Clinical Knowledge Summaries (CKS) has been further updated in December 2010 for the following clinical areas:
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
The Lancet has published the results of a meta-analysis that aimed to assess the effect of aspirin in preventing death from cancer. The results of this study have been reported in the general media (BBC).
The review included data from 8 trials involving 25,570 individuals. The aspirin was used in each of these studies to prevent or treat atherosclerotic disease. These studies also collected data on cancer deaths. Individual patient data were available in 7 of the 8 studies.
The results from all 8 studies indicate a 21% relative risk reduction (pooled odds ratio [OR] 0·79, 95% CI 0·68–0·92, p=0·003) while the individual patient data analysis involving 7 studies indicated similar results over 5 years (hazard ratio 0·66, 0·50–0·87, p=0·003).
The data from all 8 studies shows an absolute risk of death from cancer of 3.01% in patient not taking aspirin compared to 2.33% in those assigned to aspirin. This is an absolute risk reduction of 0.68% or a number needed to treat (NNT) of 147 over approximately 5 years to prevent one death from cancer.
This analysis did not make any assessment of the harms of aspirin in this patient group.
Action: Clinicians should be aware of this study. The media reporting may generate patient queries. The chance of benefit is 6 or 7 in 1,000 over 5 years and perhaps more research needs to be done before recommending aspirin as a national cancer prevention strategy.
The National Institute of Health and Clinical Excellence has published new guidance for the month of December 2010. This month there are two technology appraisals that impact upon primary care.
The clopidogrel and modified-release dipyridamole for the prevention of occlusive vascular events technology appraisal is a review (PDF). There has been a change in the advice as follows:
- Treatment with modified-release dipyridamole in combination with aspirin for people who have had an ischaemic stroke is now recommended only if clopidogrel is contraindicated or not tolerated
- Treatment with modified-release dipyridamole in combination with aspirin for people who have had an ischaemic stroke or a transient ischaemic attack is no longer limited to 2 years’ duration from the most recent event
- Clopidogrel is no longer recommended only for people who are intolerant of aspirin and have had an occlusive vascular event or have peripheral arterial disease
There is also a new appraisal for prucalopride (Resolor®) for the treatment of chronic constipation in women (PDF). Treatment is recommended provided at least two different types of laxatives at the highest possible recommended doses, for at least 6 months, which has provided inadequate relief and invasive treatment for constipation is being considered. In this instance a 4 week trial can be offered with a subsequent review of benefit. It is also recommended that prescribing is undertaken by a clinician with experience of treating chronic constipation.
Action: Clinicians should be aware of these recommendations and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Denosumab (Prolia®) has been accepted for restricted use in postmenopausal women at increased risk of fractures provided the bone mineral density (BMD) T-score is < -2.5 and ≥ -4.0 for whom oral bisphosphonates are unsuitable. The same drug has been rejected for use in men treated with hormonal manipulation for prostate cancer who are at increased risk of fractures. The manufacturer did not make a submission for this indication.
Tacrolimus granules (Modigraf®) has been accepted for restricted use in prophylaxis of transplant rejection and treatment of allograft rejection in patients for whom tacrolimus is an appropriate choice and where small dose adjustment may be needed or where seriously ill patients are unable to swallow tacrolimus capsules.
Ranolazine (Ranexa®) has been rejected for use as add-on therapy for the symptomatic treatment of patients with stable angina pectoris. The economic analysis was not sufficiently robust to gain acceptance.
Etonogestrel 68mg implant (Nexplanon®) has been accepted for use as a long-acting choice of contraception. This is the x-ray opaque version of Implanon®.
Diclofenac 4% spray gel (Mobigel Spray®) has been rejected for the local symptomatic relief of mild to moderate pain and inflammation following acute blunt trauma. The manufacturer failed to make a submission.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for December 2010 (PDF).
This issue contains drug safety advice updating clinicians on the potential risk of arrhythmia with saquinavir. This drug can prolong the QT and PR interval and as an additional precaution it is now recommended to use a reduced dose for the first week of treatment.
The stop press section informs readers that the European Medicines Agency has recently completed a review of the safety and efficacy of fibrates. This review concluded that the benefits of treatment with these drugs continue to outweigh the risks but that these drugs should not be used as first line therapies except in patients with severe hypertriglyceridaemia or those who cannot take statins.
Finally, this issue contains an end of year drug safety quiz that will test your knowledge of drug safety information and may be useful in demonstrating participation in continuing professional development.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.