1,721,308 research outputs found
Prescriptions of antidepressants in primary care in Italy: pattern of use after admission of selective serotonin reuptake inhibitors for reimbursement
No full textAcute renal failure in patients treated with dronedarone or amiodarone: A large population-based cohort study in Italy
No full textPurpose: Causes of ARF are numerous including drugs. In 2012, spontaneous reporting showed a possible association between dronedarone and ARF. To further investigate such association, a retrospective cohort study on health-service claim databases was performed taking amiodarone as comparison. Methods: All patients receiving new prescription of amiodarone or dronedarone between September 2010 and December 2012 were selected. Cox regression models to estimate the hazard ratios (HRs), with 95 % confidence intervals (CIs), for dronedarone versus amiodarone were performed. HRs were calculated: (i) for the entire cohort; (ii) for matched cohorts using propensity score; (iii) and high-dimensional propensity score. Results: New users without previous episodes of ARF were 56,739 and 1761 on dronedarone and 54,978 on amiodarone. After 1:1 matching for propensity score, new users with dronedarone and amiodarone were 1467 and 1467, respectively. The cumulative incidence rate of ARF was 1.6 % (95 % CI 0.7-3.6 %) among dronedarone group and 2.3 % (1.0-5.1 %) among amiodarone group (p from log rank test=0.4884). The unadjusted HR of ARF was 0.34 (0.18-0.64) in dronedarone new users compared to amiodarone; in propensity score matched cohort, it was 0.75 (0.26-2.16), and in high-dimensional propensity score, it was 0.83 (0.25-2.73). Conclusions: This large community-based study did not confirm the signal of an increased nephrotoxicity from dronedarone compared to amiodarone. Nevertheless, given the increasing number of reports collected from pharmacovigilance databases worldwide on this association, it is advisable for clinicians and patients to be aware of the possible kidney damage due to dronedarone in order to improve clinical outcomes with early intervention
Signal detection activity on EudraVigilance data: analysis of the procedure and findings from an Italian Regional Centre for Pharmacovigilance
No full textBackground: In July 2012 a new European legislation (Directive 2010/84/EU and Regulation No. 1235/2010) regarding pharmacovigilance has become effective. It has boosted the activity of Signal Detection through a monthly analysis of potential safety signals on EudraVigilance (EV). Our aim is to describe the procedure of signal detection on EV data and to present results obtained by the our pharmacovigilance centre. Method: Data are extracted from EV database, which collects suspected Adverse Drug Reactions (ADRs) of medicinal products in Europe. We are appointed to supervise digoxin, nicardipine, delapril, manidipine and hydrochlorothiazide/ramipril. ADRs are coded through MedDRA Preferred Terms and collected in the electronic Reaction Monitoring Report (eRMR). Statistical analysis is based on the Proportional Reporting Ratio (PRR) as a measure of disproportionality. Results: Up to April 2016 we have analyzed 45 eRMR for each drug. Two signals for nicardipine were submitted to the Pharmacovigilance Risk Assessment Committee of European Medicines Agency (EMA): acute pulmonary oedema (off-label use as tocolytic) and thrombocytopenia. Conclusions: Our experience shows the scientific and regulatory value of signal detection activity on EV data in order to continuously evaluate the benefit/risk profile of recent and older drugs
Off-label use of nicardipine as tocolytic and acute pulmonary oedema: A post-marketing analysis of adverse drug reaction reports in EudraVigilance
No full textPurpose: To evaluate a signal of acute pulmonary oedema (APO) due to nicardipine used off-label as tocolytic in pregnant women. Methods: All the suspected cases of APO recorded in EudraVigilance database up to 31/01/2013 and associated with nicardipine containing medicinal products were retrieved. The Proportional Reporting Ratio was considered as measure of disproportionality. Individual cases evaluation was conducted. Results: Thirty-four spontaneous cases regarding pregnancy women who experienced APO following nicardipine treatment as tocolytic were collected. The detected proportional reporting ratio was 50.96 (95% confidence interval lower bound equal to 36.75). The analysis focused on 10 serious cases. Most women, aged between 27 and 39 years, were treated with intravenous nicardipine. The most of the suspected adverse reactions occurred between 24 and 96hours. Conclusions: A potentially causal association between APO and off-label use of nicardipine as tocolytic has been detected during a periodic signal detection activity. The Pharmacovigilance Risk Assessment Committee confirmed our findings, recommending an update of the summary of the product characteristics for medicines containing nicardipine for both intravenous and oral formulations. Then European Medicines Agency reaffirmed that nicardipine use in other indications is no longer recommended
No Direct Survival Effect of Light to Moderate Alcohol Drinking in Community-Dwelling Older Adults
No full textOBJECTIVES: To assess the relationship between light to moderate alcohol consumption and mortality, particularly accounting for baseline health status and physical activity.
