The Salmeterol Multicenter Asthma Research Trial (SMART) has been published by Chest. This study led to additional warnings being added to Long-Acting Beta-2 Agonists (LABAs) in America, as reported here. The study is available online as abstract and PDF.
The full publication of the study may raise awareness of these warnings again. There are some key points from the study that can assist in allaying patients’ fears.
This study was:
- expected to run for 12 years, recruit 60,000 patients and examine 238 primary outcomes. In fact it ran for 8 years, recruited 26,355 patients and identified 97 primary endpoints.
- designed in the early 1990s and did not demand that patients were also on inhaled corticosteroids (ICS). Use of ICS is now accepted as good practice and is Step 2 of the British Thoracic Society Guidelines.
- not statistically significant for the primary outcome and the warnings are based on a secondary outcome. This may not be a statistically valid process.
Despite all of these potential confounders clinicians should be aware that the study might have identified a trend to harm. The MHRA issued advice to inform clinicians as follows:
The MHRA remind prescribers that:
- patients given salmeterol or formoterol should always be prescribed an inhaled corticosteroid
- patients with acutely deteriorating asthma should not be initiated on salmeterol or formoterol
- patients should be monitored closely during the first 3 months of treatment
Action: Clinicians involved in the treatment of asthma should ensure that the MHRA advice is being followed.
The manufacturer of venlafaxine (Efexor)® has written to clinicians to inform them of stock shortages.
The letter from the Medical Director states that only the 75mg tablets are affected and that they are working urgently to resolve the manufacturing difficulties and they provide a website address for weekly updates. This website suggests that the problems will begin to resolve in two months.
As previously detailed, the MHRA have suggested that this drug is only initiated by specialists or GPs with a special interest in mental health. Additionally, venlafaxine should not be used in any patient with heart disease, electrolyte imbalance or hypertension.
Action: The MHRA advice suggests that this drug has a limited place in therapy. The current stock shortage provides the ideal opportunity to review current patients with a view to stopping or changing to a different antidepressant.
The High Court has ruled that the Guidance relating to the provision of contraceptive, sexual and reproductive services issued by the Department of Health is “fully in line with the law”.
This ruling was made concluding a challenge to the guidelines brought by a mother of two teenage daughters. The ruling stated that a child’s right to confidentiality takes precendence over a parents’ rights under human rights legislation.
Confidentiality is of paramount importance, however young people should be encouraged to involve their parents. Additionally, where there are percieved risks to the health, safety or welfare of a young person such that they outweigh the right to privacy, local child protection procedures should be followed.
Action: Clinicians involved in the provision of sexual health services or advice to young people should continue to respect every persons right to confidentiality. The principles laid down in the Fraser Guidelines regarding competence and local child protections procedures should be followed when appropriate.
The manufacturers of rosiglitazone (Avandia® or Avandamet®) have written to healthcare providers to raise awareness of a safety concern regarding the risk of macular oedema.
There have been 28 reports of new onset or worsening macular oedema, all generated in North America, which were associated with use of rosiglitazone. Some of the information is limited and many of the patients were taking other antidiabetic medication or suffering from peripheral oedema. It is unclear if the link is causal at this stage.
Macular oedema is a common complication in diabetic patients with retinopathy, however clinicians should be vigilant for the signs of macular oedema in patients treated with glitazones. These signs include:
- blurred or distorted vision
- decreased colour sensitivity
- decreased dark adaptation
Action: Clinicians involved in the treatment of patients with diabetes need to be vigilant for signs of macular oedema. Patients presenting with any of the symptoms above should be referred for investigation by an ophthalmologist.
The National Institute of Health and Clinical Excellence (NICE) has issued guidance on the use of statins in cardiovascular disease. The Guidance is available in full guidance and quick reference summary formats.
The Coronary Heart Disease National Service Framework (CHD NSF) recommended statin use in all patients who have already had a cardiovascular event and those having a 10-year CHD risk greater than 30%. It was also suggested that the treatment threshold for prevention of primary events be rolled back to include patients with a 10-year CHD risk greater than 15% when resources allow.
The NICE guidance continues to recommend that all secondary prevention patients are treated and has made official the primary prevention treatment threshold of 15%. The NICE documentation refers to cardiovascular disease (CVD) risk, which includes stroke, rather than CHD risk. The equivalent values for CVD and CHD risk are:
- 20% CVD risk is equivalent to 15% CHD risk
- 40% CVD risk is equivalent to 30% CHD risk
The NICE guidance is based on a health-economic analysis of the impact of treatment to this lower level of risk in comparison to the costs to the NHS of both the intervention and the “savings” of preventing cardiovascular events. This analysis is based solely upon the use of simvastatin for treating any patient who becomes eligible for treatment under the new guidance.
Action: All clinicians are encouraged to read and implement this NICE Guidance. Effective implementation should be undertaken using Simvastatin 40mg as per the formulary recommendations.