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Europe Approves New Fixed-Dose Combination Drug for Essential Hypertension

LEVERKUSEN, Germany -- April 21, 2008 -- The European Commission has granted European marketing authorisation for the new antihypertensive fixed-dose combination drug 80 mg telmisartan/25 mg hydrochlorothiazide (T80/H25), which is marketed as PritorPlus 80/25 and Kinzalkomb 80/25. The new formulation will be launched in Germany later this month, to be followed soon by selected countries in the European Union.

This fixed-dose combination is indicated for the treatment of essential hypertension in patients whose blood pressure (BP) is not adequately controlled on 80 mg telmisartan/12.5 mg hydrochlorothiazide (T80/H12.5) or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide separately at the same dosages.(1,2)

European approval of this telmisartan/hydrochlorothiazide formulation follows the submission of efficacy and safety data from 12 clinical trials performed in patients with mild to moderate hypertension. The core clinical development program consisted of 2 consecutive trials. The superiority of the fixed-dose combination T80/H25 versus T80/H12.5 was demonstrated.(1)

Patients (N = 971) whose BP was inadequately controlled on existing antihypertensive treatment were enrolled in the program.(1) Compared with T80/H12.5, treatment with T80/H25 provided superior measures of trough systolic BP (-1.6 mm Hg; 95% CI, -2.5 to -0.6 mm Hg; P = .0012) and diastolic BP (-2.7 mm Hg; 95% CI, -4.2 to -1.2 mm Hg; P = .0003) after 8 weeks of treatment.(1) In the consecutive follow-up trial, 639 patients (633 patients evaluated for efficacy) were treated with T80/H25 for an additional 6 months. At the end of this treatment interval, the proportion of patients achieving diastolic BP control had increased from 52.4% to 71.4%.(2) No clinically meaningful differences in the adverse event profiles of T80/H25 and T80/H12.5 were detected. No specific increased incidence was identified for all adverse events. No additional specific safety issues have been identified. (1,2)

Other studies considered by the European Medicines Agency showed that T80/H25-based treatment led to a significantly greater decrease in trough systolic and diastolic BP than treatment with 160 mg valsartan /25 mg hydrochlorothiazide, the market-leading angiotensin II receptor blocker's high-strength combination.(3)

References

1. Trials.Boehringer-Ingelheim.com. Boehringer Ingelheim Trial Number 502.480.
2. Trials.Boehringer-Ingelheim.com. Boehringer Ingelheim Trial Number 502.491.
3. White WB et al. Blood Press Monit. 2008;13:21-27.


SOURCE: Bayer Schering Pharma

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