The Management of Myocardial Injury after Non-Cardiac Surgery (MANAGE) trial demonstrated that dabigatran 110 mg twice daily was more effective than placebo in preventing the primary composite outcome of vascular mortality, non-fatal myocardial infarction, non-hemorrhagic stroke, peripheral arterial thrombosis, amputation and symptomatic venous thromboembolism in patients with myocardial injury after non-cardiac surgery (MINS). The cost implications of dabigatran for this population are unknown but are important given the significant clinical implications.
Hospitalized events, procedures, and study and non-study medications were documented. We applied Canadian unit costs to healthcare resources consumed for all patients in the trial, and calculated the average cost per patient in Canadian dollars for the duration of the study (median follow-up of 16 months). A sensitivity analysis was performed using only Canadian patients, and subgroup analyses were also conducted.
The total study cost for the dabigatran group was $9985 per patient, compared with $10,082 for placebo, a difference of − $97 (95% confidence interval [CI] − $2128 to $3672). Savings arising from fewer clinical events and procedures in the dabigatran 110 mg twice-daily group were enough to offset the cost of the study drug. In Canadian patients, the difference was $250 (95% CI −$2848 to $4840). Both differences were considered cost neutral. Dabigatran 110 mg twice daily was cost saving or cost neutral in many subgroups that were considered.
Dabigatran 110 mg twice daily was cost neutral for patients in the MANAGE trial. Our cost findings support the use of dabigatran 110 mg twice daily in patients with MINS.
ClinicalTrials.gov identifier number NCT01661101.
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The MANAGE clinical trial was funded by Boehringer Ingelheim and the Canadian Institutes of Health Research, however no direct funding was allocated for this analysis. The authors had free access to the complete study data and performed all analyses independently of the sponsor.
Conflicts of Interest
Andre Lamy, Wesley Tong, Rajibul Mian, Jessica Vincent, Wojciech Szczeklik, Bruce M. Biccard, Maria Graza Franzosi, Sadeesh K. Srinathan and Joel Parlow report no conflicts of interest. Emmanuelle Duceppe reports grants from Boehringer Ingelheim, Abbott Diagnostics and Roche Diagnostics, as well as lecture fees from Roche Diagnostics. Philip J. Devereaux reports grants from Boehringer Ingelheim and Canadian Health Research Institutes of Canada during the conduct of the study, and grants from Abbott Diagnostics, Boehringer Ingelheim, Covidien, Octopharma, Philips Healthcare, Roche Diagnostics, and Stryker, all outside the submitted work. Denis Xavier reports grants from Cadila Pharmaceuticals, Boehringer Ingelheim, Sanofi-Aventis, Pfizer, Bristol Myers Squibb, and United Health, all outside the submitted work. Christian S. Meyhoff reports direct and indirect institutional research funding from Ferring Pharmaceuticals, Merck Sharp and Dohme Corp., Radiometer, and Boehringer Ingelheim, as well as lecture fees from Radiometer.
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Lamy, A., Tong, W., Mian, R. et al. The Cost Implications of Dabigatran in Patients with Myocardial Injury After Non-Cardiac Surgery. Am J Cardiovasc Drugs (2021). https://doi.org/10.1007/s40256-021-00489-3