Comparative effectiveness of triple therapy with Bisoprolol, Perindopril, Amlodipine, versus dual therapy in hypertensive patients: an observational retrospective cohort study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000374
• EU PAS number:
  EUPAS1000000374
• Study ID:
  1000000374
• Official title and acronym:
  Comparative effectiveness of triple therapy with Bisoprolol, Perindopril, Amlodipine, versus dual therapy in hypertensive patients: an observational retrospective cohort study
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study aims to determine the effectiveness on blood pressure reduction of the triple combination of Perindopril+ Amlodipine+ Bisoprolol (used concomitantly as combination), compared to the respective dual therapy components in real life conditions.; Adult hypertensive patients on two-drug combination therapy (two drugs among Perindopril, Amlodipine and Bisoprolol) and who are not controlled by the dual therapy (with systolic blood pressure (SBP) ≥140mmHg) will be included. Patients who will initiate the third drug and be on the Bisoprolol + Perindopril+ Amlodipine triple therapy will be compared to those who will remain on dual therapy.; The primary outcome will be the difference in change in SBP from baseline to week 8 between the two treatment groups, estimated with a Mixed Model of Repeated Measures. Diastolic blood pressure change at 8 weeks, blood pressure control at 8 weeks and rates of adverse events will be compared between the two treatment groups. Treatment patterns including adherence to index therapy and healthcare resource use will be also described for the triple therapy users. The rates of cardiovascular events including myocardial infarction, stroke, heart failure and chronic kidney disease as well as cardiovascular death will be also investigated as an exploratory objective.; ; These data will be used to generate evidence for the fixed-dose combination (FDC) of perindopril, amlodipine and bisoprolol, currently under development by Servier that may reduce pill burden in hypertensive patients.
• Study status:
  Planned

Research institutions and networks

Institutions

Institut de Recherches Internationales Servier

OXON Epidemiology

Spain

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 02/01/2023

Study start date

Planned: 25/11/2024

Data analysis start date

Planned: 17/02/2025

Date of final study report

Planned: 21/08/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Institut de Recherches Internationales Servier

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable