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Inhaled Insulin: Will Life be Sweeter?
It was announced today that the FDA has approved insulin for inhalation to be marketed by Pfizer and Nektar Therapeutics under the brand name Exubera. The drug is indicated for both type 1 and type 2 diabetes, to be used in place of short-acting insulin at meal times. It can be used in conjunction with long-acting insulin or oral, non-insulin pills that help to control blood sugar.
Hmmm. If you have diabetes and are on insulin therapy, have you read between the lines yet? What about those who have to take long-acting insulin? I don't know about your diabetes management, but I can't think of one individual that I know who uses insulin to manage their diabetes and only takes short-acting insulin.
Information in the popular culture magazines over the last few years have been exclaiming over the day when inhaled insulin would replace the needle stick injection of current insulin therapies. People living with diabetes have been waiting for this day! Now we find that it will replace some of the insulin that those on injection therapy use, but not all of it.
And wait! There's more news: there are concerns about the toxicity that may be awaiting your lungs from inhaling Exubera, and worry that the drug won't be able to achieve a reduction in hemoglobin A1C levels to below 7%, the accepted gold standard in good diabetes care.
Well that's no surprise, since it isn't made to replace all of the insulin that one should take, and there has been too little opportunity to work with it together with other diabetes medications long enough to learn how to optimize it's effectiveness.
The FDA reports that safety and effectiveness were demonstrated in trials involving approximately 2,500 individuals with type 1 and type 2 diabetes. Based on these trials, there are significant restrictions to Exubera's use, including that it should not be used by smokers, or those who quit smoking in the previous six months. It is also not indicated for patients with asthma, bronchitis, or emphysema. Because of this potential for lung damage, the FDA recommends baseline lung function tests before an individual begins to use Exubera, and repeat testing at 6 months, and then annually.
Given the track record for recent drug approvals and their subsequent problems, as well as the significant questions I have regarding the number of individuals who will develop lung problems after the drug becomes more widely used, I have to wonder if this is a drug that will be readily accepted by providers and individuals with diabetes alike. Since anyone managing their diabetes is very likely on at least one or two long-acting insulin injections a day, and most have come to realize that insulin injections cause little to no discomfort, will they be excited about replacing other daily injections with inhaled insulin?
I don't know, but I won't be in a hurry to recommend it until we have more safety data from those who do use it.
Related Topics: Diabetes and Your Sex Life , New Diabetes Treatments Show Promise
Technorati Tags: diabetes, inhaled insulin, Exubera
Hmmm. If you have diabetes and are on insulin therapy, have you read between the lines yet? What about those who have to take long-acting insulin? I don't know about your diabetes management, but I can't think of one individual that I know who uses insulin to manage their diabetes and only takes short-acting insulin.
Information in the popular culture magazines over the last few years have been exclaiming over the day when inhaled insulin would replace the needle stick injection of current insulin therapies. People living with diabetes have been waiting for this day! Now we find that it will replace some of the insulin that those on injection therapy use, but not all of it.
And wait! There's more news: there are concerns about the toxicity that may be awaiting your lungs from inhaling Exubera, and worry that the drug won't be able to achieve a reduction in hemoglobin A1C levels to below 7%, the accepted gold standard in good diabetes care.
Well that's no surprise, since it isn't made to replace all of the insulin that one should take, and there has been too little opportunity to work with it together with other diabetes medications long enough to learn how to optimize it's effectiveness.
The FDA reports that safety and effectiveness were demonstrated in trials involving approximately 2,500 individuals with type 1 and type 2 diabetes. Based on these trials, there are significant restrictions to Exubera's use, including that it should not be used by smokers, or those who quit smoking in the previous six months. It is also not indicated for patients with asthma, bronchitis, or emphysema. Because of this potential for lung damage, the FDA recommends baseline lung function tests before an individual begins to use Exubera, and repeat testing at 6 months, and then annually.
Given the track record for recent drug approvals and their subsequent problems, as well as the significant questions I have regarding the number of individuals who will develop lung problems after the drug becomes more widely used, I have to wonder if this is a drug that will be readily accepted by providers and individuals with diabetes alike. Since anyone managing their diabetes is very likely on at least one or two long-acting insulin injections a day, and most have come to realize that insulin injections cause little to no discomfort, will they be excited about replacing other daily injections with inhaled insulin?
I don't know, but I won't be in a hurry to recommend it until we have more safety data from those who do use it.
Related Topics: Diabetes and Your Sex Life , New Diabetes Treatments Show Promise
Technorati Tags: diabetes, inhaled insulin, Exubera
