The Lancet has published the results of an open label, randomised, non-inferiority study that compared a weekly formulation of exenatide with the current twice-daily formulation. This trial has been reported in the general media (BBC).
The study ran for 30 weeks and recruited 295 patients with type 2 diabetes. The primary endpoint was change in HbA1c with additional data being collected for body weight and adverse events including hypoglycaemia.
Patients who were treated with the weekly formulation had significantly greater reductions in HbA1c (-1.9% versus -1.5%, p=0.0023). Additionally, a larger proportion of patients reached HbA1c targets of 7% or less (77% versus 61%, p=0.0039). There was no difference in the risk of hypoglycaemia and similar reductions in bodyweight in the two groups.
Action: Clinicians should be aware of this study; media reporting may generate queries. This product is still under development and is therefore not currently available on NHS prescription.
The British Medical Journal has published the results of a study that aimed to determine the effects of low dose aspirin on cognitive function.
The study involved 3,350 men and women aged 50 years and above who were participating in another study examining the effects of aspirin in asymptomatic atherosclerosis. Participants were randomly assigned to aspirin at a dose on 100mg per day or placebo for a period of 5 years.
At baseline mean vocabulary scores were similar in the two groups. At the end of five years follow up there was no significant difference in the mean scores of the individual cognitive tests or in the proportion of individuals achieving a cognitive score greater than the median.
The authors conclude that, "aspirin does not affect cognitive function in middle aged to elderly people at increased cardiovascular risk".
Action: Clinicians should be aware of this research. Patients may be taking aspirin to maintain cognitive functioning; this study indicates that aspirin prophylaxis should focus upon preventing cardiovascular events.
The manufacturer of Ensure® has written to healthcare professionals advised that certain flavours in the range will be discontinued in the coming months.
Chicken, mushroom and asparagus flavours will be discontinued soon with nut and egg nog flavours being discontinued in 2009. This will leave three flavours on the market (Vanilla, Coffee and Chocolate).
The letter notes that some of these flavours are available in the Ensure Plus® range but clinicians should be aware of the higher energy content of this product (1.5kcal/ml compared to 1kcal/ml).
Action: Clinicians should be aware that these products are being discontinued. Patients should be review for continued need and can be moved to different flavours or change to the higher energy product if this is appropriate.
The Food and Drugs Administration (FDA) has announced that it is investigating data from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study that found an increased rate of cancer. The media have reported this announcement (Daily Express).
The SEAS Study recruited approximately 1,400 patients with aortic stenosis. Participants were randomised to treatment with simvastatin 40mg and ezetimibe 10mg daily or placebo. The primary outcome for the study was a composite of major cardiovascular endpoints including valve replacements, heart failure and cardiovascular death.
The study found no difference in the primary outcome despite a 61% reduction in low-density lipoprotein cholesterol (LDL-C). There were more adverse events related to cancer in the treatment arm of the study (93 [9.9%] versus 65 [7.0%], p=0.03) and more cancer related deaths (39 [4.1%] versus 23 [2.5%], p=0.05).
These findings are based on small numbers from a single study. Additionally, the FDA note that large prospective studies have not demonstrated any increase in cancer incidence in treatment arms compared to placebo. The FDA investigation is on-going and is likely to report final recommendations early in 2009, in the meantime they recommend that patients continue taking cholesterol lowering medication and consult their doctor if they have concerns.
Action: Patients should be reassured and advised to continue taking cholesterol lowering medication. Healthcare professionals should continue to report any suspected side effects.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for September 2008 (PDF).
This issue includes the following drug safety advice article regarding serious and fatal overdose from dosing errors, accidental exposure, and inappropriate use with fentanyl patches. It is recommended that patients are advised about correct dosing and recognition of side effects. Fentanyl should only be prescribed to patients who are known to be opioid tolerant and who have stable pain.
In addition, this issue contains a hot topic about the introduction of human papillomavirus immunisation in the UK and a yellow card update that encourages reporting of adverse reactions that may be related to vaccinations. Reporters are asked to details of the suspected reaction and include information about the brand and batch number of the suspected vaccine.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
