of body-mass index (BMI), we divided the full China STATUS II cohort into obese (BMI≥28, n=1448), overweight (≥24to<28, n=5140), or normal (<24, n=4701) categories. According to the waist circumference, the cohort was divided into four groups, abdominal obese (≥90cm for male, n=3215;>85cm for female, n=1883), normal (<90cm for male, n=3169;<85cm for female, n=2915).We analyzed the change of MSSBP/MSDSP and the control rate in different body size and waist circumference. And we also compared the parameters by baseline blood pressure and previous mono-therapy.Results The reduction of MSSBP/MSDBP was26.2±12.3/15.5±9.3mmHg in the arm of patients with BMI>28,27.1±12.0/15.3±9.3mmHg in overweight group and27.5±12.3/15.0±9.4mmHg in normal weight group (P>0.05). For male, the change of MSSBP/MSDBP was26.6±12.1/15.7±9.3mmHg for abdominal obese and26.9±11.7/15.7±9.1mmHg for normal (P>0.05); for female, the change of MSSBP/MSDBP was28.0±12.9/14.7±9.7mmHg for abdominal obese and27.5±12.3/14.6±9.2mmHg for normal (P>0.05). The control rate was74.0%,75.6%,76.1%and78.4%in groups of BMI≥32,≥28to<32,624to<28,<24, respectively (P=0.024). There is no significance in abdominal obesity group and normal group. In addition, the adverse event rate was1.45%and1.42%in obese and normal, respectively. In abdominal obese male and female, the adverse event rate was1.56%and1.70%.Conclusions The treatment based on valsartan/amlodipine80/5mg SPC on BP control for8weeks in Chinese hypertensive patients uncontrolled by mono-therapy was effective, the mean arterial blood pressure was decreased by27.1/15.2mmHg, and the blood control rate was about75%, it was effective in the patients with or without overweight and obesity. The blood pressure control rate of the patients with normal body weight was higher than that of the patients with overweight and obesity.