Aims
Patients with heart failure (HF) randomized in controlled trials are generally selected and do not fully represent the ‘real world’. The purpose of this study is to better describe the characteristics of HF by analysing administrative data of a population of nearly 2 500 000 subjects.
Methods and results
Data came from the ARNO Observatory including inhabitants of five Local Health Units of the Italian National Health Service (INHS). Patients were selected when discharged for HF (1 January 2008–31 December 2012) and prescribed at least one HF treatment. Clinical characteristics, pharmacological treatments, rehospitalization, and direct costs for the INHS were described during 1‐year follow‐up (FU). Of the 2 456 739 subjects included in the database, 54 059 (2.2%) were hospitalized for HF: 41 413 were discharged alive and prescribed HF treatments. Mean age was 78 ± 11 years and 51.4% were females. Just 26.6% were managed in a cardiology setting. The most frequent co‐morbidities were diabetes (30.7%), COPD (30.5%), and depression (21%). ACE inhibitors/ARBs, beta‐blockers, and mineralocorticoid antagonists were prescribed in 65.8, 49.7, and 42.1% of patients, respectively. During 1‐year FU, at least one rehospitalization occurred in 56.6% of patients, 49% of them due to non‐cardiovascular causes. The direct cost per patient per year to the INHS was €11 867, of which 76% was related to hospitalizations.
Conclusions
Real‐world evidence provides a description of patient characteristics and treatment patterns that are different from those reported by randomized clinical trials. Costs for the INHS are mainly driven by hospitalizations, which are often due to non‐cardiovascular reasons.
BackgroundAlthough migraine is a disabling neurological condition that causes important disability, it remains an area of underdiagnosis and undertreatment worldwide. The aim of this study was to depict the burden of the unmet medical needs in migraine treated with triptans in a large Italian population.MethodsA 2-year longitudinal analysis of migraineurs with unmet medical needs on treatment with triptans was performed. The studied cohort consisted of subjects with ≥4 triptan dose units per month, selected from the general population These patients were stratified into: possible Low-Frequency Episodic Migraine (pLF-EM: 4–9 triptan dose units per month), possible High-Frequency Episodic Migraine (pHF-EM: 10–14 triptan dose units per month) and possible Chronic Migraine (pCM:> 14 triptan dose units per month). The first follow-up year was analysed to describe the use of preventive therapies, the second year to describe the ≥50% reduction in triptan use.ResultsOf 10,270,683 adults, 8.0 per 1000 were triptan users and, of these, 38.2% were migraineurs with unmet medical needs, corresponding to 3.1 per 1000 adults. By stratifying for the number of triptan dose units per month, 72.3% were affected by pLF-EM, 17.4% by pHF-EM, and 10.3% by pCM. In this cohort, 19.1% of individuals used oral preventive drugs and 0.1% botulinum toxin. Triptan use reduction was found in 22.3% individuals of the cohort, decreasing with the intensification of need levels (25.8% pLF-EM, 13.6% pHF-EM, 12.0% pCM).ConclusionsThis real-life analysis underlined that the unmet medical needs concern a large part of patients treated with triptans and there is an undertreatment with preventive therapies whose benefit is insufficient, which may be due to the lack of effective preventive strategies, probably still reserved to severe patients. This study allows forecasting the actual impact of newest therapeutic strategies aimed to fill this gap.
Permanent olfactory dysfunction can often arise after traumatic brain injury (TBI) and while one of the main causes is the immediate loss of neurons in the olfactory bulb (OB), the emergent neuroinflammatory environment following TBI may further promote OB deterioration. Therefore, we examined the effects of acute anti-inflammatory treatment with minocycline on post-TBI olfactory behavior and on OB surface. The mouse model of closed-head injury by mechanical percussion was applied to anesthetized Swiss mice. The treatment protocol included three injections of minocycline (i.p.) at 5 min (90 mg/kg), 3 h, and 9 h (45 mg/kg) post-TBI. An olfactory avoidance test was run up to 12 weeks post-TBI. The mice were then sacrificed and their OB surface was measured. Our results demonstrated a post-TBI olfactory behavior deficit that was significant up to at least 12 weeks post-TBI. Additionally, substantial post-TBI OB atrophy was observed that was strongly correlated with the behavioral impairment. Minocycline was able to attenuate both the olfactory lesions and corresponding functional deficit in the short and long term. These results emphasize the potential role of minocycline as a promising neuroprotective agent for the treatment of TBI-related olfactory bulb lesions and deficits.
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