|
|
Post by mannmade on Aug 30, 2016 0:20:33 GMT -5
Study finds tight glycemic control provides no impact on patient-important microvascular outcomes
Published on August 29, 2016 at 3:41 PM · No Comments
inShare
5
The glucocentric focus on lowering blood sugar in Type 2 diabetes may have short-circuited development of new diabetes therapies, according to a new paper published by Mayo Clinic researchers in the journal Circulation: Cardiovascular Quality and Outcomes.
The authors, Victor Montori, M.D., and Rene Rodriguez-Gutierrez, M.D., of the Knowledge and Evaluation Research Unit at Mayo Clinic, systematically examined journal articles and clinical practice diabetes guidelines published in the last decade (2006 and 2015) for statements related to value of tight glycemic control in the prevention of chronic diabetic complications. The authors then compared them with the body of evidence accrued in the past two decades regarding the effect of tight glycemic control on patient-important micro- and macrovascular outcomes.
The study, funded by Mayo Clinic's Clinical and Translational Science Award, found that tight glycemic control (maintenance of a hemoglobin A1c value lower than 7 percent) had no statistically significant impact on patient-important microvascular outcomes (end-stage renal disease/dialysis, renal death, blindness and clinical neuropathy). In contrast, all practice guidelines and a majority of published statements (around 80 percent) support tight glycemic control to prevent those complications.
Related Stories
Hydrothermal DMR results show promise in treatment of type 2 diabetes
Prevalence of coronary calcification similar between patients with psoriasis and type 2 diabetes
Detecting diabetes’ deadly ketones
For patient-important macrovascular (cardiovascular) complications, the evidence shows that tight glycemic control reduces the risk of nonfatal heart attack by around 15 percent, but has no impact in all-cause mortality and cardiovascular mortality. Also, the risk of stroke did not seem to be lowered by tight glycemic control and the effect on amputation was imprecise. During the studied time period, statements about tight glycemic control to prevent these complications shifted from largely supportive (85 percent) to skeptical (20-30 percent) after the publication of a single study (the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial) in 2008 that is not consistent with the results of other studies (body of evidence).
Overall, the authors suggest that the widespread consensus for tight glycemic control should be re-examined.
Drs. Rodriguez-Gutierrez and Montori write that they hope this paper will spur research into new therapeutic approaches to prevent diabetes complications. They write, "Consider the list of evidence-based therapies recommended … to prevent retinopathy or neuropathy beyond glycemic control: none."
Instead of focusing on tight glycemic control, the authors suggest glycemic moderation may help advance the individualization of diabetes care, using shared decision making to select glycemic targets and treatments.
The authors point out that patients with Type 2 diabetes seem to live longer and with fewer complications, at least in some parts of the world, and suggest a careful and thoughtful recalibration of treatment could promote patient trust and provide new answers to this pandemic problem.
Source:
Mayo Clinic
|
|
|
|
Post by centralcoastinvestor on Aug 30, 2016 0:45:29 GMT -5
Study finds tight glycemic control provides no impact on patient-important microvascular outcomes Published on August 29, 2016 at 3:41 PM · No Comments inShare 5 The glucocentric focus on lowering blood sugar in Type 2 diabetes may have short-circuited development of new diabetes therapies, according to a new paper published by Mayo Clinic researchers in the journal Circulation: Cardiovascular Quality and Outcomes. The authors, Victor Montori, M.D., and Rene Rodriguez-Gutierrez, M.D., of the Knowledge and Evaluation Research Unit at Mayo Clinic, systematically examined journal articles and clinical practice diabetes guidelines published in the last decade (2006 and 2015) for statements related to value of tight glycemic control in the prevention of chronic diabetic complications. The authors then compared them with the body of evidence accrued in the past two decades regarding the effect of tight glycemic control on patient-important micro- and macrovascular outcomes. The study, funded by Mayo Clinic's Clinical and Translational Science Award, found that tight glycemic control (maintenance of a hemoglobin A1c value lower than 7 percent) had no statistically significant impact on patient-important microvascular outcomes (end-stage renal disease/dialysis, renal death, blindness and clinical neuropathy). In contrast, all practice guidelines and a majority of published statements (around 80 percent) support tight glycemic control to prevent those complications. Related Stories Hydrothermal DMR results show promise in treatment of type 2 diabetes Prevalence of coronary calcification