Prescribing Advice for GPs

Rosiglitazone heart risks were hidden

March 1, 2010 at 1:24 pm | In Prescribing Extra - Drugs |  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.

NICE Guidance – February 2010

February 24, 2010 at 9:53 am | In Prescribing Extra - Other |  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.

CKS Update – February 2010

February 23, 2010 at 9:55 am | In Prescribing Extra - Other |  Print | No Comments

Clinical Knowledge Summaries (CKS) has been updated in February 2010 for the following clinical areas:

• Depression
• Ectopic pregnancy (new)
• Glandular Fever (new)
• Itch – widespread (new)
• Miscarriage (new)
• Neck Lump (new)
• Scrotal swellings (new)

Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.

Homeopathy a waste of NHS money

February 22, 2010 at 3:41 pm | In Prescribing Extra - Other |  Print | No Comments

The Commons Science and Technology Committee has recommended that the NHS should cease funding homeopathy after a review of the available evidence for efficacy. This recommendation has been reported in the general media (BBC).

The committee aims to assess if Government policy is backed by sound scientific evidence. The committee found no evidence that homeopathy works beyond the placebo effect. They also conclude that further trial work on homeopathy is unjustified.

The press release also notes that the Government acknowledges the lack of evidence for homeopathy and that it does not intend to review or change current NHS policy. The chairman of the committee stated that the decision to fund such treatments “sends out a confused message, and has potentially harmful consequences“.

Action: Clinicians should be aware of this recommendation. Clinicians within the NHS who prescribe homeopathic remedies should individually review their continued use of these products.

Statins and diabetes risk

February 17, 2010 at 11:33 am | In Prescribing Extra - Drugs |  Print | No Comments

The Lancet has published the results of a meta-analysis of randomised statin trials with the aim of establishing whether any association exists between statin use and development of diabetes. This analysis has been reported in the general media (BBC).

This analysis included data from 13 trials involving 91,140 participants. 4,278 participants developed diabetes during the trial periods (mean duration 4 years) with 2,226 assigned statins and 2,052 assigned control treatment.

Statin therapy was found to be associated with a statistically significant 9% increase in the risk of developing diabetes (odds ratio [OR] 1·09; 95% CI 1·02–1·17). The risk was found to be highest in older participants while baseline BMI and change in low-density lipoprotein-cholesterol (LDL-C) concentrations appear to be unimportant predictive factors.

Despite this finding the authors conclude that, “in view of the overwhelming benefit of statins for the reduction of cardiovascular events, the small absolute risk for development of diabetes is outweighed by cardiovascular benefit in the short and medium term“. They recommend that current practice for statin therapy remains unchanged.

The authors also note that this analysis does not prove a causal relationship and that the observed difference may be due to residual confounding factors. They therefore also suggest that development of diabetes is included in future statin studies as a secondary outcome.

Action: Clinicians should be aware of these results and the associated media reports. Patients taking statins should be reassured that the benefits of therapy outweigh the risks. Screening for diabetes in patients taking statins, especially in older patients, may be a sensible strategy.