Archive for the ‘Medications’ Category

DAVID MENDOSA: The Simple GlucoMON

Sunday, March 9th, 2008

All of us can use a little help in managing the complexities of our diabetes. The very young and the very old sometimes need a lot.

Do you need to make sure that your child or parent has his or her blood glucose under control? Short of hovering over them all the time, you can ask them to send their test results to you or their doctor.

Unless you have a GlucoMON, that wouldn’t be easy. But with the GlucoMON it is unbelievably simple.

I know how simple it is, because I finally got my hands on one after writing about it for years.

The GlucoMON has just become commercially available. In the meantime the company, Dallas-based Diabetech, focused its efforts on perfecting its behind-the-scenes software inside of carefully controlled clinical trials while also making sure they took the steps to comply with various Food and Drug Administration regulations. Their commercialization efforts also took time, as they recently upgraded their technology to run on the GSM/GPRS wireless networks, which run most of the world’s cell phones. This new device and their commercial offering are classified in the same category as Microsoft’s Health Vault platform and a forthcoming offer from Google.

The amazing thing to me is the fact that the software is indeed behind the scenes. I hate testing software, mostly because it takes so much time to install and then to learn. And then there are always bugs. And then you have to keep it updated.

But the GlucoMON software isn’t even on your computer. It works in a similar way to Google’s “cloud computing” applications like Gmail and Google Docs that I completely rely on nowadays.

GlucoMON even does Google one better. To use it you don’t need an Internet connection. Or even a computer. Or a phone line. And soon you won’t even need electricity for it.

Currently, the device relies on electricity from a standard electrical outlet for its power. But Diabetech is a finalizing an optional mobility kit that includes a car charger and a battery pack.

The GlucoMON is an automated, long-range wireless blood glucose data monitoring and transmittal system. “Think of us as a wireless phone company that just does diabetes,” Diabetech founder and CEO Kevin McMahon told me years ago. The key, he said, is not just that it is wireless, but especially that it is automatic. “It requires no training. There are no buttons to push or computers or Palm Pilots to attach.”

While the name GlucoMON obviously stands for glucose monitoring, it actually isn’t one. Currently it works with LifeScan’s OneTouch Ultra. Kevin tells me that his company is working out licensing deals with the other major meter manufacturers.

“The data are transferred over our network and are stored in the secure patient record in our GlucoDYNAMIX server software,” Kevin says. “The data include the patient profile, patient-specific rules, alerts, reminders, reports, and education.”

Since the GlucoMON is hardware, I dreaded the setup even more than if it were software. In the event I couldn’t have been more surprised.

I plugged it in to an electrical outlet, set up the little antenna on my desk, checked my blood glucose with the Ultra, and then plugged the Ultra into the GlucoMON. It must have taken at least 60 seconds.

By that time the service had sent me an email confirming the result. Normally, of course, that message would have gone to the parent of the young child or the child of the aged parent.

The GlucoMON has to be especially attractive to parents who have children with diabetes in school. Typically, a family will find a place at school that is convenient and which usually coincides with where the child checks his or her blood glucose before lunch, which generally is the most critical time during the school day because of insulin dosing then. Or the child may carry it in his or her backpack and just plug it in when need. Then, he or she might bring it home on weekends to support sleepovers or trips to Grandma’s. It weighs less than 7 ounces.

The GlucoMON can support shared users too, Kevin tells me. “I don’t know any other device that can support this model.”

The company offers discounts for second users of a shared GlucoMON in the same family. Another option is its school plan where three or more family can use a shared GlucoMON.

For my purposes, even more impressive is the automatic log sheet that the system generates and sends out daily. I have seen and used lots of different log sheets and in fact link some of them on my website. But none of them hold a candle to the GlucoMON’s report, which is not only automatic but also logs blood glucose results in hourly time-slots, highlights highs and lows, and makes trend analysis simple.
Article by: David Mendosa

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FDA to review diabetes drugs

Tuesday, March 4th, 2008

BOSTON (MarketWatch) — Food and Drug Administration advisory panels will be reviewing the applications of two potential blockbuster diabetes drugs later this week, Bristol-Myers Squibb’s Pargluva and Pfizer’s Exubera.

First up will be Pfizer’s Exubera, the first inhaled form of insulin to be considered by the government agency. Pfizer hopes that if approved, inhaled insulin will woo over thousands of diabetics who loathe injecting insulin or who should be taking insulin but fear needles.

While the drug appears to be just as effective in controlling blood sugar levels as injected insulin, the FDA panel will be scrutinizing the drug’s data that to see if long-term use can diminish lung capacity in any way.

Still, many Pfizer watchers believe the FDA will give Pfizer the go- ahead, given the spike in diabetes cases due to obesity and an aging population.

Although decisions made by advisory panels aren’t binding, the FDA almost always follows their recommendations.

Pfizer developed the drug with Nektar Therapeutics , a specialist in drug-delivery systems, and Sanofi-Aventis, one of the world’s largest suppliers of insulin. The insulin is delivered through a device that resembles a large asthma inhaler.

