Diabetesspecialist

May 2008

Inhaled Insulin ( Exubera) linked to Lung cancer:

Inhaled insulin, Exubera was found to increase the risk of lung cancer.

Comments by an Independent Endocrinologist:

No surprise. Many endocrinologists including myself had serious concerns about the safety of Exubera. That's why I never prescribed it to my patients.

April 2008

Pioglitazone ( Actos ) reduces coronary artery disease:

Results of an excellent study showed that Pioglitazone ( Actos ) decreased Coronary Artery Disease compared to Glimepiride ( Amaryl ).The study known as PERISCOPE compared Actos with Amaryl in Type 2 diabetic patients who already had coronary artery disease. The study was carried out in 97 academic and community centers in North and South America. The narrowing of the coronary artery was measured by an excellent technique in which an ultrasound is done with a probe inserted directly into the coronary artery. It is a direct measurement of thickening of coronary artery. The researchers found that in patients taking Actos there was a decrease in the narrowing of coronary arteries as compared to patients on Amaryl in whom there was worsening of narrowing of the coronary arteries.

Comments by an Independent Endocrinologist:

Excellent Study. No surprise to me. It just validates my experience at the Jamila Diabetes and Endocrine Medical Center, which I have discussed in detail in my book, Take Charge of Your Diabetes. Coronary artery disease and Type 2 diabetes are two manifestations of the same disease process, called insulin resistance. Actos treats insulin resistance and Amaryl does not. That's why Actos not only helps to control diabetes but also treats coronary artery disease as well.

February 2008

Study halted due to increase in heart attacks:

ACCORD, a study in Type 2 diabetics was halted because of an unexpected increase in cardiac mortality in patients whose blood glucose was aggressively lowered with multiple medications including insulin.

Comments by an Independent Endocrinologist:

Its' no surprise. As I have always said," type 2 diabetes is not just a matter of lowering blood glucose by any means. Its' only when you treat type 2 diabetes at its root, the insulin resistance that you can reduce the risk for heart attacks, because heart attacks are just another manifestation of the same disease process, the insulin resistance" Also I have been saying for a long time that insulin should not be used in Type 2 diabetics, because it does not treat insulin resistance.

In my extensive experience of treating thousands of type 2 diabetics with my Five Pillar approach to treat diabetes at its root, the insulin resistance, I have observed a marked reduction in all diabetic complications including heart attacks with the aggressive treatment of type 2 diabetes.

For more details, refer to my book, "Take Charge of Your Diabetes".

October 2007

Use of Byetta linked to acute pancreatitis:

Based upon a number of case reports of acute pancreatitis linked to the use of Byetta, FDA has issued a warning as of 10-17-07. Symptoms of pancreatitis include acute abdominal pain which sometimes radiates to the back, nausea and vomiting. Diagnosis can be confirmed by blood tests, ultrasound and /or Ct of upper abdomen.

Comments by an Independent Endocrinologist:

Its' no surprise. Often new side-effects of a new drug come to surface once it hits the real world; Independent physicians prescribing it who have no economic ties to the drug company. For this reason, I often wait for a while before start prescribing a new drug. I only recently started prescribing Byetta. So far, my experience has been positive. People do lose weight because Byetta make them lose their appetite. Glucose control gets better. But remember, Byetta does not treat insulin resistance, the underlying root cause of type 2 diabetes. Therefore, I don't use Byetta alone but in combination with my overall 5-pillars strategy to treat type 2 diabetes by treating insulin resistance. For more details, refer to my book, "Take Charge of Your Diabetes".

Exubera production stopped.

As of 10-19-07, production of Exubera, an inhaled insulin, is stopped by its manufacturer, Pfizer, Inc. The reason quoted for this decision is the lack of acceptance of Exubera by the patients as well as physicians.

Comments by an Independent Endocrinologist:

Again, No surprise! The real test of a new drug is when it hits the market and used by the independent physicians. Like many of my endocrinologist friends, I had concerns about the side-effects of this drug with the long term use. Therefore, I did not prescribe it to any of my patients.

September 2007

Actos may lower the risk for heart attacks in diabeteic patients

Recently a study published in the Journal of the American Medical Association, did a statistical analysis of 19 trials in which Actos ( pioglitazone ) was used. Actos was found to lower the risk for heart attacks in diabetic patients. However, Actos increased the risk for congestive heart failure but without increasing mortality.

Comments by an Independent Endocrinologist:

Our experience at the Jamila Diabetes and Endocrine Medical Center is in line with this study. In our experience, Actos lowers the risk for heart attacks as well as stroke but can cause congestive heart failure in some individuals.

August 2007

Avandia may increase the risk for coronary artery disease

Recently a study published in the New England Journal of Medicine, did a statistical analysis of 42 studies in which Avandia ( rosiglitazone ) was used. These investigators from the Cleveland Clinic found an increased risk for coronary artery disease associated with the use of Avandia. The news media, which loves sensationalism, jumped on it and for some time this news was on the front pages, creating a lot of doubts and confusion among patients taking Avandia. I have seen patients who stopped taking Avandia after this drama unfolded on the T.V. and in the newspapers. These patients were doing very well on Avandia.

