The manufacturer of Beclazone Easi-Breathe® (Beclometasone in a breath-actuated aerosol inhaler) has written to healthcare professionals to advise that, with effect from 30th September 2009 all strengths of these inhalers will cease to be supplied and is therefore effectively discontinued.
This step is being taken in line with existing agreements to discontinue CFC containing products in 2010. The products affected are the 50 microgram, 100 microgram and 250 microgram breath-actuated inhalers. The standard pressurised metered dose inhalers (pMDI) Beclazone will remain available until the first quarter of 2010.
There is no direct replacement for this product and patients will require a change of dose, device or steroid in order to continue treatment.
A similar device is available with the Qvar® inhaler but this drug has a smaller particle size and the dose will need reducing. There are also beclometasone containing alternatives available in different devices such as standard pMDIs or dry powder inhalers. Another option would involve changing the active ingredient to an alternative steroid such as budesonide or fluticasone.
Action: Clinicians should review affected patients and discuss the available alternatives with patients. Changing the fewest parameters (dose, device or drug) would seem prudent in order to retain patient confidence in their treatment.
The Lancet has published the results of a long term study that aimed to assess the cardiovascular safety of rosiglitazone (Avandia®).
The study recruited 4,447 patients with type 2 diabetes on metformin or sulfonylurea monotherapy. The study was open label and last for a mean of 5.5 years. The primary outcome was cardiovascular death or hospital admission.
Participants in the study were randomly assigned to treatment with dual therapy of metformin and sulphonylurea or initial monotherapy (metformin or sulphonylurea) and rosiglitazone.
The primary outcome occurred in 321 patients taking a rosiglitazone combination and 323 patients in the active control. The difference was not significant and therefore rosiglitazone treatment was found to be non-inferior.
The study did find an increased risk of heart failure requiring hospital admission (Hazard Ratio 2.10, 95% confidence interval [CI] 1.35—3.27, p=0.001) and of fracture (risk ratio 1.57, 95% CI 1.26–1.97, p<0.0001).
It is also interesting to note that a greater proportion of participants treated with rosiglitazone were also treated with cardiovascular drugs by the end of the study. In particular, 9.2% more patients were using a statin (55.2% versus 46.0%) and 4.9% more were using loop diuretics (13.0% versus 8.1%).
The authors conclude that, "rosiglitazone does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs" with a caveat that, "the data are inconclusive about any possible effect on myocardial infarction.
The results of this study are consistent with what is currently known. Glitazones increase the risk of heart failure and fractures. Rosiglitazone has also been suspected of increasing the risk of heart attacks and while this study indicates no increased risk of cardiovascular death an increase in heart attacks cannot be discounted.
Action: Clinicians should continue to implement the existing guidelines. Glitazones (and gliptins) are considered as alternatives to metformin or sulphonylureas when these agents are contraindicated or poorly tolerated. Pioglitazone currently has fewer prescribing restrictions and may be a better choice where a glitazone is indicated.
The manufacturer of Minodiab® (glipizide) has written to healthcare professionals to advised that Minodiab 2.5 mg tablets are being discontinued with immediate effect.
The letter advises that there are stability issues with recent batches and these cannot be resolved. It is expected that supplies will run out by mid-July 2009. The letter also clarifies that this only affects the 2.5mg strength, the 5mg tablets remain available.
Action: Clinicians should be aware of this announcement and ensure that any patients being prescribed this branded version of glipizide and transferred to a generic prescription to ensure continued and uninterrupted supply.
The Summary of Product Characteristics for agomelatine (Valdoxan®) is now available via the electronic Medicines Compendium (eMC).
As previously discussed, agomelatine is a new class of antidepressant. The SPC gives more details for this drug including known side effects, precautions and interactions.
Action: Clinicians who are considering using this new drug would be wise to review the SPC before starting a treatment.
The World Health Organisation has declared that the influenza pandemic alert has been raised from phase 5 to phase 6 and that swine 'flu is now pandemic. The announcement has, of course, been reported in the general media (BBC).
The spread of the virus can no longer be traced through clearly-defined human to human chains. Further spread, beyond the 30,000 confirmed cases have been reported in 74 countries, is considered inevitable.
The Department of Health have responded quickly confirming that the status change is related to geographic spread and not the severity of the disease. It has also been clarified that the change in status does not trigger any material change to our current response.
Action: Clinicians should be aware of the current pandemic status since the general public are likely to seek reassurance. Treatment algorithms produced by the Health Protection Agency may be updated in light of the status change.