The European Medicines Agency (EMEA) has recommended that the product licence for rimonabant (Acomplia®) is suspended. This announcement has reached the general media (BBC).
The Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of rimonabant no longer outweigh its risks and the marketing authorisation should be suspended across the European Union (EU). This decision has been reached because post-marketing experience indicates that serious psychiatric disorders may be more common than in the clinical trials
The Medicines and Healthcare products Regulatory Agency have written to healthcare professionals (PDF) with the following advice:
- Prescribers should not issue any prescriptions for rimonabant, and should review the treatment of those who are currently taking this medicine
- Patients who are currently taking rimonabant should consult their doctor or pharmacist at a convenient time to discuss their treatment. If patients wish to stop taking rimonabant, it is safe to do so at any time
- Patients who are currently enrolled in clinical trials of rimonabant may wish to contact the trial investigator (the doctor who is treating them), who will be able to give more information. Trial investigators are being notified of this suspension of the marketing authorisation
Action: Clinicians should be aware of the licence suspension. No new prescriptions should be issued and patients currently using this medication should be advised to return it to a pharmacy for destruction.
Diabetes Care has published an updated consensus algorithm for the initiation and adjustment of therapy to treat hyperglycaemia in type 2 diabetes. The American Diabetes Association and the European Association for the Study of Diabetes make the recommendations.
The algorithm was first published in 2006 with the expectation that it would be updated as new data and new interventions become available. This update places lifestyle and metformin as first line interventions with sulphonylureas and insulin recommended as second line agents. Strategies that are less well validated include pioglitazone, gliptins and triple therapy.
The recommendations particularly advise against using rosiglitazone stating that, "although the meta-analyses are not conclusive regarding the potential cardiovascular risk associated with rosiglitazone the consensus group members unanimously advised against using rosiglitazone".
Clinicians will already be well aware of the safety concerns linking rosiglitazone with heart attacks. Updated prescribing information advises against using rosiglitazone in specific patients including acute coronary syndrome and ischaemic heart disease.
Action: Clinicians should consider exclusively using familiar therapies that have a proven efficacy and safety record.
The National Institute of Health and Clinical Excellence has published new guidance for the month of October.
There are two guidelines that may impact on primary care, a public health intervention looking at Mental wellbeing in older people (QRG) and a Clinical Guideline providing prevention and treatment advice for Surgical site infections (QRG).
The former guidance provides advice for occupational therapists led interventions to improve life satisfaction, optimism and self-esteem in people who have physical, mental and/or social needs.
The latter guidance offers advice risk minimisation and treatment of surgical site infections. Primary care clinicians may find this document useful when advising patients prior to invasive procedures.
Action: Primary care clinicians should be aware of these new guidelines. They may provide useful advice for patients.
Circulation has published the results of a study that aimed to assess the association between dietary patterns and acute myocardial infarction (AMI) using global data.
The study included data from 52 countries and matched 5,761 cases of AMI with 10,646 control subjects. Diet was classified simply using three dietary patterns:
- Oriental (high intake of tofu and soy and other sauces)
- Western (high in fried foods, salty snacks, eggs, and meat)
- Prudent (high in fruit and vegetables)
An analysis of overall dietary scores found that higher scores, indicating a poorer diet, were associated with an increased risk of AMI. This association was statistically significant (P for trend <0.001).
- First Quartile, Odds ratio 1.0 (reference)
- Second quartile, 1.29 (95% CI 1.17 to 1.42)
- Third quartile, 1.67 (95% CI 1.51 to 1.83)
- Fourth quartile, 1.92 (95% CI 1.74 to 2.11)
The authors conclude that, "An unhealthy dietary intake increases the risk of AMI globally and accounts for approximately 30% of the population-attributable risk".
Action: Clinicians should already be advising patients to consume a healthy diet. This data can be used to illustrate the impact a poor diet has on the risk of having a myocardial infarction.
Budesonide metered dose inhalers (Pulmicort®) will be replaced with CFC free versions at the end of the year. The manufacturer has advised healthcare professionals that the lowest dose (50 micrograms/actuation) will no longer be available and will be replaced by a higher strength (100 micrograms/actuation).
It is advised that patients currently taking the 50 microgram product at a dose of two puffs twice daily can be moved onto the new product however patients currently taking the lowest daily dose will require a review and perhaps an alternative treatment.
Action: Clinicians should be aware of this announcement. Patients currently using the affected product would benefit from a brief intervention to advise about the product change and to discuss alternatives.