Archive for the 'What’s New in Diabetes' Category

Avandia and Heart Disease: Anything New?

October 27, 2007

Go to fullsize imageAvandia continues to be in the limelight.  As more physicians are aware of its benefits, controversy surrounding its use and possible side effects continue to be the main issue among patients.  Further analysis have been done by the European Medicine Agency, the counterpart of the US FDA, on whether the benefits outweigh the risk in the use of Avandia among our diabetic patients:

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Finalising a review of the benefits and risks of the thiazolidinediones rosiglitazone (Avandia) and pioglitazone (Actos), the European Medicines Agency has concluded that the benefits of these antidiabetic medicines continue to outweigh their risks in the approved indications. However, the Agency recommended changing the product information for rosiglitazone and agreed further initiatives to increase scientific knowledge on the safety of both medicines.The Agency’s Committee for Medicinal Products for Human Use (CHMP) carried out this review as part of its continuous monitoring of the safety of medicines, because of new information on these medicines’ side effects. This included information on the risk of bone fractures in women, and, in patients taking rosiglitazone, a possible risk of ischaemic heart disease (reduced blood supply to the heart muscle). This raised concerns over the benefit-risk balance of both rosiglitazone and pioglitazone.

Having assessed all available data, the CHMP concluded that the benefits of both rosiglitazone and pioglitazone in the treatment of type 2 diabetes continue to outweigh their risks.

However, the prescribing information should be updated to include a warning that, in patients with ischaemic heart disease, rosiglitazone should only be used after careful evaluation of each patient’s individual risk. In addition, the combination of rosiglitazone and insulin should only be used in exceptional cases and under close supervision.These changes will be introduced in forthcoming regulatory procedures for rosiglitazone-containing medicines. No changes to the prescribing information for medicines containing pioglitazone were considered necessary.

The Committee will review the results of currently ongoing studies. It also recommended that further studies be performed in order to increase the level of scientific knowledge on the two medicines.

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Whether the US FDA will follow the same guidelines remain to be seen.  What is important to this date is that further studies need to be done.  The risk of heart attack is always inherent in any diabetic…whether the use of Avanida increases the heart attack risk was found to be negative in the interim analysis of a well designed prospective study called RECORD…a study specifically designed to address this issue. 

The controversy on Avandia started after a metaanalysis of the previous small studies on Avandia was done and showed an increase risk in heart attack.. Unfortunately the medical community does not accept studies of this caliber to suggest a relationship because of the many loopholes associated with analyzing data in a Metaanalysis. 

Do check out my blogroll on AVANDIA update for previous posts.

To this date… the agency has said it well:

The Benefits Continue to Outweigh The Risks!

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Byetta and Pancreatitis…

October 20, 2007

2520983995.jpgThis is just an information sheet to those who are on Byetta as part of the treatment regimen for Diabetes.  Any new drug in the market has post marketing survey done to determine any untoward events once a drug is marketed and used worldwide.  After its approval in 2005, it has just been available in the Philippines this year.

Byetta is known to cause nausea due to its effect in delaying gastric emptying.  This symptom usually goes away after weeks to months of use.  However if abdominal pain occurs and becomes persitsent… it is now advised to discontinue the drug and seek medical advise to rule out pancreatitis.

Acute Pancreatitis is inflammation of the pancreas and ussually is due to either alcohol intake or gallstone.  Once diagnosed and treated it is not life threatening.  Majority of the cases in the survey did well after trteatment of the disease.

The FDA has issued an alert to physicains to be aware of this effect:

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Posted 10/16/2007] FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes.

An association between Byetta and acute pancreatitis is suspected in some of these cases. Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.

Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and instruct patients taking Byetta to seek prompt medical care if they experience unexplained, persistent, severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.
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Byetta is one new drug that will be very beneficial to our newly diagnosed diabetes especially those who are obese because of its capacity ot improve insulin sensitivty and increase beta cell mass.  Preventing the rapid decline of beta cell mass and function therefore theoritically should prevent progression of this disease and in turn prevent the onset of complications. 

