Cancer incidence in a trial of an antiapoptotic agent for Parkinson's disease.

We performed a placebo-controlled trial of CEP-1347, an inhibitor of neuronal apoptotic cell death, in patients with early Parkinson's disease (PD) to determine whether long-term therapy would slow disability progression. This also provided an opportunity to monitor cancer incidence in a large cohort of PD patients followed prospectively including periods before and after patients developed disability requiring dopaminergic therapy. This was a multicenter study of 806 patients with early PD, without disability requiring dopaminergic therapy, assigned randomly to placebo or one of three doses of CEP-1347. Patients were monitored for an average of 1.8 years (1,467 patient-years) with routine cancer screening evaluations and annual skin examinations by a dermatologist. There was no significant excess of cancers among patients taking CEP-1347 compared with placebo for any cancer type (all P > 0.1). Nonmelanoma skin cancers were the most common cancer type observed. The incidence of melanomas was 20.9 times that predicted in the general population. Most melanomas occurred in patients who had never taken dopaminergic therapy. We found no evidence that CEP-1347 affected cancer incidence within 2 years of follow-up. Melanoma occurrence in our PD patients was greater than predicted compared with the general population and was unrelated to dopaminergic therapy. Clinical surveillance of PD patients for melanoma may be warranted.

In-hospital mortality among women undergoing contemporary elective percutaneous coronary intervention: a reexamination of the gender gap.

BACKGROUND: Previous studies have indicated that, compared with men, women are at increased risk for in-hospital mortality following percutaneous coronary intervention (PCI); however, angioplasty techniques and mortality rates have improved since earlier reports. HYPOTHESIS: We sought to reevaluate and explore further the relationship between gender and angioplasty outcomes in contemporary "real world" practice. METHODS: The influence of gender and other covariates on in-hospital mortality and other adverse events among all patients who underwent elective coronary angioplasty in New York State from 1999 to 2001 (n = 106,262) was examined. RESULTS: In-hospital mortality rates for elective angioplasty were low; however, women demonstrated a two-fold mortality excess compared with men (0.6 vs. 0.3%, p < 0.0001). Women were older and more likely than men to demonstrate certain higher-risk features (heart failure, class III-IV angina, renal failure, vascular disease); however, men were more likely to have depressed ejection fraction, prior myocardial infarction, and prior coronary revascularization. Using multivariate analysis adjusting for clinical risk factors, gender remained an independent predictor of in-hospital mortality at all ages. Women were also more likely to experience nonfatal adverse events following PCI, including more frequent need for emergency bypass surgery. CONCLUSIONS: Despite improvements in angioplasty outcomes with time, women remain at significantly higher risk of in-hospital death than men after elective PCI. This increased mortality is observed in every age group, even after adjusting for other significant comorbidities.