Comparing the new FDC telmisartan + bisoprolol with telmisartan + metoprolol succinate ER combination therapy.

A new study evaluated the safety, efficacy, and tolerability of a recently formulated fixed-dose combination (FDC) of telmisartan 40 mg and bisoprolol 5 mg (TBP) compared to an existing FDC of telmisartan 40 mg and metoprolol succinate ER 50 mg (TMS) in patients with stage 1 and stage 2 hypertension.

This was a multicentric, double-blind, parallel-group, phase-III clinical trial that included 264 participants with stage 1 or 2 hypertension from 10 centers across India. Participants were randomized into two groups – group A received TMS, while group B received the new TBP FDC. The primary endpoint was the mean change in seated systolic blood pressure (SeSBP) and seated diastolic blood pressure (SeDBP) from baseline to week 12. The secondary endpoint was achieving SeSBP <140 mmHg and SeDBP <90 mmHg by week 12. 

Both treatment groups displayed notable reductions in blood pressure (BP) after 2 weeks, which persisted until week 12. The mean reduction in SeSBP and SeDBP from baseline to study end was numerically greater in group B (TBP) compared to group A (TMS). The difference in SeSBP reduction was statistically significant in favor of group B. By week 12, 88.28% of subjects in group B and 86.71% in group A achieved SeSBP <140 mmHg, while 89.84% in group B and 91.40% in group A achieved SeDBP <90 mmHg. AEs were mild to moderate in both groups, with no serious AEs or deaths reported. Tolerability was rated as 'excellent' by 93.75% of group B and 91.40% of group A.

The results indicated that the new FDC (TBP) demonstrated comparable efficacy, safety, and tolerability to the existing TMS combination in managing stage 1 and stage 2 hypertension. Hence, the TBP FDC could be a valuable option for optimizing hypertension treatment and improving patient outcomes.

Source: Wander GS, Ram B, Sonkar SK, et al. Indian Heart Journal. 2024 Jun 12.