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Tarapues M.,Autonomous University of Barcelona | Tarapues M.,Fundacio Institute Catala Of Farmacologia | Cereza G.,Autonomous University of Barcelona | Cereza G.,Fundacio Institute Catala Of Farmacologia | And 2 more authors.
Expert Opinion on Drug Safety | Year: 2015

Background: Renal impairment associated with dronedarone use is hardly known. Our aim is to describe the characteristics of spontaneous reports involving renal adverse reactions with use of dronedarone.Methods: In the Spanish Pharmacovigilance database, reports with renal reactions and dronedarone until May 2014 were retrieved and analyzed. Also, a review of case reports of renal failure and dronedarone was conducted in MEDLINE.Results: Dronedarone was found as a suspected drug in 192 reports, 10 (5.2%) of these reports described renal reactions. Renal reactions appeared until 3 months after the onset of dronedarone treatment. In 5 out of 10 cases, dronedarone was withdrawn and the patient recovered. The Reporting Odds Ratio was 2.88 [95% CI 1.52-5.46; p < 0.05]. Additionally, eight cases were found in the medical literature. In five of them, the patient outcome was described as recovered. One patient had to undergo hemodialysis for the treatment of their renal impairment.Conclusions: The effect of dronedarone on the renal function is supported by limited information; therefore, the cases from spontaneous reporting system and those from the medical literature could give relevant additional information. Our analysis shows a potential relationship between dronedarone use and renal impairment. Further studies are needed to confirm these findings. © 2015 Informa UK, Ltd.


Tarapues M.,Autonomous University of Barcelona | Cereza G.,Autonomous University of Barcelona | Cereza G.,Fundacio Institute Catala Of Farmacologia | Figueras A.,Autonomous University of Barcelona | Figueras A.,Fundacio Institute Catala Of Farmacologia
Pharmacoepidemiology and Drug Safety | Year: 2013

Purpose: Gliptins are new oral antidiabetic drugs that increase insulin levels through dipeptidyl peptidase-4 inhibition. Recently, the association of serious musculoskeletal (MSk) adverse effects with the gliptin use has been suggested. The aim is to describe and analyze the characteristics of spontaneous reports related to these adverse effects and gliptin use. Methods: All spontaneous reports with MSk disorders associated with gliptins gathered in the Spanish pharmacovigilance database until May 2012 were described and analyzed using a case/non-case method. Results: Gliptins were reported as the suspected drug in 332 cases: 208 involved sitagliptin, 115 vildagliptin, and nine saxagliptin. In 34 patients (10.2% of total reports with gliptins), MSk reactions were described (22 women [64.7%] and 12 men [35.3%]). Their mean age was 65.1years; 41.2% were younger than 65years. Only seven cases were serious, but the gliptin had to be withdrawn in 22 patients because of intolerance and/or persistence of MSk discomfort, and patients recovered after its discontinuation. A positive re-challenge was observed in two cases. In seven cases, the patients were on previous chronic treatment with statins, and began to present MSk complaints shortly after starting a gliptin. The reporting odds ratio (ROR) for myalgia and arthralgia were strongly associated with gliptin use (ROR 1.96 [95% CI 1.12-3.43], p<0.05 and ROR 2.69 [95% CI 1.38-5.24], p<0.05, respectively). Conclusions: Musculoskeletal disorders are adverse reactions strongly associated with gliptins that, despite not being serious, may impair the treatment adherence in patients with type 2 diabetes. Future observational studies could confirm these findings. © 2013 John Wiley & Sons, Ltd.


