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Post by seanismorris on Jun 13, 2014 19:55:37 GMT -5
www.rttnews.com/2336291/insulin-and-metformin-combination-linked-with-early-death.aspx?type=hnrThose taking a combination of insulin and metformin as type-2 diabetes treatment may have a decreased survival rate, according to a new study from researchers at Vanderbilt University. For the study the researchers reviewed data on those taking metformin and sulfonylureas versus those taking metformin and insulin. They found that the heart attack and stroke risk was comparable between the two groups by the overall death risk from any cause and was statistically higher amongst those who used insulin and metformin: "Insulin remains a reasonable option for patients who have very high glucose [blood sugar] or who desire flexible and fast blood sugar control, but most patients taking metformin prefer to delay starting insulin," the researchers explained. "The current study suggests that adding a sulfonylurea to metformin should be preferred to adding insulin for most patients who need a second diabetes drug." ----------- The article has nothing to do with Afrezza, besides being an insulin study (obviously). This study could be negative or positive for Mannkind depending upon your perspective. It could be existing insulin therapies don't provide sufficient glycemic control. And, there is a need for a better insulin therapy (Afrezza) that more closely mimics the pancreas, etc. Or, we might be related the the population sample. (Higher risk of early death with those patents needing insulin) We really more details, so that's what I'm now looking for...
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Post by seanismorris on Jun 13, 2014 19:59:14 GMT -5
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Post by seanismorris on Jun 13, 2014 20:09:13 GMT -5
Why this could be a possitive for Afrezza.
Quote
Roumie said she doesn't know why the rate of deaths was higher among study patients taking insulin. "We have a number of studies planned to examine possible mechanisms. We are investigating type 2 diabetes outcomes associated with blood sugar swings and with episodes of hypoglycemia (low blood sugar) tied to insulin," she said.
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The blood sugar swings (to me) suggests that this could a mealtime problem, which Afrezza is intended to address.
I can see ways Mannkind could spin this to market Afrezza. ...to get doctors on board to look at their existing (patient) treatment regimens, and perhaps more quickly penetrate the diabetes treatment market.
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Post by seanismorris on Jun 13, 2014 20:31:14 GMT -5
On other interesting take away, is a seeming battle between doctors and researchers with regards to cost of treatments options vs. the quality of care. It would be interesting to look at who is funding the study (the govt?) And, is it financially influenced because of Obamacare. I'd expect the budget committee is very worried about diabetes...
Our expectation is Afrezza is cost competitive, but this shows how important it is to get a quality partner (in the diabetes or insulin space) because the data by itself isn't enough (just say no to Pfizer). I expect Afrezza to lower the total cost of healthcare (due to less hospital visits related to hypos).
The delay by Mannkind to find the right partner doesn't bother me. The future of Mannkind depends upon the quality of this partner.
Does anyone know if it would be the partners responsibly to get Afrezza subsidized for Medicare, etc.? I expect it would be.
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Post by spiro on Jun 13, 2014 21:46:57 GMT -5
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Post by silentbob on Jun 14, 2014 7:29:32 GMT -5
I don't like this type of study. Consider the following:
- It is an observational and retrospective study; subjects were not randomized but rather some data was chosen and mined after the fact (post hoc analysis). Researchers may accidentally or deliberately be cherry picking data, along with other drawbacks of this type of study.
- The group adding sulfonylurea was 40,000 strong and those adding insulin only had 3,000. That unbalance in itself can have undesirable statistical effects. Then they reduced that group to 12,000 and 2,400 that were included in the analysis.
- There was only 14 months followup. You might expect higher amount of hypos in this timeframe, but other effects such as cardiovasular issues or cancer were likely pre-existing conditions.
- In this case it is likely that the 3,000 subjects who chose insulin had a very good reason to do so. Possibly their A1c's were higher, or they had additional pre-existing health complications.
It is exactly these kind of poorly designed studies that are responsible for the general population believing that saturated fat is bad (it is not), that eating grain and whole grain every day is healthy (it is not) and that vegetable oils/margarines are good for you (most are not, due to the Omega6 content).
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Post by liane on Jun 14, 2014 7:44:51 GMT -5
silentbob,
You are exactly right. Here's the meat of the 1st link - that totally gets forgotten in the headline "news". Current protocol is metformin 1st, then a 2nd oral drug. Insulin is reserved for the most intractable diabetics. Hopefully, Afrezza will turn this protocol up on end.
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Post by spiro on Jun 14, 2014 8:10:24 GMT -5
Silentbob and Liane,
i do not disagree with you, they are only claiming a possible link between metformin use and alzheimers disease. My point was that I believe doctors should inform their patients of this possibility. I realize that doctors do not have many adequate options besides metformin, but help is on the way soon. Personally, I would rather die from diabetes than develop alzheimers disease. JMHO
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Post by liane on Jun 14, 2014 8:22:22 GMT -5
spiro,
The problem is that the early death may have nothing to do with insulin and everything to do with a sicker population. So it is irresponsible to suggest that insulin is the cause without a prospective randomized controlled study in matched populations. I have a hard enough time getting patients to accept taking a given medication simply due to some "opinions" that they have read in the lay press. This is unnecessary alarm.
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Post by spiro on Jun 14, 2014 9:58:43 GMT -5
It's interesting that this issue is being discussed in the diabetic community. When a reputable research organization like Scripps Research Institute published this data about a potential link between metfromin use and alzheimer's disease, I believe it worthy of serious consideration and disclosure to all potential patients before treatment on metformin begins. It's amazing how the FDA has kept Afrezza off the market thus far, but hasn't requested additional studies on this potential metformin link to alzheimer's. community.diabetes.org/t5/Adults-Living-with-Type-2/Metformin-and-Alzheimer-s-disease/td-p/346202 |
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Post by alcc on Jun 14, 2014 12:11:24 GMT -5
I agree with SilentBob 100%. There is so much nonsense parading about as scientific data these days. The more poorly conceived "study", the more willfully premature/exaggerated claims. Very, very disheartening. The worst imo is this anti-vaccine nonsense.
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Post by mattm on Jun 14, 2014 13:09:17 GMT -5
Another example of a FDA approved medication for diabetes with possible adverse side effects. Over $1B sales last year and rising. www.drugs.com/stats/victozawww.victoza.com/"In animal studies, Victoza® caused thyroid tumors—including thyroid cancer—in some rats and mice. It is not known whether Victoza® causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people, which may be fatal if not detected and treated early." |
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