Tuesday, January 15, 2008

Cholesterol drugs good for diabetes patients?

Very narrowly-focused thinking here. Diabetics have their systems messed up enough already without messing them up even further with statins. Furthermore the logic seems poor. The research found that people with low levels of serum cholesterol were better off than those with high levels but how do we know that the advantage concerned was solely or at all due to their intake of statins? A large enough proportion of the lucky ones may have had naturally lower levels of cholesterol -- sufficient by itself to produce the observed differences.

Note that some high quality studies (e.g. the the recent 4D and ASPEN trials) have not produced similar results and that meta-analyses can be corrupted by selective inclusion of results. This meta-analysis did not in fact include the recent negative trials - 4D, ASPEN, and CORONA. It also did not include small trials, unpublished trials, or trials published in languages other than English: Not reassuring.

CHOLESTEROL-LOWERING drugs called statins should be automatically considered for nearly all patients with diabetes, after a study showed the drugs cut heart attacks and strokes even in people with no prior signs of heart disease. Australian and British experts analysed the results of 14 previous trials involving a total of 90,000 people, and found that over nearly five years the number of deaths among the nearly 19,000 diabetes patients fell by nine per cent for every one-unit drop in their level of LDL, or "bad" cholesterol. The drop was almost the same seen in the 71,000 non-diabetic patients, and applied equally to men and women, and both main types of diabetes. Each major cut in LDL cholesterol cut the numbers of heart attacks, strokes and blocked arteries by 21 per cent in diabetic and non-diabetic groups.

Any increase in statin use may place more pressure on the Pharmaceutical Benefits Scheme. One statin drug alone, Pfizer's Lipitor (atorvastatin), was the biggest drain on the PBS in 2005-06, costing the scheme nearly $490 million for 8.5 million prescriptions.

The study's authors - from the National Health and Medical Research Council's Clinical Trial Centre at the University of Sydney and the Epidemiological Studies Unit in Oxford - said "most people with diabetes should now be considered for statin therapy", with the exception of children and pregnant women. The study was published yesterday in The Lancet.

Jonathan Shaw, deputy director of the Melbourne-based International Diabetes Institute, said the PBS eligibility criteria for statins should be widened. Currently, diabetes patients only qualify for subsidised statin drugs if they are over 60, or if their blood cholesterol exceeds 5.5 millimoles per litre of blood.


Journal abstract follows:

Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis

Background: Although statin therapy reduces the risk of occlusive vascular events in people with diabetes mellitus, there is uncertainty about the effects on particular outcomes and whether such effects depend on the type of diabetes, lipid profile, or other factors. We undertook a prospective meta-analysis to help resolve these uncertainties.

Methods: We analysed data from 18,686 individuals with diabetes (1466 with type 1 and 17,220 with type 2) in the context of a further 71,370 without diabetes in 14 randomised trials of statin therapy. Weighted estimates were obtained of effects on clinical outcomes per 1รบ0 mmol/L reduction in LDL cholesterol.

Findings: During a mean follow-up of 4.3 years, there were 3247 major vascular events in people with diabetes. There was a 9% proportional reduction in all-cause mortality per mmol/L reduction in LDL cholesterol in participants with diabetes (rate ratio [RR] 0.91, 99% CI 0.82-1.01; p=0.02), which was similar to the 13% reduction in those without diabetes (0.87, 0.82-0.92; p<0.0001). This finding reflected a significant reduction in vascular mortality (0.87, 0.76-1.00; p=0.008) and no effect on non-vascular mortality (0.97, 0.82-1.16; p=0.7) in participants with diabetes. There was a significant 21% proportional reduction in major vascular events per mmol/L reduction in LDL cholesterol in people with diabetes (0.79, 0.72-0.86; p<0.0001), which was similar to the effect observed in those without diabetes (0.79, 0.76-0.82; p<0.0001). In diabetic participants there were reductions in myocardial infarction or coronary death (0.78, 0.69-0.87; p<0.0001), coronary revascularisation (0.75, 0.64-0.88; p<0.0001), and stroke (0.79, 0.67-0.93; p=0.0002). Among people with diabetes the proportional effects of statin therapy were similar irrespective of whether there was a prior history of vascular disease and irrespective of other baseline characteristics. After 5 years, 42 (95% CI 30-55) fewer people with diabetes had major vascular events per 1000 allocated statin therapy.

Interpretation: Statin therapy should be considered for all diabetic individuals who are at sufficiently high risk of vascular events.

The Lancet 2008; 371:117-125. Extended commentary here

Caesareans heading to danger level

Although sometimes necessary, I think there is little doubt that they are overdone

THE number of caesarean births in Australia is reaching unmanageable levels, placing lives at risk and tying up thousands of hospital beds, operating theatres and health workers with a costly elective procedure. With caesarean rates now about 30 per cent, anxious governments and health groups in Australia and overseas are trying to turn back the tide, as evidence of the harm caused by repeat surgical births mounts and doubts emerge about the protection a caesarean birth is thought to provide. Modelling by the NSW Department of Health, which has been obtained by the Herald, shows that a rise of just 1 per cent in elective caesareans would come at the cost of a huge rise in "occasions of service", diverting scarce clinical resources from other areas.

About 90,000 babies are born in NSW each year, so that 1 per cent increase would mean hundreds more caesarean sections, as well as more bed days, in already overstretched public hospitals. If the caesarean rate rises to 39 per cent - which many experts fear will happen soon - it will mean thousands more surgical births every year. In a public system that is hundreds of beds and thousands of staff short, and in the midst of a mini-baby boom, that extra strain would be unbearable, obstetricians and midwives warn.

