Many patients with diabetes may not benefit from aggressive management of cardiovascular risk factors and some may even be harmed, according to a statistical model based on a government health survey.
Intensive, stepped-care management of dyslipidemia and hypertension led to gains of 1 to 1.5 quality-adjusted-life-years (QALY) in people who had a life expectancy of 10 to 11 years. But adjustment for potential harms of treatment reduced the benefits.
Only the patients at highest risk benefited from intensification beyond the first step of management protocols, suggesting that current clinical guidelines often recommend inherently flawed strategies, authors of the study reported in the June 28 issue of Archives of Internal Medicine.
"Below average to average-risk patients seem to receive virtually no net benefit from titrating beyond standard dose of a statin and two to three blood pressure medications, even if commonly recommended LDL-C and blood pressure goals have not been met," Justin W. Timbie, PhD, of the RAND Corp. in Arlington, Va., and co-authors wrote.
"Given the large set of factors that moderate the benefit of treatment intensification ... the diminishing effects of combination therapy, and increasing polypharmacy and adverse effects, we recommend a strategy of tailoring treatments to individual patients on the basis of their expected benefit of intensifying treatment. Current treatment approaches that encourage uniformly lowering risk factors to common target levels can be both inefficient and cause unnecessary harm."
Almost all clinical guidelines for diabetes recommend aggressive treatment of LDL cholesterol and blood pressure. However, the recommendations are based on averaging of benefits from clinical trials, the authors wrote.
Tailoring treatment to individual patient risk has received little or no attention in diabetes risk management, apparently because of "an implicit assumption that all patients with diabetes are at equally high risk, requiring all patients to be treated aggressively."
In fact, the benefit of intensified stepped-care therapy or treating to targets could vary substantially across the diabetic population, depending on the distribution of cardiovascular disease risk in the population, the authors continued.
Recent substudies of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial showed no survival advantage and suggested possible harm associated with a blanket approach to aggressive treatment of dyslipidemia and high blood pressure (N Engl J Med 2010; 362: 1563-74, N Engl J Med 2010; 362: 1575-85). Nonetheless, some high-risk patients might still benefit from an aggressive strategy.
In an effort to clarify the role of aggressive risk-factor management in diabetic patients, Timbie and co-authors designed a study to assess the variability in benefit and harm associated with treating to target. They identified adult diabetic participants in the third National Health and Nutrition Examination Survey (NHANES III) and developed models to simulate treat-to-target strategies for LDL and blood pressure.
The LDL target was 100 mg/dL and the blood pressure target was 130/80 mm Hg. Patients could progress through five titrations of statin therapy for LDL and eight titrations of antihypertensive therapy. The models incorporated adverse effects of treatment and the risks and burdens of polypharmacy.
Treating to the specified target for LDL resulted in a gain of 1.50 QALY and 1.35 QALY for treatment to the blood pressure target. After accounting for treatment-related harms, the QALY gain declined to 1.42 for LDL and 1.16 for blood pressure.
"Most of the total benefit was limited to the first few steps of medication intensification or to tight control for a limited group of very high-risk patients," the authors wrote.
"Intensifying beyond the first step for LDL or third step for blood pressure resulted in either limited benefit or net harm for patients with below-average risk," they added.
Statistical modeling has inherent limitations in its ability to simulate reality. Even so, "the lessons to be gleaned from this simulation are profound," Andrew L. Avins, MD, of Kaiser Permanente Northern California in Oakland, wrote in an editorial.
"Most important, the results starkly challenge some fundamental assertions regarding the appropriate treatment of patients with diabetes mellitus. Over the years, practice guidelines have advocated increasingly tighter control of blood glucose and cardiovascular risk factors, often relying on logical inference to extend thresholds beyond the available empirical evidence."
"The more and more tightly risk factors are controlled, the less benefit there will be in treating each additional risk factor," Avins continued. "The failure to account for this effect results in substantial overtreatment. Despite the fact that this phenomenon has been known for many years, it is generally ignored, to the detriment of our patients and our limited healthcare resources."
The principles reflected in the model by Timbie and colleagues apply to virtually all preventive interventions.
