Pharmacotherapy
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To evaluate steady-state bivalirudin dosing requirements in patients with a wide range of kidney function who were being treated for heparin-induced thrombocytopenia (HIT)-related disorders. ⋯ Bivalirudin dosing requirements increased with increasing Clcr values. The high degree of variability suggests that dosing in individual patients will require careful titration to achieve adequate anticoagulation.
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The primary objective was to evaluate the change in publication rate of noninferiority trials over a 20-year interval (1989-2009). Secondary objectives were to analyze the frequency of noninferiority trials by therapeutic category, the frequency of noninferiority trial publication by journal, the impact factors of the publishing journals, any potential special advantages of the study drug over the control, the funding sources of the trials, pharmaceutical industry affiliation of the authors, and the use of ghostwriters in the creation of manuscripts. ⋯ The publication of noninferiority trials increased during the 20 years from 1989 until 2009, particularly in the therapeutic areas of infectious diseases and cardiology. Because of this growth, clinicians and researchers need to be familiar with the caveats of the noninferiority study design to appropriately interpret and design these clinical studies.
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Case Reports
Possible lenalidomide-induced Stevens-Johnson syndrome during treatment for multiple myeloma.
Stevens-Johnson syndrome is a rare, severe cutaneous reaction most often associated with drug therapy. Lenalidomide is a derivative of thalidomide used in the treatment of multiple myeloma. We describe a case of Stevens-Johnson syndrome possibly induced by lenalidomide in a 73-year-old Caucasian female undergoing induction therapy for multiple myeloma. ⋯ To our knowledge, no published case reports of severe dermatologic reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, to lenalidomide have been reported. Thus, we believe this to be the first published case report of a patient who developed Stevens-Johnson syndrome while receiving lenalidomide for induction therapy for multiple myeloma. Clinicians should have a heightened awareness of the signs and symptoms of these severe skin reactions if their patients are receiving lenalidomide.