Real-time clinical correlation with the responsible physicians allowed distinction of intended from unintended discrepancies. This presumably improved the accuracy of the error rate measurement. This study confirmed the relatively high rate previously reported. Further study can focus on possible intervention to minimize these errors.
3. Liperoti R, Gambassi G, Lapane KL, et al. Conventional and atypical antipsychotics and the risk of hospitalization for ventricular arrhythmias or cardiac arrest Arch Intern Med. 2005;165:696-701.
As the number of hospitalized elderly and demented patients increases, use of both typical and atypical antipsychotics has become prevalent. QT prolongation, ventricular arrhythmia, and cardiac arrest are more commonly associated with the older conventional antipsychotics than with newer atypical agents. This case-control study was conducted to estimate the effect of both conventional and atypical antipsychotics use on the risk of hospital admission for ventricular arrhythmia or cardiac arrest.
The patient population involved consisted of elderly nursing home residents in 6 US states. The investigators utilized Systematic Assessment of Geriatric Drug Use via Epidemiology database that contains data from minimum data set (MDS), a standardized data set required of all certified nursing homes in the United States. Case patients were selected by ICD-9 codes for cardiac arrest or ventricular arrhythmia. Control patients were selected via ICD-9 codes of 6 other common inpatient diagnoses. Antipsychotic exposure was determined by use of the most recent assessment in the nursing homes prior to admission. Exposed patients were those who received atypical antipsychotics such as risperidone, olanzapine, quetiapine, and clozapine, and those who used conventional agents such as haloperidol and others. After control for potential confounders, users of conventional antipsychotics showed an 86% increase in the risk of hospitalization for ventricular arrhythmias or cardiac arrest (OR: 1.86) compared with nonusers. No increased risk was reported for users of atypical antipsychotics. (OR: 0.87). When compared with atypical antipsychotic use, conventional antipsychotic use carries an OR of 2.13 for these cardiac outcomes. In patients using conventional antipsychotics, the presence and absence of cardiac diseases were 3.27 times and 2.05 times, respectively, more likely to be associated with hospitalization for ventricular arrhythmias and cardiac arrest, compared with nonusers without cardiac diseases.
These results suggest that atypical antipsychotics may carry less cardiac risk than conventional agents. In an inpatient population with advancing age and increasing prevalence of dementia and cardiac disease, use of atypical antipsychotic agents may be safer than older, typical agents.
4. Mayer SA, Brun NC, Begtrup K, et al. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 352:777-85.
This placebo-controlled, double-blind, multicenter, industry-sponsored trial of early treatment of hemorrhagic stroke with rFVIIa at 3 escalating doses, evaluated stroke hematoma growth, mortality, and functional outcomes up to 90 days. The authors note the substantial mortality and high morbidity of this condition, which currently lacks definitive treatment. Patients within 3 hours of symptoms with intracerebral hemorrhage on CT and who met study criteria were randomized to receive either placebo or a single intravenous dose of 40, 80, or 160 mcg/kg of rFVIIa within 1 hour of baseline CT and no more than 4 hours after symptoms. Follow-up CTs at 24 and 72 hours were obtained and functional assessments were performed serially at frequent intervals throughout the study period. Three hundred ninety-nine patients were analyzed and were found similar in their baseline characteristics. Lesion volume was significantly less with treatment, in a dose-dependent fashion. Mortality at 3 months was significantly less (29% vs. 18%) with treatment, and all 4 of the global functional outcome scales utilized were favorable, 3 of them (modified Rankin Scale for all doses, NIH Stroke Scale for all doses, and the Barthel Index at the 80 and 160 mcg/kg doses) in a statistically significant fashion. However, the authors noted an increase in serious thromboembolic events in the treatment groups, with a statistically significant increased frequency of arterial thromboembolic events. These included myocardial ischemic events and cerebral infarction, and most occurred within 3 days of rFVIIa treatment. Of note, the majority of patients who suffered these events made recovery from their complications, and the overall rates of fatal or disabling thromboembolic occurrences between the treatment and placebo groups were similar. This study offers new and exciting insights into potential therapy for this serious form of stroke, although safety concerns merit further study.