Lancet Meta-analysis: Statins should be more widely prescribed for patients with diabetes

Almost all patients with diabetes should be considered for therapy with statins, according to authors of a meta-analysis published in the current issue of The Lancet. (Abstract - Efficacy of cholesterol-lowering therapy in 18 686 people with diabetes in 14 randomised trials of statins: a meta-analysis
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The study, led by researchers at the Oxford-based Cholesterol Treatment Trialists' Collaboration working with colleagues in Australia, brought together information from 14 randomised trials.

It included 18,686 patients with both type 1 and type 2 diabetes, and 71,370 without diabetes and found that those with diabetes reduced their risk of major vascular events, such as heart attack and stroke, by about 33 percent over five years, compared with those who did not take the drugs. Additionally, in patients with the disease, all-cause mortality was reduced by 9 percent over an average of 4.3 years for every step reduction in LDL cholesterol. The researchers indicated that the findings were similar for patients without diabetes who took statins.

Study co-author Colin Baigent noted that the findings suggest "statins are clearly effective for a wide range of people with diabetes, irrespective of their absolute risk and irrespective of whether they have type 1 or type 2 (diabetes) or whether they are male or female." Only those with exceptionally low risk of heart attack or stroke and those who cannot take the drugs should be exempted from consideration for statin treatment, the researchers added.

In an accompanying article, Bernard Cheung of the University of Birmingham said that statins were among the most notable triumphs of modern medicine.

He added in a statement of the bleeding obvious to all diabetics: "Apart from drug treatment, one must not forget the importance of lifestyle changes, such as cessation of smoking, healthy diet, and regular exercise."

Wikipedia on Statins

FDA issue "Black Box" warning for Diabetes Type II drugs, Avandia and Actos

The Food and Drug Administration (FDA) have determined that a "black box" warning highlighting "may cause or worsen heart failure in certain patients" has to be added to thiazolidinedione class of type 2 diabetes drugs, including GlaxoSmithKline's Avandia (rosiglitazone) and Takeda's / Eli Lilly Actos (pioglitazone). See this website for SKF/Avandia official response and here for Actos - July 30th Press Release from Takeda here.

This decision results from an FDA review of post-marketing reports that showed warning signs of heart failure found - significant weight gain and oedema, which associated with poor outcomes, including death, the agency added. This follows a "meta-analysis" published by Dr. Steven Nissen, chief cardiologist for the Cleveland Clinic, in the New England Journal of Medicine which detailed a major study showing inc reased risks of heart attacks, especially amongst Diabetes Type II patients without other signs or indicators of heart problems..

GlaxoSmithKline's Avandaryl (rosiglitazone plus glimepiride), Avandamet (rosiglitazone plus metformin), as well as Takeda's Duetact (pioglitazone plus glimepride) will also carry the new "black box" warning.

An advisory panel had earlier in June voted 22-1 to recommend that GlaxoSmithKline's type 2 diabetes drug, Avandia (rosiglitazone), should remain on the market, despite data suggesting that it increases cardiovascular risks. The panel had also recommended that the product's label should be updated with new safety warnings.The advisory panel had reviewed a 436-page report which was a compendium of reviews released in advance of an advisory panel hearing held on Monday June 30th.

In 2006 Avandia sales totalled $3 billion. Barbara Ryan, analyst for Deutsche Bank North America, said in a published report that US Avandia prescription volumes were down 50 % in the week ended July 20, compared to the week preceding May 18, when Nissen's article was published. For those same time periods, Actos US prescriptions were up 19 %. Glaxo shares rose 4% on Tuesday after the news.

Diabetes drugs to get stronger heart-failure warning - (Bloomberg)
FDA to strengthen diabetes drug warnings - (CNN)
GlaxoSmithKline Updates Prescribing Information for Avandia - (Pharmalive)

If you take Avandia or Actos you should inform yourself of the risks involved - Actos / Takeda / Lilly say "Talk to your doctor immediately if you experience rapid weight gain, fluid retention, or shortness of breath while taking ACTOS. " - I did and I spoke to the Doctor.

My Doctor says (God Bless her), "We are going to ignore the Nissen report".. what do you do ? Change Doctor, Flip a coin ? Fuller discussion of the Nissen report here in an earlier post.

Designer Vaginas - booming business on the NHS

"More and more women are said to be troubled by the shape, size, or proportions of their vulvas, so that elective genitoplasty is apparently a "booming business." Advertisements for cosmetic genitoplasty are common, often including before and after images and life changing narratives. Google produced around 490 000 results when we entered "labial reduction". Forty seven of the first 50 results were advertisements from clinics in the United Kingdom and United States offering cosmetic genital surgery. Television programmes and articles in women's magazines on "designer vaginas" may also fuel desire for ..... "

Requests for cosmetic genitoplasty: how should healthcare providers respond?

Lih Mei Liao, consultant clinical psychologist, Sarah M Creighton, consultant gynaecologist

Middlesex Centre, UCL Institute for Women's Health, Elizabeth Garrett Anderson and Obstetric Hospital, London WC1E 6DH

British Medical Journal 2007;334:1090-1092 (26 May), doi:10.1136/bmj.39206.422269.BE

The U.K.'s National Health Service in 2004 and 2005 paid for elective surgery on 800 women who had the size of their labia reduced. That's more than double the number of procedures funded by the government 6 years earlier.... who says that doubling the expenditure on the NHS isn't producing results ?

UPDATE - Toni Fabuloso calls (she gets weekends off) to tell us that in the business it's called an "Aussie makeover " ... y'know it's "Downunder".

For the diabetics amongst you the issue also contains the following ..

Study indicates diabetes drug linked to cardiovascular death

Janice Hopkins Tanne

A meta-analysis of 42 trials of the type 2 diabetes drug rosiglitazone (Avandia - GSK) has shown a significantly raised risk of myocardial infarction and an increase in cardiovascular deaths that did not quite reach statistical significance (New England Journal of Medicine 2007 May 21 doi: 10.1056/NEJMoa072761).