Evaluation of an intermittent six-month regimen in new pulmonary tuberculosis patients with diabetes mellitus.

BACKGROUND: The treatment of tuberculosis (TB) with category I regimen of the Revised National Tuberculosis Control Programme (RNTCP) for patients with diabetes mellitus (DM) needs evaluation. OBJECTIVE: To assess the cure and relapse rates in 3 years, among the new smear-positive TB patients with Type-2 DM (DMTB) treated with CAT-I regimen (2E3H3R3Z3/4R3H3) of RNTCP. METHODOLOGY: TB suspects attending the diabetology units and the TB research centre (TRC) Chennai, were investigated. Eligible DMTB cases were enrolled. Baseline estimation of cardiac, renal, liver function tests and glycosylated-HBA1c were undertaken. All patients received 2E3H3R3Z3/4R3H3 under supervision at TRC. Clinical and sputum (smear and culture) examinations and monitoring of diabetic status were undertaken every month up to 24 months, then once in 3 months up to 36 months. RESULTS: Of 100 patients admitted, 7 were excluded for various reasons from analysis. Of 93 patients, 87 (94%) had a favourable response at the end of treatment. Pre and post treatment mean glycosylated-HBA1c were 9.7% and 8.4% (>7% poor control). During follow-up period, 6 died and one lost to follow-up. Of the remaining, four relapsed. CONCLUSION: Category-I regimen, recommended for all the new smear-positive patients in the Indian TB programme, is effective in the treatment of DMTB patients, despite poor control of diabetes.

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

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.