Background Bullous pemphigoid has been associated to dipeptidase-4 inhibitors. Objectives Addressing the potential Bullous pemphigoid-dipeptidase-4 inhibitors association based on pharmacovigilance data currently available in Spain in order to obtain a composite disproportionality estimator from all the data generated by the case-non case studies conducted to this date. Setting The Spanish Pharmacovigilance System for Human Use Drugs database. Method Case-non case study based on the Spanish Pharmacovigilance System for Human Use Drugs notifications submitted between 2007 and 2018 (n = 169,280), using the Medical Dictionary for Regulatory Activities term (Preferred Term) 'pemphigoid' for sitagliptin, vildagliptin, saxagliptin, linagliptin, and alogliptin (n = 1952). As negative control, we used acetaminophen, while furosemide was the positive control. A pooled reported odds ratio analysis in the French, Japanese, and Spanish national pharmacovigilance databases was performed. On The Spanish Pharmacovigilance System for Human Use Drugs, we conducted a bullous pemphigoid-metformin association analysis within the period 1982-2018. Main outcome measure Adverse reaction cases in pharmacovigilance databases and the disproportionality through the reporting odds ratio. Results Within The Spanish Pharmacovigilance System for Human Use Drugs, we found 45 cases of bullous pemphigoid in dipeptidase-4 inhibitors patients. Median age was 77 years (range 72-82). The median latency period was 7 months (range 0.23-86). The Bullous pemphigoid-dipeptidase-4 inhibitors association was established with a reporting odd ratio = 70.0 (95% confidence intervals 49.1-10.1). In the combined analysis of the three aforementioned pharmacovigilance databases, the pooled reporting odd ratio was 81.0 (95% confidence intervals 69.5-94.4). Conclusion The composite estimator for the three national pharmacovigilance databases yields clear evidence of a Bullous pemphigoid-dipeptidase-4 inhibitors association, which was statistically significant for both the pharmacological class as a whole and each of the dipeptidase-4 inhibitors agents under investigation. Metformin's role in the incidence of bullous pemphigoid appeared casual rather than causal. No differences between Caucasian and Asian populations were noted.
Background: Despite the wide benefits of aspirin and its cost-effectiveness, aspirin prescriptions have been reduced due to idiosyncratic responses in susceptible individuals. Low-dose aspirin and single-nucleotide polymorphisms (SNPs) are independently associated with increased risk of gastrointestinal hemorrhage; however, to-date, no studies investigated the SNP-aspirin interaction effect on upper gastrointestinal hemorrhage (UGIH). Therefore, we aimed to evaluate the role of 25 SNPs in multiple genes involved in platelet activation, angiogenesis and inflammatory response in aspirin-related UGIH. Methods: A multicenter, full case-control study was conducted in patients exposed and unexposed to aspirin. Three hundred twenty-six cases diagnosed with UGIH were matched with 748 controls (1:3) by age, gender, health center, and recruitment date. Only adults of European origin were included. Participants were stratified by aspirin exposure and genotype [(Aspirin (−) , wild-type), (Aspirin (+) , wild-type), (Aspirin (+) , genetic variation), (Aspirin (−) , genetic variation)]. For each SNP, the Odds Ratio of UGIH and their 95% confidence intervals were estimated in each subgroup by using the generalized linear mixed models for dependent binomial variables. SNP-aspirin interaction effect was estimated through Relative Excess Risk due to Interaction (RERI) measures.
ObjectivesThe aims of the present study were: (1) to describe psychotropic drug consumption patterns in an outpatient population aged 65 years and older; (2) to determine the impact of a number of demographic and clinical factors on psychotropic consumption; and (3) to determine the ratio of potentially inappropriate psychotropic agents prescribed to the above population.MethodsCross-sectional, observational study of outpatients aged 65 years and older. Data on sociodemographic and clinical variables were collected. Psychotropic drugs were classified into three categories: anxiolytics-hypnotics, antidepressants, and antipsychotics. To determine the risk factors for psychotropic drug use among these patients, a multivariate logistic regression model was developed and subsequently validated using bootstrap resampling techniques. To identify the psychotropic drugs to be avoided, a review of treatments received by the patients was performed based on the 2015 version of the Beers criteria.ResultsThe study included 225 outpatients of whom 30.7% were on psychotropic drugs for chronic treatment. The highest likelihood of psychotropic utilisation corresponded to the following profile: female, living in a nursing home, having two or more prescribing physicians, and having received six or more different diagnoses. According to Beers criteria, 51 patients (22.7% of the sample and 73.9% of patients on psychotropic drugs) had been prescribed at least one potentially inappropriate psychotropic drug.ConclusionElderly patients commonly use psychotropic medications and are the most vulnerable to the adverse effects of these drugs. It is necessary to re-evaluate the pertinence and accuracy of these medical prescriptions.
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