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Conventional NSAIDs are unlikely to pose a substantial cardiovascular risk and there is no need for GPs to change their use of the drugs, regulators have ruled.

The European Medicines Agency and the UK's Medicines and Healthcare Products Regulatory Agency reviewed NSAID safety after a clutch of new studies raised doubts over potential cardiovascular risks.

But the MHRA ruled the evidence on non-selective NSAIDs was 'insufficient' to change the balance of risks and benefits and said there should be no change to current prescribing practice.

The ruling comes in contrast to the recent review of cox-2 inhibitors, which concluded that cox-2s should be contraindicated in patients with ishaemic heart disease, cerebrovascular disease and peripheral arterial disease.

Professor Gordon Duff, chair of the MHRA's Committee on Safety of Medicines, said: 'Any cardiovascular risk of non-selective NSAIDs is likely to be small and associated with continuous long-term treatment and higher doses.'

But he said the evidence on NSAIDs did not allow 'firm conclusions' on the cardiovascular safety of naproxen, ibuprofen and diclofenac relative to one another or selective cox-2 inhibitors.

He added that the 'absence or paucity of evidence' on other NSAIDs should not be taken as meaning there was a lack of risk with them, and more studies were needed.

A study published in the BMJ in June sparked widespread confusion over the safety of conventional NSAIDs, after finding ibuprofen and diclofenac were associated with an increased risk of myocardial infarction.

Professor Julia Hippisley-Cox, leader of the BMJ study and professor of clinical epidemiology and general practice at the University of Nottingham, told Pulse that she agreed with the MHRA that there was insufficient evidence to change prescribing advice. But she also agreed that there was a need for further research on NSAIDs other than ibuprofen, diclofenac and naproxen.

She added: 'We have a paper on the gastrointestinal risks with the BMJ and it is clearly important to weigh up NSAID risks and benefits.'

By Nerys Hairon

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