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:12/5/2016)... and BOCA RATON, Fla. , ... for the Commercialization of Public Research (the ... a funding agreement SegAna, LLC, an ... University of Central Florida. The Florida Institute supports ... bridges early funding gaps for companies spinning out ...
(Date:12/5/2016)... , Dec. 5, 2016  Breckenridge Pharmaceutical, Inc. ... multi-product marketing agreement with development and manufacturing partner ... Under the terms of this agreement, Breckenridge will ... in the United States . ... tentatively-approved ANDA. The products cover a wide range ...
(Date:12/5/2016)... , Dec. 5, 2016  Sharn Anesthesia Inc. ... anesthesia sales and distribution partner for Salter Labs.  The ... the Year in recognition of outstanding sales performance. ... for respiratory and anesthesia care, including the market gold ... also the master distributor of the Parker Flex-Tip® Endotracheal ...
Breaking Medicine Technology:
(Date:12/6/2016)... ... December 06, 2016 , ... The Behavioral Health Center of ... the organization as a top behavioral service provider in the country. The award ... staff satisfaction and qualifications, and consumer satisfaction. These areas are measured via a ...
(Date:12/6/2016)... ... 2016 , ... Gateway Analytical, one of the world’s most ... sizing services for USP 788 and 789 particulate standards compliance. The new service ... to the needs of pharmaceutical and medical device manufacturers, who are required to ...
(Date:12/6/2016)... ... December 06, 2016 , ... ... when SevenPoint2 released the much-anticipated HydroFX for Water®. This first-of-its-kind water-soluble powder ... one of the world’s most powerful antioxidants, molecular hydrogen, HydroFX for Water ...
(Date:12/6/2016)... ... December 06, 2016 , ... Specialty Technical Publishers (STP) ... Audit Protocol Consortium (IAPC) EHS audit protocol for Great Britain . Leading ... of their EHS regulatory obligations and rapidly collect, share, archive, and export audit ...
(Date:12/6/2016)... ... 06, 2016 , ... U.S. Security Associates (USA) was named ... their industry leading training methods that engage their associates and link their achievements ... elite in employer-sponsored training and development programs. , “The 2017 Training Top 125 ...
Breaking Medicine News(10 mins):