Servier Receives Positive European Opinion for Quadruple Combination Pill for Resistant Hypertension
Servier has received a positive opinion from the decentralized European procedure for a first-of-its-kind pre-constituted four-component fixed combination pill – perindopril/indapamide/amlodipine/bisoprolol. This medication is indicated for the treatment of patients with resistant hypertension, a condition where blood pressure remains uncontrolled despite treatment with three different antihypertensive medications [1]. The favorable opinion paves the way for the French pharmaceutical group to pursue national marketing authorizations across 21 European Union member states.
Understanding the Decentralized Procedure
The decentralized European procedure (DCP) is a regulatory pathway within the European Union designed to facilitate the simultaneous approval of a drug in multiple member states when it hasn’t yet been authorized in any of them. This streamlined process allows for efficient access to new medications across the region.
A New Approach to Resistant Hypertension
The combination of perindopril, indapamide, amlodipine, and bisoprolol represents a significant advancement for individuals whose blood pressure remains stubbornly high despite being treated with three separate antihypertensive drugs at their maximum tolerated doses. Resistant hypertension is a serious health concern, as it significantly elevates the risk of cardiovascular events.
The Cardiovascular Risk of Uncontrolled Hypertension
Demanding-to-control or uncontrolled hypertension is a major risk factor for cardiovascular diseases. Patients with resistant hypertension face a 65% higher risk of experiencing a myocardial infarction (heart attack) or stroke. Globally, the prevalence of hypertension is on the rise, according to the World Health Organization (WHO).
Servier’s Perspective
“We have always had confidence in the therapeutic potential of this first quadripill for patients with resistant hypertension not controlled by triple hypertensive therapy,” stated Emmanuel Arnaud, Global Head of Therapeutic Area Cardio-Metabolic and Venous Diseases, R&D, Servier. “And now, following the favorable outcome of the decentralized European procedure, we have further confirmation of the importance of this innovation, which offers a new therapeutic option to European patients.”
The QUADRO Study: Evidence of Efficacy
The positive opinion from the DCP is based on the results of the QUADRO study, also known as the FRAMEWORK study. This study demonstrated the effectiveness and safety of the quadripill compared to existing triple antihypertensive therapy.
Study Details: A Phase III Clinical Trial
FRAMEWORK was an international, Phase III, randomized, double-blind, and controlled clinical trial involving 183 patients from 13 countries across Europe, Asia, and South America. The primary goal of the study was to determine if the quadruple therapy – combining perindopril/indapamide/amlodipine/bisoprolol into a single capsule – was superior to triple therapy (perindopril/indapamide/amlodipine) in lowering blood pressure in patients with confirmed resistant hypertension.
Key Findings: Significant Blood Pressure Reduction
Following an initial 8-week period of triple therapy, patients were randomly assigned to receive either the quadruple therapy or continue with their existing triple therapy regimen at the same dosage. Efficacy was assessed after another 8 weeks of treatment, using measurements of systolic blood pressure (SBP) taken in a medical office (the primary endpoint), as well as 24-hour ambulatory blood pressure monitoring and self-measurement of home blood pressure.
Detailed Results: A Clear Benefit
The QUADRO trial successfully met its primary endpoint, demonstrating a significantly greater reduction in systolic blood pressure in patients receiving the quadruple therapy (-8 mmHg; P < 0.0001). This result was further supported by secondary endpoints, which showed greater reductions with quadruple therapy in ambulatory systolic blood pressure over 24 hours (-8 mmHg), diastolic blood pressure (DBP) measured in the doctor’s office (-6 mmHg), and home systolic blood pressure (-5 mmHg) (all P < 0.0001). Patients on quadruple therapy exhibited a superior response rate and improved blood pressure control. The safety profiles of both treatment groups were comparable.
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