Diabetic drug Avandia in trouble

September 23, 2010 by  

The antidiabetic drug rosiglitazone is in big trouble as the decisions from major regulatory bodies were announced today.

The European Medicines Agency (EMA) announced today that it is recommending the suspension of the marketing license of antidiabetic drugs that contain rosiglitazone. This includes the drugs marketed in Europe as Avandia, Avandamet, and Avaglin.

The EMA suspension will take effect within the next few months and “will remain in place unless the marketing authorisation holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks.”

In the US, the Food and Drug Administration (US FDA) decided that Avandia stays on the US market but under strong restrictions. According to an FDA statement today:

The U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

Rosiglitazone has been under scrutiny due to the side effects of fluid retention and increased risk of heart failure which came out during postmarketing studies. Avandia is a product of the UK drug marker GlaxoSmithKline (GSK).

What should patients in Europe who are taking rosiglitazone do?

The European Association for the Study of Diabetes (EASD) issued the following press statement earlier today:

EASD urges patients who are currently taking any of the above medications to contact their medical advisors for advice concerning alternative treatment options.

Patients should be aware that stopping a diabetes medication without consulting a doctor can result in higher levels of blood glucose that may cause serious short term health problems and increase the risk of long-term diabetes-related complications.

Optimal control of glucose, cholesterol and blood pressure is needed in order to limit the risk of long-term complications, and several alternative types of treatment are available to help those with type 2 diabetes achieve these objectives.

 In any case, this may be the end of rosiglitazone. Even if its stays in the US market, its cardiovascular safety is seriously suspect that no clinician will ever consider prescribing the drug to patients.

Photo source: www.healthcare-digital.com/news/avandia/avandia-recieves-mixed-reactions

Heart(y) News February 26: Non-heart drugs that can affect your heart

February 26, 2010 by  

Some noncardiovascular medications have the potential to affect cardiovascular function causing adverse effects that can potentially be life-threatening. The lesson learned from Vioxx was a hard one. That is why new drugs are thoroughly screened on cardiovascular safety.

Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety
One of the drugs most recently scrutinized is the antidiabetes drug Avandia (rosiglitazone). The US FDA recently issued a notification to healthcare professional and patients about ongoing reviews of clinical trial data. The data in question were primarily from the large, long-term RECORD trial. The US FDA expects to complete the review in the coming months and will publicly report the review results in July this year. In the meantime, the regulatory body recommends that doctors should follow closely the prescribing info, including the black boxed warning.

New senate report puts Avandia safety in spotlight again
The ongoing US FDA review is just one of Avandia’s manufacturer GlaxoSmithKline’s (GSK) problems. A new senate report accuses Avandia researchers for unethical conduct in relation to another clinical trial called Thiazolidinediones Intervention with Vitamin D EvaluationThiazolidinediones Intervention with Vitamin D Evaluation (TIDE). The TIDE study compared Avandia with the competitor drug pioglitazone. However, the report questions the safety, thus the ethical status of the trial.
This is not the first time that GSK is criticized about Avandia. In 2007, a study was published indicating cardiovascular safety issues in connection with the diabetic drug. Furthermore, some experts believe that the pharma company was aware about the safety issues but didn’t disclose it to the authorities. The company, however, denies the allegations

“The safety and effectiveness of Avandia is well characterized in the label approved by the FDA. Contrary to the assertions in the report… the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events.”

Invirase (saquinavir): Ongoing safety review of clinical trial data
Another drug scrutinized for cardiovascular safety is the antiviral agent Invirase (saquinavir). Invirase is used in combination with another antiviral drug Norvir (ritonavir) in the treatment of HIV infection. The combination therapy, however, seems to have an adverse effect on the heart. According to the US FDA:

The data suggest that together the two drugs may affect the electrical activity of the heart, known as prolonged QT or PR intervals. A prolonged QT interval can increase the risk for a serious abnormal rhythm called torsades de pointes. A prolonged PR interval can cause the electrical signal responsible for generating a heart beat to slow or even stop, known as heart block.

The US FDA is also conducting a review of clinical trial data on Invirase.

Photo credit: stock.xchng

It’s not all bad news for rosiglitazone

June 17, 2009 by  
Filed under DIABETES

capsuleRemember the controversy about the diabetic drug rosiglitazone (market name Avandia)? Remember the issues surrounding the APPROACH Trial – Assessment on the Prevention of Progression by Rosiglitazone on Atherosclerosis in Type 2 Diabetes Patients with Cardiovascular History? The drug was thought to increase cardiovascular risk, which brings to mind the problems faced by Vioxx.

