The National Institute of Health and Clinical Excellence (NICE) has published new guidance for the month of November 2012. This month is one technology appraisal and two public health guidelines that impact upon primary care.
The Chronic heart failure - ivabradine technology appraisal recommends ivabradine as a possible treatment for people with chronic heart failure provided the following conditions are met.
- New York Heart Association (NYHA) class II to IV stable chronic heart failure with systolic dysfunction and
- who are in sinus rhythm with a heart rate of 75 beats per minute or more and
- who are given ivabradine in combination with standard therapy including beta-blocker therapy, angiotensin-converting enzyme (ACE) inhibitors and aldosterone antagonists, or when beta-blocker therapy is contraindicated or not tolerated and
- with a left ventricular ejection fraction of 35% or less
It is also recommended that ivabradine is initiated by a specialist after a 4 week period of stabilisation on a combination of ACE inhibitors, beta-blockers and aldosterone antagonists.
The Walking and cycling public health guideline aims to encourage people to increase the amount they walk or cycle for travel or recreation purposes. It is hoped this would help meet public health goals as well as impacting on other areas such as traffic congestion, air pollution and greenhouse gas emissions.
The Obesity - working with local communities public health guideline aims to support effective, sustainable and community-wide action to prevent obesity. The recommendations cover 14 areas from strategic leadership and integrated commissioning to planning and implementing monitoring and evaluation.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2012 (PDF).
This update contains hot topic information advising clinicians that when reporting suspected adverse drug reactions to biological medicines, such as biosimilar products or vaccines, it is important to include the brand name and if possible the batch number. Products in this category may not be identical and reporting may also help to identify concerns related to specific batches.
This section also contains the findings of a safety review of the HPV vaccine Cervarix® which confirmed that the "balance of its risks and benefits remains clearly positive".
Finally, this issue contains a link to a new learning module for antipsychotics. This module is accredited for up to 3.5 CPD credits.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The British Medical Journal has published the results of a study that aimed to assess any association between varenicline use and cardiovascular events.
Post marketing surveillance has raised concerns that there may be cardiovascular risks associated with the use of varenicline in stopping smoking. A retrospective cohort analysis of a Danish medical database was use to compare the rates of cardiovascular events in individuals prescribed varenicline as compared to those prescribed buproprion.
The study accessed data for 4,781,228 individuals and identified 92,540 people who had been prescribed either varenicline or bupropion. A total of 35,852 patients were reviewed after being matched in a 1:1 ratio for each drug. The primary outcomes were acute coronary syndrome, ischaemic stroke and cardiovascular death analysed individually and as a composite of any major cardiovascular event.
There were 57 major cardiovascular events in those prescribed varenicline (6.9 cases per 1,000 person years) compared to 60 events in those prescribed buproprion (7.1 cases per 1,000 person years). The hazard ratio was 0.96 (95% confidence interval 0.67 to 1.39). There were no differences in rates of the individual component outcomes.
An accompanying editorial notes that the use of an active comparator limits the usefulness of this study. The only conclusion that can be drawn is the varenicline poses the same level of cardiovascular risk as buproprion. The editorial states, "This may not help us determine whether varenicline should be prescribed to patients at higher risk of cardiovascular disease, or to determine whether myocardial infarction in a patient who has taken varenicline is causally related to the drug".
Action: Clinicians should be aware of this study. Although, at first glance, this study is reassuring perhaps more research is necessary and continued post marketing surveillance is vital.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Aclidinium (Eklira®) has been accepted for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Adalimumab (Humira®) has been rejected for use in the treatment of moderately active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. The manufacturer failed to make a submission.
Nepafenac (Nevanac®) has been accepted for use to reduce the risk of postoperative macular oedema associated with cataract surgery in diabetic patients.
Ranolazine (Ranexa®) has been rejected for use as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies. The manufacturer failed to make a sufficiently robust clinical and economic case.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Department of Health has announced that rotavirus vaccine will be added to the childhood vaccination programme with effect from September 2013.
Rotavirus is reported as causing approximately 140,000 cases of diarrhoea per year in the children under 5 years old. Of these some 14,000 cases result in a hospital admission. It is expected that the introduction of this vaccine will reduce hospital admissions by up to 70%. The vaccine is a live oral vaccine and two doses are recommended.
The JCVI statement recommending the vaccine provides further analysis and detail.
Action: Clinicians involved in the delivery of the child immunisations should be aware of this change. More information about this vaccine should be expected before September 2013.