DESIGN: Prospective, longitudinal, population-based study.
SETTING: The Pianoro Study, which consisted of community-dwelling older adults in three towns in northern Italy.
PARTICIPANTS: Noninstitutionalized individuals of both sexes aged 65 and older (N = 5,256; 2,318 abstainers, 2,309 light to moderate drinkers (≤2 alcoholic units/d)).
MEASUREMENTS: Baseline information about demographic characteristics, lifestyle factors, physical activity (Physical Activity Scale for the Elderly (PASE)), perceived health status (visual analog scale (VAS)), dependency level, risk factors, and previous cardiovascular events was obtained using a structured questionnaire. Follow-up information was obtained 6 years later from 2,752 survivors, and mortality information was obtained from death certificates.
RESULTS: Male sex, being physically active, and good health status were independently associated with light to moderate drinking (P < .001). An apparent protective effect of light to moderate drinking on mortality was evident in the unadjusted analysis and after adjusting for age, sex, risk factors, and cardiovascular events (adjusted hazard ratio (aHR) = 0.77, 95% confidence interval (CI) = 0.68-0.88, P < .001), but after also adjusting for PASE and VAS, the relationship was no longer significant (aHR = 0.92, 95% CI = 0.80-1.05, P = .19). Follow-up physical activity was associated with baseline alcohol consumption; baseline physical activity did not predict alcohol consumption during follow-up.
CONCLUSION: After accounting for health status and physical activity, light to moderate alcohol drinking had no direct protective effect on mortality
Safety profile of the direct oral anticoagulants: an analysis of the WHO database of adverse drug reactions
No full textAim: Direct oral anticoagulants (DOACs) have shown noninferiority to warfarin for stroke prevention in nonvalvular atrial fibrillation (AF) and a more promising safety profile. Unanswered safety aspects remain to be addressed and available evidence on the risk associated with these drugs are conflicting. In order to contribute to the debate on their safety profile, we conducted a comparative analysis of the reports of suspected adverse drug reactions (ADRs) associated with DOACs in VigiBase. Methods: Study based on reports of suspected ADRs held in VigiBase as at December 2014, in which a DOAC or warfarin were administered in patients with nonvalvular AF and listed as suspected/interacting drugs. Medical Dictionary for Regulatory Activities was used to classify ADRs. Reporting odds ratio (ROR) with 95% confidence interval were calculated. Results with P â¤Â 0.05 were statistically significant. Results: We retrieved 32 972 reports. We identified 204 ADRs with a ROR >1 (P â¤Â 0.05) and we focused on 105 reactions. Positive ROR emerged for DOACs and gastrointestinal haemorrhage compared with warfarin [(1.6 (1.47â1.75)], but no disproportionality with cerebral haemorrhage was found [0.31 (0.28â0.34)]. We identified other potential signals that have not been associated with DOACs previously. Conclusions: As well as premarketing authorization clinical trial studies, we found a reduced risk of intracranial haemorrhage, but an increased risk of gastrointestinal haemorrhage in patients treated with DOACs compared to warfarin. We provide new data and we highlight several differences between the three novel oral anticoagulants, in the rate and type of ADRs occurred
Drug-Induced Progressive Multifocal Leukoencephalopathy: A Comprehensive Analysis of the WHO Adverse Drug Reaction Database
No full textObjective To identify safety signals concerning the association
between the use of various drug classes and the onset
of progressive multifocal leukoencephalopathy (PML).