The PLUS factor of thes agent: It can lead to significant weight loss and is the only agent so far that can really make a diabetic well controlled without necesarily increasing weight but rather lose weight!

For now with this new alert, I would have to make sure patients with history of pancreatitis, alcohol abuse or gallstone to refrain from using Byetta.   The data showed that those who developed Pancreatitis had at least 1 of the above risk factors.  Vigilance of these factors should lessen one’s risk to develop pancreatitis.

Just Like Any Drug… If It Has An Effect… It Should Have A Side Effect..Precaution Is The KEY!

The Latest on The Safety Of Aspartame….

September 24, 2007

Aspartame has been at the forefront in terms if its use among diabetic patients as a low calorie sugar substitute.  It is the primary component of the low calorie sodas that allow us to enjoy these drinks once in a while without feeling too much guilt of the calories they have.  But controversies surround the popularity of this sweetener due to reports of associated illnesses related to its intake. 

Just recently an international expert panel from 10 universities and medical schools gathered together and evaluated the safety of aspartame for people of all ages and with a variety of health conditions.  The results of the study was recently published in the September issue of Critical Reviews in Toxicology.

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The Expert Panel’s evaluation concluded the following:

Aspartame is safe at current levels of consumption, which remain well below established ADI levels, even among high user sub-populations. No credible evidence was found that aspartame is carcinogenic, neurotoxic or has or any other adverse effects when consumed even at levels many times the established ADI levels.

Specifically:

* Based on results of several long term studies, aspartame does not have carcinogenic or cancer-promoting activity.

* Results of extensive investigation in studies that mimic human exposure do not show any evidence of neurological effects, such as memory and learning problems, of aspartame consumption.

* Overall the weight of the evidence indicates that aspartame has no effect on behavior, cognitive function, neural function or seizures in any of the groups studied.

* Aspartame has not been shown to have adverse effects on reproductive activity or lactation.

* Studies conclude that aspartame is safe for use by diabetics and may aid diabetics in adhering to a sugar-free diet.

* There is no evidence to support an association between aspartame consumption and obesity. On the contrary, when used in multidisciplinary weight control programs, aspartame may actually aid in long-term weight control.

* The studies provide no evidence to support an association between aspartame and brain or hematopoietic tumor development.

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In the past several insitutions have already provided proofs and guidelines regarding the safety of aspartame… which up to this point in 2007 remains a safe alternative to all of us who wants a good tasting beverage but low in calorie and no fear of raising our blood sugar!  Reports of this compund to cause complications ranging from cancer to neurological deficits continue to be written in the internet causing a lot of our patients concerns but these claims remian unfounded.

The expert panel reports, I would say,  should close this issue on aspartame.  The panel clearly summarized their findings with one simple conclusion:

 The weight of existing evidence is that aspartame is safe at current levels of consumption as a nonnutritive sweetener.

A Simple Blood Test To Determine Your Risk for Diabetes…

September 17, 2007

imagesx.jpgIf you think you are at risk of developing diabetes, our recommendation for now is to check your fasting blood sugar.  This is a test always included in executive panels.  However a more important measure of diabetes control is called A1c.  It is being done every three months among our diabetic patients to check their control or compliance to their medications.  Now a new study has supported the possible role of this blood test in predicting a patient’s risk of developing diabetes.

This study published in the American Journal of Medicine looked at a cohort of subjects in the Nurses Health Study and established the possible linked of A1c and the future risk of developing diabetes:

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(HbA1c) is a marker of cumulative glycemic exposure over the preceding 2- to 3-month period.   The authors examined baseline HbA1c levels as a predictor of incident clinical diabetes in a prospective cohort study beginning in 1992 of 26,563 US female health professionals aged 45 years or more without diagnosed diabetes or vascular disease (median follow-up 10.1 years).

