Efficacy, safety and cost-effectiveness of fixed dose combination therapy in management of hypertension

Background: - Raised blood pressure is one of the major public health challenge and cardiovascular risk factor worldwide. Studies have clearly demonstrated that in 2000, nearly 972 million people in the world suffered from hypertension and it is presumed to increase to 1.56 billion by 2025. In usual practice, treatment of mild to moderate hypertension starts with single drug, though ESH-ESC guidelines recommends initiating treatment with two drugs when blood pressure is >20 mmHg above systolic targets or >10 mmHg above diastolic targets.
Material and Methods: - The study was prospective, open labeled, three armed and randomized. A total of 96 adult hypertensive patients(aged 18 to 60 years) having uncontrolled blood pressure (systolic BP ≥ 140 to 179 mmHg and/or Diastolic BP ≥ 90 to 109 mmHg) on low dose mono-therapy with either Amlodipine (5mg) or Telmisartan (40 mg) were enrolled in the study after obtaining written informed consent. In order to conduct the study approval from the Institutional Ethics Committee was obtained.
Result:- 90.32% patients from combination therapy arm (group C) achieved the target BP, unlike 59.37% cases from group B (treated by amlodipine 10 mg) and 76.66% from group A (treated by Telmisartan 80 mg) had shown this response. 40.63% patients from group B remained hypertensive even after completion of 8 weeks therapy. In our study, maximum ADRs were reported in Amlodipine monotherapy group, though the difference with other treatment groups was not significant. In term of achieving target BP, group B treatment was least effective but had minimum cost of therapy, while group A treatment was more effective than group B but had highest cost of therapy. Group C was on top in achieving target BP and cost of therapy was lower than group A, but higher than group B.
Conclusion:-In this study, fixed dose combination (Telmisartan–Amlodipine) therapy has demonstrated significantly greater BP reductions in terms of Efficacy, safety and Cost-effectiveness for both SBP and DBP compared to mono-therapy in the overall study population.