similar between patients with psoriasis and type 2 diabetes Detecting diabetes’ deadly ketones For patient-important macrovascular (cardiovascular) complications, the evidence shows that tight glycemic control reduces the risk of nonfatal heart attack by around 15 percent, but has no impact in all-cause mortality and cardiovascular mortality. Also, the risk of stroke did not seem to be lowered by tight glycemic control and the effect on amputation was imprecise. During the studied time period, statements about tight glycemic control to prevent these complications shifted from largely supportive (85 percent) to skeptical (20-30 percent) after the publication of a single study (the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial) in 2008 that is not consistent with the results of other studies (body of evidence). Overall, the authors suggest that the widespread consensus for tight glycemic control should be re-examined. Drs. Rodriguez-Gutierrez and Montori write that they hope this paper will spur research into new therapeutic approaches to prevent diabetes complications. They write, "Consider the list of evidence-based therapies recommended … to prevent retinopathy or neuropathy beyond glycemic control: none." Instead of focusing on tight glycemic control, the authors suggest glycemic moderation may help advance the individualization of diabetes care, using shared decision making to select glycemic targets and treatments. The authors point out that patients with Type 2 diabetes seem to live longer and with fewer complications, at least in some parts of the world, and suggest a careful and thoughtful recalibration of treatment could promote patient trust and provide new answers to this pandemic problem. Source: Mayo Clinic It seems like the study's intent is to cause an uproar. It doesn't appear that any kind of direct study has been done to corroborate their findings. They pull evidence together from journals and general studies about tight glycemic results. I can't remember the name of the study that attempted very tight glycemic control that had to be stopped because the study was killing people due to hypoglycemia. It's interesting but I would say that no tight glycemic control study could be done without a drug like Afrezza that quickly leaves the system. So if very few studies have been done on tight glycemic control then how do they draw these conclusions. Also, what do they mean by tight control? Do they mean time in range TIR that results in tight glycemic control or widely varying gluclose levels that result in a lower average A1c? With a drug like Afrezza, it is possible to obtain consistent TIR and a lower A1c, a worthy goal. The study above needs to clarify what they mean by tight glycemic control. |
|
|
|
Post by peppy on Aug 30, 2016 7:47:29 GMT -5
quote: The study, funded by Mayo Clinic's Clinical and Translational Science Award, found that tight glycemic control (maintenance of a hemoglobin A1c value lower than 7 percent) had no statistically significant impact on patient-important microvascular outcomes (end-stage renal disease/dialysis, renal death, blindness and clinical neuropathy). In contrast, all practice guidelines and a majority of published statements (around 80 percent) support tight glycemic control to prevent those complications.
reply: if type two they were probably all on metformin which takes out peoples renal systems. screencast.com/t/exiok0lrMv
the guidelines show metformin used in all therapies.
Iatrogenic?
|
|
|
|
Post by beardawg on Aug 30, 2016 8:20:17 GMT -5
If anything, it supports Afrezza's value. Current prandial insulin is shown to not affect outcomes because it is an average of something that needs to be in the "middle". An average in that case doesn't tell you much, because huge swings and a straight line look the same.
Say I'm on a 70mph max, 40mph min highway. If I drive 1mph for 30 minutes then 101mph for 30 minutes, I'd average 51mph and drive 50 miles, but I'd be in danger of getting tickets the whole way. I'd get to the destination at the same as if I drive 51mph the whole way, but I'd likely be hundreds of dollars poorer.
How about getting the continuous blood sugar levels of a healthy person who doesn't experience those outcomes and comparing the blood sugar levels of prandial insulin users to that?
|
|
|
|
Post by agedhippie on Aug 30, 2016 8:48:48 GMT -5
quote: The study, funded by Mayo Clinic's Clinical and Translational Science Award, found that tight glycemic control (maintenance of a hemoglobin A1c value lower than 7 percent) had no statistically significant impact on patient-important microvascular outcomes (end-stage renal disease/dialysis, renal death, blindness and clinical neuropathy). In contrast, all practice guidelines and a majority of published statements (around 80 percent) support tight glycemic control to prevent those complications.
reply: if type two they were probably all on metformin which takes out peoples renal systems. screencast.com/t/exiok0lrMv
the guidelines show metformin used in all therapies.
Iatrogenic?
