TRIPLIXAM (perindopril/ indapamide/amlodipine) - Essential hypertension

The Committee deems that the clinical benefit of TRIPLIXAM (perindopril/indapamide/amlodipine) film-coated tablet, at the 5 mg/1.25 mg/5 mg, 5 mg/1.25 mg/10 mg, 10 mg/2.5 mg/5 mg and 10 mg/2.5 mg/10 mg strengths, is substantial in the MA indication.

Considering:

• expert opinions highlighting the benefit of fixed-dose triple antihypertensive drug combinations, supported by international and European guidelines specifying that these “single pill combinations” should be favoured for dual and triple therapies because they promote patient adherence and compliance with their antihypertensive treatment;
• observational data based on Italian medico-administrative databases reporting a better level of treatment compliance in patients on fixed-dose perindopril/indapamide/amlodipine antihypertensive triple therapy compared to a fixed-dose dual therapy combined with a free component or a free triple combination;
• the absence of any new identified safety signals since the last assessments and safety data in line with the already known safety profiles of the three active substances of the medicinal product;

but in view of:

• the limited clinical interpretation of the compliance data supplied in view of the low level of evidence of the observational studies;
• the absence of clinical data enabling the efficacy of the TRIPLIXAM (perindopril/ indapamide/amlodipine) fixed-dose combination to be assessed in the management of patients whose blood pressure is stabilised by the components of this combination;

the Committee deems that TRIPLIXAM (perindopril/indapamide/amlodipine) provides no clinical added value (CAV V) compared to the free combination of perindopril, indapamide and amlodipine taken concomitantly at the same dosage.