Doctors are quick to point out that, when the health of the mother or baby is at risk, or in an emergency, a caesarean is often the safest way to give birth. There is further evidence that private obstetricians' fees are eating away at the Medicare safety net, meaning taxpayers are bearing the brunt of the increases in elective caesareans at state and federal levels.

Such is the concern that NSW Health organised a meeting of the state's leading midwives and obstetricians to develop strategies to reduce the number of women choosing elective caesareans. Six months later many who attended that meeting despair at the absence of a coherent, statewide plan to reduce the number of women who elect to give birth surgically without a medical reason. The director of women's and children's health at St George Hospital, Michael Chapman, believes the rate of elective caesarean sections could be reduced by at least 5 per cent if women were presented with "accurate information in a believable manner".

Professor Chapman said there were strong health and economic arguments for reducing the number of elective caesareans. A caesarean was at least twice as expensive as a vaginal delivery, he said. "The State Government has to face this issue - we have gone up from 2260 births three years ago to 2700 this year [at St George Hospital] and, with a 30 per cent caesarean rate, that is an extra 100 caesars . it is pushing our operating lists to the limit."

A professor of women's health, nursing and midwifery at the Royal Hospital for Women at Randwick, Sally Tracy, said that not only was it far riskier for women to have caesareans when there was no medical reason, but there was now overwhelming evidence that it carried great risk for babies, too. "Up until now . caesarean section was first and foremost done to protect the baby," she said. Yet a study by Professor Tracy, published in the journal Birth last month, found babies born in an elective caesarean at full term were almost twice as likely to be admitted to a neo-natal intensive care unit as those born vaginally. Professor Tracy's research is one of a dozen studies in the past year cataloguing the harm from elective caesareans.

Last month, in its "committee opinion" on elective caesareans, the American College of Obstetricians and Gynaecologists said surgical birth resulted in a longer hospital stay for the mother, increased respiratory problems for the baby and greater complications in later pregnancies.

A spokesman for the Minister for Health, Reba Meagher, said a policy was released last year to prevent elective caesareans before 39 weeks of gestation unless there were medical reasons. Maternity services were being reviewed, and the Government expected a new policy to be finalised this year, he said. [Don't rush, now!]



Just some problems with the "Obesity" war:

1). It tries to impose behavior change on everybody -- when most of those targeted are not obese and hence have no reason to change their behaviour. It is a form of punishing the innocent and the guilty alike. (It is also typical of Leftist thinking: Scorning the individual and capable of dealing with large groups only).

2). The longevity research all leads to the conclusion that it is people of MIDDLING weight who live longest -- not slim people. So the "epidemic" of obesity is in fact largely an "epidemic" of living longer.

3). It is total calorie intake that makes you fat -- not where you get your calories. Policies that attack only the source of the calories (e.g. "junk food") without addressing total calorie intake are hence pissing into the wind. People involuntarily deprived of their preferred calorie intake from one source are highly likely to seek and find their calories elsewhere.

4). So-called junk food is perfectly nutritious. A big Mac meal comprises meat, bread, salad and potatoes -- which is a mainstream Western diet. If that is bad then we are all in big trouble.

5). Food warriors demonize salt and fat. But we need a daily salt intake to counter salt-loss through perspiration and the research shows that people on salt-restricted diets die SOONER. And Eskimos eat huge amounts of fat with no apparent ill-effects. And the average home-cooked roast dinner has LOTS of fat. Will we ban roast dinners?

6). The foods restricted are often no more calorific than those permitted -- such as milk and fruit-juice drinks.

7). Tendency to weight is mostly genetic and is therefore not readily susceptible to voluntary behaviour change.

8). And when are we going to ban cheese? Cheese is a concentrated calorie bomb and has lots of that wicked animal fat in it too. Wouldn't we all be better off without it? And what about butter and margarine? They are just about pure fat. Surely they should be treated as contraband in kids' lunchboxes! [/sarcasm].

9). And how odd it is that we never hear of the huge American study which showed that women who eat lots of veggies have an INCREASED risk of stomach cancer? So the official recommendation to eat five lots of veggies every day might just be creating lots of cancer for the future! It's as plausible (i.e. not very) as all the other dietary "wisdom" we read about fat etc.

10). And will "this generation of Western children be the first in history to lead shorter lives than their parents did"? This is another anti-fat scare that emanates from a much-cited editorial in a prominent medical journal that said so. Yet this editorial offered no statistical basis for its opinion -- an opinion that flies directly in the face of the available evidence.

Even statistical correlations far stronger than anything found in medical research may disappear if more data is used. A remarkable example from Sociology:
"The modern literature on hate crimes began with a remarkable 1933 book by Arthur Raper titled The Tragedy of Lynching. Raper assembled data on the number of lynchings each year in the South and on the price of an acre's yield of cotton. He calculated the correlation coefficient between the two series at -0.532. In other words, when the economy was doing well, the number of lynchings was lower.... In 2001, Donald Green, Laurence McFalls, and Jennifer Smith published a paper that demolished the alleged connection between economic conditions and lynchings in Raper's data. Raper had the misfortune of stopping his analysis in 1929. After the Great Depression hit, the price of cotton plummeted and economic conditions deteriorated, yet lynchings continued to fall. The correlation disappeared altogether when more years of data were added."
So we must be sure to base our conclusions on ALL the data. But in medical research, data selectivity and the "overlooking" of discordant research findings is epidemic.

"What we should be doing is monitoring children from birth so we can detect any deviations from the norm at an early stage and action can be taken". Who said that? Joe Stalin? Adolf Hitler? Orwell's "Big Brother"? The Spanish Inquisition? Generalissimo Francisco Franco Bahamonde? None of those. It was Dr Colin Waine, chairman of Britain's National Obesity Forum. What a fine fellow!


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