INGELHEIM, Germany -- April 14, 2008 -- The European Commission has granted marketing authorisation for fixed-dose combination 80 mg telmisartan/25 mg hydrochlorothiazide (MicardisPlus 80/25) in all 27 member states of the European Union. The combination drug was approved for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled by a lower-dose combination of 80 mg telmisartan/12.5 mg hydrochlorothiazide.
It also is approved for the treatment of patients who have been previously stabilised on telmisartan and hydrochlorothiazide separately at the same dosages.
European approval of the fixed-dose combination drug follows the submission of efficacy and safety data from 12 clinical trials performed in patients with mild to moderate hypertension. The core clinical development programme consisted of 2 consecutive trials designed to demonstrate the superiority of the fixed-dose combination 80 mg telmisartan/25 mg hydrochlorothiazide versus 80 mg telmisartan/12.5 mg hydrochlorothiazide.
Patients who were inadequately controlled for their blood pressure on existing antihypertensive treatment were enrolled in the programme (N = 971). Treatment with combination 80 mg telmisartan/25 mg hydrochlorothiazide provided superior diastolic and systolic blood pressure-lowering power after 8 weeks of treatment compared with the lower-dose combination drug.
In the consecutive follow-up trial, 639 patients (n = 633, evaluated for efficacy) were treated with the higher-dose combination drug for an additional 6 months. At the end of this treatment interval, the proportion of patients achieving diastolic blood pressure control had increased from 52.4% to 71.4%.
No clinically meaningful differences in the adverse event profiles of combination 80 mg telmisartan/25 mg hydrochlorothiazide and combination 80 mg telmisartan/12.5 mg hydrochlorothiazide were detected, and no specific increased incidence was identified for all adverse events. No additional specific safety issues have been identified.
Other studies considered by the European Commission showed clearly superior clinical benefits for 80 mg telmisartan/25 mg hydrochlorothiazide treatment compared with 160 mg valsartan/25 mg hydrochlorothiazide.
The fixed-dose combination drug will be launched in Germany and Denmark in the coming weeks, followed by Ireland, the United Kingdom, and the remaining countries in the European Union.
SOURCE: Boehringer Ingelheim GmbH
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