Online Pharmacy Medicine Blog

Federal Advisory panel will vote today on whether Avandia, a popular drug for Type 2 diabetes, is safe enough to stay on the market. Avandia is one of many diabetes medications like Metformin, Actos, Glucotrol, Byetta, and Januvia used to treat type 2 diabetes.

Conflicting study results from the drugs maker GlaxoSmithKline along with other problems due to feuding scientist have made it hard for reviewers to get a bead on what should be done about the diabetes medication.

According to the New York Times,

On Tuesday, panel members heard evidence that patients in a crucial trial of Avandia who suffered heart attacks did not have their problems included in the trial’s final tally. And internal company documents made public in recent days show that the company hid from the public crucial information about Avandia’s safety woes.

Some reviewers within the F.D.A. said Tuesday that studies demonstrate conclusively that Avandia is far more dangerous to the heart than a similar medicine, Actos, made by Takeda. But other reviewers said that the trials are far more equivocal and provide little evidence that Avandia is dangerous. Scientists at GlaxoSmithKline argued that Avandia is a safe and important option in the treatment of Type 2 diabetes.

I am surprised that the FDA has let this drag on as long as it has. Hopefully a decision will be made one way or the other so people can stop living in fear of there diabetes medication.

Today the FDA reported that it was examining data from several different studies to determine if the risks with commonly used Hormone treatment for prostate cancer Gonadotropin-Releasing Hormone. Recent findings hint that certain hormone treatments for men with prostate cancer pose greater risk for diabetes or heart trouble.

Products under investigation are: Lupron, Zoladex, Trelstar, Vantas, Eligard and Synarel.

According to Reuters, the agency said it has not made any conclusions about GnRH agonists but that patients should be monitored for potential onset of diabetes or cardiovascular disease that can result in heart attacks, stroke and sudden cardiac death.

Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults, has been approved by the FDA to compete with the other DPP-4 inhibitor on the U.S. market, Januvia (sitagliptin).

So, is Onglyza or Januvia the better choice for you?

Let’s look at the two drugs along a number of criteria –

Price. Both drugs are priced at approximately $5.72 per pill for common dosages (U.S. wholesale).

Effectiveness. Both drugs improve the body’s ability to lower elevated blood sugar levels and are part of a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. This is a relatively new class of drugs that can be taken along with older diabetes drugs, such as metformin. The potential advantages for Onglyza are (1) that it’s a smaller pill than Januvia and thus easier to swallow; and (2) that it can be taken as a once-daily combo with metformin, whereas the Janumet combo is taken twice daily.

Side effects. The most common side effects of Onglyza are the headache and runny nose that are also found with Januvia; these result from the inhibition of the immune system these drugs cause.

Safety. There is some concern that Onglyza may increase the risk of “cardiovascular events” for those who already have heart problems. The FDA is requiring Onglyza’s makers to conduct testing to address this issue. General concerns have been expressed about the potential cardiovascular risks of DPP-4 inhibitors, which is one reason similar drugs by Novartis and Takeda are still not available on the U.S. market.

In general, the prescribing information on Onglyza seems to offer no advantages over Januvia. And since the drugmaker has decided to match the price of Januvia, rather than getting in a price war, there’s no financial advantage to picking one over the other, either.

Of course, most physicians like to have more than one drug choice in the same class, because individual patients respond to medications differently. So ask your doctor.

Either way, we’re sure to get saturation TV advertising on Onglyza now that it is FDA-approved. So if you love watching pharmaceutical ads, stay tuned.

Sources: PharmaGossip, Diabetes Update, Fierce Pharma

The childhood obesity epidemic in the United States continues to worsen, as parents are resorting to greater reliance on prescription drugs for high cholesterol, high blood pressure and diabetes than ever before. As CVS Caremark reports in a new study:

…over a two-and-a-half year period ending in June 2007, the use of medications to treat high blood pressure, high cholesterol and diabetes among children increased 15.2%…

“The increasing use of antidiabetic and antihypertensive medications in this younger population likely reflects the rise of pediatric obesity and a failure of lifestyle changes to control cardiovascular risk factors typically associated with adults,” said Josh Liberman, Ph.D., Vice President, Strategic Research CVS Caremark and lead author of the study…

The study was designed to document trends in the use of prescription medications indicated for the treatment of type 1 and type 2 diabetes, high blood pressure and high cholesterol among children and adolescents over a time period that spanned close to three years. Results found that the one-month prevalence of use of these medications increased 15.2%, from 3.3 per 1,000 youths in November 2004 to 3.8 per 1,000 youths in June 2007…

“There is growing recognition that childhood obesity is nearing an epidemic and, as a result, consensus treatment guidelines for the associated cardiovascular conditions and risk factors recommend the introduction of pharmaceutical treatments if life style and behavioral modifications fail to achieve desired results,” said Dr. Liberman…

The study looked at drug usage data for about six million U.S. children aged six to 18, based on CVS Caremark PBM pharmacy insurance claims records.

Drugs that affect your metabolism are the top-selling prescription drugs, according to a new report by the Agency of Healthcare Research and Quality. This category of medications includes popular drugs to lower cholesterol, control diabetes, and control weight gain.

These drugs accounted for $38 billion of the $208.1 billion spent on prescription medications in the United States — or 18.3 percent of total prescription expenses by adults.

The top-selling drug in the United States, by a wide margin, is the cholesterol medication Lipitor. Lipitor is used along with diet to help lower “bad” cholesterol (LDL) and raise “good” cholesterol (HDL) in the blood. It’s part of a group of medications known as “statins”. Lipitor works by reducing the amount of cholesterol made by the liver.

You can read a summary of the study here.