Effects of oral fixed-dose combinations of telmisartan plus ramipril and losartan plus ramipril in hypertension: A multicenter, prospective, randomized, double-blind, phase iii trial in adult indian patients.

BACKGROUND

A new oral fixed-dose combination (FDC) of telmisartan plus ramipril is being introduced in India for the treatment of patients with stage 2 hypertension.

OBJECTIVE

The aim of this study was to compare the effectiveness and tolerability of an oral FDC of telmisartan plus ramipril with those of an oral FDC of losartan plus ramipril in adult Indian patients with stage 2 hypertension.

METHODS

This multicenter, prospective, randomized, double-blind, Phase III study was conducted at 5 centers in India. Indian patients aged 18 to 65 years with uncomplicated stage 2 essential hypertension (systolic/diastolic blood pressure [SBP/DBP], >160/>100 mm Hg) were enrolled. After a 2-week placebo run-in period, patients were randomly assigned to receive telmisartan 40 mg plus ramipril 5 mg (T + R) or losartan 50 mg plus ramipril 5 mg (L + R), PO (tablet) QD (before the morning meal) for 8 weeks. Supine blood pressure (BP) was measured at 0 (baseline) and 8 weeks of treatment. The primary end point was the mean reduction from baseline in BP. Responders were classified as patients who had a DBP <90 mm Hg at the end of 8 weeks of therapy. Tolerability was assessed using spontaneous reports of adverse events (AEs) during the follow-up visits and laboratory analyses performed at week 8.

RESULTS

A total of 289 patients were enrolled (155 men, 134 women; mean age, 50.74 years). Of these, 8 patients in the T + R group and 7 in the L + R group were lost to follow-up and considered withdrawals. At the end of week 8, the mean percentage reduction in SBP was significantly greater in the T + R group compared with that in the L + R group (24.1% vs 19.4%; P < 0.05). The mean percentage reduction in DBP was also significantly greater in the T + R group compared with that in the L + R group (17.3% vs 12.5%; P < 0.05). The response rates in the T + R and L + R groups were statistically similar (79.1% vs 68.7%). The most common AEs in the T + R and L + R groups were cough (9 [6.1%] and 11 [7.8%] patients, respectively) and headache (7 [4.7%] and 8 [5.7%] patients, respectively).

CONCLUSIONS

The results in this study in Indian patients with stage 2 essential hypertension suggest that the FDC of T + R controlled BP more effectively compared with the FDC of L + R over 8 weeks. The response rates were similar between the 2 groups. Both treatments were well tolerated.