By Alisdair Stirling
GPs reviewing patients on rosiglitazone should consider switching them straight over to pioglitazone- unless there is a reason for them not to be on a thiazolidinedione – say diabetes GPSIs.
The advice from the Primary Care Diabetes Society comes after the European Medicines Agency suspended the licence for rosiglitazone after deciding the benefits no longer outweighed the risks of myocardial infarction and strokes.
The UK drugs regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), advised GPs to call in anyone taking rosiglitazone while patients were told to keep taking their treatment but to contact their GPs.
Avandia, and the rosiglitazone-metformin combination Avandamet, will stop being available in Europe within the next few months, the EMA announced, insisting the suspension will remain in place unless the manufacturer, GlaxoSmithKline, can ‘provide convincing data to identify patients in whom the benefits of the medicines outweigh their risks.’
Sir Gordon Duff, chair of the MHRA’s committee on human medicines, said in a letter to all GPs: ‘The [regulator] has reviewed the available data and has concluded that there is an increased cardiovascular risk for rosiglitazone.
‘It has not been possible to identify additional measures that would reduce the cardiovascular risk or to identify a patient population in whom the benefits continue to outweigh the risks.’
Dr Brian Karet, diabetes lead for North Bradford PCT and committee member of the Primary Care Diabetes Society said the society was suggesting GPs should switch patients to pioglitazone –unless the review suggested there was a reason they should not be on a thiazolidinedione. “If there is a reason why TZD treatment is not appropriate – such as their control isn´t good on the higher doses of rosiglitazone – GPs should review the patient´s glycaemic needs and consider alternative treatments such as a gliptin or a GLP-1. are,” he said.
Data from clinical trials, observational studies and meta-analyses of existing studies that have become available over the last three years have suggested an increased risk of ischaemic heart disease associated with the use of rosiglitazone.
Dr Ellen Strahlman, chief medical officer at GSK, said the company still considered that the drug was a safe and effective treatment ‘when used appropriately’.
‘GSK is working closely with the regulatory authorities and healthcare professionals to implement the changes,’ she said.
Diabetes test Timeline to suspension
2007: US Food and Drug Association issues alert after studies find rosiglitazone may increase the risk of heart attack by up to 43%
2008: New NICE guidance says there is a “clinically important risk” of hearts attacks associated with the drug
2009: Analysis shows GPs have switched a third of patients on rosiglitazone to alternative drugs
July 2010: EMA announces major review after study shows 28 to 39% increased risk of heart attack. Commission on Human Medicines which advises the MHRA calls for prompt action
July 2010: The US regulator decides not to suspend the licence after a tense, two day meeting but recommends stricter prescribing controls
September 2010: BMJ editorial calls for drug to be withdrawn immediately September 23 2010 EMA recommends drug should be pulled from the market