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Utrecht, Netherlands

Garcia Rodriguez L.A.,Spanish Center for Pharmacoepidemiologic Research | Herings R.,Pharmo Institute | Herings R.,Erasmus University Rotterdam | Johansson S.,Astrazeneca | Johansson S.,Gothenburg University
Pharmacoepidemiology and Drug Safety | Year: 2010

Background: Statins (inhibitors of 3-hydroxy-3-methyl-glutaryl-CoA reductase) are associated with rare but serious adverse events involving the muscle, kidney and liver. To compare the safety profile of rosuvastatin with other marketed statins, four pharmacoepidemiological studies were conducted using different national healthcare databases. These studies used a coordinated methodology to facilitate future meta-analysis. Objective: To achieve enhanced estimates of rosuvastatin safety relative to other statins, by performing a meta-analysis of four rosuvastatin safety studies. Methods: Outcomes were identified using computerised codes, and validated using hospital records or questionnaires. Incidence estimates were based on current statin exposure. Incidence estimates for hospitalised myopathy, rhabdomyolysis, acute renal failure and acute liver injury among users of rosuvastatin and users of other statins were pooled across studies using a weighted average corresponding to the Mantel-Haenszel estimate of the common relative risk. Results: More than 29 900 person-years were accrued for rosuvastatin use and more than 166 900 person-years were accrued for other statin use. Relative to other statins, rosuvastatin was not associated with significant differences in the incidence of hospitalised myopathy (+0.5 cases per 10 000 person-years; 95%CI: -0.6 to 1.6), rhabdomyolysis (+0.7 cases per 10 000 person-years; 95%CI: -0.3 to 1.6), acute renal failure (-0.2 cases per 10 000 person-years; 95%CI: -2.9 to 2.5) or acute liver injury (-0.8 cases per 10 000 person-years; 95%CI: -1.8 to 0.2). Conclusion: In this large sample (~200 000 person-years), no significant difference in the risk of myopathy, rhabdomyolysis, acute liver injury or acute renal failure was seen between rosuvastatin and other statins. Copyright © 2010 John Wiley & Sons, Ltd. Source

Van Den Ban E.,Institute for Mental Health | Van Den Ban E.,University Utrecht | Souverein P.,University Utrecht | Meijer W.,Pharmo Institute | And 4 more authors.
European Child and Adolescent Psychiatry | Year: 2014

To study the association between attention deficit hyperactivity disorder (ADHD) drug use and the incidence of hospitalization due to injuries. A random sample of 150,000 persons (0-18 years) was obtained from the Dutch PHARMO record linkage system. An ADHD medication cohort as well as an up to six age/sex/index date sampled control cohort with no history of ADHD drug use was formed. Differences in incidence of hospitalization due to injuries were stratified for age and sex and compared prior, during and after exposure on ADHD drugs. The overall incidence of hospital admissions for injuries was two times higher in the ADHD medication cohort [incidence rate ratios (IRR) 2.2 (95 % CI 1.6-2.9)]. The incidence rate for injuries during exposure to ADHD drugs was lower in the exposed period compared to the period prior to ADHD drug use, although the difference was not statistically significant [IRR 0.68 (95 % CI 0.29-1.60)]. The relative risk for injuries was almost five times higher in the ADHD medication cohort among those who concomitantly used other psychotropics [IRR 4.8 (95 % CI 1.4-16.9)]. Risk for injuries was highest in 12-18 years olds. Children and adolescents using ADHD medication showed a twofold risk for hospital admissions for injuries. ADHD drug use might diminish the increased injury risk, but still overall risk is higher than in age/sex sampled children and adolescents without treatment with ADHD drugs. Use of ADHD and concomitant psychotropics increases the risk for injuries compared to only ADHD drug use. © 2013 Springer-Verlag Berlin Heidelberg. Source

Penning-van Beest F.J.,Pharmo Institute
Journal of medical economics | Year: 2011

Several pharmacological therapies are available to help smokers quit. The aim was to investigate the utilisation and effectiveness of smoking cessation drugs in daily practice in the Netherlands. Subjects aged ≥18 years with a pharmacy prescription of varenicline, bupropion, nicotine replacement therapy (NRT) or nortriptyline between March 2007 and September 2008 were identified from the PHARMO data warehouse, which includes drug dispensing, hospitalisation and other data from approximately 2.5 million residents in the Netherlands. Using an encrypted methodology, corresponding non-person-identifiable dispensing IDs were linked to a web-based system for patient-reported data collection. Corresponding pharmacists asked the subjects to participate in the study and complete a web-based questionnaire on smoking history and cessation, including utilisation of (pharmaco) therapies. Of 2,684 invited subjects, 698 responded (26%), of whom 612 were included in the analyses. Bupropion was the most frequently used smoking cessation drug (35% of patients), followed by varenicline (28%), bupropion+NRT (12%) and varenicline+NRT (9%). Overall, 51% of patients also reported behavioural therapy. A total of 53% of bupropion users, 51% of varenicline users, 42% of NRT users and 20-40% of patients using multiple drugs reported to not smoke at the time of questionnaire. Median (interquartile range) number of days between time of questionnaire and start date of last quit attempt ranged from 271 (104-432) for varenicline+bupropion to 356 (205-518) for bupropion. Mean duration of drug use ranged from 42 to 53 days among quitters and from 19 to 42 days among relapsers. In this study up to 50% of patients who obtained smoking cessation drugs at the pharmacy stopped smoking. Better access to smoking cessation drugs as recommended in guidelines will help to further decrease smoking prevalence. Source

