Telmisartan & Amlodipine FDC for BP Control in Indian Patients with Hypertension: TACT‑India Study
Introduction
Hypertension, a major global health concern is associated with substantial amount of cardiovascular morbidity and mortality. Despite serious health implications, the management of hypertension remains suboptimal. Treatment with fixed-dose combination (FDC) antihypertensives is encouraged to improve blood pressure (BP) control and to alleviate the risk of associated complications. An FDC of telmisartan-amlodipine is widely used in practice, yet large‑scale studies evaluating its safety and efficacy in the Indian population remain limited.
Aim
“The Evaluation of Effectiveness and Safety of Telmisartan and Amlodipine Fixed Dose Combination in Indian Hypertensive Patients” (TACT-India) study determined the efficacy and safety of telmisartan and amlodipine FDC in hypertensive patients in India.
Patient Profile
- Patients diagnosed with hypertension and prescribed telmisartan and amlodipine FDC (age ≥ 18 years, n=6232)
- The study participants had both systolic blood pressure (SBP) ≥ 140 mmHg and diastolic blood pressure (DBP) ≥ 90 mmHg or had uncontrolled BP while on monotherapy.
Methods
Study Design
- TACT-India was a prospective, multi-center, observational, real-world study conducted across 982 centres in India.
Treatment Strategy
- The study subjects were treated with an FDC of telmisartan 40 mg once daily + amlodipine 5 mg once daily or telmisartan 80 mg once daily + amlodipine 5 mg once daily.
Outcome
Primary Outcome
- Mean change in SBP from baseline to 8 weeks.
Safety Outcomes
- The incidence of adverse events.
Results
- The final analysis included data for 5363 patients. The mean age of the study population was 57.11 years. The mean SBP and DBP of patients were 155.12 mmHg and 104.47 mmHg, respectively.
- The mean SBP and DBP decreased significantly from baseline to 8 weeks with treatment (Fig. 1).
Fig. 1: Change in BP during the study period
- Majority of the study population (69.98%) achieved the target BP (< 140/90 mmHg).
- Five patients experienced mild, cough‑related adverse events; no serious events or deaths occurred during the study period
- The physicians’ global efficacy assessment suggested that 51.35% were extremely satisfied and 48.01% were satisfied with the treatment outcomes. The tolerability assessment revealed that 52.95% of physicians were extremely satisfied and 45.84% were satisfied, only a small proportion of physicians (0.54–0.64%) remained neutral.
Conclusion
- According to the findings of the TACT-India study, telmisartan–amlodipine FDC significantly reduced SBP and DBP over 8 weeks, with majority of the patients reaching target BP.
- The combination was effective and well‑tolerated in a large, diverse Indian hypertensive cohort, offering valuable real‑world insights and underscoring the need to optimize hypertension control strategies in routine practice.
Drugs Real World Outcomes. 2026 Jan 5 (Online ahead of print). doi: 10.1007/s40801-025-00534-6.
