Servier has received a positive opinion from a regulatory agency for a novel four-drug combination therapy targeting resistant hypertension in Europe.
Servier Receives Positive Opinion for Quadruple Combination Therapy
Servier, an independent international pharmaceutical group, announced a positive opinion from the European decentralized procedure for its investigational product – the first fixed-dose four-drug combination for hypertension, including resistant hypertension.
The positive opinion covers a single-capsule formulation containing four active ingredients used in the treatment of hypertension.
Simplified Therapy Improves Adherence
Combination medications simplify daily therapy, promoting adherence to treatment recommendations and aiding in the management of chronic diseases.
This positive opinion is a crucial step before obtaining national marketing authorizations in 21 EU member states.
QUADRO Trial Demonstrates Efficacy and Safety
Servier, a global leader in hypertension therapy, continuously develops combination therapies (SPC) that combine multiple active substances into a single tablet.
The new four-drug combination, soon to be available in Europe, represents a breakthrough for patients whose blood pressure remains insufficiently controlled with triple therapy (perindopryl, indapamide, and amlodypine).
Uncontrolled Hypertension: A Major Risk Factor
Uncontrolled hypertension is a major risk factor for cardiovascular diseases.
Patients with resistant hypertension have a 65% higher risk of heart attack or stroke. The WHO reports a rising global prevalence of hypertension, making it a leading cause of premature death.
Early detection and appropriate treatment can effectively improve control of the disease in most patients.
QUADRO Trial Results
The positive opinion is based on the favorable results of the QUADRO study, which demonstrated the efficacy and safety of the four-drug therapy compared to existing triple therapy.
QUADRO Study Design
QUADRO was an international, randomized, double-blind, controlled trial involving 183 patients across 13 countries in Europe, Asia, and South America.
The study aimed to confirm the superior efficacy of the new four-drug therapy (perindopryl, indapamide, amlodipine, and bisoprolol) compared to triple therapy (perindopryl, indapamide, and amlodipine) in lowering blood pressure in patients with confirmed resistant hypertension.
After an 8-week triple therapy period, participants were randomized to receive either the four-drug therapy or continue the triple therapy at the same dose for another 8 weeks.
Significant Blood Pressure Reduction Observed
The QUADRO trial achieved its primary endpoint, demonstrating a significantly greater reduction in systolic blood pressure (SBP) in patients receiving the four-drug therapy (-8 mmHg;
This result was confirmed by secondary endpoints, showing greater SBP reductions with 24-hour ambulatory monitoring (-8 mmHg), diastolic blood pressure (DBP) reductions in the office (-6 mmHg), and SBP reductions at home (-5 mmHg) – all statistically significant (
Safety Profile Confirmed
The safety profile was similar in both groups.
About Servier
Servier is an independent international pharmaceutical group managed by a foundation, committed to advancing medical knowledge for the benefit of patients.
A global leader in cardiology, Servier also aims to become a leader in innovation in oncology and neurology, focusing on targeted molecular therapeutic solutions and dedicating nearly 20% of its revenue from original drug sales to research and development.
Servier employs over 20,000 people worldwide and its medicines are available in over 130 countries.