Another interesting e-mail.
One of the joys of running a website is the oddball e-mails that arrive. I'd like to comment upon one interchange, that started with the following overexuberant hype about a new diabetes medication, which sounds like a sales rep's pitch to an unsuspecting physician:
(The quoted language in my responses 3, 4, and 5 is from the FDA Approval Letter, available at the FDA website.)
He never responded, despite repeated requests. I wonder if he learned anything from my reply, or continued in his blissful ignorance?
Bill the diabetesdoc
Diabetes.Blog.Com is a blogcompanion to our main website, the Diabetes Monitor, which you can find at www.DiabetesMonitor.com
At the Diabetes Monitor today: Reports from the ADA meeting: additional impressions.
- Byetta
- 1. Weight loss
- 2. No risk of hypoglycemia
- 3. Postprandial glucose regulation
- 4. Self-regulating medication
- 5. No need for finger sticks
- 6. Improved beta cell health, possible regeneration
- 7. Forestalling or eliminating the inevitable progression to insulin dependence
- 8. Hope for a cure
- 9. FDA liked it so much THEY initiated a new NDA for use as a monotherapy!
What else would a diabetic want in order to consider Byetta?
"What else would a diabetic want in order to consider Byetta?" Well, perhaps not marketing hype such as you provide, but that their physicians are comfortable with the drug, and with its safety profile. Among other things needing clarification:
1) Documented long-term safety.
2) Pediatric safety
3) Mechanism of interaction with lovastatin:
"Exenatide reduced lovastatin AUC by 40%. This effect does not appear to be explained by delayed gastric emptying due to exenatide. We recommend that you investigate the mechanism(s) of the lovastatin-exenatide interaction..."
4) Understanding of its effects on other drugs:
"In addition, you should study how exenatide impacts the bioavailability of drugs that are instructed to be taken with food and thus may, by necessity, be taken in temporal proximity to exenatide."
5) clarification of interaction with BCPs:
"A human in vivo drug interaction study between exenatide and a combination oral contraceptive (e.g., ethinyl estradiol plus norethindrone) to define the effect of timing of the exenatide injection relative to the administration of the oral contraceptive on the bioavailability of the components of the oral contraceptive."
BTW, I'm an endocrinologist. Who are you, and why are you so "high" on this drug?
You are WRONG when you state "no risk of hypoglycemia." Per the label:
1) "when BYETTA was used in combination with a sulfonylurea, the incidence of hypoglycemia was increased over that of placebo in combination with a sulfonylurea. Therefore, patients receiving BYETTA in combination with a sulfonylurea may have an increased risk of hypoglycemia"
2) ODs: "One of the three patients experienced severe hypoglycemia requiring parenteral glucose administration."
and what do you mean by "5. No need for finger sticks"
1) Documented long-term safety.
2) Pediatric safety
3) Mechanism of interaction with lovastatin:
"Exenatide reduced lovastatin AUC by 40%. This effect does not appear to be explained by delayed gastric emptying due to exenatide. We recommend that you investigate the mechanism(s) of the lovastatin-exenatide interaction..."
4) Understanding of its effects on other drugs:
"In addition, you should study how exenatide impacts the bioavailability of drugs that are instructed to be taken with food and thus may, by necessity, be taken in temporal proximity to exenatide."
5) clarification of interaction with BCPs:
"A human in vivo drug interaction study between exenatide and a combination oral contraceptive (e.g., ethinyl estradiol plus norethindrone) to define the effect of timing of the exenatide injection relative to the administration of the oral contraceptive on the bioavailability of the components of the oral contraceptive."
BTW, I'm an endocrinologist. Who are you, and why are you so "high" on this drug?
You are WRONG when you state "no risk of hypoglycemia." Per the label:
1) "when BYETTA was used in combination with a sulfonylurea, the incidence of hypoglycemia was increased over that of placebo in combination with a sulfonylurea. Therefore, patients receiving BYETTA in combination with a sulfonylurea may have an increased risk of hypoglycemia"
2) ODs: "One of the three patients experienced severe hypoglycemia requiring parenteral glucose administration."
and what do you mean by "5. No need for finger sticks"
(The quoted language in my responses 3, 4, and 5 is from the FDA Approval Letter, available at the FDA website.)
He never responded, despite repeated requests. I wonder if he learned anything from my reply, or continued in his blissful ignorance?
Bill the diabetesdoc
Diabetes.Blog.Com is a blogcompanion to our main website, the Diabetes Monitor, which you can find at www.DiabetesMonitor.com
At the Diabetes Monitor today: Reports from the ADA meeting: additional impressions.
