Varenicline (Champix®) is in the news today after the National Institute of Health and Clinical Excellence issued a positive Final Appraisal Determination (FAD).
Final Guidance is expected in July and may be based upon the FAD provided there are no appeals against the existing content. The majority of the news coverage is focussing upon the efficacy of varenicline and debating whether this drug should be funded when recent cancer and Alzheimer's drugs have been rejected.
As previously discussed, varenicline is an option for patients who have failed to stop smoking using nicotine replacement therapy (NRT).
Action: Media coverage of varenicline is likely to increase requests, especially with the imminent smoking ban in England. NRT remains the first line choice; bupropion and varenicline are suitable alternatives where NRT treatment fails.
The Archives of Internal Medicine has published a paper that aimed to examine the impact of using Decision Aids to help patients make informed decisions about their medicines and thus improve compliance.
The study was a small study involving 98 patients with diabetes who were seen in an outpatient setting and provided with information about their 10-year cardiovascular risk. They were randomly provided with a standard pamphlet about statins or a tailored decision aid presenting information about absolute risk reduction and potential disadvantages to statin therapy.
Patients in the latter group were found to have a better understanding of the risks and benefits of treatment and were better prepared to make a decision about their own treatment. It was also observed that fewer patients in this group reported missing one or more doses at three months follow up (6% versus 21% in the control group).
This study demonstrates that provision of information is a key step in healthcare provision. Use of decision aids appears to provide patients with the information they need to make a decision and may improve medication compliance. Improved compliance is likely to improve outcomes and reduce waste.
Action: Clinicians should use Decision Aids and other tools to provide information to patients. Better transfer of information is likely to improve patient understanding of the therapy and may provide improved outcomes and reduced waste.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a statement following the publication of a meta-analysis in the New England Journal of Medicine linking rosiglitazone with cardiovascular events.
The publication of the original paper has already been covered, as has the FDA response to the study.
The MHRA have highlighted that the product information for rosiglitazone has carried warnings about heart failure since 2000 and myocardial infarction since 2006.
The MHRA advice is that "patients should not stop treatment with rosiglitazone but should discuss their medication with their doctor at their next routine appointment".
Action: Clinicians should be aware of the MHRA advice and discuss alternative treatment options with patients currently taking rosiglitazone at their next routine appointment.
The National Institute of Health and Clinical Excellence has published new guidance for the month of May. There are two new Clinical Guidelines covering Feverish Illness in Children and Secondary Prevention of Myocardial Infarction (MI).
The quick reference guideline for feverish illness in children provides advice for the assessment and management of fever in children under the age of 5. The topics covered include remote assessment, non-paediatric practitioner assessment, antipyretic interventions, a traffic light system for signs and symptoms and a list of symptoms and signs of specific diseases including meningitis, pneumonia and urinary tract infections.
The quick reference guideline for secondary prevention of MI provides a summary of lifestyle advice, cardiac rehabilitation after acute MI, recommendations for drug therapy for recent MI (less than 12 months ago) and less recent history of MI (more than 12 months ago). One of the key areas of change from the draft appears to be the advice about prescribing omega-3-acid ethyl esters. The advice in the full guideline recommends increased dietary intake of omega-3 fatty acids in the first instance. For patients who have had an MI within 3 months and who are not achieving this, supplementation can be considered and continued for up to 4 years. Treatment should not routinely be started in patients who are more than 3 months post-MI. Statins are recommended as the first line intervention for management of lipids, taking into account acquisition costs simvastatin will be the drug of choice.
Action: Clinicians, in both the primary and secondary care settings, who see feverish children or who treat patients for secondary prevention following an MI will find these guidelines to be a useful resource.
The Food and Drugs Administration in America has issued a safety alert for rosiglitazone in response to cardiovascular safety concerns raised by the New England Journal of Medicine (NEJM).
As previously discussed, the meta-analysis in the NEJM revealed a statistically significant 43% increase in myocardial infarctions and a non-significant 64% increase in the risk of cardiovascular death in patients taking rosiglitazone when compared to controls (placebo or other hypoglycaemics).
The FDA are advising that patients who have heart disease, or who are at high risk of developing heart disease, should talk to their doctor about this new information and the treatment options.
Action: Clinicians should be aware of this evolving situation and be prepared to discuss the risks and benefits of the alternative treatment options with concerned patients.