Evaluation of fixed dose combination (FDC) of telmisartan+ramipril usage in patients with micro-albuminuria and persistent hypertension: A TRIUMPH study.

ABSTRACT

Micro-albuminuria is a marker for declining kidney function and predicts increasing cardiovascular risk especially in diabetic hypertensives. Angiotensin receptor blockers and angiotensin-converting enzyme inhibitors may slow the progression of proteinuric kidney disease and thus would be valuable in these high risk patients. The present study was undertaken to assess the efficacy and tolerability of a fixed dose combination (FDC) of telmisartan and ramipril in adult Indian patients with sustained stage 2 hypertension, comorbidities and micro-albuminuria. A total 382 patients were enrolled in this multicentric, prospective open, non-comparative phase IV postmarketing surveillance study by 40 physicians in India and treated with FDC of telmisartan 40 mg+ ramipril 5 mg once daily for 12 weeks. A total 370 patients completed the study but 12 patients were lost to follow-up and considered as drop-outs. There was a significant (p<0.05) reduction in the systolic blood pressure (SBP) from 170.89 at baseline to 132. 77 mm Hg at week 12 and diastolic blood pressure (DBP) from 104.47 to 83.30 mm Hg at the end of 12 weeks therapy as well as urine albumin levels from 186.25 mg/24-hour to 62.42 mg/24-hour (66.49%) at the end of 12 weeks. Overall assessment of treatment was rated as good to excellent in 87.3% and fair in 11.4% patients. The most common adverse event reported was cough (5.2%). Results of the present study indicate that the FDC of telmisartan+ramipril brings about significant reductions in the systolic and diastolic blood pressure as well as urine albumin excretion.