Well, it seems that new trials indicate that it is not all bad news about rosiglitazone. In a late-breaking clinical trial using IVUS technology, rosiglitazone was compared with another diabetic drug glipizide. The trial’s primary endpoint, which is “a significant difference in percent atheroma, or plaque, buildup in coronary arteries“, was not met, but it did bring up some good points about rosiglitazone, especially with the secondary end points. The recent results show that:

IVUS stands for intravascular ultrasound and is the world’s largest study of diabetic patients with established coronary artery disease (CAD). The study involved 672 patients from 92 hospitals in 19 countries worldwide. The effect of diabetic drugs on the progression of CAD was assessed using the intravascular ultrasound technique. This was done by measuring the plaque burden using IVUS in a 40 mm segment of an atherosclerotic artery which hasn’t undergone any intervention because level of plaque build up was considered to be too low to require treatment.

People suffering from diabetes have increased risks for atherosclerosis, heart attack, stroke, and other cardiovascular disorders. Diabetes a metabolic disorder which interferes with blood sugar metabolism due to problems with insulin, the hormone produced by pancreas needed to metabolize glucose in the blood.

About the two drugs:

Rosiglitazone is a member of the thiazolidinedione class of diabetes drugs. It works by making the cells of the body more sensitive to insulin. In addition, the drug also has a positive impact on blood pressure, high density lipoprotein (HDL “good”) cholesterol and has anti-inflammatory properties. However, in 2007, the US FDA issued warnings about rosiglitazone increasing risk of cardiac events.

In a more recent report, the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) trial reports that rosiglitazone “does not increase overall cardiovascular risk.

Glipizide belongs to the sulfonylurea class of insulin secretagogues. It works by inducing the pancreas to secrete more insulin. It has been on the market for more than 40 years.

Photo credit: stock.xchng

Treatment Methods for Diabetes

January 3, 2008 by  
Filed under DIABETES

Exactly how diabetes is treated depends on a number of factors: which type the patient has, how severe it is, the age of the patient and others.

Gestational diabetes, for example, that sometimes afflicts pregnant women at around 6-7 months into the pregnancy, may disappear after birth. Treatment may be as mild as doing nothing to additional diet management. Type 1 diabetes, on the other hand, is currently incurable and typically requires lifelong insulin shots.

But there are other forms of treatment, many of them amounting virtually or literally to self-care.

On the more extensive end of treatments there are a variety of drugs used apart from insulin.

Sulfonylureas, for example (such as Glucotrol® and Micronase®) help the body make insulin. That’s helpful for Type 1 diabetes patients who produce too little. Biguanides, on the other hand (such as Glucophage®), aid in using insulin more efficiently, the common characteristic of Type 2 diabetes. Thiazolidinediones (like Avandia®) help make cells more sensitive to insulin, again useful in treating Type 2.

Other drugs work on glucose levels. Meglitinides (such as Prandin®) help control the blood sugar level after eating. Alpha-glucosidase inhibitors (like Precose®) slow down the absorption of sugars in the digestive tract.

All of these treatment options, and any others, will naturally involve careful monitoring of blood glucose level by use of one or more methods. Once that’s known, the patient and his or her physician can focus on a particular category of treatment and/or self care.

In some cases, particularly those involving Type 2 diabetes, adjustment of the diet and an appropriate exercise regimen may be enough to control the disease without drugs. This is particularly true for those who suffer from elevated glucose levels with a condition called pre-diabetes.

There is a strong correlation between obesity and Type 2 diabetes, especially for those who tend to carry the excess weight mostly around the waist. For those, simply losing weight may be enough to bring the condition to the point that no drug treatments are necessary.

Many factors play into such a lifestyle adjustment and they tend to have other beneficial effects. Careful control of the amount and type of carbohydrates, adjustment of alcohol intake and other dietary changes aid in reducing cardiovascular problems of many types, including heart attack and stroke.

Physical exercise lowers blood sugar levels, having a direct effect on the condition. But exercise also helps the body’s immune system along with having other positive benefits. That helps reduce the odds of subsidiary problems produced by diabetes. Stress, in particular, can produce changes that affect how hormones, including insulin, are used by the body. Exercise and an overall attitude adjustment can bring that under control.

If insulin becomes necessary, there are other forms apart from traditional injections. Oral insulin is now in widespread use. Insulin inhalers have recently been approved by the FDA for treatment of diabetes. An insulin pump, which injects the appropriate amount automatically as needed, may be appropriate for some patients.

The only way to know which treatment is best in a given circumstance is to be tested and diagnosed by a physician. Seek early diagnosis and treatment if you suspect you may have diabetes. That will provide the most, and the least objectionable, options for long term care.

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NOTE: The contents in this blog are for informational purposes only, and should not be construed as medical advice, diagnosis, treatment or a substitute for professional care. Always seek the advice of your physician or other qualified health professional before making changes to any existing treatment or program. Some of the information presented in this blog may already be out of date.