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Abstract
Rimonabant suspended
The EMEA has recommended suspending the marketing authorisation for rimonabant (Acomplia) across the EU because adverse effects outweigh its benefits.
Rimonabant, a cannabinoid receptor antagonist, was introduced in 2006 for the treatment of obesity. Adverse psychiatric effects, in particular depression, were known at the time but the EMEA believes early clinical trials underestimated the risk.
Postmarketing surveillance data and recent trials show that rimonabant doubles the risk of psychiatric disorders compared with placebo. Further, rimonabant has proved less effective than trials predicted because in practice the duration of use has been shorter.
Patients need not stop taking rimonabant immediately but should review their treatment with a doctor or pharmacist. No new prescriptions should be issued.
Orlistat goes OTC
The EMEA has recommended a switch from POM to P for a low‐dose formulation of orlistat. Alli contains a 60mg dose — half the prescription‐only dose — and is licensed for use by overweight patients (BMI ≥28) in conjunction with diet. Package labelling will encourage users to continue to see their doctor for health issues related to overweight, such as hypertension and diabetes.
Alli is already available in the United States, where it is supported by the manufacturer's website ( www.myalli.com).
Only metformin reduces diabetes CV mortality
Metformin may be the only oral antidiabetic agent that reduces cardiovascular death in people with diabetes, a systematic review suggests (Arch Intern Med 2008;168: 2070–80).
The meta‐analysis of 40 controlled trials found that metformin was associated with a statistically significant 26 per cent reduction in cardiovascular death compared with placebo or other antidiabetic drugs; the results for CV morbidity and all‐cause mortality were similar but not significant. No other drugs were associated with these outcomes. The risk of cardiovascular morbidity and mortality was higher with rosiglitazone but not significantly so.
Longer trials with clearer cardiovascular end‐points are needed, the authors conclude.
No stillbirth risk with nicotine replacement
Nicotine replacement therapy (NRT) does not increase the risk of stillbirth, Danish epidemiologists say (Br J Obstet Gynaecol 2008;115: 1405–10).
Their cohort study involving 87 032 pregnancies found an overall rate of stillbirth of 5.7/1000. The rate among women using NRT was 4.2/1000. Compared with nonsmoking women who did not use NRT, the risk of stillbirth was not significantly different among NRT users and smokers who also used NRT, but was increased among smokers (hazard ratio 1.46).
Policy to use cheaper statins supported
PCTs using high levels of simvastatin and pravastatin achieve their QOF cholesterol targets for CHD, stroke and diabetes as effectively as those using expensive statins such as atorvastatin (Lipitor) and rosuvastatin (Crestor), the Leeds Prescribing Support Unit has shown (J Health Serv Res Policy 2008;13:99–102).
Average PCT values for these targets were 78, 72 and 79 per cent respectively; simvastatin and pravastatin accounted for an average of 57 per cent of statins prescribed (range 18–84 per cent). There was no evidence that type of statin used correlated with success achieving QOF targets.
This evidence supports a policy of prescribing the least expensive statins, the authors say.
Dihydropyridine CCBs/clopidogrel interaction?
Dihydropyridine calcium‐channel blockers (CCBs) may impair the antiplatelet effect of clopidogrel (Plavix), Austrian researchers believe (J Am Coll Cardiol 2008;52: 1557–63).
In patients undergoing percutaneous coronary interventions, platelet inhibition was decreased in 40 per cent of those taking a CCB plus clopidogrel compared with 20 per cent taking clopidogrel alone, after adjustment for cardiovascular risk factors. ADP‐induced platelet aggregation was 30 per cent higher in those taking both drugs. These effects were not evident in vitro, suggesting they may be due to inhibition of CYP3A4 enzymes by CCBs. Clinical outcomes were worse in patients taking a CCB. Copyright © 2008 Wiley Interface Ltd
Digital Object Identifier (DOI)
10.1002/psb.313 About DOI
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