EFFICACY AND SAFETY OF METOPROLOL+TELMISARTAN FDC IN ESSENTIAL HYPERTENSION: TREATMENT ON VARIABILITY INDEX AND SMOOTHNESS INDEX ANALYSES ASSESSED BY AMBULATORY BP MONITORING

Objective: Increased blood pressure variability (BPV) is an important risk factor for hypertensive organ damage and cardiovascular (CV) outcomes. We evaluated efficacy and safety of fixed-dose combination (FDC) of Metoprolol extended release and Telmisartan in Indian patients with essential hypertension with stable ischemic heart disease (IHD) using ambulatory BP monitoring (ABPM). The data here presents effect of study drug on BPV through treatment on variability index (TOVI) and smoothness index assessed by ABPM. Design and method: This Phase-IV, prospective, open-label, single-arm, multicenter study conducted at 7 centers across India included adult patients of both genders having uncontrolled hypertension (in-clinic SBP 140-200 and/or DBP 90-110 mmHg AND 24hr average SBP>=130 and/or DBP>=80 mmHg based on ABPM) with stable IHD. Patients received metoprolol 25 mg/50 mg + telmisartan 40 mg for 8 weeks based on the baseline heart rate and clinician’s discretion. Patients underwent 24hr ABPM at screening visit, after 2-4 weeks treatment and at 8 weeks. Results: For 88 patients (69 males, 19 females) enrolled, mean baseline 24hr SBP and DBP was 143.38 mmHg and 88.84 mmHg, respectively. The 24-hr mean SBP and DBP reduced significantly at Week 8 by -14.41 mmHg (+/-4.69) and -9.52 mmHg (+/-9.96), respectively (p<0.0001 for both). BPV assessed using TOVI was 0.749 (+/-1.03) for SBP and 0.612 (+/-0.78) at Week 2 to 4 which improved significantly to 0.950 (+/-1.03) for SBP and 0.774 (+/-0.87) for DBP at Week 8 (p<0.0001). Smoothness index at Week 2 to 4 was 0.620 (+/-0.93) for SBP and 0.532 (+/-0.77) for DBP which significantly improved to 0.765 (+/-0.78) for SBP and 0.637 (+/-0.71) for DBP at Week 8 (p<0.0001). Overall, 23.9% (21/88) patients experienced at-least one treatment-emergent adverse event (AE). All AEs were mild and not related to study drug. Conclusions: This is the first study on metoprolol+telmisartan FDC in patients with uncontrolled hypertension with stable IHD in India that demonstrated significant reduction in 24hr BP. BPV significantly reduced as measured by TOVI and smoothness index, indicating a consistent and smoother BP reduction. This could prevent CV consequence associated with uncontrolled hypertension. (Clinical Trial Registration: CTRI/2022/09/045464)