Archive for February, 2010

Avandia or Rosiglitazone is In The News Again!

February 24, 2010

I have to write this special post on avandia as many of my patients at present are on it.   Unfortunatelty people responsible for this controversy will not lay to rest the issue that has long been addressed.  In short this is plain OLD issue that has been repackaged and made again into a media hype!  The problem is the laymen – our patients who read the news and interpret the news as they are written. 

Here is the response of the American Association of Clinical Endocrinologists: the Voice of Endocrinology on this particular issue.  The same sentiments as I have.  It is just unfortunate that this drug is involved in  the midst of a controversy inside the FDA.

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AACE Patient Safety – Editorials
 
Commentary on February 19 New York Times article on Avandia
2010-02-22 15:41:32
By: Alan Garber, MD, PhD
Editor, AACE Patient Safety Exchange

 

A rash of headlines appeared this weekend as a Senate report on Avandia was leaked to the New York Times. It contained the usual accusations and concerns of certain FDA staffers such as Dr Graham who spoke 1-2 years ago at prior Avandia Advisory Boards and whose comments were largely based upon the meta-analysis of Nissen and Wolski using post hoc data derived from short term studies with Avandia. Those studies were largely conducted to obtain glycemic control data. Since that time considerable republication of similar meta-analyses, using the same or similar data have appeared. These have spread the concerns regarding Avandia further. Of course since that original meta-analysis was published in 2007, a number of subsequent studies have appeared to alleviate or to directly address the concerns raised by Drs Nissen and Wolski. In 2007, two prior large scale randomized prospective clinical trials had also contained data regarding CHD events with Avandia, namely DREAM and ADOPT. Both studies failed to show increased risk with Avandia, contrary to the conclusions attributed to them in the current New York Times article by Gardiner Harris. But these were post hoc analyses and therefore not definitive. Of course the meta-analysis was as well. Subsequent studies were also analyzed for potential adverse consequences of Avandia, including ACCORD and VADT. Neither trial showed adverse effects and VADT may have suggested benefit instead. A direct test of cardiovascular safety – the RECORD was completed and published in Lancet in June 2009 (373:2125-35) by Philip Home and colleagues. This five year study of nearly 4500 patients with diabetes randomized to treatments containing or not containing Avandia showed no increased risk of death or hospitalization for cardiovascular disease in patients taking Avandia as compared to those not taking Avandia. Since this was the prespecified primary endpoint, it seems proven that the suggestions provided by the meta-analysis have no validity. This conclusion is support by the recently published Perspective by Charles Hennekens and David DeMets in JAMA (302:2361-2, 2009). Here the authors decry overreliance upon meta-analyses of small scale short term studies in favor of data provided by large scale randomized long term trials. Dr Hennekens, a former Professor of Preventive Medicine at Harvard, and a colleague on the NCEP, concludes that the findings of RECORD lay to rest the concerns raised by the meta-analysis.
 
None of these newer studies are addressed or even considered in the article now appearing in the New York Times and the concerns it raises appear to have been adequately addressed and laid to rest by these newer studies. In short, this is old news, quite old indeed.

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So to my patients: no need to worry.  Again this is an old issue repackaged by the New York Times made big in the headlines due to Senate inquiry.

Unless the US FDA will succumb to the pressures by the media and the senate…. there is no reason for this drug not to be available to our patients who need it!

Subsequent proscpective- meaning better made studies like the RECORD, ACCORD and the BARI2D that looked at patient safety on avandia have consistently shown that those taking avandia had in fact lesser risk for cardiovascular  mortality than the comparator drugs including a recent publication in UK  that compared avandia to the commonly used sulfonylurea and metformin.

A Diabetes Care metaanalysis in 2008 likewise showed that Sulfonylurea -metfomin combination in fact also increases risk of heart attack but this study was never caught by the media.  Again since this is only a metaanalysis- exactly the same kind of study that started the Avandia contorversy…it is a hypothesis driven article and therefore cant be trusted but worth proving by making prospective randomized trials.

I hope this article will clear some issues hounding the patients on avandia.  Remember…one reason why we need to control a patient’s blood sugar together with cholesterol and blood pressure is to reduce a patient’s risk for heart attack and stroke!

In medical field…. Analysis of data is of paramount importance.  Dont believe what you read in the news!