If approved, Exubera could have peak worldwide sales of up to $1.5 billion by 2010, according to Caris & Co. analyst Le Anne Zhao.

“I think Exubera’s chances are 70% to 80% of being approved,” said Zhao.

If it’s approved, Exubera could face strong competition down the road. Eli Lilly & Co. is currently in late-stage testing with drug-delivery developer Alkermes for their version of inhaled insulin. Novo Nordisk and delivery partner Aradigm are also in the game, along with niche drug developer Mannkind.

On Friday, the same FDA panel will review Bristol-Myers’ Pargluva, also known as muraglitazar, which is used to help control blood sugar and triglyceride levels in type 2 diabetics.

If approved, Bristol-Myers would be splitting any profits with partner Merck & Co., and Pargluva would also be in competition with two other drugs in its chemical class, Eli Lilly’s Actos and GlaxoSmithKline’s Avandia.

Zhao said that she estimates Pargluva could have peak worldwide sales of $3 billion by 2010.

However, analysts say that while Pargluva appears to be slightly more effective in treating diabetes than Actos and Avandia, the drug also has a higher incidence of causing cardiovascular problems such as edema.

Because of this, analysts add, the FDA, which is still stinging from accusations that it has dropped the ball on drug safety, may be wary of approving Pargluva.

“I give it a 50-50 chance,” said Zhao. “If the FDA does give the green light, it will require extensive Phase IV [postmarket] studies, and the drug will probably have a bold-faced warning on its label.”

Lehman Brothers’ Anthony Butler said he thinks the FDA will probably approve Pargluva, although he put the odds at “a little better than 50%.”

Butler added that while Pargluva performed “marginally better” than Actos or Avandia, “it also has marginally worse side effects at higher doses.”

Pargluva’s side effects are an issue, said Butler, in that many general practitioners tend to prescribe oral diabetic medications in very high amounts to patients who still don’t have their blood sugar levels under control.

But Butler added that if Pargluva is turned down on Friday, it would probably be with the caveat that the companies conduct additional safety and dosing studies.

“There’s clearly a need for improved glucose-control drugs,” said Butler. “I think they’ll get an approval because there’s a marginal benefit.”

Val Brickates Kennedy is a reporter for MarketWatch in Boston.

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FDA MedWatch Alerts: Avandia (rosiglitazone maleate)

Wednesday, February 27th, 2008

February 26, 2008

Audience: Endocrinologists, pharmacists, patients
[Posted 02/26/2008] FDA and GlaxoSmithKline notified pharmacists and physicians of a new Medication Guide for Avandia (rosiglitazone maleate). The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. A list of currently approved Medication Guides are available at http://www.fda.gov/cder/Offices/ODS/medication_guides.htm. The Medication Guide and current Prescribing Information for Avandia are provided below.

Product Description

Most important information about Avandia

Pharmacokinetics

Possible Side Effects

More information about AVANDIA (Rosiglitazone):

AVANDIA (Rosiglitazone): What You Should Know

Can Avandia or other drugs prevent diabetes?

Actos beats Avandia in sugar, fat control: study

Avandia approved for combination with insulin in type 2 diabetes treatment

Avandia Reduces Risk of Progresson from Pre-Diabetes to Type 2 Diabetes by 62 percent

EMEA Statement on Recent Publication on Cardiac Safety of Rosiglitazone (Avandia, Avandamet, Avaglim)

GSK Revises US Labeling for Avandia

Data Affirms Avandia (Rosiglitazone maleate) Cardiovascular Safety Profile

Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures

Texas Family Sues GlaxoSmithKline (GSK) Over Man’s Heart Attack Death Following Avandia Use

Older Diabetics Using Avandia Face Increased Death Risk

To buy AVANDIA click HERE: My Family Drugstore

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Diabetes drugs dangers revealed

Sunday, February 24th, 2008

Two popular drugs used to treat late-onset diabetes may double the risk of heart failure, according to a new study.

Researchers who analysed data on 78,000 patients who took Avandia or Actos to treat type II diabetes found that it increased the risk of heart failure by up to 100 percent, said the study released on Thursday.

The researchers estimate that for every 50 patients taking the medications over a period of 26 months, one person will develop heart failure.

The manufacturers cautioned from the beginning that the drugs were not suitable for patients at risk for – or with a history of – heart failure, and that patients who combined the drugs with insulin treatments were at increased risk for this complication.

But this analysis found that this adverse effect occurred in patients with no risk for heart failure, even in the absence of insulin. The study also showed that it occurred in young people and at high and low doses.

On average, patients who developed this complication did so 24 weeks after starting on the drug, the investigators report in the journal Diabetes Care.

“Our analysis quantifies the risk for the first time and it shows that nobody is immune,” said Sonal Singh, lead author of the study and an assistant professor in internal medicine at Wake Forest University Baptist Medical Center in Winston Salem, North Carolina.

