Prescribing Advice for GPs

Statin or Target Debate deepens!

November 17, 2005 on 6:32 pm | In Prescribing Extra - Drugs |  Print | No Comments

The Journal of the American Medical Association (JAMA) has published the results of the IDEAL Study. The study enrolled 8888 patients under the age of 80 with a history of acute myocardial infarction and followed them up for a mean of 4.8 years after randomisation to Atorvastatin 80mg or Simvastatin 20mg.

The study was powered to compare these two lipid lowering strategies based on Major Coronary Endpoints. These included CHD Death, non-fatal MI and cardiac arrest with resuscitation.

The study did not reach statistical significance on the primary outcome. Looking at the three separate components of the primary outcome only non-fatal MI was significantly different (NNT of 83 over 4.8 years to prevent one event).

The study also reported on adverse effects and while overall the adverse effects were similar in the two groups, twice as many people in the Atorvastatin arm has treatment stopped (NNH of 18 over 4.8 years).

This study complicates the fire and forget vs treat to target debate. It seemed for a while that the evidence was starting to point to target based treatment. This study and perhaps the TNT Study might start to counter this evidence and point more towards a fire and forget approach. The TNT Study has been appraised in MeReC Extra 17.

In terms of preventing deaths, this study shows that Atorvastatin 80mg and Simvastatin 20mg are equivalent. There was a benefit in terms of non-fatal MI in the Atorvastatin arm, but would this have been as large or present at all if the comparator had been Simvastatin 40mg instead of 20mg?

Action: Clinicians can feel more confident in using Simvastatin 40mg as first line treatment for elevated cholesterol levels. The impact this study on the treat to target vs fire and forget debate will continue to be investigated.

References:

1. High-Dose Atorvastatin vs Usual Dose Simvastatin for Secondary Prevention After Myocardial Infarction. JAMA 2005;294:2437-2445

New ABPI Code of Ethics

November 16, 2005 on 9:53 pm | In Prescribing Extra - Other |  Print | No Comments

The Association of the British Pharmaceutical Industry (ABPI) has announced that a new Code of Practice will be introduced from January 2006.

The new code contains the follow key changes:

• Patient safety is being further promoted by a requirement for all printed, promotional material to include prominent information about reporting adverse drug reactions.
• Further definition and restrictions are being applied on what can be provided to health professionals in the way of promotional aids, hospitality, subsistence, travel, and accommodation.
• Relationships with patient groups and the provision of information to the public are covered in greater depth.
• A reduction in the permitted number of pages of medicines advertising and an outright ban on all promotional competitions are introduced.
• Moves to speed up the process of determining complaints so that decisions can be made more quickly and sanctions imposed faster.
• Materials or activities ruled in serious breach of the code may, under certain circumstances, be suspended, even if an appeal is intended, which will reduce the time such material remains in use.
• Results of some, more serious cases will be advertised in the medical and pharmaceutical press, thus strengthening the sanctions available.

The new Code of Practice is available in full on the ABPI website.

Action: Clinicians who are involved with the Pharmaceutical Industry should be aware of the existence and contents of the Code Of Practice. Adherence to the code allows the relationship between clinicians and representatives of the industry to be conducted professionally and ethically. Knowledge of the code allows lapses in adherence to be report.

Do all NSAIDs increase post-MI mortality?

November 15, 2005 on 3:59 pm | In Prescribing Extra - Drugs |  Print | No Comments

An epidemiological study conducted on Danish patients reported by the American Heart Association has concluded that taking NSAIDs (including COX-II selective NSAIDs) after a heart attack increases the risk of death.

The Hazard ratios for certain NSAIDs are as follows:

• 4.24 for Celecoxib at 200mg/day or more
• 1.70 for Celecoxib at lower doses
• 5.03 for Rofecoxib at 25mg/day or more
• 2.23 for Rofecoxib at lower doses
• 3.76 for Diclofenac at 100mg/day or more
• 1.96 for Ibuprofen at 1200mg/day or more
• 1.22 for other NSAIDs

The hazard ratios were lower with low doses of Ibuprofen (0.66) and Diclofenac (0.74). There were confounders in this study and an extension to the study will follow up the actual cause of death. Also, there was no association with recurrent MI. The full study has not yet been published and will need further investigation.

The lead author, Gunnar H. Gislason, said, “These results are a cause for concern but not panic. If you can avoid them, it makes sense to switch to another type of medication if you have cardiovascular disease.”

Action: This study does not add to what we already know but it does raise awareness again. NSAIDs should be avoided where possible, and when they are required the NSAID with the lowest risk (usually Ibuprofen) should be used at the lowest dose for the shortest duration.

NOTE: This study did not include Aspirin.

MHRA to vet adverts for new drugs

November 14, 2005 on 12:31 pm | In Prescribing Extra - Other |  Print | No Comments

The Medicines and Healthcare product Regulatory Agency is to start assessing adverts for all new drugs according to a press release on the website. Currently adverts for certain new drugs are vetted, but following the Health Select Committee’s Report on “The Influence of the Pharmaceutical Industry” the remit is to be widened to cover all new drugs.

The period of vetting is likely to extend to about 6 months unless problems are identified in which case this could be extended. This extension also comes at a time when the MHRA are upholding more complaints about drug adverts, as published on the website.

Action: Clinicians may be interested to know that controls on drug adverts are being tightened. This extra safeguard should not stop individuals making complaints to the MHRA or Prescription Medicine Code of Practice Authority (PMCPA) if the advert is misleading or inaccurate.

Sedatives in Older People

November 11, 2005 on 2:54 pm | In Prescribing Extra - Drugs |  Print | No Comments

The British Medical Journal has published a meta-analysis¹ of 24 studies to quantify the risks and benefits of short-term sedative treatment in older people with insomnia.

The BBC has reported this study and therefore patients may be aware of this study.

The authors conclude that while there is statistically significant evidence of a beneficial effect upon sleep variables, the benefits are small. They also point out that the clinical effect may be modest and the added risk of adverse events may not justify these benefits.

They go on to suggest that as cognitive based therapies are as effective as pharmacological interventions, and associated with fewer risks they may be a viable alternative.

The Committee on Safety of Medicines (now part of the Medicines and Healthcare products Regulatory Authority) have long advised that benzodiazepines should only be used short-term for insomnia only when it is severe, disabling or causing extreme distress.

Action: Clinicians should be aware of this new study as patients may ask questions about their medication. Any opportunity to reduce and stop benzodiazepine consumption should be exploited to maximum benefit for the patient.

References

1. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ 2005;331:1169-73