EFFECTIVENESS & TOLERABILITY OF METOPROLOL ER, TELMISARTAN & CHLORTHALIDONE FDC IN PATIENTS OF ESSENTIAL HYPERTENSION WITH STABLE CAD IN INDIA: REAL WORLD RETROSPETIVE STUDY

Objective: Efficacy and tolerability of fixed dose combination (FDC) of 25/50 mg Metoprolol extended release + 40 mg Telmisartan + 12.5 mg Chlorthalidone is demonstrated in Phase 3 trial in patients with hypertension and stable coronary artery disease (CAD). This study was planned to assess its effectiveness on blood pressure (BP; mmHg) and tolerability in real world setting. Design and method: This retrospective, multicentric study retrieved aggregated and anonymized data over 15 months from electronic medical records of 1,810 adult patients with essential hypertension [systolic blood BP (SBP) >= 140 and/or diastolic BP (DBP) >= 90] and stable CAD. Primary endpoint was mean change in BP from baseline to post-index (composite of FDC discontinuation, new therapy addition, or 24 ± 2 weeks treatment with FDC). Secondary endpoints included mean change in BP from baseline to 24 ± 2 weeks, proportion of patients achieving target BP (SBP<140 and DBP < 90) and incidence of adverse events. The study was registered on Clinical Trial Registry, India - CTRI/2023/11/060349) Results: Of 1,810 patients, 1,784 received this FDC for 24 ± 2 weeks. Mean age was 54.81±11.50 years and 58.78% were males. Mean SBP/DBP at baseline was 158.46 ± 15.96/94.23 ± 8.91. Mean changes in SBP (-30.02) and DBP (-12.10) from baseline to post-index in 1,810 patients were significant (p<0.001). In 1,784 patients, mean changes in SBP (30.04) and DBP (-12.07) were significant (p<0.001); 85% patients achieved target BP. Mean change in BP at 4/8/12 ± 2 week was also significant (p<0.001) (Figure 1). Fourteen patients had adverse events; hypotension being most common.Conclusions: In a real-world setting, FDC of Metoprolol + Telmisartan + Chlorthalidone demonstrated effectiveness in controlling blood pressure and was well tolerated in the treatment of hypertension and CAD. Significant reduction in both SBP and DBP, along with a high proportion of patients achieving the target BP, highlights the potential benefits of this FDC in managing hypertension and CAD.