Olmesartan medoxomil evaluated for safety and efficacy in Indian patients with essential hypertension: a real world observational postmarketing surveillance.

OBJECTIVE(S): To assess the efficacy and safety of once daily olmesartan medoxomil 20 mg in Indian patients with stage 1 essential hypertension.

METHOD(S): This was an open label, multicentre, real world observational postmarketing surveillance conducted in male and female patients (N=825), in age group of 18 to 65 yrs who had clinically diagnosed stage 1 hypertension (JNC-7 guidelines) and were prescribed olmesartan medoxomil 20 mg once daily as treatment. There were total of seven study visits, Visit-1 (day 1) and end of study visit-7 (end of week 8). Except for those patients who did not achieve the target BP levels, all the patients continued to receive olmesartan medoxomil 20 mg for 8 weeks, given once a day at 24 hourly intervals. At end of surveillance (EOS; week 8) visit-7 clinical response to treatment was determined by "responder rate" and changes in level of systolic blood pressure (SBP) and diastolic blood pressure (DBP). Responder rate criteria was defined as, SBP and DBP levels of <140 mmHg and <90 mmHg respectively, and for hypertensive patients with diabetes mellitus SBP and DBP levels of < 130 mmHg and < 80 mmHg respectively.

RESULT(S): There were significant changes in mean sitting systolic and diastolic blood pressure, the primary end point of the study. From baseline visit to the end of the surveillance visit-7 (week 8), a mean change of -18.7 (147.86 to 129.16; p < .0001; 95% CI) in sitting SBP and a mean change of -14.47 (95.99 to 81.56; p < .0001; 95% CI) in sitting DBP respectively was observed with olmesartan 20 mg once daily. The response rate at the end of study was 81.82% and 70.18% for SBP and DBP respectively, in stage 1 hypertensive patients without diabetes mellitus. It was 73.38% and 65.47% respectively for SBP and DBP in patients with diabetes. Overall efficacy of Olmesartan medoxomil 20 mg was excellent to very good in 92.5% patients, only 05 (0.6%) of patients, reported of poor efficacy. Tolerability as assessed globally was reported to be excellent to very good by 92.1% of patient, with only one patient (0.1%) reported it to be poor. The most common adverse events reported were dizziness (82.52%), headache (63%), respiratory tract infection (50.40%) and nausea (40.24%); all the AE's were mild-moderate in nature which did not require stoppage of treatment.

CONCLUSION(S): Our findings reiterated that Olmesartan medoxomil 20 mg once daily is not only effective in achieving the desired BP in a significant number of patients, it also shows excellent tolerability and hence compliance. Olmesartan is a valuable option for treatment of essential hypertension in adult Indian patients.