PubMed | b Regional Health Ministry and Irccs Instituto Of Ricerche Farmacologiche Mario Negri
Type: Journal Article | Journal: Amyotrophic lateral sclerosis & frontotemporal degeneration | Year: 2016
To investigate the association between angiotensin converting enzyme inhibitors (ACEIs), angiotensin II receptors blockers (ARBs) and motor neuron disease (MND).This is a population-based nested case-control study. Data were obtained from a population registry and the administrative database of the Lombardy Region (Northern Italy) from 2000 through 2010. Included were 1,200 patients with newly diagnosed MND/ALS and 120,000 controls, randomly selected from the same population and matched for gender, age and area of residence. Exposure to ACEIs or ARBs was quantified using defined daily doses (DDDs). Cumulative DDD (cDDD) was estimated as the sum of dispensed DDDs in the preceding 5 years, excluding 1 year before the MND/ALS diagnosis. Overall exposure, levels of exposure, and individual drugs were all assessed. Subgroup analyses were performed according to age, sex, ALS and ACEI-ARB association.There was no significant association between MND/ALS and antecedent use of ACEIs or ARBs. Data were confirmed in multivariable models and in subgroups.A protective role of ACEIs and ARBs in MND was not confirmed. Differences with a previous report (showing an inverse association between ACEIs and ALS) can be explained by different genetic background, dietary habits and susceptibility to environmental exposures, including drugs.
PubMed | c Scientific Institute, b Regional Health Ministry and University of Milan
Type: Journal Article | Journal: Expert opinion on drug safety | Year: 2016
To recognise and prevent ADRs (including DDIs) in the elderly through a 4-year post-marketing active pharmacovigilance programme. The programme was designed to enhance high quality spontaneous reporting of ADRs in elderly patients by sampling the Italian population and was termed Pharmacovigilance in Geriatry (ViGer).ADRs were collected for adults aged over 65 years of age treated in nursing homes, continuing care retirement communities and territorial health services in Lombardy. ADRs were evaluated using the Adverse Drug Reaction Probability Scale (Naranjo) and analysed with respect to time, sex, category of ADR, seriousness, suspected medicines, notoriety. We analysed all the potential DDIs.We detected 1073 cases reports corresponding to 2110 ADRs. Vaccines, antibacterials for systemic use and antineoplastic agents were the pharmacotherapeutic subgroups most frequently involved. 18% of ADRs reports were classified as serious. In 752 reports patients were described as in polytherapy; in 55 patients (7.3%) the reported ADR were probably preventable because of DDIs involvement.The ViGer project demonstrated that active pos-marketing pharmacovigilance programmes are a valid strategy to increase awareness on geriatrics pharmacology, reduce underreporting and provide important information on previous unknown ADRs and DDIs, resulting in a therapy optimisation in clinical practice in the geriatric setting.