Metformin does not take out peoples renal systems. Peoples renal systems have an impact on the clearance of metformin to avoid acidosis in damaged cases. If metformin really did take out renal function dialysis units would be a lot busier than they are. The most recent guidance this year for the use of metformin allows it to be prescribed at a new lower eGFR than previously. The paper is not really that contentious. Most of what they are saying is understood and HbA1c is not a useful indicator for a lot of complications. For kidneys blood pressure is far more important and HbA1c, and for cardiac it is level fluctuation that does damage. The only thing HbA1c seems to correlate to neuropathy in it's many forms and retinopathy. The biggest problem is that most of the current opinion is formed from three major studies that were done decades ago. This is unavoidable since by definition you cannot do true long term longitudinal studies in months and they are hugely expensive. Over that time span though whole new drug classes have appeared and insulins have improved. The studies absorb these changes but the consequences still take time to show. Lastly the real world implications of the complication figures from studies focuses on reduction and not on incidence. As an example the probability of a heart attack halves for every 1% drop in HbA1c. However when you get to an HbA1c of 6.5 the probability is so low that halving it is meaningless - you can increase your chances of winning the jackpot in a lottery by 100% by buying two tickets but it doesn't increase the likelihood of that event in any meaningful way. ACCORD created a big stir because it said the risk of a cardiac event was U shaped. It was high for a high HbA1c, dropped to a low point, and then rose again as the HbA1c continued to drop. The intensive group targeted an HbA1c of under 6.0% and achieved a median of 6.4% at the cost of 22% more cardiac events. I remember it because my endo suddenly got a lot less keen on me getting a low HbA1c ("Lets just go for 6.5") and stopped talking about experimenting with some Type 2 drugs to get there. |
|
|
|
Post by agedhippie on Aug 30, 2016 8:52:32 GMT -5
If anything, it supports Afrezza's value. Current prandial insulin is shown to not affect outcomes because it is an average of something that needs to be in the "middle". An average in that case doesn't tell you much, because huge swings and a straight line look the same. Say I'm on a 70mph max, 40mph min highway. If I drive 1mph for 30 minutes then 101mph for 30 minutes, I'd average 51mph and drive 50 miles, but I'd be in danger of getting tickets the whole way. I'd get to the destination at the same as if I drive 51mph the whole way, but I'd likely be hundreds of dollars poorer. How about getting the continuous blood sugar levels of a healthy person who doesn't experience those outcomes and comparing the blood sugar levels of prandial insulin users to that? It's been done using CGMs. From memory they typical range 75 to 140 settling mostly at 90 to 105 with short excursions up to 180 if they eat a lot of fast carbs (a lot of sugary soda is a popular choice). |
|
|
|
Post by avichen on Aug 30, 2016 8:55:19 GMT -5
I'm no medical profession, but the title doesn't sound right based on my personal experience... most of my friends who never tightly control their blood sugar level ended up have their toes removed... the worst case, he went to heaven.
|
|
|
|
Post by mnholdem on Aug 30, 2016 9:07:33 GMT -5
This is a weird study of studies, looking for specific evidence found (or not found) in hundreds of other studies. In other words, this report is a complaint that little evidence has been presented in multiple studies over the past decade to substantiate any claims that tight glycemic control will improve chronic diabetes-related complications.
The study highlights an oxymoron:
The authors' study of glycemic control-related studies over the past decade deduces that tight glycemic control, "had no statistically significant impact on patient-important microvascular outcomes (end-stage renal disease/dialysis, renal death, blindness and clinical neuropathy)" and yet the authors point out that in spite of the lack of evidence to support the viewpoint, "all practice guidelines and a majority of published statements (around 80 percent) support tight glycemic control to prevent those complications."
---
I think that these two authors, who work at the Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Department of Medicine, at Mayo Clinic, Rochester, MN are simply challenging the industry to provide more evidence before publishing statements about the benefits of tight glycemic control.
That, or they simply needed a plausible explanation that would justify them spending the funding they received to conduct this study. 
|
|
|
|
Post by peppy on Aug 30, 2016 9:09:04 GMT -5
quote: The study, funded by Mayo Clinic's Clinical and Translational Science Award, found that tight glycemic control (maintenance of a hemoglobin A1c value lower than 7 percent) had no statistically significant impact on patient-important microvascular outcomes (end-stage renal disease/dialysis, renal death, blindness and clinical neuropathy). In contrast, all practice guidelines and a majority of published statements (around 80 percent) support tight glycemic control to prevent those complications.
reply: if type two they were probably all on metformin which takes out peoples renal systems. screencast.com/t/exiok0lrMv
the guidelines show metformin used in all therapies.