Methods All reports containing suspected or interacting
PML-related or leukoencephalopathy-related drugs, held in
the World Health Organization spontaneous individual case
safety reports database as at 1 September 2014, were
retrieved.Weidentified safety signals by analysing the drug–
reaction pairs, using the reporting odds ratio as a measure of
disproportionality. A safety signal was defined if a drug was
reported more than twice in PML cases with a reporting odds
ratio[2 and a lower 95 % confidence limit[1.
Results We retrieved 2452 reports associated with PML
(N = 1612), leukoencephalopathy (N = 835) or both
(N = 5), corresponding to 343 different drugs. PML was
reported similarly in male and female adults (18–64 years),
and almost 30 % of the cases had a fatal outcome. The
most frequent Anatomical Therapeutic Chemical (ATC)
classification groups concerned antineoplastic agents
(23.5 %), antivirals for systemic use (10.1 %) or
immunostimulants (4.6 %). Significant disproportionality
was found for 88 drugs in the overall analysis (of cases with ‘progressive multifocal leukoencephalopathy’ or
‘leukoencephalopathy’ as the Preferred Term), and a new
safety signal was identified for 59 active substances (e.g.
muromonab-CD3, basiliximab and antithymocyte Ig), as
no information on a possible risk of PML was acknowledged
in their Summary of Product Characteristics documents.
Some safety signals were confirmed also after
sensitivity analysis adjustment for several confounding
factors (underlying diseases and considering only ‘progressive
multifocal leukoencephalopathy’ as the Preferred
Term).
Conclusion We report a possible association between
several drugs and PML that has not been previously
described. In addition, we have confirmed previously
reported signals in a number of drugs. We highlight the
need for follow-up by regulatory agencies
Ibuprofen-associated hypothermia in children: analysis of the Italian spontaneous reporting database
No full textPurpose: An analysis of Italian spontaneous adverse drug reactions (ADR) reporting database highlighted a potential association between hypothermia and ibuprofen in children. Hypothermia is defined as a core body temperature of 35 °C (95 °F). Ibuprofen is the most prescribed NSAID for the treatment of fever and moderate pain in children. We aimed to analyze the cases of ibuprofen-associated hypothermia retrieved in the Italian database in order to contribute to the discussion on this potential association. Methods: We extracted all suspected cases of ibuprofen-associated hypothermia from the Italian spontaneous reporting database and from VigiBase up to December 2015. We considered the proportional reporting ratio (PRR) as a measure of disproportionality for the Italian cases and the information component (IC) for the reports from VigiBase. We performed a case-by-case analysis to exclude duplicates. Results: Nineteen cases of hypothermia associated with ibuprofen use were retrieved from the Italian spontaneous reporting database (PRR 19.8, CI 95 %, 12.0–32.9). The reports concerned ten females and nine males with an average age of 2.5 years. Up to 31 December 2015, 168 cases of hypothermia associated with ibuprofen were reported to VigiBase, with an IC of 2.05 (IC025, 1.82). Among these, 126 cases involved children (49 % males) with an average age of 4.4 years. Conclusions: Although the risk of this ADR is unknown so far, the widespread use of this drug recommends the need for further studies to better characterize this possible association. Clinicians and pharmacists but also parents should be aware that this risk is theoretical as not yet been confirmed
Going Beyond Counting First Authors in Author Co-citation Analysis
Full text linkThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
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