New information on Diabetes II treatment

[MRC_Hans]

The "Steno Study" reveals how a new regimen for Diabetes II patients can reduce risk of long-term complications by appr. 50%

http://content.nejm.org/cgi/content/short/348/5/457


Hans

[Goshawk]

Eh, Hans, your NEJM link won't let me read the article without a $ub$cription. ;)

Was this (http://www.docguide.com/news/content.nsf/news/8525697700573E1885256CBE00007CBB?OpenDocument&id=48DDE4A73E09A969852568880078C249&c=Diabetes&count=10) the news item?
Cardiovascular Risks In Diabetics Can Be Halved
New England Journal of Medicine (NEJM)

01/30/2003
By Anne MacLennan

Intense, long-term intervention aimed at multiple risk factors in type two diabetics cuts their risk of cardiovascular (CV) and microvascular events by about half.

This is the finding of multi-centre study in Denmark led by Dr Peter Gaede from the Steno Diabetes Centre, Copenhagen.

Cardiovascular (CV) morbidity remains a major problem among patients with type two diabetes, especially those with microalbuminuria.

The investigators compared conventional with intensive therapy involving stepwise implementation of behaviour modification and pharmacologic therapy targeted at hyperglycaemia, hypertension, dyslipidaemia and microalbuminuria, along with secondary prevention of CV disease with aspirin.

Primary end point in the open, parallel (Steno-2) study, was a composite of death from CV causes, nonfatal myocardial infarction, nonfatal stroke, revascularisation and amputation.

Eighty patients were randomly assigned to receive conventional treatment (per national guidelines) and 80 to receive intensive treatment.

Mean age of the patients was 55.1 years, and mean follow-up was 7.8 years.

Decline in glycosylated haemoglobin values, systolic and diastolic blood pressure, serum cholesterol and triglyceride levels measured after an overnight fast, and urinary albumin excretion rate were all significantly greater in the intensive- than in the conventional-therapy group.

Patients on the intensive therapy also had a significantly lower risk of CV disease, nephropathy, retinopathy and autonomic neuropathy than did those on conventional therapy.

This study included contributors from Herlev County Hospital, Herlev, Amtssygehuset Roskilde, Roskilde and Aarhus University, Aarhus, as well as the Steno Diabetes Centre.
N Engl J Med 2003;348:383-393. A slightly different slant on it here (http://asia.reuters.com/newsArticle.jhtml?type=healthNews&storyID=2135967), formulated for the Reuters mass media market.
Key to Diabetes Treatment: Stay Ambitious
Wed January 29, 2003 05:34 PM ET
By Alison McCook

NEW YORK (Reuters Health) - Ambition helps when reaching for life goals, and new research released Wednesday shows that the same holds true for diabetics.

According to a report in The New England Journal of Medicine, diabetics who are given more ambitious goals for lowering their blood pressure, cholesterol, and blood sugar are less likely to suffer from cardiovascular problems than patients whose doctors set less ambitious treatment goals.

All patients had type 2 diabetes, the most common form of the disease, which is often linked to obesity.

When the study began, doctors did not routinely try to help diabetics meet the ambitious treatment goals offered in the study. But times have changed--according to Dr. Caren G. Solomon of the New England Journal of Medicine, current treatment recommendations from the American Diabetes Association (ADA) closely resemble those set for the ambitious group.

< snip >

During the current study, patients offered intensive treatment were followed by a "team," consisting of a doctor, nurse and dietician, all focused on helping patients keep up with their medications and stay healthy, such as with diet and exercise.
In contrast, patients with less ambitious goals to reduce risk factors for health problems only visited a doctor during each consultation, although both groups received approximately the same number of consultations...[more]
SOURCE: The New England Journal of Medicine 2003;348:383-393,457-459.

[MRC_Hans]

Ooops, thanks! Yes, your link covers the story. I made the post from work, and apparantly my company is a subscriber, heheh. I have to add that I'm working for one of the worlds 3 largest insulin producers. But the study I mention is independent.

Hans

[sickstan]

Perhaps I should spell out what the "intensive-therapy group" received:

1. Light-to-moderate exercise >30 min, 3-5x/wk.
2. Smokers and their partners invited to quit smoking courses.
3. ACE inhibitor or Angiotensin II receptor antagonist therapy
4. Vitamin supp: 250 mg vit C, 100 mg vit E (in the D-alpha-tocopherol), 400 mcg folate, 100 mcg chromium picolinate
5. Dietary fat limitation <30% calories with <10% saturated
6. 150 mg aspirin daily
7. Hypoglycemic therapy was initially through lifestyle. Drugs were initially metformin, with glicazide and NPH insulin also used.
8. Goal was HbA1c < 6.5%
9. Statin (HMG-CoA reductase inhibitor) therapy was used for hypercholesterolemia. Fibrates were used for isolated hypertriglyceridemia.

Endpoints were death by cardiovascular causes and nonfatal cardiovascular events, including interventional peripheral or cardiac vascular procedures, stroke, and heart attacks.

Very good study again demonstrating the value of tight control. This one also uses adjunct therapy for renal, cardiac, and peripheral vascular risk. The endpoints are also more geared to larger-bore vessels than previous studies.

Hey MRC your company wouldn't be making Hagedorn NPH insulin would it?

[Roadtoad]

More on Diabetes:

By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON - Losing your memory in old age sometimes may have nothing to do with Alzheimer's and lots to do with blood sugar.

So suggests new research that found people who don't process blood sugar normally — a silent, pre-diabetic condition — are likely to suffer poor memory and even a shrinkage of the brain region crucial for recall.