Ferrer P.,Fundacio Institute Catala Of Farmacologia | Ballarin E.,Fundacio Institute Catala Of Farmacologia | Ballarin E.,Hospital Universitari Vall Dhebron | Ballarin E.,Autonomous University of Barcelona | And 14 more authors.
International Journal of Public Health | Year: 2014

Objectives: This study aimed at outlining the characteristics of nationwide administrative databases monitoring drug consumption in Europe.Methods: Internet and bibliographic databases (April 2010) were searched and experts in drug utilization (DU) research interviewed to find nationwide administrative medicines consumption databases in Europe, with data for the out- and inpatient healthcare sector. A questionnaire was developed to gather additional information. We collected data providers, websites, accessibility, data sources, healthcare settings, population coverage, medicines-related data, patient and prescriber data, periods covered, and linkage to other databases.Results: Thirty-one administrative nationwide medicine consumption databases in 25 countries were identified. Questionnaires were responded for 20 databases. Eleven provided wholesalers’ sales data, 11 on reimbursed, 5 on prescribed, and 4 on dispensing medicines. Fifteen databases provided inpatient drug consumption data, mainly wholesalers’ sales.Conclusions: Nationwide administrative databases are of value to all stakeholders involved in the conduct and interpretation of post-marketing safety studies, and in the conduct of DU research. The endorsement of the anatomical therapeutic chemical/defined daily dose methodology by these databases contributes to data harmonization. However, there is still a lack of information on inpatient medicines consumption at a patient-level. © 2014, Swiss School of Public Health.


Hereu P.,Fundacio Institute Catala Of Farmacologia | Perez E.,Fundacio Institute Catala Of Farmacologia | Perez E.,Hospital Universitari Vall dHebron | Perez E.,Autonomous University of Barcelona | And 9 more authors.
Contemporary Clinical Trials | Year: 2010

Objective: To assess participants' knowledge of key aspects about the clinical trials in which they are enrolled, describe the consent process, and assess the importance that investigators give to various aspects of trial information when verbally informing candidates. Design: Prospective study based on a structured questionnaire interview of participants within 3. months after trial enrollment and an anonymous questionnaire sent to clinical trial investigators. Subjects: A total of 140 participants included in 40 clinical trials were interviewed, and 51 investigators answered the questionnaire. Results: The formal steps to obtain informed consent were usually carried out. Participants were aware of the purpose of the trial and the right to discontinue participation, but only 23% knew that treatment was randomly allocated, 57% knew they might receive a placebo, and 42% was aware that adverse effects could occur. Patients who had read the information sheet had better knowledge of most aspects, except for the risk of adverse effects. The investigators considered that compensation, insurance coverage, possibility of receiving a placebo, and treatment allocation were the least important aspects of the trial when informing candidates for participation. Conclusions: Although the formal steps for obtaining informed consent were usually carried out, a relevant percentage of patients included in clinical trials were unaware of important aspects of their participation. Patients showed more limited knowledge about the same points that investigators considered less important when informing potential participants. Deferring signature on the consent form and encouraging reading of the information sheet may improve participants' knowledge about clinical trials. © 2010 Elsevier Inc.


San-Jose A.,Hospital Universitari Vall dHebron | San-Jose A.,Autonomous University of Barcelona | San-Jose A.,Multimorbidity and Elderly Patients Group of the Spanish Society of Internal Medicine | Agusti A.,Hospital Universitari Vall dHebron | And 20 more authors.
European Journal of Internal Medicine | Year: 2014

Purpose: This study aims to assess inappropriate prescribing (IP) to elderly patients during the month prior to hospitalization and to compare different IP criteria.Methods: An observational, prospective and multicentric study was carried out in the internal medicine services of seven Spanish hospitals. Patients aged 75 years and olderwere randomly selected after hospital admission for a year. To assess potentially inappropriate medicines (PIMs), the Beers and STOPP criteriawere used and to assess potentially prescribing omissions (PPOs), the START criteria and ACOVE-3 medicine quality indicatorswere used. An analysis to assess factors associated with IP was performed.Results: 672 patients [median age (Q1Q3) 82 (7986) years, 55.9% female] were included. Median prescribed medicines in the month prior to hospitalization were 10(Q1Q3 713). The prevalence of IP was 87.6%, and 54.3% of patients had PIMs and PPOs concurrently. A higher prevalence rate of PIMs was predicted using the STOPP criteria thanwith the Beers criteria (p < 0.001) and a higher prevalence of PPOs using the ACOVE-3 criteria than using the START criteria (p < 0.001) was observed. Polypharmacy (≥10 medicines) was the strongest predictor of IP [OR = 11.34 95% confidence interval (CI) 4.9625.94], PIMs [OR = 14.16, 95% CI 6.4431.12], Beers-listed PIMs [OR = 8.19, 95% CI 3.0122.28] and STOPP-listed PIMs [OR = 8.21, 95% CI 3.4719.44]. PIMs was the strongest predictor of PPOs [OR = 2.79, 95% CI 1.814.28].Conclusions: A high prevalence of polypharmacy and PIMs and PPOs were reported. More than half the patients had simultaneous PIMs and PPOs. The related factors to PIMs and PPOs were different. © 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.


