Navigation Links
American Heart Association Comment: Advisory Committee Recommends that U.S. Food and Drug Administration Keep Rosiglitazone (Avandia) on the Market, Continue Clinical Trial of Safety and Efficacy
Date:7/14/2010

DALLAS, July 14 /PRNewswire-USNewswire/ -- After two days of hearings, an advisory committee to the U.S. Food and Drug Administration (FDA) recommended that the FDA allow the type 2 diabetes drug rosiglitazone (brand name, Avandia), to stay on the market, but with most committee members suggesting that the label be revised to include increased warnings. Rosiglitazone is one in a class of drugs called thiazolidinediones (TZDs), used to treat type 2 diabetes.

(Logo: http://www.newscom.com/cgi-bin/prnh/20100222/AHSALOGO)

(Logo: http://photos.prnewswire.com/prnh/20100222/AHSALOGO)  

The advisory committee voted 20 to 12 (with one abstention) to keep rosiglitazone on the market and recommended 20 to 10 (with two abstentions) that the TIDE trial continue. This trial, requested by the FDA, is evaluating patients with type 2 diabetes and a history of or risk for cardiovascular disease, and comparing the cardiovascular effects of long-term treatment with rosiglitazone, pioglitazone or placebo when added to standard care. The trial will also compare the effects of long-term supplementation with vitamin D on death and cancer.

The FDA will consider these recommendations and make a final ruling. "The advisory committee's deliberations were difficult, since the available data were limited, controversial, and subject to multiple interpretations by seasoned investigators and reviewers," said Ralph Sacco, M.D., president of the American Heart Association. "We agree with the committee that further research is necessary to answer the remaining questions, and we encourage the FDA to continue to evaluate and assess carefully all new clinical data as they become available."

For patients with diabetes, the most serious consequences are heart disease and stroke, and the risk of suffering from them is significantly increased when diabetes is present.

"It's especially important that patients not change or stop medications without consulting their healthcare provider," said Sacco.

For patients with diabetes, the American Heart Association recommends the following:

  • The cornerstone of prevention and treatment should be healthy lifestyle choices, such as not smoking, following a healthy diet and remaining physically active.
  • Because of the increased risk of heart disease and stroke, it is very important to achieve optimal control of your blood sugar, blood pressure and lipids (such as cholesterol and triglycerides) with lifestyle and medications when needed. For people with diabetes who are also at increased risk for heart disease, low-dose aspirin therapy is recommended as a reasonable way to prevent a first heart attack or stroke.
  • Focus on blood sugar control, keeping your HbA1c level below 7.0, is likely to reduce the risk of the "microvascular" complications of diabetes, such as kidney failure, painful nerve problems and decreased vision or even blindness.

For healthcare providers, the American Heart Association offers the following guidance on glucose-lowering medications:

  • Metformin should generally be the first choice, particularly in obese patients. If it does not produce adequate HbA1c control, other medications can be considered, recognizing that knowledge is limited about the effect of other glucose-lowering agents on cardiovascular risk.
  • If a TZD (such as pioglitazone or rosiglitazone) is considered for lowering glucose, patients should not expect it to reduce the occurrence of heart attack or stroke. The rationale for choosing a TZD should be discussed with a physician. However, patients who have successfully achieved recommended HbA1c control on a TZD may consider remaining on their medication. If the treating physician and/or the patient are uncomfortable with using a TZD, another medication could be substituted.

Related links:

2010 AHA/ACC issue advisory on diabetes drugs and heart risk

http://www.newsroom.heart.org/index.php?s=43&item=970

2010 Aspirin for Primary Prevention of Cardiovascular Events in People With Diabetes,

A Position Statement of the American Diabetes Association, a Scientific Statement of the American Heart Association, and an Expert Consensus Document of the American College of Cardiology Foundation

http://circ.ahajournals.org/cgi/content/full/121/24/2694

2007 Statement from the American College of Cardiology, American Diabetes Association and American Heart Association Related to NEJM article, "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes" http://americanheart.mediaroom.com/index.php?s=43&item=61


'/>"/>
SOURCE American Heart Association
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
2. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
3. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
4. Aspirin Named 8th World Wonder by Majority of Americans
5. MedImmunes Motavizumab Reduced RSV Hospitalizations by 83 Percent Among High-Risk Native American, Full-Term Infants in Placebo-Controlled Phase 3 study
6. American Heart Association Comment Saving Lives in Type 2 Diabetics: Could It Be as Easy as Lowering Blood Pressure?
7. TrialCheck(R) Cancer Clinical Trial Matching Interface to Debut on American Cancer Society Web Site
8. Hypertension: Journal of the American Heart Association Rapid Access Reports: Hispanics Hypertension Better Controlled With Equal Access to Care
9. Positive Results for NKTR-118 (oral PEG-naloxol) Presented at American Academy of Pain Management Meeting
10. Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers
11. New MIRCERA(R) Data Analyses to be Featured at the American Society of Nephrology Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... Wegener Polyangiitis - Pipeline Review, H2 ... Polyangiitis - Pipeline Review, H2 2015, provides an ... This report provides comprehensive information on the therapeutic ... at various stages, therapeutics assessment by drug target, ... and molecule type, along with latest updates, and ...
(Date:2/4/2016)... Frontier Pharma: Chronic Obstructive Pulmonary Disease ... Chronic Obstructive Pulmonary Disease (COPD) is ... the airways and lungs. Persistent breathing difficulties and ... one of the leading causes of morbidity and ... COPD is linked to cumulative exposure to risk ...
(Date:2/4/2016)... 2016 In response to the opioid abuse epidemic, ... for Medical Products and Tobacco, along with other FDA leaders, ... approach to opioid medications. The plan will focus on policies ... pain access to effective relief. --> ... Re-examine the risk-benefit paradigm for opioids and ensure that the ...
Breaking Medicine Technology:
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... Steven Tonkinson, ... he has completed every year since it started in 2003. This year, he ran ... attention of fellow runners and NBA team the Miami Heat. , This Sunday, while ...
(Date:2/5/2016)... ... February 05, 2016 , ... Today, the Whole-Food Warrior TV show, ... much-anticipated feature with author Jahnavi Foster, specialist in healthy vegetarian cuisine, will stream on ... week, on his weekly Whole-Food Warrior TV show, Frank Davis highlights Whole-Food Warriors - ...
(Date:2/5/2016)... ... 05, 2016 , ... The Muscular Dystrophy Association and Sailormen ... the 14th annual “Appetite for a Cure” campaign on Feb. 1 to raise ... related diseases that severely limit strength and mobility. , Now through March ...
(Date:2/5/2016)... ... February 05, 2016 , ... ... George H. Van Allen have signed a joint enrollment and degree completion agreement. ... pathway toward associate and baccalaureate degrees at FHU|Dickson. , The agreement allows ...
(Date:2/5/2016)... ... 2016 , ... US Sports Camps , official operators of Nike Yoga ... kids yoga training. ChildLight Yoga Studio is centrally situated in the picturesque New England ... Yoga Studio founder Lisa Flynn expresses her excitement, “We are thrilled to be partnering ...
Breaking Medicine News(10 mins):