CONTROL-IHD Study: 24-h BP Control with Metoprolol-Telmisartan FDC in Hypertension and Stable Ischemic Disease.
TL;DR
The reductions observed during the early post-application and late dosing-interval periods suggest sustained BP lowering over 24 h, and may suggest sustained BP lowering over 24 h in patients with hypertension and stable IHD.
Abstract
INTRODUCTION Optimal blood pressure (BP) control is essential in ischemic heart disease (IHD) to reduce cardiovascular risk. Current guidelines recommend fixed-dose combinations (FDCs) to enhance efficacy, patient adherence, and compliance. The study aimed to evaluate the efficacy and tolerability of metoprolol succinate extended-release 25/50 mg and telmisartan 40 mg FDC (Metosartan®) in patients with essential hypertension and stable IHD, using ambulatory BP monitoring (ABPM).
Methods
This open-label, single-arm, multicentric, Phase IV study enrolled 88 patients who received Metosartan® once daily (OD) for 8 weeks. Primary endpoint was change in mean 24-h systolic and diastolic BP (SBP, DBP) on ABPM from baseline to week 8. Secondary endpoints included responder rates, changes in mean heart rate (HR), short-term BP variability (BPV), 24-h distribution of BP reduction, and safety outcomes.
Results
Seventy-two patients completed the study. The FDC significantly reduced 24-h mean ABPM-measured SBP (143.38 ± 12.55 mmHg to 129.03 ± 11.77 mmHg) and DBP (88.84 ± 8.12 mmHg to 79.34 ± 7.93 mmHg) over 8 weeks. Mean reductions were - 14.41 ± 14.69 mmHg and - 9.52 ± 9.96 mmHg, for SBP and DBP, respectively (p < 0.0001). The ABPM-based responder rate was 36.62% (26/71). HR and 24-h BP indices improved significantly. From Weeks 2-4 to Week 8, the smoothness index increased by 0.15 (SBP) and 0.11 (DBP), while the treatment on variability index increased (TOVI) by 0.20 (SBP) and 0.16 (DBP) (all p < 0.0001). Short-term BPV showed mixed findings. Treatment was well tolerated, with only mild adverse events reported.
Conclusion
Metosartan® demonstrated effective and sustained 24-h BP reduction and good tolerability in Indian patients with hypertension and stable IHD. The reductions observed during the early post-application and late dosing-interval periods suggest sustained BP lowering over 24 h. TRIAL REGISTRATION Clinical Trials Registry India, CTRI/2022/09/045464.