HbA1c reductions and Afrezza
May 30, 2019 23:33:21 GMT -5
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Post by peppy on May 30, 2019 23:33:21 GMT -5
Is this the ticket? HbA1c reduction? Just asking....
1. Multi-point reduction in HbA1c
Commonly, new diabetes medications are touted due their ability to reduce HbA1c. Reductions of one-half point to a full point, say from 8 to 7.5 or even 7, are meaningful. This is especially true given the oft-cited statistic that for every one-point reduction in HbA1c, there is a 40% drop in damage to the body. Multi-point drops in HbA1c, however, tend to be uncommon.
In our experience we have routinely seen multi-point reductions in HbA1c. It is not unusual for a Vdex patient to drop 4 or 5 points, for example from 10 to 6. The highest HbA1c we’ve seen is 18.1 and presently this patient’s HbA1c is below 10 (and heading lower).
This experience has been more common in the New Mexico patients who are more poorly controlled than those we’ve seen in Los Angeles. Certainly, starting at a higher HbA1c permits more multi-point reductions. But the salient conclusion is that use of insulin, specifically Afrezza insulin, is far more effective at controlling blood sugar than other medications. page 7
2. Speed of Reduction
Related to the point above, we have achieved multi-point reductions in HbA1c very rapidly. For context, it is important to understand that the typical diabetes-treating medical practice sees pa- tients every three months. So, the HbA1c improvement of a patient, if any, occurs over a period of many months or years. This has many, predictable disadvantages. At Vdex, we intensively manage patients so as to achieve very significant improvement in weeks, not months. Consider Figure 5 below, which graphically illustrates the results from three actual patients. The first, il- lustrated by the red line, saw his HbA1c fall from 10.8 to 7.4, a drop of 3.4 points, in two weeks. Another patient’s HbA1c (blue line) came down from 14 to 6.7 also in two weeks. A third real- ized an improvement of 7.5 points, from 13.2 to 5.7 in one month. These are not outlier results. They are the norm. The dotted line represents a hypothetical patient starting with an HbA1c of 12 and the expected improvement over the course of treatment. Changes of this magnitude are simply not happening with conventional therapies today, and certainly would not happen this quickly. page 10
3. Hypoglycemia experience
To date, with over 200 patients treated, we have yet to observe a single, severe hypoglycemic event. This is unheard of with the use of traditional insulin, especially when one considers the low levels of HbA1c we achieve. Part of the reason that the ADA target for HbA1c is set higher than the point at which microvascular damage occurs is due to the unacceptable level of hypo- glycemia that happens as one lowers HbA1c.
As an aside, we define “severe hypoglycemia” as hypoglycemia requiring the intervention of a third party to correct. Some patients who’ve had rapid, multi-point reductions in HbA1c have reported symptoms associated with hypoglycemia, even though their blood sugar was not in
the range of hypoglycemia. Such symptoms were relatively transient, lasting several minutes
and definitely less than an hour. With continuous glucose monitors (CGM), we’ve been able to actually observe patients’ blood glucose levels and have seen this phenomenon occur in patients with blood sugar levels well above 100. Most important, these patients did NOT need any help in dealing with the temporary “low” blood sugar experience. page 11
static1.squarespace.com/static/5a37ff648fd4d234be3cea06/t/5c2ea96170a6ad1b09ad6f9a/1546561892258/vdex-whitepaper2-092618.pdf
1. Multi-point reduction in HbA1c
Commonly, new diabetes medications are touted due their ability to reduce HbA1c. Reductions of one-half point to a full point, say from 8 to 7.5 or even 7, are meaningful. This is especially true given the oft-cited statistic that for every one-point reduction in HbA1c, there is a 40% drop in damage to the body. Multi-point drops in HbA1c, however, tend to be uncommon.
In our experience we have routinely seen multi-point reductions in HbA1c. It is not unusual for a Vdex patient to drop 4 or 5 points, for example from 10 to 6. The highest HbA1c we’ve seen is 18.1 and presently this patient’s HbA1c is below 10 (and heading lower).
This experience has been more common in the New Mexico patients who are more poorly controlled than those we’ve seen in Los Angeles. Certainly, starting at a higher HbA1c permits more multi-point reductions. But the salient conclusion is that use of insulin, specifically Afrezza insulin, is far more effective at controlling blood sugar than other medications. page 7
2. Speed of Reduction
Related to the point above, we have achieved multi-point reductions in HbA1c very rapidly. For context, it is important to understand that the typical diabetes-treating medical practice sees pa- tients every three months. So, the HbA1c improvement of a patient, if any, occurs over a period of many months or years. This has many, predictable disadvantages. At Vdex, we intensively manage patients so as to achieve very significant improvement in weeks, not months. Consider Figure 5 below, which graphically illustrates the results from three actual patients. The first, il- lustrated by the red line, saw his HbA1c fall from 10.8 to 7.4, a drop of 3.4 points, in two weeks. Another patient’s HbA1c (blue line) came down from 14 to 6.7 also in two weeks. A third real- ized an improvement of 7.5 points, from 13.2 to 5.7 in one month. These are not outlier results. They are the norm. The dotted line represents a hypothetical patient starting with an HbA1c of 12 and the expected improvement over the course of treatment. Changes of this magnitude are simply not happening with conventional therapies today, and certainly would not happen this quickly. page 10
3. Hypoglycemia experience
To date, with over 200 patients treated, we have yet to observe a single, severe hypoglycemic event. This is unheard of with the use of traditional insulin, especially when one considers the low levels of HbA1c we achieve. Part of the reason that the ADA target for HbA1c is set higher than the point at which microvascular damage occurs is due to the unacceptable level of hypo- glycemia that happens as one lowers HbA1c.
As an aside, we define “severe hypoglycemia” as hypoglycemia requiring the intervention of a third party to correct. Some patients who’ve had rapid, multi-point reductions in HbA1c have reported symptoms associated with hypoglycemia, even though their blood sugar was not in
the range of hypoglycemia. Such symptoms were relatively transient, lasting several minutes
and definitely less than an hour. With continuous glucose monitors (CGM), we’ve been able to actually observe patients’ blood glucose levels and have seen this phenomenon occur in patients with blood sugar levels well above 100. Most important, these patients did NOT need any help in dealing with the temporary “low” blood sugar experience. page 11
static1.squarespace.com/static/5a37ff648fd4d234be3cea06/t/5c2ea96170a6ad1b09ad6f9a/1546561892258/vdex-whitepaper2-092618.pdf