Singh said the findings raise the question of whether doctors should revert to using older drugs such as Glucophage and or insulin injections.

The researchers did not evaluate whether the adverse effects were fatal, nor did they study what went wrong. They suggest that the drugs cause some people to retain fluid which can trigger heart failure, symptoms of which include shortness of breath and an inability to exercise.

GlaxoSmithKline, which has been marketing Avandia in the United States since 1999 and in Europe since 2000, downplayed the findings. Actos is made by Takeda Pharmaceutical.

“The risk of heart failure in diabetes patients and with use of these medicines is well recognized and is clearly identified in prescribing information to doctors,” the company said in a statement.

“GSK is confident in the overall safety profile of rosiglitazone when used appropriately.”

Rosiglitazone is the trade name for Avandia.

GSH’s blockbuster drug has also been linked with other problems. In May, a study in a US medical journal said people taking the drug had a 43 percent higher risk of heart attack.

The US Food and Drug Administration will consult with medical experts on Monday to see whether the data merits adding so-called “black box warnings” to the drug packaging that would alert consumers to the potential risk.

Product Description

Most important information about Avandia

Pharmacokinetics

Possible Side Effects

More information about AVANDIA (Rosiglitazone):

AVANDIA (Rosiglitazone): What You Should Know

Can Avandia or other drugs prevent diabetes?

Actos beats Avandia in sugar, fat control: study

Avandia approved for combination with insulin in type 2 diabetes treatment

Avandia Reduces Risk of Progresson from Pre-Diabetes to Type 2 Diabetes by 62 percent

EMEA Statement on Recent Publication on Cardiac Safety of Rosiglitazone (Avandia, Avandamet, Avaglim)

GSK Revises US Labeling for Avandia

Data Affirms Avandia (Rosiglitazone maleate) Cardiovascular Safety Profile

Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures

Texas Family Sues GlaxoSmithKline (GSK) Over Man’s Heart Attack Death Following Avandia Use

Older Diabetics Using Avandia Face Increased Death Risk

FDA MedWatch Alerts: Avandia (rosiglitazone maleate)

To buy AVANDIA click HERE: My Family Drugstore

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DAVID MENDOSA: “Curing Diabetes”

Monday, February 4th, 2008

“I was watching some doctors on TV recently where a couple of overweight people with diabetes had three months to see whether they could reduce their weight through good nutrition and exercise,” Gita in Australia emailed me this week. “These people achieved their goals and in describing the results, the doctors made the comment that, ‘They didn’t have diabetes any more.’”

Gita had thought that there is no cure for diabetes. So she searched the Internet and found other doctors who claim that they can reverse it.

Since Gita was still appropriately skeptical, she wrote me. I replied:

If a doctor thoroughly examined me today, he would find absolutely no evidence that I have diabetes (normal A1C, normal weight, normal cholesterol, normal blood pressure, no complications, no diabetes drugs). While it doesn’t look like I have diabetes, I act like I do, so it won’t return. I absolutely must adhere to the best principles of diabetes management to minimize the chances of recurrence.

There is no cure.

The most that I will claim for myself and for anyone who has his or her diabetes absolutely under control is that it is in remission. The word “reversing” is not precise enough for me.

If I had type 1 diabetes, all my efforts would not have put my diabetes into remission. That’s because, based on current understanding, type 1s have lost all their beta cells in their pancreas and nothing can replace them short of a transplant, which would require them to take dangerous immunosuppressive drugs for the rest of their lives.
But I have type 2 diabetes, which is by far more common than type 1. There are two problems with type 2, which is why I call it a “two-hit disease.”

Generally, the first problem that develops is insulin resistance in the cells of our bodies. So the pancreas must secrete more and more insulin in an attempt to get the insulin to transport glucose into the cells where we need it. Then, even before diabetes develops, these people — who we say have pre-diabetes or the metabolic syndrome — start to burn out their beta cells. They lose some of the beta cells in their pancreas, although not all of them (or essentially all of them) as type 1s do.

It is the insulin resistance that is reversible.

But we have absolutely no evidence in living people that any of the things that I did to put my diabetes into remission or those doctors did with the overweight people on the TV show that you saw will help to regenerate those dead beta cells. So people like me have to be extremely careful in our weight management and exercise lifestyle since we are essentially running on a gas tank that is nearly running out.

That said, there is some test tube evidence that we might be able to regenerate beta cells now or in the near future. This beta cell neogenesis might possibly be a huge side effect of taking the drug Byetta (and possibly some other drugs including insulin and Symlin), which I took for two years. It also looks like it might be occurring when tested in animals, but humans are a bit different from them.

This problem is the Heisenberg principle — that you can’t measure something without changing it. Most likely, the only way that we have to measure beta cell neogenesis is probably through an autopsy. For some personal reason, no one has volunteered.

http://www.healthcentral.com/diabetes/c/17/20924/curing-diabetes/

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