Iatrogenic?
Metformin does not take out peoples renal systems. Peoples renal systems have an impact on the clearance of metformin to avoid acidosis in damaged cases. If metformin really did take out renal function dialysis units would be a lot busier than they are. The most recent guidance this year for the use of metformin allows it to be prescribed at a new lower eGFR than previously. The paper is not really that contentious. Most of what they are saying is understood and HbA1c is not a useful indicator for a lot of complications. For kidneys blood pressure is far more important and HbA1c, and for cardiac it is level fluctuation that does damage. The only thing HbA1c seems to correlate to neuropathy in it's many forms and retinopathy. The biggest problem is that most of the current opinion is formed from three major studies that were done decades ago. This is unavoidable since by definition you cannot do true long term longitudinal studies in months and they are hugely expensive. Over that time span though whole new drug classes have appeared and insulins have improved. The studies absorb these changes but the consequences still take time to show. Lastly the real world implications of the complication figures from studies focuses on reduction and not on incidence. As an example the probability of a heart attack halves for every 1% drop in HbA1c. However when you get to an HbA1c of 6.5 the probability is so low that halving it is meaningless - you can increase your chances of winning the jackpot in a lottery by 100% by buying two tickets but it doesn't increase the likelihood of that event in any meaningful way. ACCORD created a big stir because it said the risk of a cardiac event was U shaped. It was high for a high HbA1c, dropped to a low point, and then rose again as the HbA1c continued to drop. The intensive group targeted an HbA1c of under 6.0% and achieved a median of 6.4% at the cost of 22% more cardiac events. I remember it because my endo suddenly got a lot less keen on me getting a low HbA1c ("Lets just go for 6.5") and stopped talking about experimenting with some Type 2 drugs to get there. aged, metformin is not metabolized in the liver and is excreted through the kidneys. www.fda.gov/ohrms/dockets/dailys/02/May02/053102/800471e6.pdf page 1 and 2 the renal clearance.
metformin does not take out kidneys and governments do not use microwaves to control people. shhhhh.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Aug 30, 2016 9:09:07 GMT -5
A1C is merely an average. It does not now nor has it ever spoke to the volatility of a patients blood glucose levels which are the culprit in long term health complications with I believe incidences of hypoglycemia being a greater contributor to long term health complications than hyperglycemia. Here is the benchmark study - Diabetes Control and Complications study. Everyone knew tight control of blood glucose levels would reduce long term health complications but the magnitude of the reductions was what surprised all. www.niddk.nih.gov/about-niddk/research-areas/diabetes/dcct-edic-diabetes-control-complications-trial-follow-up-study/Documents/DCCT-EDIC_508.pdfIf you want to put it in simple terms, look at the incidence of long term health complications for people without diabetes who are not obese and compare to those that are. Controlling blood glucose levels and volatility of blood glucose levels matters and if your doc ever tells you it doesn't, find another doc. Just because its they Mayo Clinic doesn't make it right. It just makes it the Mayo Clinic. |
|
|
|
Post by agedhippie on Aug 30, 2016 10:59:39 GMT -5
Metformin does not take out peoples renal systems. Peoples renal systems have an impact on the clearance of metformin to avoid acidosis in damaged cases. If metformin really did take out renal function dialysis units would be a lot busier than they are. The most recent guidance this year for the use of metformin allows it to be prescribed at a new lower eGFR than previously. aged, metformin is not metabolized in the liver and is excreted through the kidneys. www.fda.gov/ohrms/dockets/dailys/02/May02/053102/800471e6.pdf page 1 and 2 the renal clearance.
metformin does not take out kidneys and governments do not use microwaves to control people. shhhhh.
I think we are both agreeing here, at least on part of it. Metformin clears through the kidneys and that is why there is a minimum eGFR before you can take it. Wait. The government doesn't use microwaves to control people? I can take off this tinfoil hat? No, you are just trying to fool me, I know, I won't do it....  |
|
|
|
Post by lakon on Aug 30, 2016 12:45:53 GMT -5
I think we are both agreeing here, at least on part of it. Metformin clears through the kidneys and that is why there is a minimum eGFR before you can take it. Wait. The government doesn't use microwaves to control people? I can take off this tinfoil hat? No, you are just trying to fool me, I know, I won't do it.... Metformin does not interfere with sexual differentiation of fish in our waterways either... |
|
