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Ketoconozole: Experimental Drug Improves Glycemic Control, Lipids in Type 2 Diabetes: Presented at ENDO

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http://www.docguide.com/news/content.nsf/n...52572F0006FD68C

 

Experimental Drug Improves Glycemic Control, Lipids in Type 2 Diabetes: Presented at ENDO

 

By Louise Gagnon

 

TORONTO, CANADA -- June 4, 2007 -- An experimental compound has demonstrated effective glycemic control and improvement in dyslipidemia in type 2 diabetics, according to research presented at a poster session here at the 89th annual meeting of the Endocrine Society (ENDO).

 

Dubbed DIO-902, an enantiomer of ketoconazole, the compound was administered in type 2 diabetes patients who were drug na?ve - they had been treated with diet and exercise alone or were on stable metformin.

 

"This was a dose-finding study," said Bernice Welles, MD, one of the study's investigators and vice-president of development, DiObex Inc., San Francisco, California, United States. "The therapy improves glycemic control and as well positively affects lipid levels. The effect on lipids is important because type 2 diabetic patients are at increased risk for cardiovascular illness."

 

Dr. Welles noted that ketoconazole, a racemic combination of two enantiomers, has been used to treat cortisol excess in patients with Cushing's syndrome, the results of which have led to improved insulin resistance, glycemic control, lipid measures, and blood pressure. Pre-clinical data has suggested that the novel compound may offer greater efficacy and safety than ketoconazole as a therapy, said Dr. Welles.

 

The researchers recruited 37 patients, aged 18 to 70, who had type 2 diabetes for at least six months. Their HbA1c level ranged from 6.5% to 10.9% and their body mass index measured 26 to 40. Patients were randomised to one of five arms including placebo (six patients), 400 mg of ketoconazole (eight patients), 200 mg of DIO-902 (10 patients), 400 mg of DIO-902 (six patients), and 600 mg of DIO-902 (three patients).

 

Dr. Welles noted subjects underwent a 3-week washout period to eliminate any effect of existing lipid-lowering therapies. They were on their therapy for two weeks and then followed for two weeks after treatment.

 

When looking at glycemic measures, fructosamine levels decreased by 2.3 umol/l in the placebo and ketoconazole arms of the study. The levels were reduced by 12.2, 8.3, and 29.3 umol/l in the 200 mg, 400 mg, and 600 mg arms, respectively.

 

Moreover, C-reactive protein, which Dr. Welles stressed was a marker of inflammation, was elevated in the placebo and ketoconazole arms, but fell in a dose-dependent fashion in the three study groups where DIO-902 was administered. The reductions ranged from 28% to 48% (J-T trend test, P =.27).

 

Similarly, a dose-dependent decrease (J-T trend test, P <.001 was seen in all dio-902 treated patients with total cholesterol reductions ranging from to and ldl-cholesterol>

 

Dr. Welles noted patients experienced adverse events of a gastrointestinal nature such as bloating and nausea, but that no patients withdrew from the study because of adverse events. Patients had a normal cortisol response to ACTH stimulation testing when it was performed within 24 hours after the last dose of study drug.

 

Future research will look at the effect of administering another set of doses of DIO-902 in several hundred patients, said Dr. Welles.

 

The study was funded by DiObex Inc., the manufacturer of DIO-902.

 

 

[Presentation title: Effects of 14-Day Treatment with DIO-902 on Lipids and Glycemic Control: Results of a Randomized Placebo-Controlled Trial in Patients with Type 2 Diabetes. Abstract P2-243]

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Guest erica_wv

Thanks for posting this article Mary. I did take ketoconazole for a short time prior to surgery last summer. My endo's goal being to get my cortisol level down prior to surgery. I didn't notice any glucose changes, was advised that Pit patients should not stay on this medication long term because it could cause tumor growth. That kinda freaked me out, but I only had a month to go at that time. The brand name is Nizoral & is usually used to treat fungal infections. (Not that I needed any more strange looks at the pharmacy counter!) From what I remember it did help bring the AM cortisol down, but not enough to be considered "normal".

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Thanks for posting this article Mary. I did take ketoconazole for a short time prior to surgery last summer. My endo's goal being to get my cortisol level down prior to surgery. I didn't notice any glucose changes, was advised that Pit patients should not stay on this medication long term because it could cause tumor growth. That kinda freaked me out, but I only had a month to go at that time. The brand name is Nizoral & is usually used to treat fungal infections. (Not that I needed any more strange looks at the pharmacy counter!) From what I remember it did help bring the AM cortisol down, but not enough to be considered "normal".

