Saturday, November 19, 2011

Cycloset benefits

Have you heard of Cycloset?
Cycloset was approved by the U.S. Food and Drug Administration (FDA) in May 2009 to treat Type 2 Diabetes.  
That’s over 2 years ago. But I suspect you have not heard of Cycloset.

Yet Cycloset benefits are many. These include lowering blood glucose without causing hypoglycemia (too low blood glucose) and reducing serum triglycerides. And Cycloset does not cause weight gain.
But most important are Cycloset benefits to the heart.

But what is Cycloset? Cycloset is a special quick release formulation of bromocriptine. Bromocriptine has been on the market for over 35 years. Bromocriptine has been used to treat elevated prolactin levels and to treat Parkinson’s disease. So we have a thorough understanding about the safety of bromocriptine. After all, it has been well studied over the past few decades.

Side effects of Cycloset are mostly nausea, dizziness and headache. These tend to be mild and go away over time. And slowly increasing the dose over several weeks and taking the pills with food helps. For most people, these side effects are no big deal.

Cycloset lowers blood glucose modestly.  Fasting glucose drops around 20 mg/dl and after meal glucose drops around 35-50 mg/dl. The Hemoglobin A1c (Hgb A1c) drops around 0.5 to 0.9 %.

These effects on glucose are about as much as you get with the DPP4 inhibitors.
That class of drugs for Type 2 Diabetes includes Januvia, Onglyza and Tradjenta.  
I bet you’ve heard of at least one of those DPP4 inhibitors. They are prescribed fairly often. Especially Januvia; it’s been out the longest.

But I think doctors should be thinking of Cycloset before a DDP4 inhibitor.

Why? Here’s the story.

The FDA requires that all new drugs for diabetes have to be tested for heart safety. That means usually that a clinical trial has to be performed in which the drug is tested versus placebo and the number and type of cardiovascular events is carefully evaluated.

The idea is that any drug used to control the blood sugar for people with Type 2 Diabetes should not increase the risk of heart attack, heart failure or stroke.
Of course, it would be great to reduce those risks but at a minimum the drug should not increase cardiovascular risk. This recent FDA requirement for drugs for Type 2 Diabetes came about after the uncertainty about the heart safety of Avandia.

All new drugs for Type 2 Diabetes are being studied for their cardiovascular safety. 
The study with Cycloset has already been completed.

Cycloset or identically appearing placebo was given to about 3000 adults with Type 2 Diabetes. The average age was 60 years and 31 % already had a history of coronary artery disease and about 5 % had a previous stroke.

Only 12% of the group were using just diet for control of their blood glucose.
The others were on pills or insulin. The study participants were followed closely over 52 weeks. The main result planned was the combined rate of several cardiovascular events. These events included heart attack, need for bypass surgery, hospitalization for heart failure or angina and stroke.

The risk of a cardiovascular event with Cycloset was 42% less! There were 3.2% events in those on placebo but only 1.8% in those on Cycloset.

And many of the patients in the study were already on the usual drugs shown to reduce cardiovascular risk, like aspirin, statins and ACE inhibitors.

How might Cycloset reduce cardiovascular risk? The answer is not known.
There are many possible mechanisms.

 But the clinical results are clear. This is the first medication for Type 2 Diabetes that appears in a randomized placebo controlled clinical trial to reduce the risk of cardiovascular events.

I think Cycloset should be considered more often for people with Type 2 Diabetes. 
And now you know why.

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