The perioperative safety of aprotinin, an antibleeding agent commonly used in cardiac surgery, was recently challenged. To investigate the long-term safety of aprotinin, Mangano and colleaguesArticle assessed all-cause mortality through 5 years of follow-up in patients who had coronary artery bypass graft (CABG) surgery and who received aprotinin, aminocaproic acid, tranexamic acid, or no antibleeding therapy. The authors found that patients who received aprotinin, but not those who received aminocaproic acid or tranexamic acid, had a significantly increased risk of death compared with patients who received no antibleeding agent. In an editorial, FergusonArticle discusses the use of observational data sets to assess the long-term safety of drugs and devices.
Additional patent protection is granted to pharmaceutical companies conducting clinical trials to assess drug safety and efficacy in children (“pediatric exclusivity”). Whether the benefits to industry are disproportionate to the costs of the studies is not clear. In a cohort study of clinical trials conducted for pediatric exclusivity and submitted to the US Food and Drug Administration in 2002-2004, Li and colleagues quantified the trial costs and economic return to industry. The authors found considerable variability in the net economic return and the net return-to-costs ratio from the pediatric exclusivity trials, with some companies experiencing loss and others substantial economic benefit.
Pathway proteins or enzymes that regulate hemostasis are well characterized, but the contribution of genetic variations in these components to the risk of venous thrombosis (VT) has not been fully investigated. Smith and colleaguesArticle conducted a population-based, case-control study in which they investigated the association of common genetic variations in 24 coagulation and fibrinolysis candidate genes with the risk of incident VT in postmenopausal women. Among the 280 single nucleotide polymorphisms (SNPs) analyzed, the authors identified 5 SNPs associated with VT risk. In an editorial, Dupuis and O’DonnellArticle discuss elements of study design and statistical considerations that are critical to the interpretation of large-scale studies of genetic associations.
Statin therapy is associated with small increases in high-density lipoprotein cholesterol (HDL-C) levels, but whether statin-induced changes in HDL-C levels are reflected in reduced coronary artery atheroma volume is not known. Nicholls and colleagues report results of a post hoc analysis of data from patients enrolled in 4 prospective randomized trials of statin therapy and who had treatment-related atheroma volume change assessed with serial intravascular ultrasonography. The authors found that statin therapy was associated with regression of coronary artery atherosclerosis in patients whose low-density lipoprotein cholesterol levels were substantially reduced and whose HDL-C levels were increased by at least 7.5% above baseline levels.
Ms R is a 27-year-old woman who was diagnosed with polycystic ovarian syndrome (PCOS) during college. Legro discusses the diagnosis, pathophysiology, fertility-related issues, and treatment of PCOS.
“All patients can be treated with respect and compassion—and thus be reassured that, at the very least, their physician cares about their welfare.” From “The Importance of the Right Heart.”
A growing body of evidence indicates that cognitive-behavioral therapy can be effective for children with some mental illnesses.
Considerations and feasibility of hemoglobin A1c (HbA1c) thresholds as a measure of diabetes care quality.
Reordering priorities in clinical practice, policy, and research to maximize health outcomes and control costs.
Join David Ganz, MD, MPH, February 21, 2007, from 2 to 3 PM eastern time to discuss The Rational Clinical Examination “Will My Patient Fall?” To register, go to http://www.ihi.org/AuthorintheRoom.
Dr DeAngelis summarizes and comments on this week's issue. Go to http://jama.ama-assn.org/misc/audiocommentary.dtl.
For your patients: Information about polycystic ovary syndrome.
This Week in JAMA . JAMA. 2007;297(5):439. doi:10.1001/jama.297.5.439