Prevention of adverse drug reactions in hospitalized older patients with multi-morbidity and polypharmacy: the SENATOR* randomized controlled clinical trial.

BACKGROUND: Multi-morbidity and polypharmacy increase the risk of non-trivial adverse drug reactions (ADRs) in older people during hospitalization. Despite this, there are no established interventions for hospital-acquired ADR prevention. METHODS: We undertook a pragmatic, multi-national, parallel arm prospective randomized open-label, blinded endpoint (PROBE) controlled trial enrolling patients at six European medical centres. We randomized 1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n = 772, mean number of daily medications = 9.34) or standard care alone (control, n = 765, mean number of daily medications = 9.23) using block randomization stratified by site and admission type. Attending clinicians in the intervention arm received SENATOR-generated advice at a single time point with recommendations they could choose to adopt or not. The primary endpoint was occurrence of probable or certain ADRs within 14 days of randomization. Secondary endpoints were primary endpoint derivatives; tertiary endpoints included all-cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life. RESULTS: For the primary endpoint, there was no difference between the intervention and control groups (24.5 vs. 24.8%; OR 0.98; 95% CI 0.77-1.24; P = 0.88). Similarly, with secondary and tertiary endpoints, there were no significant differences. Among attending clinicians in the intervention group, implementation of SENATOR software-generated medication advice points was poor (~15%). CONCLUSIONS: In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.

Underrecognition and undertreatment of dementia in Italian nursing homes.

OBJECTIVE: To determine the prevalence of dementia diagnoses and the use of antidementia drugs in a cohort of Italian older nursing home (NH) residents. DESIGN: Cross-sectional study. SETTING: The NH residents participating in 2 studies: the U.L.I.S.S.E. study and the Umbria Region survey. PARTICIPANTS: A total of 2215 nursing home residents. MEASUREMENT: Each resident underwent a comprehensive geriatric assessment at baseline by means of the RAI MDS 2.0. Dementia diagnosis was based on ICD-9 codes. RESULTS: The prevalence of dementia diagnosis according to ICD-9 codes was 50.7% (n = 1123), whereas 312 subjects had cognitive impairment with a cognitive performance scale score ≥3 without a diagnosis of dementia. Only 56 NH residents were treated (5% of the sample) and the main drugs used were cholinesterase inhibitor, whereas only 1 subject was treated with memantine. Limiting our analysis to patients with mild to moderate Alzheimer's disease, who are those reimbursed by the public health care system for receiving antidementia drugs, the percentage rose to 11.3%. CONCLUSION: These findings demonstrate a high rate of underdiagnosis and undertreatment of dementia in Italian NH residents. Potential explanations include the lack of systematic assessment of cognitive functions, the limitations to antidementia drug reimbursement, the complexity of the reimbursement procedure itself, and the high prevalence of patients with severe dementia. Older NH residents still lack proper access to state-of-the-art diagnosis and treatment for a devastating condition such as dementia.

[The exclusion of older patients from clinical trials regarding heart failure. Causes and consequences]. / L'esclusione degli anziani dai trial clinici sullo scompenso cardiaco: cause e conseguenze.

Older subjects are commonly excluded from clinical trials, that are the gold standard to assess the efficacy and safety of new drugs and non pharmacological therapies. The consequence is the lack of evidence about the optimal drug therapy in this population, who makes the highest consumption of drugs, with increased risk of adverse reactions and undertreatment. A clear example is heart failure: data obtained in the context of the European Project PREDICT confirm a widespread exclusion of older individuals from ongoing clinical trials in heart failure, despite the recommendations of regulatory agencies.