An interim analysis of the HORIZON study was presented at the annual meeting of the American Society of Bone and Mineral Research.
The Health Outcomes and Reduced Incidence with Zoledronic acid Once yearly (Horizon) study aimed to assess the impact of an annual dose of zoledronic acid on the rate of fractures in postmenopausal women.
The complete data are not yet available however a press release claims that the early analysis shows that results appear promising for the drug.
The obvious major drawback is that the drug is formulated as an intravenous infusion and delivering it in primary care raises challenges.
Action: The investigated indication is currently unlicensed. If a licence extension is granted the challenges presented by intravenous administration are likely to significantly limit use.
The Diabetes Reduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial has been made available as an early online publication in two parts. The ramipril arm of the study is available from the New England Journal of Medicine and the rosiglitazone arm is available from The Lancet.
The results from the ramipril arm appear to have been largely ignored while the results from the rosiglitazone arm have been reported in the media over the weekend, for example by the BBC.
The results in the ramipril arm of the study showed no difference between ramipril and placebo in preventing progression of impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) states to diabetes. There was a statistical difference in blood pressure with a difference of 3.9/2.7mmHg at 2 months and 3.9/2.4mmHg at the end of the study. There was no significant difference in cardiovascular outcomes however this outcome was a composite secondary outcome and conclusions should not be reached without further investigation.
The accompanying editorial concludes that ramipril should not be used to prevent type II diabetes and that the mainstay of treatment is diet and exercise.
The result of the rosiglitazone arm of the study demonstrated a statistically significant decrease in the number of patients with IFG or IGT who progressed to diabetes. The absolute risk reduction was 14.4% with a number needed to treat of 7 over 4 years. However, this benefit is not risk free. There were trends towards more cardiovascular events, although most were not statistically significant.
- 66% more likely to suffer a myocardial infarction (not significant)
- 39% more likely to suffer a stroke (not significant)
- 20% more likely to suffer a cardiovascular death (not significant)
- 20% more likely to be diagnosed with angina (not significant)
- 29% more likely to undergo a revascularisation procedure (not significant)
- 703% more likely to develop heart failure (statistically significant)
The paper concludes that more work needs to be done to examine the impact that the beneficial metabolic effects observed have on cardiovascular, renal, retinal and other health events. The accompanying editorial concludes that the benefits would need to be balanced against the increased risk of heart failure and that "given the prolonged benefits and demonstrable cost effectiveness of intensive lifestyle intervention for people at high risk of diabetes, such interventions should remain the mainstay of the prevention of type II diabetes."
Action: Lifestyle interventions including diet, exercise and smoking cessation remain as the mainstay for the prevention and treatment of diabetes and cardiovascular disease. Using drugs to prevent disease will involve an assessment of future benefits against potential risks. Based on current evidence the benefits of drug intervention do not outweigh the risks of treatment.
The Scottish Medicines Consortium (SMC) has rejected Inhaled Insulin (Exubera®) for use on the NHS in Scotland.
The manufacturers failed to supply the economic analysis required to gain approval. The product was therefore rejected for use in both Type I and Type II diabetes.
The advice document contains a cost comparison table showing the comparative costs of current treatment options and inhaled insulin. The price range for inhaled insulin appears to be at least double that of existing treatments and depending upon dose equivalences this may be up to 8 times the price.
Action: Previous advice has recommended that inhaled insulin should not be initiated in primary care. The SMC advice suggests that this product should not be used at all.
Thanks to PharmaGossip, I had missed the original press release on this item.
Promotion of medicines relies heavily on data from clinical studies but many people want to know what others are doing before they will consider using a new product. To overcome this obstacle promotional activity will often seek to use opinion leaders.
Opinion Leaders are well-respected authorities in their area of expertise, whose name will be recognised and who are preferably working in the local area. This will include hospital consultants, medical directors and increasingly pharmaceutical advisors.
Adding the opinion leaders positive endorsement to the sales message bolsters the promotional message.
Critical Appraisal of this type of information is useful when considering the impact of the promotional message on current practice.
- Does the opinion leader provide care for or advice about patients who are similar to your own in terms of age, gender, ethnicity and social status
- Do your patients have the same disease and at the same severity to those seen by the opinion leader
- Can the endorsement of the opinion leader be substantiated, either at the time of the promotional activity or independently later
For example, I have recently been misquoted during promotional activity for a product undertaken in the PCT where I work. I have made a complaint through the normal channels and will post further details once the outcome is confirmed to me in writing.
The Scottish Medicines Consortium has accepted the combination product containing metformin 850mg and pioglitazone 15mg (Competact®) for use in Type II Diabetes on the NHS in Scotland.
The advice document states that the product is cost equivalent to separate preparations and may therefore offer a more convenient, if less flexible, dosing regimen.
Pragmatically, reducing the number of tablets taken will have a beneficial effect upon compliance. In practice, individuals who are likely to be prescribed this medicine are likely to be on several other agents including antiplatelets, statins and antihypertensives. Substituting this product may not have a dramatic impact in this instance.
Action: This product is an option when compliance is a known issue. Using concordant approach when initiating prescriptions to provide patients with information about the benefits and risks of treatment is also likely to aid future compliance.