Perspective:

The present study suggests that the real-world discontinuation rate of dofetilide is 20%. At least one prior, much larger study of real-world practice suggested that it was closer to 12%. In large clinical trials leading to the approval of the drug, <3% of patients had to discontinue the medication. Many factors may play a role in the decision to discontinue dofetilide. They include coadministration of drugs known to prolong QT interval in general or directly interact with dofetilide elimination, provider’s confidence in the measurement of the QT interval during atrial fibrillation, and a host of intangible factors affecting risk benefit assessment, such as the severity of symptoms, eligibility for alterative antiarrhythmic medications or ablation, and the last case discussed at the mortality and morbidity conference. In light of this and other studies, it was perplexing to learn that the Food and Drug Administration recently removed the Risk Evaluation and Mitigation Strategies (REMS) restriction on prescribers and pharmacies, so that any physician or nurse practitioner may now prescribe this potentially dangerous drug, and any pharmacy may dispense it.