Regulators are examining whether there is a link between Type 2 diabetes drug Actos and bladder cancer, according to an article from WebMD.

Early data suggests there may be one, but not enough of a link to cause the FDA to pull the drug from the market. When the regulator initially approved the drug, it required Takeda Pharmaceuticals to keep data on a possible link.

The article suggests that no increased risk was found simply from taking the drug. However, in patients taking the drug the longest and accumulating the highest dosage, there appears to be a link. The risk appeared to be the highest among those taking the drug for at least two years.

The FDA says the findings do not prove a link and the article notes that those taking the medication should not stop taking it unless they are advised to do so by their doctors.

Source: http://diabetesnewshound.com/type2/bladder-cancer-actos/

The U.S. Food and Drug Administration announced it has begun a safety review of the diabetes drug Actos (pioglitazone), after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer associated with use of this drug.

The preliminary results are based on five-year data from an ongoing, 10-year observational study by the manufacturer, Takeda Pharmaceuticals North America Inc., San Diego. These early results showed no overall association between Actos exposure and risk of bladder cancer. However, there was an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug.

At this time, the FDA’s review is ongoing. The agency has not concluded that Actos increases the risk of bladder cancer.

Actos (pioglitazone) is used to control blood sugar in patients with type 2 diabetes mellitus. It is in the class of drugs known as peroxisome proliferator-activated receptor (PPAR) agonists. The only other drug in this class is Avandia (rosiglitazone). The FDA has no clinical information associating Avandia with bladder cancer in patients receiving that drug.

Patients should talk to their health care professional if they have concerns about Actos. They should not stop taking the drug unless told to do so by their health care professional.

Source: U.S. Food and Drug Administration

View drug information on ACTOS; Avandia.

Source: http://www.medicalnewstoday.com/articles/201685.php

The preliminary results are based on five–year data from an ongoing‚ 10–year observational study by drugmaker Takeda Pharmaceuticals North America Inc. The early findings showed no overall association between pioglitazone use and risk of bladder cancer‚ although data showed an increased risk of the cancer in patients with the longest exposure to pioglitazone‚ or those with the highest cumulative dose. The FDA’s review is ongoing‚ and the agency has not yet concluded that the drug increases the risk of bladder cancer. Individuals taking pioglitazone should talk to their healthcare professional if they have concerns about the drug; however‚ they are advised not to stop taking it unless instructed to do so by their physician.

FDA News Release (09/17/10)

Source: http://www.diabetes.org/news-research/news/diabetes-in-the-news/fda-reviewing-preliminary.html

Newly published research shows Avandia poses roughly the same heart-attack risk as competing drug Actos, contradicting earlier studies suggesting Avandia was more dangerous.

The new study, published this week in the journal Circulation: Cardiovascular Quality and Outcomes, may have arrived at a different conclusion in part because its subjects may have been younger and healthier than in previous studies, says study author Debra Wertz in a WebMD interview.

A recent FDA study finding an elevated risk with Avandia focused on diabetics over age 65, with an average age of 74.4, WebMD notes. The Wertz study subject’s average age, by contrast, was 54, and all were privately insured, suggesting that they were likely to be employed and consequently in generally good health.

The findings will likely muddle Avandia’s regulatory status. Last month, an FDA advisory panel recommended adding a second warning to Avandia’s label warning of the cardiac risks while holding off on a similar warning for Actos.

Sales of Avandia have plunged this year, to about $1.1 billion from as high as $3.4 billion in 2006, while Actos sales have soared to $4.6 billion, according to the Los Angeles Times.

Source: http://diabetesnewshound.com/type2/avandia-actos/

A new analysis of diabetes medications Avandia (rosiglitazone) and Actos (pioglitazone) revealed that the risk of heart attack and/or heart failure, or death were the same, approximately 4%. The study has been published in the latest issue of Circulation: Cardiovascular Quality and Outcomes , an American Heart Association journal.

Takeda Pharmacuetical Co. makes Actos, while GlaxoSmithKline (GSK) makes Avandia. Avandia sales had dropped after a previous study had found it was linked to higher heart disease risk. American regulators are reviewing whether Avandia should be taken off the market after an FDA Advisory Committee said warnings about heart disease risks should be added to prescription information.

Debra Wertz, Pharm.D., lead author and outcomes research manager, HealthCore, Inc., research subsidiary of health insurance company WellPoint, Inc., said:

This study provides patients and their doctors with another source of information about rosiglitazone and pioglitazone as they determine the best therapy for diabetes patients.

This latest 33-month study, involving over 36,000 patients aged 54 years (average) and 14 months treatment on Actos or Avandia found that:602 who took Avandia (rosiglitazone) had a heart attack and/or heart failure, or died.
96 had a heart attack.
265 had heart failure.
24 had both heart attack and heart failure.
217 died599 who took Actos (pioglitazone) had a heart attack and/or heart failure, or died.
121 had a heart attack.
243 had heart failure.
18 had both heart attack and heart failure
217 diedThis translates into approximately 4% of all patients taking either Actos or Avandia.58% of the patients in this study were male. Wertz and colleagues obtained death records from the National Death Index, a central database administered by the National Center for Health Statistics.

The patients were divided into two equal groups, one receiving Avandia and the other Actos. After adjusting for factors such as age, gender, previous heart and blood vessel disease, complications related to diabetes, and severity indicators, they compared the incidence of heart failure, heart attack and death for 14 months (average) treatment and 19 months follow up after treatment.

Diabetes, a chronic disease in which the patient’s body cannot produce enough insulin, or does not use it properly, has a significant risk of blood-sugar buildup, resulting in a higher risk of cardiovascular problems – the main cause of diabetes-related deaths.

Avandia both belong to a class of medications called thiazolidinediones (TZDs), which help the body use insulin more effectively – they improve the body’s sensitivity to insulin, resulting in better blood-sugar control.

Wertz said:

Besides its findings that rosiglitazone and pioglitazone have comparable risks, what distinguishes this latest study from other claims-based analyses is its analysis of death records, which include out-of-hospital deaths.

Wertz added that this latest study monitored patients for longer than some earlier ones.

Mark J. Cziraky, Pharm.D., study co-author, and vice president of research development and operations at HealthCore, said:

One of the reasons we embarked on this analysis was to see if there were any differences in effect that we could identify between these two agents. We did not find that with the approach and methods we took within this population.

“Risk of Cardiovascular Events and All-Cause Mortality in Patients Treated With Thiazolidinediones in a Managed-Care Population”
Debra A. Wertz, PharmD; Chun-Lan Chang, PhD; Chaitanya A. Sarawate, MS; Vincent J. Willey, PharmD; Mark J. Cziraky, PharmD and Rhonda L. Bohn, MPH, ScD
Circulation: Cardiovascular Quality and Outcomes . 2010
Published online before print August 24, 2010, doi: 10.1161/CIRCOUTCOMES.109.911461

Written by Christian Nordqvist

View drug information on ACTOS; Avandia.
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Source: http://www.medicalnewstoday.com/articles/198939.php