The good news: If the small study from New York University is confirmed, simple diet and exercise could help many people protect their brains from the fogged memory associated with aging.

Maybe the threat of memory loss — an oft-cited fear among aging baby boomers — will provide the final push for people to take those steps, says lead researcher Dr. Antonio Convit.

"That's a great motivator to stay off the calories and stay off the couch," he said.

For every Alzheimer's patient, there are eight older people who suffer enough memory loss to significantly harm their quality of life yet have no dementia-causing disease, says Convit, an NYU psychiatry professor who set out to uncover the causes.

Blood sugar was a natural suspect because scientists have long known that diabetics are at higher-than-normal risk for memory problems, possibly because diabetes harms blood vessels that supply the brain, heart and other organs.

The new study, published Monday in the Proceedings of the National Academy of Sciences, found that people's memory may be harmed long before they ever develop full-fledged diabetes — and that it's a problem of fuel, not plumbing.

Convit studied 30 non-diabetic middle-age and elderly people. He measured how they performed on several memory tests; how quickly they metabolized blood sugar after a meal; and, using MRI scans, the size of the hippocampus, the brain region responsible for recent memory.

The slower those outwardly healthy people metabolized blood sugar, the worse their memory was — and the smaller their hippocampus was, Convit found.

Unlike most other tissues that have multiple fuel sources, the brain depends on blood sugar for almost all its energy, Convit explained. The longer that glucose stays in the bloodstream instead of being metabolized into body tissues, the less fuel the brain has to store memories.

Convit's research found no specific threshold at which memory automatically worsened. Instead it was a spectrum: The slower glucose metabolism, the worse people did.

Once that metabolism reaches certain levels, it becomes a condition called "impaired glucose tolerance" or pre-diabetes, thought to afflict 16 million Americans. It strikes mostly in middle age, although people of any age who are overweight and sedentary are at risk — and Americans are getting fatter every year. Without treatment, pre-diabetes usually turns into full-fledged diabetes, which in turn brings deadly heart attacks, kidney failure and numerous other ailments.

Why did only the memory-crucial hippocampus seem harmed? Previous animal and human research shows it's the region most likely damaged by any brain insult, Convit said. Conversely, it's also a very adjustable region, with the potential for some recovery if people bring their blood sugar under control, he said.

Convit's study sheds important light on yet another risk of bad blood sugar, said Dr. Fran Kaufman, president of the American Diabetes Association.

She cautioned that it was a small study that requires confirmation before doctors test glucose solely for memory complaints.

But if confirmed, the same advice for lowering people's overall diabetes risk — drop a few pounds and do exercise as simple as walking 30 minutes a day — apparently would help protect people's brains, too, Kaufman said.

Meanwhile, the diabetes association already recommends pre-diabetes testing for everyone 45 or older, and for younger people who are significantly overweight and have one other risk factor: a diabetic relative; bad cholesterol; high blood pressure; diabetes during pregnancy or gave birth to a baby bigger than 9 pounds; or belong to a racial minority group.

[BillyJoe]

Two major problems not mentioned in either article:

(1) A significant adverse affect of intensive treatment is a three fold increase in the rate of hypoglycaemic attacks.
(if you think about it, this makes sense!)
This is not to be scoiffed at either because it significantly reduces enjoyment of life for diabetics and can lead to neurological symptoms if prolonged or severe attacks are experienced.
(A friend of mine with diabetes lost his job because of the number of hypos he was having under the intense regimen)

(2) The benefits achieved in a trial will not be expected to be duplicated in other settings. The input and enthusiasm of participants - both patients and medical and ancillary personel - is unlikely to be able to be replicated, for example, in a general practice setting.

Still, an interesting trial.

[sickstan]

Originally posted by BillyJoe
Two major problems not mentioned in either article:

(1) A significant adverse affect of intensive treatment is a three fold increase in the rate of hypoglycaemic attacks.
(if you think about it, this makes sense!)

Umm... If you are able to achieve control without insulin or sulfonureas, you have no increased risk for hypoglycemic events! Your data may be based on the older data from the Microvascular Complications studies, one on Type I and one on Type II diabetes. Those used insulin and sulfonureas, respectively.

[BillyJoe]

sickstan,

You are right.
Apologies.

:o

[MRC_Hans]

Originally posted by sickstan
*snip*

Hey MRC your company wouldn't be making Hagedorn NPH insulin would it? Ooops, sorry for the late answer, this thread dropped out of my display. Mmmm, Dr. Hagedorn is very much a part of the past of Novo Nordisk, but I cant find the product you mention in our register. Perhaps you have some more info?

Insulin is not exactly my speciality.

Hans

[a_unique_person]

I think the critical issue here is 'behaviour modification'. All the rest is easy, actually getting yourself up and off your fat butt and exercising and eating a proper diet are the hard parts.

while the people these studies have a massive research team to help motivate them, modification is made easier. To actually do it yourself is much more difficult.

[BillyJoe]

Originally posted by a_unique_person
.....while the people [in] these studies have a massive research team to help motivate them, modification is made easier. To actually do it yourself is much more difficult. Yes, I only retracted my first point. I stand by my second point......
Originally posted by BillyJoe
(2) The benefits achieved in a trial will not be expected to be duplicated in other settings. The input and enthusiasm of participants - both patients and medical and ancillary personel - is unlikely to be able to be replicated, for example, in a general practice setting.

[MRC_Hans]

Any regimen (well, almost any) requires compliance from the patient, and I agree that in this case, compliance will be a major challenge. This, however, only makes the result more important because it shows that it is important (cost-effective) to use ressources on this.

It will also provide important motivation for many patients to know that their efforts actually make a difference.

Hans