A pilot study for evaluation of the efficacy and safety of telmisartan in reducing microalbuminuria in hypertensive patients with type 2 diabetes mellitus.

ABSTRACT

To evaluate efficacy and tolerability of telmisartan, an angiotensim II receptor blocker, in reducing microalbuminuria in adult Indian hypertensive patients with type 2 diabetes mellitus, a prospective, open-label, non-comparative, assessor-blind, multicentric, pilot study was conducted in 60 eligible hypertensive patients with type 2 diabetes mellitus and microalbuminuria after obtaining their informed consent. The study was approved by the respective institutional review boards. Each patient received telmisartan 40 mg initially once daily for first 4 weeks which was titrated upwards to 80 mg once daily for the next 8 weeks. Blood pressure was assessed at the end of every 2 weeks and urinary albumin excretion and creatinine clearance were measured at baseline and after 12 weeks of therapy. Safety outcome measures included monitoring of physical examination, laboratory parameters and monitoring treatment-emergent adverse events. Fifty-five patients completed the study while 5 cases were lost to follow-up. The mean age of the patients was 48.27 years. Of the total patients 63.6% were males and 46.4% were females. At baseline the mean urinary albumin excretion rate was 131.81 +/- 38.82 mg/minute. A statistically significant (p < 0.05) reduction (32.96%) in urinary albumin excretion rate occurred after 12 weeks of therapy (118.36 +/- 37.22). The mean pre-study systolic blood pressure was 165.05 +/- 15.24 mmHg which was significantly (p < 0.05) reduced to 123.72 +/- 5.88 mmHg at the end of 12 weeks. At baseline the mean diastolic blood pressure was 103.55 +/- 9.84 mmHg which was significantly (p < 0.05) reduced to 84.71 +/- 8.54 mmHg. The JNC-VII goal of blood pressure below 130/80 was achieved in 34 (61.8%)of the 55 patients at the end of 12 weeks. Both fasting and postprandial blood sugar levels were well-controlled at the end of the study. Telmisartan was well tolerated with only 9.09% of the patients reported mild and transient adverse events like fatigue, dizziness, nausea and diarrhoea. No abnormalities were detected in the laboratory parameters. The results of this pilot study indicate that telmisartan is effective, safe and well tolerated while reducing microalbuminuria in adult Indian hypertensive patients with type 2 diabetes mellitus.