Hospitalized patients with atrial fibrillation compared to those included in recent trials on novel oral anticoagulants: a population-based study.

BACKGROUND: Nonvalvular atrial fibrillation is associated with a substantial risk of stroke. Novel oral anticoagulants (NOACs) with predictable anticoagulant effect and no need for routine coagulation monitoring have recently shown good results when compared with warfarin in phase III clinical trials. OBJECTIVE: To describe clinical features and pharmacological treatments of a population-based cohort of patients with nonvalvular atrial fibrillation and ascertain whether they are comparable with those included in the three main phase III clinical trials on NOACs. RESULTS: Of the 2,862,264 subjects considered for this study 13,360 patients (0.47%) were recently discharged from the hospital with a diagnosis of nonvalvular atrial fibrillation. Mean age was 76.3 (SD 10.7), 49.8% were men and 64.6% were ≥75 years of age. 50% of patients were treated with warfarin and 44.1% with antiplatelet agents. The proportion of patients on antiplatelet therapy increased with age up to a rate of 54.3% in subjects ≥85 years. 92.9% of the studied cohort was on polypharmacy (mean 8 drugs/patient). Around 20% of the entire cohort was treated with amiodarone, a drug potentially interfering with NOACs, and 3.6% from a subgroup analysis had renal failure, which is an exclusion criterion in trials on NOACs. CONCLUSION: In patients recently discharged from the hospital with the diagnosis of nonvalvular AF, warfarin use decreases and aspirin treatment increases with patients' age. These patients are older, more frequently female, and on multiple medications. The benefit of NOACs in these subjects needs to be confirmed in phase IV clinical studies.

Psychotropic drug use in Italy, 1984-99: the impact of a change in reimbursement status.

After years of corruption surrounding drug reimbursement, in 1994, a change in drug reimbursement status was implemented in Italy according to cost-effectiveness criteria. The aim of this study was to assess the impact of these changes on the use of psychotropic drugs. National trends in antipsychotic, antidepressant and benzodiazepine prescriptions were analysed from 1984 to 1999. During the study period, prescriptions of antipsychotic drugs were stable from 1984 to 1994 but, in the subsequent 5 years, increased by 54%. Although the use of atypical compounds in 1999 accounted for only 6% of total antipsychotics sold, the cost of these new drugs accounted for almost one-half the total antipsychotic expenditure. The use of benzodiazepines increased by 53%. In 1999, the psychotropic drugs lorazepam and alprazolam were the most sold by value. From 1984 to 1999, the total antidepressants sold increased by 55%. Although the use of selective serotonin reuptake inhibitors and newer antidepressants in 1999 accounted for less than 50% of total antidepressants sold, the cost of these drugs accounted for 65% of total antidepressant expenditure. This analysis highlights specific areas of concern which should become the object of public health programs.