Comments by an Independent Endocrinologist:

In our analysis, this study had many flaws: First of all, the investigators did not have any access to patients or their medical records, which makes it a very weak study. Only 11 of 42 studies were peer reviewed and many of them were small in size.

Interestingly, a few weeks later, the investigators at the Cedars Sinai medical Center in Los Angeles did the statistical analysis using the same 42 studies as researchers from the Cleveland Clinic had used and found NO increased risk for coronary artery disease with the use of Avandia. These investigators seriously challenged the methodology used by the Cleveland Clinic researchers. But this study did not get much publicity because it lacked sensationalism.

WE should, however caution our readers that Avandia as well as Actos, the other TZD ( short for thiazolidinedions ) drug, have been shown to cause congestive heart failure, which is different from coronary artery disease, and usually manifests itself as shortness of breath, leg swelling or unexplained sudden weight gain.

December, 2006

Actos may reduce the risk for stroke

A study published in the December 6,2006 issue of the journal of the American Medical Association, showed that pioglitazone ( Actos ) can reduce the narrowing of carotid arteries, (the blood vessels in the neck) of diabetic patients.

Comments by an Independent Endocrinologist:

This study confirms what has already been shown by the other investigators: pioglitazone can reduce narrowing of the blood vessels. Therefore it should reduce the risk for strokes and heart attacks.

Certainly this has been our observation at the Jamila Diabetes and Endocrine medical Center.

October 2006

Avandia may reduce the risk for developing type 2 diabetes

Results of a study (known as DREAM) were announced and the findings were as follows:

Study design:

The study enrolled 5269 adults over the age of 30 with Pre-diabetes (Impaired Fasting Glucose or Impaired Glucose Tolerance or both). These individuals did not have any previous cardiovascular disease.

These patients were randomly assigned to receive Ramipril, (an Ace-inhibitor) or Rosiglitazone, (an anti-diabetic drug ) or a placebo. The duration of the study was three years.

Results:

10.6% of individuals treated with Rosiglitazone ( Avandia ) versus 25% in the placebo group developed diabetes. This translates into a 60% risk reduction by Rosiglitazone in the progression to diabetes from pre-diabetes.

Ramipril( Altace ) had no significant effect in preventing diabetes.

39% of individuals on Rosiglitazone versus 21% on the placebo reverted from impaired fasting glucose back to a normal fasting glucose of less than 100 mg/dl.

0.5% of individuals on Rosiglitazone versus 0.1% on placebo developed congestive heart failure.

There was a significant weight gain with Rosiglitazone treatment.

Comments by an Independent Endocrinologist:

What is Pre-diabetes?

Pre-diabetes is a serious condition and must not be taken lightly. It is a manifestation of an ongoing harmful disease process in the body, known as insulin resistance. The term Pre-diabetes denotes two conditions of glucose abnormalities: Impaired Glucose Tolerance (IGT) and Impaired Fasting Glucose (IFG). Impaired Glucose Tolerance (IGT) is diagnosed on a 2-Hour Glucose Tolerance Test and Impaired Fasting Glucose is diagnosed on a routine fasting blood glucose. In my experience, many individuals with normal fasting blood glucose turn out to be having IGT on a 2-hour Oral Glucose Tolerance Test. A 2-Hours Glucose Tolerance test includes a baseline fasting blood glucose and therefore, can diagnose both IFG as well as IGT.

The other manifestations of insulin resistance include high Triglycerides level, low HDL cholesterol (the good cholesterol), high blood pressure, heart attack, stroke, fatty liver, Polycystic Ovary Syndrome, high uric acid level and gout.

What Causes Insulin Resistance Syndrome?

Genetics, aging, abdominal obesity, sedentary life-style, and stress are the main factors that interplay to cause the Insulin Resistance Syndrome.

Prevention of Diabetes!

Rosiglitazone belongs to a class of antidiabetic drugs known as TZDs', short for thiazolidinediones. The other drugs in this class include Pioglitazone and Troglitazone. Troglitazone was taken off the market because of its association with some cases of liver toxicity.

In the current study, Rosiglitazone was found to be effective in preventing progression from pre-diabetes to diabetes in a significant number of people, but of course not in every person. Weight gain and congestive heart failure are two significant side-effects of Rosiglitazone that one should keep in mind. In the past, Troglitazone was also shown to be similarly effective in the prevention of diabetes.

Life-style modifications including diet and exercise have been shown to be similarly powerful in preventing diabetes. In my practice, I advise my patients about my diet, (Dr. Z's diet), exercise and stress management. I believe there is a strong mind body connection. A stressed out mind affects our body adversely and most of us stay stressed in our daily life. (ie. traffic jams, overdue bills, family problems). Sadly life has shrunk to "trying to make a living".

The placebo effect in this study ( and in almost every study ) is a reminder of strong mind-body connection. The mere thought of receiving a pill ( although a dummy pill) had a beneficial effect on these people.

In addition to Life-style changes certain vitamins can be beneficial for the health of people with Prediabetes. One such vitamin is GLUPRIDE Multi.

In addition, people with Prediabetes should also ask their doctor if they should go on a drug such as Rosiglitazone or Pioglitazone especially if they also have low HDL cholesterol, high triglycerides level, coronary artery disease, stroke or polycystic ovary syndrome.