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Parents: WE Still RULE

February 13, 2010

 Go to fullsize imageWhile coming back from San Francisco after attending the postgrad course of the American Diabetes Association, I happened to read a very nice article in USA today on: Teenagers do Listen.  I will be having a teenager son soon, so I was intrigued about the article.

 The article discussed a recent media survey by Kaiser Family Foundation that showed typical kids spend as much as 7 hours and 38 minutes a day consuming entertainment media like TV, computer and game consoles.  Not surprisingly why obesity is now a main global concern with our kids high tech lifestyle.

 But what was astounding about the survey was that the kids whose parents set the rule plugged in to the media for only 3 hours suggesting parents have a big influence on our kids in terms of what they do and think.

 Other studies likewise have shown that activities and behavior of kids are mainly influence by their parents:

 1. Teens who had a bedtime at 10PM or earlier set by parents got more sleep and were less likely to be depressed published in Sleep in January.

2. Teen drivers whose parents set and enforced rules were more likely to wear seat belts and less likely to suffer road accidents including the use of cellphones while driving published in Pediatrics in September.

3.Teens whose parent also set the rules also smoke less, delay sex and do better in school.

 The reality is… Teenagers care deeply about what their parents say… the challenge is getting across the rules and boundaries that don’t seem controlling!

 There you go guys.  It’s not too late. 

Let’s GIVE MORE  time to communicate with our kids…be it while eating dinner together or while driving our kids to school or while bringing them back home. The notion that fewer rules mean lesser fights may not be right after all.  The welfare of our kids continue to be a priority because for me…

What they will become is a reflection of how good we are AS  parents!!!

Ways To A Healthier Heart

February 3, 2010

See full size imageJust came across this wonderful wonderful article in Harvard HealthBeat News Letter that I want to share.  They are practical steps yet very true to every word.  Worth meditating and taken seriously… and true to its mission…A Healthy Heart!

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10 small steps for better heart health

Change is an important part of living with heart disease or trying to prevent it. A jump in blood pressure or cholesterol earns you a lecture on healthy lifestyle changes. Heart attack and stroke survivors are often told to alter a lifetime of habits.

Some people manage to overhaul their exercise pattern, diet, and unhealthy habits with ease. The rest of us try to make changes, but don’t always succeed. Instead of undertaking a huge makeover, you might be able to improve your heart’s health with a series of small changes. Once you get going, you may find that change isn’t so hard. This approach may take longer, but it could also motivate you to make some big changes.

Here are 10 small steps to get you on the road to better health in 2010.

1. Take a 10-minute walk. If you don’t exercise at all, a brief walk is a great way to start. If you do, it’s a good way to add more exercise to your day.

2. Give yourself a lift. Lifting a hardcover book or a two-pound weight a few times a day can help tone your arm muscles. When that becomes a breeze, move on to heavier items or join a gym.

3. Eat one extra fruit or vegetable a day. Fruits and vegetables are inexpensive, taste good, and are good for everything from your brain to your bowels.

4. Make breakfast count. Start the day with some fruit and a serving of whole grains, like oatmeal, bran flakes, or whole-wheat toast.

5. Stop drinking your calories. Cutting out just one sugar-sweetened soda or calorie-laden latte can easily save you 100 or more calories a day. Over a year, that can translate into a 10-pound weight loss.

6. Have a handful of nuts. Walnuts, almonds, peanuts, and other nuts are good for your heart. Try grabbing some instead of chips or cookies when you need a snack, adding them to salads for a healthful and tasty crunch, or using them in place of meat in pasta and other dishes.

7. Sample the fruits of the sea. Eat fish or other types of seafood instead of red meat once a week. It’s good for the heart, the brain, and the waistline.

8. Breathe deeply. Try breathing slowly and deeply for a few minutes a day. It can help you relax. Slow, deep breathing may also help lower blood pressure.

9. Wash your hands often. Scrubbing up with soap and water often during the day is a great way to protect your heart and health. The flu, pneumonia, and other infections can be very hard on the heart.

10. Count your blessings. Taking a moment each day to acknowledge the blessings in your life is one way to start tapping into other positive emotions. These have been linked with better health, longer life, and greater well-being, just as their opposites — chronic anger, worry, and hostility — contribute to high blood pressure and heart disease.

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As the saying goes…

Dont Worry…Be Healthy and Be Happy!