 

Just wondering who advised you that Ketoconazole could cause tumor growth in pituitary patients? I have a microscopic pituitary tumor and have been taking Ketoconazole since my radiation in 2001. My pituitary tumor has not grown (it can't even be seen on MRI). I'm not physically able to have a BLA due to other medical conditions and Ketoconazole has been a life saver for me. I was on a much higher dose of the medication but ultimately my adrenal glands are starting to stop working. Therefore, I only take 200 mg. daily now.

 

I would like more information if you have it because in all of my research on Ketoconazole I've never found anything that says it can cause pituitary tumors to grow. However, I have seen reports supporting that (GH) Growth Hormone can cause tumor growth.....not only pituitary tumors but tumors located anywhere in the body. For this reason....I cannot take GH since I have pituitary tumor cells..... as well as other tumors in my body due to Sarcoidosis.

 

Cathy :)

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Just wondering who advised you that Ketoconazole could cause tumor growth in pituitary patients? I have a microscopic pituitary tumor and have been taking Ketoconazole since my radiation in 2001. My pituitary tumor has not grown (it can't even be seen on MRI). I'm not physically able to have a BLA due to other medical conditions and Ketoconazole has been a life saver for me. I was on a much higher dose of the medication but ultimately my adrenal glands are starting to stop working. Therefore, I only take 200 mg. daily now.

 

I would like more information if you have it because in all of my research on Ketoconazole I've never found anything that says it can cause pituitary tumors to grow. However, I have seen reports supporting that (GH) Growth Hormone can cause tumor growth.....not only pituitary tumors but tumors located anywhere in the body. For this reason....I cannot take GH since I have pituitary tumor cells..... as well as other tumors in my body due to Sarcoidosis.

 

Cathy :)

 

Cathy, it is like causing adrenal blockade induced nelsons in some patients. I figure the same number of patients who get a bla and get nelsons (no radiation done - 30%) would be the same for the keto patient population. I guess if you decided to get a BLA, your endo would probably not be too worried about your nelson's risk.

 

I am on 500mgs of keto. I could probably go higher to make my body happier, but my endo says no way.

 

My brother is on 40 mgs of prednisone to keep his sarcoid in check. He has multisystemic sarcoidosis, and his long term prognosis is poor, but he keeps on ticking... :) How are you doing?

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Kristy,

First of all....Is your Cushing's back? I had no idea.

 

My sarcoidosis is multisystemic also with my most concern being a tumor in the center of my brain that we're fairly certain is a sarcoid tumor. I saw a new doctor just yesterday who is a sarcoid specialist and I will start on the drug methotrexate this week. I can't take the prednisone due to my Cushing's.

 

It dosen't look like a BLA is in my future due to the sarcoidosis and other medical issues. Does your brother have Erethema Nodosum due to his sarcoidosis? I do and it can be so painful.

 

Cathy

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Kristy,

First of all....Is your Cushing's back? I had no idea.

 

My sarcoidosis is multisystemic also with my most concern being a tumor in the center of my brain that we're fairly certain is a sarcoid tumor. I saw a new doctor just yesterday who is a sarcoid specialist and I will start on the drug methotrexate this week. I can't take the prednisone due to my Cushing's.

 

It dosen't look like a BLA is in my future due to the sarcoidosis and other medical issues. Does your brother have Erethema Nodosum due to his sarcoidosis? I do and it can be so painful.

 

Cathy

 

He has type 1 diabetes too, so when the skin eruptions started many years ago, they attributed it to the diabetes. It wasn't until about a year and a half ago, when my mom started to take him to the endo and got his diabetes straight, that the endo realized something wasn't quite right. His skin eruptions had gotten so bad that they would grow to the size of a fist in weird places - legs, lower arms, and a huge one developed on his neck. The endo did some blood work and told my brother to go to the emergency room. His kidneys were in failure. Fortunately, after about 4 major hospital stays, and being poked and prodded by every kind of doctor, and put on real high dose steriods along with another mess of meds, he is stable for as well as he can be stable. He lost much of his vision in one eye due to the sarcoid. He has it in his lungs, csf, heart, kidneys, eyes, and probably everywhere else. The doctor almost put him on dialysis. His kidney function is right around 25%. His long term prognosis is poor, but we have faith that God isn't done with him yet. Each turn with him is full of joys and and others heartbreak. So much for a man of 35. Through him, I learned taht sarcoid can be very serious and life threatening. When I look at all he has gone through and how many times he sat on death's door, I am very thankful for the time God is giving us to be with him. Cathy, his fight is much worse than mine has ever been, and probably ever will be.

 

I'll keep you in my prayers, Cathy. I will pray for you strength and wisdom for your doctors.

 

Hugs...

Kristy

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