Long-term, open-label evaluation of the safety and efficacy of telmisartan 80 mg/hydrochlorothiazide 25 mg fixed-dose combination alone or with other antihypertensive medication.

Objective: To assess the safety and efficacy of long-term treatment with telmisartan 80 mg/hydrochlorothiazide 25 mg (T80/H25) fixed-dose combination (FDC) in patients who completed a previous double-blind study, in which T80/H25 provided more blood pressure (BP) reduction and produced a BP response in more patients than did T80/H12.5 FDC.

Methods: Patients received open-label T80/H25 for 24 weeks; further antihypertensive medication was permitted. Seated trough BP was measured at weeks 0, 4, 12 and 24.

Results: Primary end point (seated trough diastolic BP (DBP) control (< 90 mmHg)) was achieved in 71.4% of patients versus 52.4% at baseline (n = 639). The improvement was apparent at week 4 and sustained thereafter. In patients who received more antihypertensive medication (111/639 (17.4%)), DBP control increased from 24.8% at baseline to 58.6% at week 24. Seated trough systolic BP (SBP)/DBP were reduced from 141.0/89.0 mmHg at baseline by 4.6/3.6 mmHg by week 24. SBP response (< 140 or > or = 20 mmHg reduction from start of previous trial) and DBP response (< 90 or > or = 10 mmHg reduction from start of previous trial) increased at week 24 versus baseline from 51.8 to 69.3% and from 55.8 to 74.3%, respectively. At week 24, 110 (17.4%) patients achieved normal SBP/DBP (< 130/< 85 mmHg) and a further 24 (3.8%) patients achieved optimal SBP/DBP (< 120/< 80 mmHg). T80/H25 FDC was well tolerated; drug-related adverse events occurred in 29 (4.5%) patients.

Conclusion: T80/H25 provides sustained and well-tolerated additive BP control, given alone or as part of a multi-antihypertensive therapy.