"One wonders why such examinations are not generally incorporated into the guideline development process rather than, as in this case, conducted in response to it," Avins concluded.
I don't know what is so hard to grasp about the idea that aggressively adding one medication on top of another as a way of managing cardio risk factors is counterproductive. What is needed is a re examination of the causes of diabetes.
How about recognising the role of carbohydrates in a condition like diabetes which clearly is a failure in the response to carbohydrate consumption.
As diabetes is in effect an inability to safely consume refined carbohydrates why not reduce the carbohydrate burden?
Instead of adding one medication after another why not consider the role of inflammation in diabetes and ensure the natural anti inflammatory status of all diabetics is optimized. It's pretty easy, cheap, simple to check vitamin D status and ensure all diabetics have a reserve store of D3 on board and a circulating plasma level around 60ng/ml the natural level of vitamin D homoeostasis.
Now we understand better the anti inflammatory role of omega 3 and the potential of omega 6 to be pro inflammatory is it really too difficult to recommend an effective omega 3 intake alongside the elimination of industrial seed oils such as corn, soybean, safflower, sunflower and cottonseed oil omega 6 rich sources.
As we know that only 10% of US adults achieve the RDA intake for magnesium isn't it about time all diabetics were reminded to take a form of magnesium the body actually is able to absorb. Now we know diabetes worsens magnesium status in diabetics surely it's a simple and straightforward matter to ensure ALL DIABETICS TAKE MAGNESIUM SUPPLEMENTS.
Instead of aggressively piling one medication on top of the last so Treating diabetes becomes unaffordable we need to think smarter and instead of using expensive medications to treat symptoms we need to use cheap natural OTC supplements with a proven track record to curb inflammation at source and dietary lifestyle changes (low carb + exercise) to prevent symptoms in the first place. Humans evolved for hundreds of thousands of years before the invention of farming, it's only in the last 60yrs we've seen the escalation in diabetes incidence.
We can turn the clock back.
We can tax sodas and stop cheap booze deals.
We could easily tax HFCS and sugars.
We can reduce the use of omega 6 oils.
What we can't do is afford the cost of an exponential increase in the cost of diabetes medications treatments and related complications.
Des Spence, general practitioner, Glasgow
Interesting to see some UK doctors with similar thoughts. This time it's about Chronic Kidney Disease.
the article is in the BMJ and ends with the line
Quote:
Chronic kidney disease is a failed experiment, a mockery of evidence based medicine, and just more bad modern medicine.
It's quite interesting also to read the replies to see the response he got.
I like this one
Quote:
If the road to hell is paved with QoF intentions, CKD was the last paving stone before the entrance. We are now poisoning half the population over 65 with mass medication. We know the cost and workload is astronomical - leaving aside side-effects and iatrogenic deaths. Where are the outcome data?
Silence.
from Dr Malcolm Kendrick. (who wrote the Cholesterol Con)
and this from the original author of the article
Quote:
the unregulated widespread use of medications in the USA is a testimony to the dangers of profit before care.
Think of this: You go into a hospital. You are fed organic fresh foods, no trans fats. If you are ok to do it, you go to the hospital gym. You are given fish oil (if not on high level coumadin or have a bleeding disorder), Vit D if needed, Vit C and E and Magnesium. Probiotics. I bet the results would be different.
Less is definitely more. Any disease is a warning sign that the body is not coping. The human body will always show improvement when it is supplied with good quality nutrition and a serious look at ones lifestyle. If healthy changes can be taken quickly enough the problem will be easy to correct. If we rely on medical intervention to rescue us we often just go back to what we were doing which may have exacerbated our illness in the first place and it's a slippery slope. Some medical treatment is sometimes essential, but not as a matter of course. Recently I was talking with someone in the 60's, very healthy and fit, who went to their Dr for an annual check-up, was told they were probably the fitness person in the country. Then the Dr asked him when he would like to go on statens - the Dr said it wasn't a matter of "if" for most people, but when!!!!!!! Scary stuff!
Authors' conclusions
Prostate cancer screening did not significantly decrease prostate cancer-specific mortality in a combined meta-analysis of five RCTs. Only one study (ERSPC) reported a benefit in a subgroup of men aged 55 to 69. Within this subgroup of men it was determined that 1410 men needed to be invited to screening and 48 additional men subsequently diagnosed with prostate cancer needed to receive early intervention to prevent one additional prostate cancer death at 10 years. Men should be informed of this and the demonstrated adverse effects when deciding whether or not to undertake screening for prostate cancer. Any benefits from prostate cancer screening may take up to 10 years to accrue; therefore, men who have a life expectancy less than 10 to 15 years should be informed that screening for prostate cancer is unlikely to be beneficial.
Quote from Dr. Royal Lee in Conversations in Nutrition:
"I heard a lecturer a few months ago who said that disease is a natural and normal reaction to an abnormal environment. Heatlh is a natural reaction to a normal environment. Now what's the medical profession trying to do? They're trying to take people who have been developing disease because of an abnormal environment and find some truck way to make them healthy in spite of that environment. That's something that, I believe you and I will agree, is impossible."
On April 1, 2010, www.newsmaxhealth.com published an article describing how a flawed "research" study has been used to get the FDA to approve the statin drug Crestor for use with healthy people in order to "prevent" heart attacks.
After all these years of drug companies and medical doctors touting the relationship between high cholesterol levels and heart attacks, the focus has now shifted to inflammation as one of the main causative factors in heart attacks. C-reactive protein (CRP) is the new measure of heart attack risk that is related to inflammation of the arteries.
Dr. Paul Ridker, the inventor of the CRP test, did the study of Crestor�s effect on "reducing" heart attacks, supposedly by reducing CRP levels. So, a statin drug that was promoted for lowering cholesterol levels now is being touted for its supposed ability to reduce heart attacks by reducing inflammation.
Dr. Ridker claimed that this Astra/Zeneca/Crestor funded study reduced the incidence of heart attacks by 55%. How did Ridker arrive at this amazing statistic? Well, he used a little mathematical magic. You see the actual incidence rates of heart attacks in the study groups were 0.38 per cent for the placebo group, whereas the rate for the Crestor group was 0.17 per cent. Both of these incident rates for heart attacks were below 1%. These are so extremely low incidence rates that they are clinically insignificant. But, there is gold even in such low numbers.
All you have to do subtract 0.17 from .038 to get a difference of 0.21. Then, take 0.21 and divide it by .038 and, voila, you have created a very impressive number � 55%. Now, that sounds much more impressive than just a plain old difference of 0.21 percent. In fact, you can submit this study touting a 55% reduction in heart attacks among healthy people taking Crestor and you can convince the FDA to "approve" prescribing Crestor to healthy people.
This mathematical sleight of hand research method along with FDA�s complicity now provides AstraZeneca with an estimated expanded market of 6.5 million Americans for Crestor.
With all of the well recognized statin drug hazards to people�s health, the FDA continues to play this game of pseudo-science with Big Pharma drug companies at the expense of the health of the American people. It�s business as usual when it comes to scientific fraud, the FDA, and Big Pharma whose sales and profits trump everything else.
If anything, the data from this study show that the heart attack rates are extremely low in a healthy group of people and that taking Crestor is not worth the health risks that commonly occur with this type of drug. Also, it is interesting to note that Dr. Ridker who invented the CRP test did not compare CRP blood levels of the control group and the Crestor group. This is a very interesting fact in his "research" methodology. But, they want to use CRP levels to justify prescribing Crestor to healthy people.
The cholesterol/heart attack myth has been soundly criticized and undermined. But, many doctors refuse to take a look at this evidence. On the other hand, a wealth of evidence has been accumulating that does establish inflammation of the arteries as a real factor in heart attack risk.
Given the fact that magnesium is nature�s anti-inflammatory mineral and that magnesium deficiency is at epidemic levels, it would be very safe and effective to recommend magnesium supplementation to most people including healthy people to really reduce their risk of heart attacks.
Tight Risk Factor Control No Help for Most Diabetics
Hybrid Mode
