Key result
Telmisartan–amlodipine lowers office SBP ~3 mmHg more than amlodipine–chlorthalidone in uncontrolled hypertension.
Why the study?
Hypertension uncontrolled on monotherapy is a common clinical challenge, and the optimal fixed-dose combination for treatment intensification remains uncertain.
Does fixed-dose telmisartan–amlodipine reduce mean seated office systolic blood pressure more than amlodipine–chlorthalidone at 12 weeks in adults with essential hypertension uncontrolled on stable monotherapy?
RCT (n=186)
Open-label (with blinded outcome assessment where feasible)
1:1 parallel-group randomization
No
Does fixed-dose telmisartan–amlodipine reduce mean seated office systolic blood pressure more than amlodipine–chlorthalidone at 12 weeks in adults with essential hypertension uncontrolled on stable monotherapy?
In adults with essential hypertension uncontrolled on monotherapy, fixed-dose telmisartan–amlodipine achieved a modestly greater reduction in systolic blood pressure at 12 weeks (−2.8 mmHg) and avoided the risk of hypokalemia compared with amlodipine–chlorthalidone.
Favors telmisartan–amlodipine for greater SBP reduction in uncontrolled hypertension; extends RCT evidence on ARB-CCB versus CCB-diuretic combinations.
Received: 12-09-2026 Revised: 19-09-2026 Accepted: 21-09-2026 Background: Hypertension uncontrolled on monotherapy represents a common clinical challenge, yet the optimal fixed-dose combination for treatment intensification remains uncertain. We compared the efficacy and safety of telmisartan–amlodipine versus amlodipine–chlorthalidone in patients with uncontrolled hypertension despite stable monotherapy. Methods: In this 12-week, randomised, open-label, parallel-group trial conducted at a tertiary care centre in India, 186 adults aged 30–70 years with uncontrolled essential hypertension on stable monotherapy were randomised 1:1 to receive fixed-dose telmisartan 40 mg–amlodipine 5 mg (n = 93) or amlodipine 5 mg–chlorthalidone 12.5 mg (n = 93) once daily. The primary outcome was change in mean seated office systolic blood pressure (SBP) from baseline to week 12, analysed using ANCOVA with baseline SBP as a covariate. Secondary outcomes included changes in diastolic blood pressure (DBP), blood pressure control rate, adherence, and adverse events. Results: Baseline characteristics were well balanced between groups. Mean SBP reduction was 25.8 mmHg with telmisartan–amlodipine and 23.0 mmHg with amlodipine–chlorthalidone (adjusted between-group difference: −2.8 mmHg; 95% CI: −5.6 to −0.1; p = 0.04). DBP reductions were similar between groups (−11.8 vs −9.6 mmHg; adjusted difference: −1.5 mmHg; 95% CI: −3.2 to 0.2; p = 0.08). Blood pressure control was achieved in 68.9% versus 62.5% of participants, respectively (p = 0.37). Hypokalemia occurred exclusively with amlodipine–chlorthalidone (6.5% vs 0%; p = 0.01); peripheral oedema was more frequent with telmisartan–amlodipine (7.5% vs 3.2%; p = 0.19). Adherence exceeded 88% in both groups. Conclusions: Both fixed-dose combinations provided substantial blood pressure reduction in patients with uncontrolled hypertension on monotherapy. Telmisartan–amlodipine conferred modestly greater systolic blood pressure reduction and a more favourable metabolic profile, supporting its preferential use for treatment intensification.
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Gupta et al. (2026) conducted an RCT in Uncontrolled essential hypertension (n=186). Telmisartan–amlodipine fixed-dose combination vs. Amlodipine 5 mg plus chlorthalidone 12.5 mg fixed-dose combination orally once daily was evaluated on Change in mean seated office systolic blood pressure (SBP) from baseline to week 12 (MD -2.8 mmHg, 95% CI -5.6 to -0.1, p=0.04). Telmisartan–amlodipine reduced 12-week seated office SBP more than amlodipine–chlorthalidone (−25.8 vs −23.0 mmHg; adjusted MD −2.8 mmHg, 95% CI −5.6 to −0.1, p=0.04) in uncontrolled hypertension.
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