Clinical Knowledge Summaries (CKS) has been updated in February 2011 for the following clinical areas:
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
The manufacturer of Humalog® and Humulin® has written to healthcare professionals to advise that older style pre-filled insulin pens will be discontinued at the end of March 2011.
The affected products will continue to be available in a new pre-filled device called the KwikPen™. The affected products are as follows:
- Humalog Pen
- Humalog Mix 25 Pen
- Humalog Mix 50 Pen
- Humulin I Pen
- Humulin M3 Pen
Action: Clinicians should be aware of this product withdrawal. Patients on the affected devices will need to be identified and changed to a suitable alternative.
As reported in the British Medical Journal (BMJ), Prescrire are being sued by the manufacturer of tacrolimus ointment (Protopic®).
Prescrire has reviewed the drug several times and classified is as "not acceptable" based on the conclusion that the product is "without evident benefit but with real or potential disadvantages". This is based upon reports of skin irritation, infection and skin cancer, all of which are known and documented side effects. Prescrire were also highly critical of a licence extension covering maintenance use.
Action: The verdict in this case is due by the end of this month. Clinicians may wish to be aware of this case and the impact it may have on future drug reviews in medical journals and other healthcare organisations.
The Lancet has published the results of a retrospective analysis of date from the Heart Protection Study that aimed to assess whether individuals with raised baseline C-reactive protein (CRP) levels would gain greater benefit from statin therapy. This study acknowledges the JUPITER study which studied the effect of rosuvastatin for primary prevention of cardiovascular events in individuals with low levels of low density lipoprotein cholesterol (LDL-C) but high risk of a cardiovascular event based on age and high sensitivity CRP.
HPS randomly assigned 20,536 men and women aged 40 to 80 years old who were at high risk of vascular events to treatment with simvastatin 40mg daily or placebo. Follow up was for 5 years with a composite primary endpoint including coronary death, myocardial infarction, stroke or revascularisation.
2,727 of the participants in the study also had baseline and follow up data for CRP and (LDL-C). In this subset of patients, treatment with simvastatin resulted in an average reduction of 0.85mmol/L in LDL-C and 0.32 log mg/L in CRP. This equates to a relative reduction 25% and 27% respectively.
Treatment with simvastatin in the study also resulted in a 24% proportional risk reduction in the primary endpoint and this reduction did not vary greatly in 6 predefined bands of baseline CRP. In patients with a baseline CRP of <1.25mg/L given simvastatin there was a risk reduction of 29% compared to those given placebo.
The authors conclude that, "evidence from this large-scale randomised trial does not lend support to the hypothesis that baseline CRP concentration modifies the vascular benefits of statin therapy materially". They do not that this analysis only reviews data on simvastatin and my not be applicable to other statins. However, they also note that the benefits of statins can be largely explained through the effect on LDL-C and that the reductions in LDL-C and CRP observed in this data are of a similar ratio to that observed with rosuvastatin in the JUPITER study. They also note that the size of the study and the wide range of LDL-C and CRP baseline figures allow for a robust analysis.
Action: Statins are of benefit to patients across a range of LDL-C and CRP baseline levels. Eligibility for statin therapy is currently based on the presence of cardiovascular disease or a high risk of developing cardiovascular disease. In the future, CRP may help identify individuals who are at high risk that are not identified with the current risk prediction tools but additional research is needed.