Efficacy and safety of valsartan 160/HCTZ 25 mg in fixed combination in hypertensive patients not controlled by candesartan 32 mg plus HCTZ 25 mg in free combination.

OBJECTIVE

Free combination hypertension medication is associated with a lower compliance and less persistence compared to fixed combination therapy and can, therefore, be associated with insufficient blood pressure reductions. This non-randomized study investigated whether valsartan 160 mg/hydrochlorothiazide 25 mg (Val 160/HCTZ 25) in fixed dose combination could provide additional blood pressure control in hypertensive patients not adequately controlled by the free combination of candesartan 32 mg plus HCTZ 25 mg.

RESEARCH DESIGN AND METHODS

One hundred and ninety-seven patients with a mean sitting diastolic blood pressure (MSDBP) between 100 and 110 mmHg entered a 4-week treatment phase with 32 mg of candesartan in free combination with 25 mg of HCTZ once daily. One hundred and thirty-eight patients with uncontrolled BP at Week 4, entered a second 4-week treatment phase with Val160/HCTZ 25 once daily.

MAIN OUTCOME MEASURES

The primary efficacy parameter was the reduction in MSDBP at trough between Week 4 and Week 8 in the intent-to-treat population.

RESULTS

At baseline, MSDBP was 103.0 +/- 2.8 mmHg. After Week 4, MSDBP had decreased to 93.8 +/- 4.5 mmHg. Subsequent treatment with Val 160/HCTZ 25 for 4 weeks reduced MSDBP to 88.7 +/- 8.6 mmHg. This represented an additional decrease in MSDBP of 5.1 +/- 7.9 mmHg (p < 0.0001). Val 160/HCTZ 25 reduced mean sitting systolic BP by 3.4 +/- 13.0 mmHg (p = 0.0029).

CONCLUSIONS

The fixed dose combination of valsartan 160/HCTZ 25 mg provided a statistically and clinically significant additional BP reduction in patients not controlled by the free combination of candesartan 32 mg and HCTZ 25 mg.