Results: During follow-up, 1238 cases of diabetes events occurred.  After multivariable adjustment, HbA1c remained a strong predictor of diabetes.

 In analyses of threshold effects, adjusted relative risks for incident diabetes in HbA1c categories of less than 5.0%, 5.0% to 5.4%, 5.5% to 5.9%, 6.0% to 6.4%, 6.5% to 6.9%, and 7.0% or more were 1.0, 2.9, 12.1, 29.3, 28.2, and 81.2, respectively.

Conclusions:  HbA1c levels are elevated well in advance of the clinical development of type 2 diabetes, supporting recent recommendations for lowering of diagnostic thresholds for glucose metabolic disorders.

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It has been a continuing debate whether to use A1c as a diagnostic tool for diabetes.  We are using it to assess control rather than diagnosis.  We know that the higher the A1c… the higher the risk of complications of diabetes espcially death and heart attacks.  Therefore, we should impart the information to our diabetics that lowering A1c is lowering your risk to suffer from disability!

Now, our focus is for those at risks and those with apparently no risks to embark on a healthy lifestyle to avoid getting this chronic disease strongly associated with obesity and poor lifestyle!  If in doubt, we may be able to use this simple blood test to determine our risk… and if indeed that risk is high… it can be a better motivational tool to change lifestyle and be better in terms of choices of food and more physical activity!

The study has shown that in those with no risk… checking A1c can predict the outcome. That if ones A1c is >5% ; the risk to develop diabetes in the future starts to double!

Be Proactive… Better to Check Early Than Have The Disease!

BYETTA and Weight Loss

August 18, 2007

imageslo.jpgExtensive research is being done in the field of Diabetes. The prevalence of this disease is just increasing worldwide and expected to reach 333 million by year 2025.  The scary thought coupled with difficulty in getting drugs invented and approved can make this a big epidemic in the future.

As new drugs come…some are worth it some are not.  The avandia scare made everyone realized that any drug no matter how great will always have side effects.  Any avandia taker should have realized that any patient with heart failure should not take the drug because it can worsen the condition.  

So what’s with this new agent called Byetta?  Is it all worth the hype?

Discovered from the Saliva of a Gila monster…Exenatide (Byetta) was just recently approved by the Food and Drug Administration in April 2005 for the treatment of type 2 diabetes. It was just recently launcehd in the Philippines. It is to be taken as an injection but although it is an injection, Byetta is not insulin!!!

Byetta improves blood sugar control by mimicking the action of the hormone incretin called GLP1 which allows insulin to work more effectively in the body.  The good thing with Byetta is that it also helps in preventing the further destruction of the Beta cells which are the cells that produce insulin.  It is this defect that remains unabated by current medications that will make a patient require insulin in the long run.  Now we have drugs that are proven to help prevent these cells from deteriorating including Rosiglitazone, Pioglitazone and now Byetta.

What is the Major Side effect of Byetta that as endocrinologist and patients alike like? It’s the WEIGHT LOSS! Finally we have a good drug that does not make a patient gain weight but instead lose weight. Its the downside that’s actually a PLUS! A weight loss of around 10 to 12 lbs can be achieved and sustained long term. A report from the New York Times mentioned about a patient who lost 60 lbs after Byetta use…  BUT… dont use this drug as a weight loss agent because this has not yet been studied for that purpose and the safety of this agent for non diabetics is not yet known.

Cost however is pretty prohibitive so better discuss this option with your doctors to assess benefit cost ratio.

Do I recommend this drug?  Yes I do and have started using this agent already. It was just recently launched at the AACE Philippine Chapter meeting in Shangrila and few doctors have been given the privilege to start using this drug for their patients by Eilly Lilly.  Its something new and revolutionary thus am writing about this in my website.  The New York Times Calls It: The Ray of Hope

For more information on Byetta: check out this site: www.byetta.com

The Gila Monster and the Man in Byetta!