SMC Update – March 2010

March 8, 2010 at 4:28 pm | In Prescribing Extra - Other | Print Print | No Comments

The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.

Ketoprofen and omeprazole (Axorid®) has been rejected for the symptomatic treatment of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis in patients with a previous history or who are at risk of developing NSAID associated ulcers or erosions in whom continued treatment with ketoprofen is essential. The economic analysis provided was not sufficiently robust to gain approval.

Saxagliptin (Onglyza®) has been accepted for restricted use in adult patients with type 2 diabetes mellitus as add-on combination therapy with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control. This agent is only recommended when the addition of sulphonylureas is not appropriate and is an alternative to other agents such as thiazolidinediones (glitazones).

Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.

Copyright ©2005-2010 Prescribing Advice for GPs

Aspirin ineffective in those with low ABI

March 4, 2010 at 3:38 pm | In Prescribing Extra - Drugs | Print Print | No Comments

The Journal of the American Medical Association (JAMA) has published the results of a study that aimed to assess the efficacy of aspirin in preventing primary cardiovascular events in patients with a low ankle brachial index (ABI).

ABI is the ratio of systolic blood pressure at the ankle and arm. ABI is used to diagnose peripheral vascular disease and is associated with an elevated risk of coronary events.

3,350 men and women aged 50 to 75 were recruited to the study. None had clinical cardiovascular disease but all had ABI less than or equal to 0.95. Follow up was for a mean of 8.2 years for a primary composite outcome of fatal or nonfatal coronary event, stroke or revascularisation. Participants were randomly assigned to treatment with 100mg aspirin daily or matching placebo.

The study found no significant difference in the rate of the primary outcome between the two study groups (Hazard Ratio 1.03, 95% confidence interval 0.84 – 1.27). Additionally, there were no differences in the two secondary outcomes (a composite of the primary outcome and angina, intermittent claudication or transient ischaemic attack or all-cause mortality). The study also assessed the rate of major haemorrhage requiring a hospital admission. This was higher in the patients treated with aspirin but the difference was not significant (HR 1.71, 95% CI 0.99 – 2.97).

The authors conclude that among this population “the administration of aspirin compared to placebo did not result in a significant reduction in vascular events“. The authors also suggest that ABI assessment is unlikely to be a useful screening tool in primary care settings.

The results of the study may be limited by low levels of medication compliance with the treatments taken for 60% of the trial person-years. Also, the study was designed and powered to detect a 25% relative reduction in events. Recent analyses have indicated that aspirin may only produce a 12% reduction and perhaps this study was underpowered.

Action: This study adds some more weight to the conclusions reached by the Drug and Therapeutics Bulletin that the use of aspirin in the primary prevention of cardiovascular events is unjustified.

Copyright ©2005-2010 Prescribing Advice for GPs

Peer pressure blamed for excessive drinking

March 2, 2010 at 11:54 am | In Prescribing Extra - Other | Print Print | 3 Comments

The Department of Health (DH) has published the results of a survey into the drinking habits of more than 2,000 English adults.

The survey found that 22% of respondents have drunk more alcohol than they planned because of peer pressure. 39% stated that they made up an excuse or lied to avoid another drink.

However, the survey also noted that these steps may be unnecessary because the survey also found that:

  • Only 1% of respondents think less of people who refuse a drink or choose to drink less than them
  • Just 4% expect their friends to keep up with them when drinking
  • Only 2% admit to piling on the pressure for friends to drink more when they don’t want to

The DH has also issued the following advice to those wanting to drink less:

  • Take it a day at a time: try and cut back a little every day. Each day you cut back is a success
  • Make it a smaller one: you can still enjoy a drink but have less. Try bottled beer instead of a pint or a small glass of wine instead of a large
  • Have a lower strength drink: manage how much you drink by swapping a strong strength beer or wine for one with a lower ABV [Alcohol By Volume]
  • Take a break: have the odd day here and there when you don’t have a drink

Action: Clinicians may find this information useful when advising patients on strategies to reduce alcohol consumption. The results of this survey indicate that peer pressure to drink is more of an internal pressure than an external one.

Copyright ©2005-2010 Prescribing Advice for GPs

Rosiglitazone heart risks were hidden

March 1, 2010 at 1:24 pm | In Prescribing Extra - Drugs | Print Print | No Comments

According to the findings of a report prepared by the United States Senate Committee on Finance the manufacturer of rosiglitazone failed to warn patients or regulatory authorities of cardiovascular concerns. This publication has been reported in the British Medical Journal.

A two year investigation has reviewed over 250,000 documents submitted by GlaxoSmithKline, the Food and Drugs Administration (FDA) and other organisations after the publication of a study in the New England Journal of Medicine that raised concerns that rosiglitazone increased the risk of myocardial infarction.

This investigation found that the manufacturer of rosiglitazone knew for several years prior to this study that there were possible cardiac risks associated with [rosiglitazone] Avandia®. Additionally, independent physicians were intimidated, the risks were misrepresented and positive results for competing drugs were downplayed.

Finally, this investigation is critical of the role played by the FDA. The FDA requested a cardiovascular safety trial be conducted however internal FDA documents note that two safety officials conducted an analysis of the available data at that time and concluded that any proposed head-to-head trial of rosiglitazone vs. pioglitazone would be unethical and exploitative.

Action: As previously advised, clinicians should continue to implement the existing guidelines. Glitazones (and gliptins) are considered as alternatives to metformin or sulphonylureas when these agents are contraindicated or poorly tolerated. Pioglitazone currently has fewer prescribing restrictions and may be a better choice where a glitazone is indicated.

Copyright ©2005-2010 Prescribing Advice for GPs

NICE Guidance – February 2010

February 24, 2010 at 9:53 am | In Prescribing Extra - Other | Print Print | No Comments

The National Institute of Health and Clinical Excellence has published new guidance for the month of February 2010.

There is one guidance document that has an impact in primary care. Public health guidance has been published regarding school-based interventions to prevent the uptake of smoking among children.

This guidance recommends that information on smoking is integrated into the school curriculum, smoking policies should support both prevention and stop smoking activities and that these activities are coordinated with outside agencies.

Action: Clinicians should be aware of this guidance and support local activities where appropriate.

Copyright ©2005-2010 Prescribing Advice for GPs
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