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Wednesday, 28 December 2016

Effect of SGLT2 on Mortality Type 2 Diabetics. The EMPA-REG OUTCOME trial we can trust. December 28, 2016

New England Journal of Medicine published The EMPA-REG OUTCOME trial and its effect on diabetics type 2 mortality. This is the conclusion authors presented. I do have my own conclusion, based on the same studies. I think, I can trust in studies which were conducted under supervision of company which developed medicine they studied.
In conclusion, patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin had significantly lower rates of the primary composite cardiovascular outcome and of death from any cause than did those in the placebo group when the study drugs were added to standard care.
It does not mean I do come to the same conclusion as investigators. The matter of fact, my conclusion is right opposite. The medicine which was studied is the same medicine as a few others the same family, so I can spread the conclusion to the all other medicine the same family but developed by other companies. Invokana  and Farxiga  other known this kind medicine.

The trial was designed and overseen by a steering committee that included academic investigators and employees of Boehringer Ingelheim. The role of Eli Lilly was limited to cofunding the trial.
These two companies are Developers of medicine which was studied, so we can trust in results because of no one more interested in the results to be positive then these investigators. The result is
 Even though investigators were encouraged to adjust glucose-lowering therapy according to local guidelines, many patients did not reach their glycemic targets, with an adjusted mean glycated hemoglobin level at week 206 of 7.81% in the pooled empagliflozin group and 8.16% in the placebo group. Our trial was designed to assess the specific effects of empagliflozin on clinical outcomes, and the mechanisms behind the observed benefits are speculative.
The results of the studies I can trust. Medicine, empagliflozin, the same family medicine as Invokana, does not control blood sugar level. This is most important outcome published in medical journal. All covered by a lot of %%%%%%%% ..... how great medicine is, how effective this medicine for heart attacks and MI prevention (or developing if we are consider the outcome of the studies) because of only  
The primary outcome occurred in a significantly lower percentage of patients in the empagliflozin group (490 of 4687 [10.5%]) than in the placebo group (282 of 2333 [12.1%])
Remember, Primary Outcome is
 The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction (excluding silent myocardial infarction), or nonfatal stroke.
 So, only 10.5% of diabetics died because of heart attacks during the study period, and what is this period? Simple, one out of ten diabetics who was treated with Jardiance died due to CVD. Probably for Anne Peters it is great result. Not for me. The outcome is devastated!!!!!!!!!
Patients were treated at 590 sites in 42 countries. The trial continued until an adjudicated primary outcome event had occurred in at least 691 patients.
Great result, the conclusion I can trust. What really these studies were about, and what are outcome of those studies? At the time when patients started to die as a result of glucose lowering medicine, studies were stopped because of 691 patient already died, the outcome already achieved. Now with all excitement  it is presented for us, diabetics type 2, that Medicine such as Invokana and Jardiance (empagliflozil) prevent CVD. Really? In what studies this outcome come from? Not from this which is so widely and proudly advertised. This studies show right opposite outcome. I see, 691 Death, and it would be more if studies will go on. So, they stoped to study how fast Diabetic type 2 gone with Jardiance , a sodium-glucose cotransporter 2 (SGLT2) inhibitor, or any other medicine same family such as Invokana or Farxiga
The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors
They continue investigations, and we are continue to die. Diabetes type 2 number 7 cause of Death in America. Great Outcome.
       There is very complicated rules to be met to conduct studies. What I will say, I will never take part in any studies like that. Patients such as diabetics type 2  naively hope they will have help with the problems we do have, or at least be part in the helping to other people. Not at all. This studies nothing about science to develop better medicine. These studies to convince health companies they pay to provide their patients with best available medicine. The real result is right opposite.
 All the patients had established cardiovascular disease ....... and had received no glucose-lowering agents for at least 12 weeks before randomization and had a glycated hemoglobin level of at least 7.0% and no more than 9.0% or had received stable glucose-lowering therapy for at least 12 weeks before randomization and had a glycated hemoglobin level of at least 7.0% and no more than 10.0%.
       12 weeks no medicine for diabetic type 2 which would control blood sugar level.  I do understand, they were looking for clear results, but what about victims of studies? According to medical publications if diabetic type 1 will not take glucose lowering medicine, insulin, to miss even one shot, diabetic type 1 can die. In contrary, diabetics type 2 were left without medicine, glucose lowering medicine, for 12 weeks. Those diabetics already have A1c>9.%. What does it mean? That random level of sugar run over 600mg/dl. What also this mean, that blood is glue-like, highly clotting. With type of medicine which does not effect insulin secretion level of sugar in blood constantly going up, blocking blood vessels and leading to the high fatality.
  
 Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes  

Bernard Zinman, M.D., Christoph Wanner, M.D., John M. Lachin, Sc.D., David Fitchett, M.D., Erich Bluhmki, Ph.D., Stefan Hantel, Ph.D., Michaela Mattheus, Dipl. Biomath., Theresa Devins, Dr.P.H., Odd Erik Johansen, M.D., Ph.D., Hans J. Woerle, M.D., Uli C. Broedl, M.D., and Silvio E. Inzucchi, M.D., for the EMPA-REG OUTCOME Investigators
N Engl J Med 2015; 373:2117-2128November 26, 2015DOI: 10.1056/NEJMoa1504720

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