Cohort Study of the Relative Incidence of Major Cardiovascular Events Among Patients Initiating Prucalopride Versus a Matched Comparator Cohort

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42866
• EU PAS number:
  EUPAS9200
• Study ID:
  42866
• Official title and acronym:
  Cohort Study of the Relative Incidence of Major Cardiovascular Events Among Patients Initiating Prucalopride Versus a Matched Comparator Cohort
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Sweden

  United Kingdom
• Study description:
  The primary objective of this study is to estimate, in real-world settings, the adjusted incidence rate ratio (IRR) and 95% confidence interval (CI) for major adverse cardiovascular events (MACE) in initiators of prucalopride versus initiators of polyethylene glycol 3350 (PEG). Prucalopride and PEG are both used to treat chronic constipation in women for whom laxatives do not work. The primary objective of this study is to estimate, in real-world settings, the adjusted incidence rate ratio (IRR) and 95% confidence interval (CI) for major adverse cardiovascular events (MACE) in initiators of prucalopride versus initiators of polyethylene glycol 3350 (PEG). Prucalopride and PEG are both used to treat chronic constipation in women for whom laxatives do not work. Drugs similar to prucalopride have been associated with adverse cardiovascular events in the past. This study is being done to gain a better understanding of the safety of prucalopride. The study will be implemented in five health care data sources in three countries: in the United Kingdom, the Clinical Practice Research Datalink (CPRD), The Health Improvement Network (THIN), and the Information Services Division of Scotland, in Germany, the German Pharmacoepidemiological Research Database, and in Sweden, the Swedish National Registers. Individuals in the databases will be included in the study if they were 18 years and older, were treated for chronic constipation and meet the criteria of at least 1 year of electronic data before study entry and at least 1 year of enrolment with their GP (for CPRD and THIN). The study period starts January 1, 2010, and will end at the latest available data at each database at the time of analysis. The primary cardiovascular outcome MACE, is a composite of any of the following: (1) hospitalization for nonfatal acute myocardial infarction, (2) hospitalization for nonfatal stroke, and (3) in-hospital cardiovascular death.
• Study status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Fundación Centro Español de Investigación Farmacoepidemiológica (CEIFE)

Spain

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

MEMO Research, University of Dundee

United Kingdom (Northern Ireland)

Study timelines

Date when funding contract was signed

Planned: 29/08/2014

Actual: 29/08/2014

Study start date

Planned: 28/02/2015

Actual: 09/04/2015

Date of final study report

Planned: 31/12/2017

Actual: 21/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Shire Pharmaceuticals

Study protocol

Initial protocol

SPD555-802 protocol_ final 30May2014_to Shire

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable