Much like a roadblock, but with a fortuitous outcome -- an experimental heart drug didn't achieve the primary goal of a late-stage trial but it did dramatically reduce the risk patients would develop diabetes.
The anti-oxidant, anti-inflammatory drug, the first of its kind, reduced the risk of developing diabetes by 64% and demonstrated a small but statistically significant reduction in blood sugar after 12 months. The study included data from 6,144-patients. The company believes this finding to be a serendipitous outcome, despite the initial shortcomings of the trial objective. They need to confirm it in a large clinical trial. The impressive diabetes results may come as a surprise to investors who have abandoned AtheroGenics or who have been betting the drug will fail.
Heart patients in the study received either 300 milligrams of the drug or a placebo on top of a host of standard-of-care medicines they were already taking, such as aspirin, cholesterol-lowering statins, blood thinners and/or diabetes medicines.
The drug had an undesirable impact on blood fats, raising bad LDL cholesterol by about 12% and lowering good HDL cholesterol by roughly the same amount. There were also some potentially troubling safety signals with a trend toward more heart failure in those taking the drug. In spite of the undesirable affects on blood lipids, the drug has a profound effect on diabetes. Further research will be conducted on the efficacy of this drug in reducing the risk of developing diabetes.
1. A. If Type 2 diabetes is a physiological response for improving health … to support that possibility … a drug or that could reduce specific symptoms of Type 2 diabetes would likely change other physiological markers, for health, in a negative way…
B. What is the most definitive study which substantiates the benefit of drug/insulin treated acute&chronic 'insulin-resistant diabetes' [Type 2] … as compared with treatment-free [drug/insulin] acute&chronic 'insulin-resistant diabetes' [ie in a ZERO drug (repeat zero) treatment control Group]? {ps please note the word written there says: “zero”}…
... Am seeking a ‘peer reviewed’ study that clearly disassociates drug/insulin treatment from any changes in Patient behaviour [eg diet/exercise] and/or categorically proves that drug/insulin treated acute&chronic 'insulin-resistant diabetes' is healthier than doing absolutely nothing [‘zero’] ie just accepting the higher [possibly beneficial] blood glucose value [and possibly beneficial “insulin resistance”]; and
C. What is the most definitive study which provides incontrovertible evidence that the apparent insulin receptor mediated down-regulation [in response to: transient supernormal glycaemia ‘TSG’] is anything substantially other than a stress-adaptive mechanism of 'local' [on a cell-by-cell basis] intracellular cyto-protection from influx of excessive [blood] circulating glucose [ie homeostasis] eg cardio muscle protective?
... My understanding is that insulin receptor mediated down-regulation ‘IRD’ [aka “insulin resistance”] is primarily an adaptive [protective/regulatory/beneficial] reply to transient [and chronically repeated] oral indulgence/stress …
eg "...healthy young students were fed a very high fat diet containing egg yolks, heavy cream, and butter, and within 2 days all of the students had blood sugar levels high enough to be labelled diabetic..."
Sweeney J. Dietary factors that influence the dextrose tolerance test: A preliminary study. Archives of Internal Medicine 1927; 40:818.
Warm thanks, Nicholas Dynes Gracey, BSc(Hons) Medical Biochemistry, Birmingham University, UK c/o www.TheDiabetesBlog.com @ 18:54hrs THU.29.MAR.2007.
Posted at 1:56PM on Mar 29th 2007 by Nicholas Dynes Gracey