Fiz J.,Institute Of Recerca Hospital Del Mar Imim | Fiz J.,Autonomous University of Barcelona | Duran M.,Fundacio Institute Catala Of Farmacologia | Capella D.,Autonomous University of Barcelona | And 4 more authors.
PLoS ONE | Year: 2011

Background: The aim of this study was to describe the patterns of cannabis use and the associated benefits reported by patients with fibromyalgia (FM) who were consumers of this drug. In addition, the quality of life of FM patients who consumed cannabis was compared with FM subjects who were not cannabis users. Methods: Information on medicinal cannabis use was recorded on a specific questionnaire as well as perceived benefits of cannabis on a range of symptoms using standard 100-mm visual analogue scales (VAS). Cannabis users and non-users completed the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburgh Sleep Quality Index (PSQI) and the Short Form 36 Health Survey (SF-36). Results: Twenty-eight FM patients who were cannabis users and 28 non-users were included in the study. Demographics and clinical variables were similar in both groups. Cannabis users referred different duration of drug consumption; the route of administration was smoking (54%), oral (46%) and combined (43%). The amount and frequency of cannabis use were also different among patients. After 2 hours of cannabis use, VAS scores showed a statistically significant (p<0.001) reduction of pain and stiffness, enhancement of relaxation, and an increase in somnolence and feeling of well being. The mental health component summary score of the SF-36 was significantly higher (p<0.05) in cannabis users than in non-users. No significant differences were found in the other SF-36 domains, in the FIQ and the PSQI. Conclusions: The use of cannabis was associated with beneficial effects on some FM symptoms. Further studies on the usefulness of cannabinoids in FM patients as well as cannabinoid system involvement in the pathophysiology of this condition are warranted. © 2011 Fiz et al.


Sabate M.,Fundacio Institute Catala Of Farmacologia | Sabate M.,University of Barcelona | Ferrer P.,Fundacio Institute Catala Of Farmacologia | Ballarin E.,Fundacio Institute Catala Of Farmacologia | And 9 more authors.
Basic and Clinical Pharmacology and Toxicology | Year: 2015

Drug utilization (DU) studies in inpatient settings at a national level are rarely conducted. The main objective of this study was to review the general information on hospital medicine management in Europe and to report on the availability and characteristics of nationwide administrative drug consumption databases. A secondary objective was to perform a review of published studies on hospital DU of a group of selected drugs, focusing on methodological characteristics (ATC/DDD). General information on hospital drug management was retrieved from several websites, nationwide administrative drug consumption databases and reports published by governmental organizations. A PubMed search was conducted using keywords related to the selected group of drugs AND 'hospital drug utilization'. The data sources for hospital DU information varied widely and included 14 databases from 25 reviewed countries. Bulgaria, Croatia, Denmark, Estonia, Finland, France, Hungary, Iceland, Latvia, Norway and Sweden obtain information on inpatient DU at a national level from wholesalers/manufacturers. In Belgium, Italy and Portugal, drugs dispensed to patients in hospitals are registered at a national level. Data are freely available online only for Denmark and Iceland. From the PubMed search, of a total of 868 retrieved studies, only 13 studies used the ATC/DDD methodology. Although the number of DDD/100 bed-days was used in four studies, other units of measure were also used. The type of information provided for the inpatient sector allowed primarily for conducting DU research at an aggregated data level. The existence of national administrative structures to monitor hospital DU would contribute to promoting the rational use of medicines and improving the safety and quality of prescribing. © 2014 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).


PubMed | Novartis, Fundacio Institute Catala Of Farmacologia, University of Barcelona, Witten/Herdecke University and Ludwig Maximilians University of Munich
Type: | Journal: SpringerPlus | Year: 2015

Monitoring the use of antibiotics is relevant due to the public health impact of microbial resistance, adverse effects, and costs. We present data on the consumption of macrolides, lincosamides, streptogramins and amoxicillin/clavulanate (AMC) between 2007 and 2010 in the in-and outpatient healthcare setting in 10 European countries provided by IMS Health. Antibiotics were classified according to the anatomical therapeutic chemical classification and consumption was expressed in defined daily doses/1000 inhabitants/day (DIDs). We analysed the number of prescriptions by diagnostic codes between 2008 and 2010, based on the International Classification of Diseases, 10th revision (ICD-10). These ICD-10 codes were grouped into four main categories: respiratory infections, genitourinary infections, other infections and other diagnoses. In 2010, the consumption of macrolides and lincosamides ranged from 0.45 DIDs (Sweden) to 5.46 DIDs (Italy), and from 0.04 DIDs (Denmark) to 1.00 DID (Germany), respectively. Streptogramins were available in France, Germany, Italy, Norway, Spain and United Kingdom with a consumption of <0.001 DID exclusively in the hospital setting. The consumption of AMC ranged from <0.001 DIDs (Norway) to 11.67 DIDs (Spain). During the study period, the consumption of macrolides decreased, the consumption of AMC increased in most of European countries, and lincosamides varied very slightly. Macrolides and AMC were mainly prescribed for respiratory infections in all countries but United Kingdom, where most of the prescriptions were assigned to diagnostic codes not clearly related with an infection. Lincosamides were prescribed for the respiratory infections and other infections groups. There was a wide inter-country variability in the percentage of the prescriptions assigned to each of the diagnostic categories. The inter-country differences in the consumption of these antibiotics and their prescription by diagnostic categories point to an inappropriate use of antibiotics.


Ferrer P.,Fundacio Institute Catala Of Farmacologia | Rafaniello C.,The Second University of Naples | Sabate M.,Fundacio Institute Catala Of Farmacologia | Sabate M.,Autonomous University of Barcelona | And 10 more authors.
Epidemiology Biostatistics and Public Health | Year: 2014

Background: Antiepileptic drug (AED)consumption has increased in recent years mainly from those AEDs marketed since 1990. The purpose is to describe and compare AED consumption in Catalonia, Denmark and Norway.Methods: Population-based descriptive study set in the outpatient healthcare sector. Data were retrieved from the Norwegian Prescription Register, Danish Register of Medicinal Product Statistics and DATAMART® in Catalonia, for 2007-2011.We calculated defined daily doses/1000 inhabitants/day (DID), by age and gender. AEDs were defined according to the Anatomical Therapeutic Chemical classification (N03A). We reviewed the population covered by the databases, the drug data source and the definition of outpatient healthcare sector to compare the results across the three settings.Results: Total AED use steadily increased over the study period in the three settings. In 2011, consumption was highest in Catalonia (15.20 DID), followed by Denmark (15.06 DID) and Norway (14.24 DID). The “other AEDs” (N03AX) subgroup represented 60% of all AED use. The N03A pattern by gender did not differ across the three settings. Marked differences by age and gender appeared when studying lamotrigine, topiramate, gabapentin, pregabalin and levetiracetam. Differences among the databases were mainly in the definition of outpatient healthcare setting.Conclusions: There was a rapid increase in “other AEDs” in all three settings. Although we did not have information on the indication for the use of AEDs, the drug data source, population coverage of the database and definition of the healthcare setting helped us interpret the results. © 2014 Prex S.p.A. All right reserved.

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