![]() ![]() In the PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin–Thrombolysis in Myocardial Infarction 54) trial, it was found that long-term treatment with ticagrelor reduced the risk of major adverse cardiovascular events among stable outpatients with a history of myocardial infarction. Trial Registration Identifier: NCT01225562 These data demonstrate how adverse events considered “nonserious” by traditional trial criteria may have an effect on quality of life and, thus, may precipitate the discontinuation of treatments and underscore the need for patient education and counseling on the timing and nature of adverse effects with the aim of improving adherence when appropriate. For patients completing 1 year of treatment, the subsequent discontinuation rate was low. The discontinuation rates are annualized for patients who received 90 mg of ticagrelor twice daily (hazard ratio, 2.00 for the first year HR, 1.12 for the second and third years) and patients who received 60 mg of ticagrelor twice daily (HR, 1.59 for the first year HR, 1.18 for the second and third years) compared with patients who received placebo.Ĭonclusions and Relevance When initiated among stable patients with prior myocardial infarction, discontinuation of treatment with ticagrelor was driven primarily by nonserious adverse events occurring primarily early after randomization. Eighty-six percent of bleeding events that led to the discontinuation of treatment with ticagrelor were nonmajor, and 86% of adverse events due to dyspnea that led to discontinuation of treatment with ticagrelor were mild or moderate in severity. The most frequent adverse events leading to discontinuation of treatment were bleeding (with Kaplan-Meier event rates of 7.8%, 6.2%, and 1.5% of patients, respectively P < .001) and dyspnea (6.5%, 4.6%, and 0.8% of patients, respectively P < .001). Discontinuation of treatment due to an adverse event occurred in 19%, 16%, and 9% of patients, respectively ( P < .001). Results Over 33 months, 32%, 29%, and 21% of patients receiving 90 mg of ticagrelor, 60 mg of ticagrelor, and placebo, respectively, discontinued treatment ( P < .001). Main Outcome and Measure Discontinuation of treatment. Discontinuation of treatment was evaluated by treatment arm, cause, and timing. These participants were followed up for a median of 33 months (study start date: October 2010 completion date: December 2014). Objective To investigate the reasons and timing of discontinuation of treatment with ticagrelor among stable patients prior myocardial infarction.ĭesign, Setting, and Participants In the PEGASUS-TIMI 54 trial, 21 162 stable outpatients with prior myocardial infarction were randomly assigned to 90 mg of ticagrelor twice daily, 60 mg of ticagrelor twice daily, or placebo, with all of the patients receiving a low dose of aspirin. However, more patients prematurely discontinued treatment with ticagrelor than with placebo. Importance In the PEGASUS-TIMI 54 trial, treatment with ticagrelor reduced the incidence of cardiovascular death, myocardial infarction, or stroke by 15% to 16% among stable patients compared with placebo. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography. ![]()
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