ArticleDrug safety2012
Prescribing of rosiglitazone and pioglitazone following safety signals: analysis of trends in dispensing patterns in the Netherlands from 1998 to 2008.
Article in Drug safety, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
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Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Measuring the impact of medicines regulatory interventions - Systematic review and methodological considerations.British journal of clinical pharmacology · 2018Pooled it
- Assessing the Impact on Health of Pharmacovigilance Activities: Example of Four Safety Signals.Drug safety · 2021Article
- Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies.Pharmacology research & perspectives · 2020Article
- Prescribing Variation in General Practices in England Following a Direct Healthcare Professional Communication on Mirabegron.Journal of clinical medicine · 2018Article
- Effects of a primary care intervention to improve the quality of zolpidem prescriptions in elderly patients.European journal of clinical pharmacology · 2017Article
- Prescription behavior for gastroprotective drugs in new users as a result of communications regarding clopidogrel - proton pump inhibitor interaction.Pharmacology research & perspectives · 2016Article
- Treating Diabetes in Patients with Heart Failure: Moving from Risk to Benefit.Current heart failure reports · 2016Review
- Prescribing Pattern of Oral Antihyperglycaemic Drugs, Rationality and Adherence to American Diabetes Association (ADA) Treatment Guidelines among Type 2 Diabetes Mellitus (T2DM) Postmenopausal Women.Journal of clinical and diagnostic research : JCDR · 2016Article
- Cardiovascular safety of dipeptidyl peptidase-4 inhibitors: recent evidence on heart failure.American journal of translational research · 2016Article
- Influence of health warnings on the use of rosiglitazone and pioglitazone in an area of Spain: A time-series study.SAGE open medicine · 2016Article
- Effects of safety warnings and risk management plan for Thiazolidinediones in Taiwan.Pharmacoepidemiology and drug safety · 2015Article
- Comment on: prescribing of rosiglitazone and pioglitazone following safety signals analysis of trends in dispensing patterns in The Netherlands from 1998 to 2008.Drug safety · 2014Article
- Article
- Utilisation trends of rosiglitazone and pioglitazone in Australia before and after safety warnings.BMC health services research · 2014Article
- The impact of direct healthcare professional communication on prescribing practice in the UK hospital setting: an interrupted time series analysis.Drug safety · 2013Article
- The past, present and perhaps future of pharmacovigilance: homage to Folke Sjoqvist.European journal of clinical pharmacology · 2013Article
- Rosiglitazone use and associated adverse event rates in Canada between 2004 and 2010.BMC research notes · 2013Article
- Prescribing pattern of glucose lowering drugs in the United Kingdom in the last decade: a focus on the effects of safety warnings about rosiglitazone.British journal of clinical pharmacology · 2013Article
- Article
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRelevant safety signals in the EU are regularly communicated in so-called 'Direct Healthcare Professional Communications' (DHPCs) or European Medicines Agency (EMA) press releases. Trends of a decrease in the use of rosiglitazone following regulatory safety warnings have been described in the US. In the EU, however, relatively little is known about dispensing patterns following DHPCs or other safety signals such as EMA press releases.
objectiveThe objective of this study was to analyse trends in dispensing patterns of rosiglitazone and pioglitazone following DHPCs and EMA press releases in the EU member state, the Netherlands.
methodsData for this study were obtained from the PHARMO Record Linking System, which includes drug dispensing records from community pharmacies of approximately 2.5 million individuals in the Netherlands. Over the period 1998-2008 an auto-regressive, integrated, moving average model (ARIMA) was fitted. The DHPC letters or EMA press releases were used as determinants. Adjustments were made for publication of certain literature. Stratification was performed for dispensings prescribed by general practitioners (GPs) and those prescribed by specialists.
resultsFor rosiglitazone, four EMA press releases and two DHPCs were issued; for pioglitazone, one DHPC was issued. The number of rosiglitazone dispensings prescribed by GPs decreased significantly after publication of DHPCs and EMA press releases concerning the risk of macular oedema and risk of fractures (both p-values 0.001). The number of rosiglitazone dispensings decreased statistically significantly after publication of EMA press releases 2 and 3 concerning cardiovascular risks but not for EMA press release 4. Adjustment for certain publications in the literature reduced the effect of communicated safety issues on the proportion of dispensings.
conclusionsAlthough it is difficult to disentangle the effect of DHPCs and EMA press releases from the effect of reports published in the literature, our results suggest that prescribers may react to such safety communications.
Indexed as
Identifiers
22540371What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.