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Background <p>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.</p> Methods <p>This prospective, multicenter (<i>n</i> = 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.</p> Results <p>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 (<i>P</i> &lt; 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 (<i>P</i> &lt; 0.0001). Around 70% of patients achieved the target BP (&lt; 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.</p> Conclusions <p>Treatment with telmisartan and amlodipine FDC demonstrated significant antihypertensive effectiveness and was well-tolerated in the real-world among Indian patients with hypertension.</p> Graphical Abstract <p></p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月5日

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  • Ashok Kumar Das,
  • Mangesh Tiwaskar,
  • Jabir Abdullakutty,
  • Arindam Pande,
  • Viveka Kumar,
  • Febin Francis,
  • Nitin Zalte,
  • Amarnath Sugumaran,
  • Sandesh Sawant,
  • Senthilnathan Mohanasundaram

摘要

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.

Graphical Abstract