RESUMEN
Contemporary anticancer therapies frequently have different efficacy and side effects in men and women. Yet, whether women are well-represented in pivotal trials supporting contemporary anticancer drugs is unknown. Leveraging the Drugs@FDA database, clinicaltrials.gov, MEDLINE, and publicly available FDA-drug-reviews, we identified all pivotal (phase II and III) non-sex specific trials supporting FDA-approval of anticancer drugs (1998-2018). Observed-enrollment-rates were compared to expected-population-rates derived from concurrent US-National-Cancer-Institute's Surveillance-Epidemiology-and-End-Results (SEER) reported rates and US-Census databases. Primary outcome was the proportional representation of women across trials, evaluated by a participation-to-prevalence ratio (PPR), according to cancer type. Secondary outcome was the report of any sex-specific analysis of efficacy and/or safety, irrespective of treatment-arm. Overall, there were 148 trials, enrolling 60,216 participants (60.5 ± 4.0 years, 40.7% female, 79.1% biologic, targeted, or immune-based therapies) evaluating 99 drugs. Sex was reported in 146 (98.6%) trials, wherein 40.7% (24,538) were women, compared to 59.3% (35,678) men (p < .01). Altogether, women were under-represented in 66.9% trials compared to the proportional incidence of cancers by respective disease type; weight-average PPR of 0.91 (relative difference: -9.1%, p < .01). Women were most under-represented in gastric (PPR = 0.63), liver (PPR = 0.71), and lung (PPR = .81) cancer trials. Sex-based safety data was reported in 4.0% trials. There was no association between adequate female enrollment and drug efficacy (HR: 0.616 vs. 0.613, p = .96). Over time, there was no difference in the percentage of women recruited into clinical trials. Among pivotal clinical trials supporting contemporary FDA-approved cancer drugs, women were frequently under-represented and sex-specific-efficacy and safety-outcomes were commonly not reported.
RESUMEN
The varied clinical presentation and objective findings associated with colonic ischemia (CI) overlap with multiple disease processes. A high index of suspicion is critical for timely diagnosis and prognostication to avoid delays in treatment. We present a case that highlights the challenges of diagnosing CI and the high morbidity associated with severe disease. Case report: A sixty-four-year-old female presented to our community hospital with acute onset abdominal pain, nausea, and diarrhea, complicated by septic shock. She was initially given a diagnosis of infectious colitis until a colonoscopy was performed revealing extensive pancolonic ulcerations. Histopathological features on biopsy were most consistent with colonic ischemia. Blood cultures grew Fusobacterium Necrophorum. Surgery was avoided due to the high morbidity and mortality of performing a total colectomy and ileostomy. The patient continued to struggle with abdominal pain, diarrhea, and hematochezia, consistent with continuous CI, leading to recurrent hospitalizations.
RESUMEN
PURPOSE OF REVIEW: Optimal duration of antiplatelet therapy continues to attract extensive debates and has been progressively adjusted in the setting of advancements in stent design and assessment of patient clinical characteristics. Given the ever-changing landscape of antiplatelet therapy and the multitude of clinical trials that have examined this duration, there are varying scenarios for optimal duration based on patient presentation and risk profile. This review highlights the current concepts and recommendations regarding duration of antiplatelet therapy in coronary heart disease. RECENT FINDINGS: In particular, we review the current data on the use of dual antiplatelet therapy in the different clinical scenarios. Relatively longer dual antiplatelet therapy is perhaps limited to patients with higher risk for cardiovascular events and/or high-risk lesions and shorter durations of dual antiplatelet therapy have been shown to reduce bleeding complications at the same time as stabilization of ischemic endpoints. More recent trials have demonstrated the safety of shorter durations of dual antiplatelet therapy in appropriate patients with coronary heart disease.
