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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Rosuvastatin of no benefit in heart failure

The New England Journal of Medicine has published the results of the CORONA study. This study aimed to assess the cardiovascular benefits of rosuvastatin (Crestor®) in older patients with heart failure.

The study recruits 5,011 patients who were at least 60 years of age and had a diagnosis of heart failure (New York Heart Association class II, III or IV). Participants were randomly assigned to rosuvastatin 10mg or placebo and followed up for a median of 32.8 months. The primary outcome of the study was a composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.

The study found no statistical difference in the primary outcome or in the rate of all cause mortality. A secondary outcome found a statistical difference in rates of hospital admissions however this finding should be viewed with caution because the primary outcome was not significant.

The NPCi review concludes that simvastatin 40mg remains the first line statin. Additionally, clinicians should consider therapy with all other statins before resorting to rosuvastatin.

Action: Rosuvastatin currently has no published data demonstrating beneficial effects in outcomes that are important to patients, namely reducing the rate of cardiovascular morbidity and mortality.

This article is based on an NPCi Rapid Review and is used with permission

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Vitamin supplements: No benefit and may cause harm

The Cochrane Library has published a review of antioxidant supplements for preventing mortality in health individuals and those with various diseases. The general media (The Times) have reported the findings.

The study identified 67 trials including 232,550 participants. 21 trials were conducted in 164,439 healthy individuals and 46 trials were conducted in 68,111 participants with various diseases (including gastrointestinal, cardiovascular, neurological, ocular, dermatological, rheumatoid, renal or endocrinological diseases).

The study analysed the data in many different ways examining different supplement components (for example beta-carotene, vitamin A, vitamin C, vitamin E and selenium), trials with low risk of bias and whether the study assessed primary or secondary prevention.

Overall there was no significant difference in mortality however some analyses of vitamin A, vitamin E and beta-carotene found an increased risk of mortality. Vitamin C had no significant effect either way. Selenium appeared to reduce mortality overall but when high-bias risk and low-bias risk trials were analysed separately the effect was not significant.

The authors conclude that, "we found no convincing evidence that antioxidant supplements decrease mortality". Furthermore that state, "we cannot recommend the use of antioxidant supplements as a primary and secondary preventive measure".

Action: Clinicians should be aware of this review; the wider reporting may generate patient queries. Patients who eat a healthy diet should be advised that vitamin supplements are not usually necessary.

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SMBG not cost effective

The British Medical Journal has published the results of a study that aimed to assess the cost effectiveness of self monitoring of blood glucose (SMBG) in patients with non-insulin treated type 2 diabetes. This study has been covered by the general media (BBC).

Data from the diabetes glycaemic education and monitoring (DiGEM) study were analysed comparing standardised care with two levels of self monitoring. Data for clinic visits and drug usage were available for 12 months prior to study entry and for 12 months follow up. Quality of life was assessed at baseline and during follow up.

Overall there was a trend to more clinic visits and greater drug costs in the two groups where self monitoring was used although no statistical differences were found. There was a statistically higher cost in terms of the intervention and there was a reduction in quality of life in the intervention groups; this was statistically significant for the patients who were more intensively monitoring.

The authors conclude that, "self monitoring of blood glucose with or without additional training in incorporating the results into self care was associated with higher costs and lower quality of life in patients with non-insulin treated type 2 diabetes".

Action: Clinicians should be aware of this study; the wider reporting may generate patient queries. Self monitoring should be discouraged in patients with non-insulin treated type 2 diabetes.

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Rimonabant - two year data

The European Heart Journal has published data from a two year follow up of the Rimonabant In Obesity - Europe study. A summary of the article is available via the National Electronic Library for Medicine.

The original RIO-Europe study recruited 1,057 individuals with a body mass index (BMI) of 30kg/m2, or BMI 27kg/m2 and either hypertension or dyslipidaemia. Participants were randomised to placebo, rimonabant 5mg or rimonabant 20mg. At the end of follow up, originally one year, weight loss was 1.8kg, 3.4kg and 6.6kg respectively. The study also reported improvements in cardiovascular risk factors including waist circumference, lipids and blood glucose.

This article compares two year data with baseline levels. It should be noted that drop out was high in all groups with less than half the original participants continuing treatment for two years. Weight loss was 1.2kg, 2.9kg, and 5.5kg, again in the respective groups. These figures are calculated from last known values carried forward where participants have been lost to follow up. The authors of the study conclude that, "rimonabant 20 mg over 2 years promoted clinically relevant and durable weight loss".

It is apparent from the data that there was an average weight gain in the second year of follow up when compared to the end of year one weight loss averages. This is despite all patients being provided with a dietary regimen that equivalent to a 600kcal daily energy deficit.

Action: The results of the study highlight the challenges of continued and persistent weight loss, even when pharmacologically aided. It also serves to highlight that pharmacological treatment should be stopped immediately if continued weight loss is not observed.

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Dust mite control ineffective for asthma

The Cochrane Library has published a review of house dust mite control measures for asthma. The review aimed to assess the efficacy of reducing dust mite allergen levels with the intention of reducing asthma symptoms.

The review included forty-nine trials including 2,733 patients that assessed both physical and chemical methods of controlling dust mite allergen levels. There were no statistical differences in morning peak flow, number of patients reporting improved symptoms, asthma symptom scores or medication usage.

The authors conclude that, "chemical and physical methods aimed at reducing exposure to house dust mite allergens cannot be recommended". The results of the review have reached the general media (BBC).

Action: Clinicians should ensure that advice given to patients with asthma is updated with the recommendations of this review. Dust mite control measures should not be recommended or endorsed.

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