G-019 THE INFLUENCE OF BODY MASS INDEX ON BLOOD PRESSURE CONTROL AND SAFETY IN HYPERTENSIVE PATIENTS UNDER AMLODIPINE AND VALSARTAN SINGLE PILL COMBINATION

Abstract

Background The efficacy, safety and tolerability of amlodipine (aml) and valsartan (val) single pill combination (SPC) in hypertensive patients was evaluated in the post-marketing, non-interventional study. This sub-analysis aimed to evaluate influence of BMI on efficacy and safety of aml/val SPC. Methods A total of 1184 patients (62.2% female; mean ± SD age: 58 ± 11 years and 26% ≥65 years) under aml/val SPC therapy were included in study at 166 centers in Turkey. Of the patients; 1024 (87%), 862 (73%) and 659 (56%) have attended to the 1st, 2nd and 3rd follow-up visits conducted in median 30 ± 5, 90 ± 11 and 178 ± 17 days after baseline, respectively. Results Mean baseline BMI was 30.0 ± 5.6 kg/m2 and it was <25 kg/m2 in 17% (n = 198, 50% females), 25–29.99 kg/m2 in 37% (n = 436, 53% females) and ≥30 kg/m2 in 45% (n = 538, 74% females) of the patients. The msSBP/DBP (mmHg) decreased to 131.3 ± 0.5/80.5 ± 0.3 at the last visit from 166.5 ± 0.6/98.1 ± 0.4 in the entire group. Similarly, it decreased to 132.1 ± 1.4/79.7 ± 0.7 from 166.6 ± 1.4/96.0 ± 0.9, to 130.6 ± 0.8/79.6 ± 0.5 from 166.6 ± 1.0/98.4 ± 0.6 and to 131.6 ± 0.6/81.4 ± 0.4 from 166.7 ± 0.9/98.6 ± 0.9 in BMI sub-groups, respectively (p < 0.0001 for each). The control ratio (≤140/90 mmHg) was 87% in the entire and all BMI sub-groups. The respond rate at the last visit (DBP<90 mmHg or ≥10 mmHg reduction in DBP compared to baseline) was 95% in entire group whereas 95%, 96% and 94% in BMI sub-groups, respectively. During the study, 150 (13%) patients experienced 174 adverse events (AEs). The most common one was edema and its incidence rose as BMI increased (9%, 11% and 14%, respectively), but the new-onset edema incidence was 5%, 7% and 7% in BMI sub-groups, respectively; since many patients already had edema at the baseline. Conclusions In conclusion, aml/val SPC reduces BP efficaciously independent of BMI while patients with higher BMI seem to be at higher risk for edema.