Assessment of efficacy, safety and tolerability of fixed dose combination of telmisartan 40mg and hydrochlorothiazide 12.5mg in adult Indian patients with mild to moderate hypertension.

The objective of the study was to assess the efficacy, safety and tolerability of a fixed dose combination of telmisartan 40 mg and hydrochlorothiazide 12.5 mg in adult Indian patients with mild to moderate hypertension. A prospective, multicentric, open-label, non-comparative, phase IV study was conducted. A total of 353 patients of either sex, between 18- 65 years of age with supine blood pressure (BP) levels of systolic BP (SBP) of 140-200 mmHg and diastolic BP (DBP) of 95-114 mmHg were included. After a placebo run-in period of 2 weeks, each patient received a fixed dose combination of telmisartan/hydrochlorothiazide (40mg/12.5mg) once daily, for 8 weeks. Supine BP was assessed at the end of every 2 weeks. Tolerability and safety were assessed by physical examination, laboratory parameters and evaluation of adverse events. A total of 339 patients completed the study with 14 drop-out cases because of loss to follow-up. There was a significant fall (p<0.05) in both the SBP and DBP starting from the second week as compared to the baseline. Mean SBP had a significant reduction of 23.55 mmHg (15.0%) and 27.79 mmHg (18%) at the end of 6th and 8th week respectively, compared to baseline values. Mean DBP had also had a significant reduction of 12.51 mmHg (12.6%) and 15.17 mmHg (15.3%) at the end of 6th and 8th week respectively, compared to baseline values. This combination was well tolerated with only 3.9% of the total cases reporting mild adverse events like fatigue, dizziness, nausea, diarrhoea etc. The laboratory values were within normal limits. Fixed dose combination of telmisartan/hydrochlorothiazide (40 mg/12.5 mg) once daily has a significant therapeutic effect and a good tolerability profile in adult Indian patients with mild to moderate hypertension.

Evaluation of efficacy, safety and tolerability of valdecoxib in osteo-arthritis patients--an Indian study.

Valdecoxib, a COX-2 inhibitor, has been introduced as a new treatment for osteo-arthritis (OA). The present study was conducted to evaluate the efficacy, safety and tolerability of valdecoxib, in OA patients in an Indian setting. The present 4-week study was a prospective, non-comparative, assessor blind, single group, multicentric trial with OA patients treated with valdecoxib, 10 mg once a day. Efficacy was assessed by analysing the changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analogue scale (VAS), patient's and physician's global assessment of arthritis. The incidence of adverse events was monitored throughout the study. There was a clinical and statistical significant improvement in the mean pain score, stiffness score, physical function, composite WOMAC index score and VAS (p<0.05). Patient's and physician's global evaluation of valdecoxib treatment was very good to good in 84.1% and 83.6% of cases respectively. The present study has shown that valdecoxib, in a dose of 10 mg/day given over 4 weeks, is an effective and safe treatment for the signs and symptoms of OA of hip and knee joints.