The Food and Drugs Administration has issued a 'not approvable' letter for lumiracoxib (Prexige®) according to a press release from the manufacturer. PharmaTimes have also reported this story.
This rejection follows shortly after withdrawal of the drug in Australia, announcement of a full review of the drug in Canada and restrictions on use in Europe.
Action: Clinicians should be aware of the continued concerns about this drug. Patients on existing treatment should be changed to safer alternatives where possible.
A research article published in PLoS:Medicine has found that many clinicians are not aware of the cost of the drugs they prescribe but that they would welcome improved access to cost information.
The paper included 24 articles in the analysis and overall cost accuracy was low with less than a third of responses within a 25% margin of the actual cost of the drug. Fewer than half of the estimates could be defined as accurate using any definition of cost accuracy. High-cost drugs were estimated more accurately but there was a consistent (p < 0.001) overestimation of the cost of inexpensive products and underestimation of the cost of expensive ones.
The authors recommend that, "much more focus is required in the education of physicians about costs and the access to cost information". They also suggest that future work could involve assessment of accessibility and reliability of medical cost information and whether this information improves clinician prescribing.
Action: Access to cost information in sources such as the British National Formulary or Drug Tariff will allow clinicians to prescribe with due consideration of the true cost of treatment.
Thanks to Jane Dickson for spotting this article
The Lancet: Infectious Diseases has published a review of the evidence base supporting the use of influenza vaccination to reduce mortality in the elderly.
Placebo-controlled randomised trials have shown that the influenza vaccine is effective in younger adults but few trials have included older people despite the majority of influenza-related deaths occurring in those aged over 70. Recent mortality studies have failed to show reductions in influenza-related mortality since 1980 even though uptake of the vaccine has risen from 15% to 65%. It is also noted that observational studies that do report a benefit often contain a substantial and unadjusted selection bias.
The authors conclude that the remaining evidence is insufficient to indicate the magnitude of the mortality benefit but they also state that the current vaccination programme should continue because "even a partly effective vaccine would be better than no vaccine at all".
Action: Clinicians should be aware of this review and the conclusion that vaccination is still recommended. Patients may need some reassurance if this paper is reported in the general media.
A second Human Papillomavirus Vaccine (Ceravix®) has been licensed for use in Europe. The Summary of Product Characteristics (SPC) is available online and PharmaTimes has reported the launch.
The officially licensed indications are slightly different compared to Gardasil®. The Ceravix vaccine is licensed for use in the prevention of high-grade cervical dysplasia (CIN 2/3) and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18.
Gardasil (SPC) is additionally indicated for high-grade vulvar dysplastic lesions (VIN 2/3) and external genital warts causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18.
As previously reported, the Department of Health has announced that it has agreed, in principle to accept Joint Committee on Vaccinations and Immunisations (JCVI) advice that Human Papilloma Virus vaccines and it is expected that vaccinations could start in Autumn 2008.
Action: Clinicians should be aware of this alternative vaccine and the slightly different licensed indications. Until a national programme is launched, the decision to prescribe should be made on an individual basis after consideration of the clinical benefit to the patient and assessment of the overall cost incurred.
The manufacturer has insulin detemir (Levemir®) has announced that previously observed weight benefits extend to 2 years in patients with type 1 diabetes. PharmaTimes has reported this finding following presentation of the results at the Annual Meeting of the European Association for the Study of Diabetes (EASD).
The study was a 2 year open-label study in 497 patients with type 1 diabetes comparing insulin detemir with NHP insulin. Both groups were also treated with short acting insulin at mealtimes.
In patients who were treated with insulin detemir:
- Average HbA1c was lower (7.36% versus 7.58%)
- More patients reached a HbA1c target of <7% (22% versus 13%; p = 0.019)
- Were at 69% less risk of major hypoglycaemia
- Were at 46% less risk of nocturnal hypoglycaemia
- Weight gain was reduced (1.7kg versus 2.7kg; p=0.024)
While these are interesting results it should be noted that this study relates to patients with type 1 diabetes and may not be applicable to patients with type 2 diabetes.
Action: Clinicians should be aware of this study but take care to ensure that the results are not automatically applied to patients with type 2 diabetes.
