Alea Comp (olmesartan, hydrochlorothiazide and amlodipine)
Alea Comp consists of a fixed combination of olmesartan, hydrochlorothiazide and amlodipine and is indicated for the treatment of arterial hypertension. The combination product has not been shown to have any advantages over treatment with the individual substances. As expected, triple-therapy is more efficient than double-therapy, but it is also associated with more adverse events (28% vs 23%).
The advantages of combining several drugs into one tablet are generally questionable, but the documentation for the safety profile combination therapy is improved. As regards Alea Comp, the combination of olmesartan and thiazide seems to have an additive tendency to both dizziness and increased creatinine levels, and thus the combination should be used with caution.
IRF does not find it expedient to treat patients with combination tablets if the combination product has not proven to be more efficient than treatment with the individual substances administered separately.
Moreover, it is IRF's assessment that olmesartan or products containing this substance are not first line treatment, because of the less expensive alternatives among angiotensin II antagonists.
Alea Comp was marketed on 31 March 2014. This product has not been granted general reimbursement, but single reimbursement may be applied for.