Study Design and Cohort Comparability in a Study of Major Cardiovascular Events in New Users of Prucalopride Versus Polyethylene Glycol 3350

Joan Fortuny, Alicia Gilsenan (), Miguel Cainzos-Achirica, Oscar F. Cantero, Robert W. V. Flynn, Luis Garcia-Rodriguez, Bianca Kollhorst, Pär Karlsson, Love Linnér, Thomas M. MacDonald, Estel Plana, Ana Ruigómez, Tania Schink, Ryan Ziemiecki and Elizabeth B. Andrews
Additional contact information
Joan Fortuny: RTI Health Solutions
Alicia Gilsenan: RTI Health Solutions
Miguel Cainzos-Achirica: RTI Health Solutions
Oscar F. Cantero: Centro Español de Investigación Farmacoepidemiológica
Robert W. V. Flynn: University of Dundee
Luis Garcia-Rodriguez: Centro Español de Investigación Farmacoepidemiológica
Bianca Kollhorst: Leibniz Institute for Prevention Research and Epidemiology-BIPS
Pär Karlsson: Karolinska Institutet
Love Linnér: Karolinska Institutet
Thomas M. MacDonald: University of Dundee
Estel Plana: RTI Health Solutions
Ana Ruigómez: Centro Español de Investigación Farmacoepidemiológica
Tania Schink: Leibniz Institute for Prevention Research and Epidemiology-BIPS
Ryan Ziemiecki: RTI Health Solutions
Elizabeth B. Andrews: RTI Health Solutions

Drug Safety, 2019, vol. 42, issue 10, No 6, 1167-1177

Abstract: Abstract Introduction Given prior safety experience with other 5-HT4 agonists for chronic constipation, an observational, population-based cohort study in five data sources from Germany, Sweden, and the UK was conducted to evaluate the cardiovascular safety of prucalopride. Objectives Our objective is to describe the methods and resulting comparability of cohorts in a multi-database, multinational study of prucalopride initiators and polyethylene glycol 3350 (PEG) initiators following a harmonized protocol. Methods Prucalopride initiators were matched on age, sex, and index date to PEG initiators (1:5 ratio). Study exposures, cardiovascular risk factors, and other covariates were identified from healthcare utilization codes harmonized across databases. Cardiovascular outcomes were identified using database-specific algorithms based on diagnosis codes. The propensity score (PS) in each database was estimated using logistic regression, with prucalopride versus PEG as the outcome and including clinically relevant variables associated with major adverse cardiovascular events. Results In total, 12,030 prucalopride initiators and 59,985 PEG initiators were identified. After matching and trimming, cohorts from the UK and Sweden were well-balanced for cardiovascular risk factors and cancer. However, in Germany, PEG initiators remained older and sicker than prucalopride initiators. The prevalence of these characteristics also differed from those in the UK and Sweden. The pooled analyses included only data from the UK and Sweden. Conclusions Matching, trimming, and PS stratification yielded comparable cohorts in four of five data sources. Use of these methods could not achieve balance for key covariates within the German cohort, likely due to reimbursement differences in Germany.

Date: 2019
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DOI: 10.1007/s40264-019-00836-z

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