Coloma P.M.,Erasmus Medical Center | Schuemie M.J.,Erasmus Medical Center | Trifiro G.,Erasmus Medical Center | Gini R.,Agenzia Regionale di Sanita | And 8 more authors.
Pharmacoepidemiology and Drug Safety | Year: 2011

Purpose: In this proof-of-concept paper we describe the framework, process, and preliminary results of combining data from European electronic healthcare record (EHR) databases for large-scale monitoring of drug safety. Methods: Aggregated demographic, clinical, and prescription data from eight databases in four countries (Denmark, Italy, Netherlands, the UK) were pooled using a distributed network approach by generation of common input data followed by local aggregation through custom-built software, Jerboa©. Comparison of incidence rates of upper gastrointestinal bleeding (UGIB) and nonsteroidal anti-inflammatory drug (NSAID) utilization patterns were used to evaluate data harmonization and quality across databases. The known association of NSAIDs and UGIB was employed to demonstrate sensitivity of the system by comparing incidence rate ratios (IRRs) of UGIB during NSAID use to UGIB during all other person-time. Results: The study population for this analysis comprised 19 647 445 individuals corresponding to 59 929 690 person-years of follow-up. 39 967 incident cases of UGIB were identified during the study period. Crude incidence rates varied between 38.8 and 109.5/100 000 person-years, depending on country and type of database, while age-standardized rates ranged from 25.1 to 65.4/100 000 person-years. NSAID use patterns were similar for databases within the same country but heterogeneous among different countries. A statistically significant age- and gender-adjusted association between use of any NSAID and increased risk for UGIB was confirmed in all databases, IRR from 2.0 (95%CI:1.7-2.2) to 4.3 (95%CI: 4.1-4.5). Conclusions: Combining data from EHR databases of different countries to identify drug-adverse event associations is feasible and can set the stage for changing and enlarging the scale for drug safety monitoring. © 2010 John Wiley & Sons, Ltd.. Source

Sasane R.,Global Health Economics and Outcomes Research | Hodgkins P.,Global Health Economics and Outcomes Research | Meijer W.,Pharmo Institute | Meijer W.,Erasmus Medical Center
Current Medical Research and Opinion | Year: 2010

Objective: To evaluate the number of patients reaching stable treatment with a stimulant (methylphenidate or dexamphetamine) or non-stimulant (atomoxetine) attention-deficit/hyperactivity disorder (ADHD) medication approved for use in the Netherlands, and the time to treatment stabilization among children and adolescents aged 617 years. Research design and methods: Prescription data from the PHARMO medical record linkage system from 48 geo-demographic areas in the Netherlands (20032006) were analyzed from newly treated patients with ADHD aged 617 years. Only patients with 5 dispensings for any ADHD drug during follow-up (at least 12 months) and no missing information on type of drug, strength, and number of pills per day were included. Main outcome measures: Attainment of a stable dosing regimen was defined as no change in type of drug (including a switch from an immediate release (IR) to a long-acting (LA) formulation), strength, and number of pills per day for five consecutive dispensings. Time to stable dosing regimen was defined as the number of days between the first dispensing for an ADHD drug and the first of five unchanged dispensings. Results: Of 4909 children or adolescents initiating treatment, 3099 met selection criteria. More patients starting therapy with LA methylphenidate (82.4) achieved treatment stabilization during follow-up than with IR methylphenidate (74.8; p<0.01) or atomoxetine (69.8; p<0.05). More patients initiated on LA methylphenidate patients (43.9) achieved treatment stabilization without changing their index medication or dose compared to those initiated on IR methylphenidate (25.3) or atomoxetine (8.1; p<0.0001 for both comparisons). Among patients achieving treatment stabilization, those initiating treatment with LA methylphenidate had a significantly shorter time to treatment stabilization (14 days) than patients initially treated with IR methylphenidate (56 days; p<0.001) or atomoxetine (31 days; p<0.05). Mean number of pills per day varied between 1.0 and 1.8 at initial treatment and 1.1 and 1.9 at treatment stabilization. Potential limitations of the study include the use of ADHD-medication dispensing as a proxy for an ADHD diagnosis and the impact of different titration schedules for the various ADHD medications. Conclusion: Overall, 2316 of the 3066 eligible patients (75.5) achieved treatment stabilization during follow-up. Among children and adolescents with ADHD in the Netherlands, the time to treatment stabilization varied according to choice of initial treatment and was shortest for LA methylphenidate. © 2010 Informa UK Ltd All rights reserved. Source

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