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Establishing Therapeutic Equivalence of Complex Pharmaceuticals: The Case of Dabigatran
Publication date: Available online 5 June 2018Source: Canadian Journal of CardiologyAuthor(s): Jeffrey Weitz, Karen M. Earl, Kori Leblanc, William Semchuk, Fakhreddin JamaliAbstractDabigatran is widely used for stroke prevention in atrial fibrillation. Dabigatran is no longer patent protected in Canada and 2 generic formulations were recently approved by Health Canada. Branded dabigatran utilizes a complex formulation to maintain the acidic microenvironment required for maximal absorption. Consequently, food does not influence its bioavailability and the efficacy and safety of dabigatran are similar with or without concomi...
Source: Canadian Journal of Cardiology - July 10, 2018 Category: Cardiology Source Type: research

Rationale, Design and Baseline Characteristics of Participants in the Cardiovascular OutcoMes for People Using Anticoagulation StrategieS (COMPASS) Trial
Conclusion COMPASS will provide information on the efficacy and safety of rivaroxaban, alone or in combination with aspirin, in the long-term management of patients with stable CAD or PAD, and on the efficacy and safety of pantoprazole in preventing upper GI complications in patients receiving antithrombotic therapy. Teaser COMPASS is a global randomized controlled trial comparing rivaroxaban 2.5mg twice-daily plus aspirin 100mg once-daily, rivaroxaban 5mg twice-daily, and aspirin 100mg once-daily for prevention of myocardial infarction, stroke, or cardiovascular death in patients with stable coronary or peripheral artery ...
Source: Canadian Journal of Cardiology - June 8, 2017 Category: Cardiology Source Type: research