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. 2026 Jan 5.
doi: 10.1007/s40801-025-00534-6. Online ahead of print.

Evaluation of Effectiveness and Safety of Telmisartan and Amlodipine Fixed-Dose Combination in Indian Patients with Hypertension: TACT-India Study

Ashok Kumar Das  1   2 , Mangesh Tiwaskar  3 , Jabir Abdullakutty  4 , Arindam Pande  5 , Viveka Kumar  6 , Febin Francis  7 , Nitin Zalte  7 , Amarnath Sugumaran  8 , Sandesh Sawant  7 , Senthilnathan Mohanasundaram  7
Affiliations

Evaluation of Effectiveness and Safety of Telmisartan and Amlodipine Fixed-Dose Combination in Indian Patients with Hypertension: TACT-India Study

Ashok Kumar Das et al. Drugs Real World Outcomes. .

Abstract

Background: Hypertension is a major global health burden associated with significant cardiovascular morbidity and mortality. Fixed-dose combinations (FDC) may improve blood pressure (BP) control and prevent associated complications. This study aimed to evaluate the effectiveness and safety of telmisartan and amlodipine FDC in Indian patients with hypertension.

Methods: This prospective, multicenter (n = 982), observational, real-world study enrolled patients aged ≥ 18 years diagnosed with hypertension and prescribed telmisartan and amlodipine FDC. The primary outcome was the mean change in systolic blood pressure (SBP) from baseline to 8 weeks. Safety was assessed on the basis of the incidence of adverse events reported by patients or observed by clinicians.

Results: Out of 8541 individuals screened, 6232 were enrolled. A significant reduction in mean SBP was observed, decreasing from 155.12 mmHg at baseline to 135.96 mmHg at week 8 (P < 0.0001). Similarly, a reduction in mean diastolic blood pressure (DBP) was seen from 104.47 mmHg at baseline to 88.45 mmHg at week 8 (P < 0.0001). Around 70% of patients achieved the target BP (< 140/90 mmHg). Within the context of the study design, the physicians' global efficacy assessment suggested that 51.35% were extremely satisfied and 48.01% were satisfied with the treatment outcomes. Similarly, the tolerability assessment indicated that 52.95% of physicians were extremely satisfied and 45.84% were satisfied, while only a small proportion (0.54-0.64%) reported neutrality.

Conclusions: Treatment with telmisartan and amlodipine FDC demonstrated significant antihypertensive effectiveness and was well-tolerated in the real-world among Indian patients with hypertension.

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Conflict of interest statement

Declarations. Conflict of Interest: Febin Francis, Nitin Zalte, Amarnath Sugumaran, Sandesh Sawant, and Senthilnathan Mohanasundaram are/were employees of Cipla Ltd. All other authors have no conflicts of interest to declare. Ethical Approval: The protocol of the study was approved by an independent ethics committee (Suraksha—Ethics Committee, Asian Institute of Medical Sciences [AIMS], Dombivli, Maharashtra, India) on 31 August 2023 prior to the commencement of the study. The study was performed in accordance with the standards of ethics outlined in the Declaration of Helsinki. Consent to Participate: Written informed consent was obtained from each participant before their enrollment. Availability of Data and Material: The data supporting the findings of this study are available from the corresponding author upon reasonable request. Code Availability: Not applicable. Consent for Publication: Not applicable. Authors’ Contributions: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work. Conceptualization: A.K.D., M.T., and J.A. Methodology: J.A., A.P., V.K., F.F., N.Z., and A.S. Formal analysis: F.F., N.Z., and S.S. Investigation: A.K.D., M.T., J.A., A.P., V. K., F.F., N.Z., and S.S. Resources: A.S., S.S., and S.M. Writing—original draft preparation: A.K.D., A.P., S.S., F.F., A.S., and S.M. Writing—review and editing: A.K.D., M.T., J.A., A.P., V.K., and S.M. Visualization: S.M. Supervision: M.T., V.K., F.F., N.Z., A.S., and S.S. Project administration: F.F. and S.M. All authors have read and agreed to the published version of the manuscript.

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