The European Medicines Agency (EMEA) has completed a review (PDF) of the safety of conventional (typical) antipsychotics in elderly patients with dementia.
The available evidence suggests that conventional antipsychotics are likely to be associated with increased mortality and that the excess mortality observed may be greater than that observed for the newer atypical antipsychotics. These findings cannot be confirmed due to methodological limitations and no firm conclusions are available for differences in risk between individual antipsychotics. The increased risk is assumed to apply to all medicines in the class.
The review concludes that product information for the conventional antipsychotics should be updated to include information on the increased risk of mortality.
Clinicians are advised to follow national guidelines when treating dementia patients presenting with episodes of psychotic symptoms or aggressive behaviour including a discussion of the risks and benefits. Switching between atypical and conventional antipsychotics is not recommended.
Action: Clinicians who see elderly patients with dementia should be aware of this review and the implement these recommendations.
The Archives of Internal Medicine has published the results of a retrospective observational study that aimed to compare cardiovascular and mortality outcomes in patients initiating pioglitazone and rosiglitazone therapy.
The study analysed data from the Medicare database for a five year period between January 2000 and December 2005. 28,361 individuals aged 65 years and older were identified who were treated with rosiglitazone or pioglitazone. The treatment split was even with 50.3% of patients receiving pioglitazone and 49.7% receiving rosiglitazone. There were 1,869 deaths during the time period analysed. The study outcomes were all-cause mortality, myocardial infarction, stroke and hospital admission for heart failure.
After adjustment for potential confounding factors the authors found a 15% increase in the risk of death in users of rosiglitazone (95% CI 5% - 26%) and a 13% increase in the risk of hospital admission for heart failure. No differences were found for myocardial infarction or stroke.
The authors conclude that these results "are compatible with an increased risk of all-cause mortality and congestive heart failure in patients initiating therapy with rosiglitazone" although they concede that due to the nature of the analysis, residual confounding may have an influence on the results.
Action: Glitazones continue to be a third line option after metformin and sulphonylureas. The use of rosiglitazone should be avoided where alternative options are available.
Original story found on Pharmagossip
The British Medical Journal has published an editorial discussing the results of the recently completed JUPITER Study.
This editorial aims to put the results of the study in context with the existing evidence based and understand what the results mean in terms of current practice. The authors of this study conclude that no change is required. In addition the Rapid Responses are heavily critical of the decision to stop the study early and make for interesting reading.
Action: The hype generated by the publication of this study continues. Clinicians should be aware of the study and the growing opinion that the results should not change current practice.
The National Prescribing Centre (NPC) has published MeReC Extra 36 (PDF).
The MeReC discusses some new evidence supporting the use of patient decision aids (PDAs) to help patients make informed choices about their treatment. It includes information about:
- The advantages of using PDAs within the consultation process
- Where to find PDAs
- How to use PDAs and put risks into context
Action: Clinicians who discuss risks and benefits with patients will find this information about PDAs useful and informative.
The Journal of the American Medical Association has published the results of the Physicians' Heart Study II. This study aimed to assess whether long-term vitamin E or vitamin C supplementation decreases the risk of major cardiovascular events among men.
The study recruited 14,641 male physicians in America. All were at least 50 years old and 754 had prevalent cardiovascular disease. Participants were randomly assigned to vitamin E 400IU on alternate days or matching placebo and vitamin C 500mg daily or matching placebo. The primary end point of the study was a composite of nonfatal myocardial infarction, nonfatal stroke and cardiovascular disease death.
The study found no reduction in risk for either treatment over a period of 8 years. Additionally there was no risk reduction in any of the individual end points that made up the primary end point.
The authors conclude that, "neither vitamin E nor vitamin C supplementation reduced the risk of major cardiovascular events".
Action: Clinicians should ensure that vitamin supplements are not prescribed or recommended for the prevention of cardiovascular events.
