Navigation Links
Study Compares Risk With Two Diabetes Drugs
Date:8/24/2010

DALLAS, Aug. 24 /PRNewswire-USNewswire/ -- In contrast to previous reports, the risks of the composite endpoint of heart attack, heart failure, both, or death were the same – about 4 percent – for patients taking the diabetes drugs rosiglitazone or pioglitazone, according to a study published in the American Heart Association journal Circulation: Cardiovascular Quality and Outcomes.

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

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

"This study provides patients and their doctors with another source of information about rosiglitazone and pioglitazone (sold as Avandia and Actos, respectively) as they determine the best therapy for diabetes patients," said Debra Wertz, Pharm.D., lead author and outcomes research manager at HealthCore, Inc., the research subsidiary of health insurance company WellPoint, Inc.

This study evaluated more than 36,000 diabetes patients. Of the 28,938 patients who were propensity-score matched, a methodology used to provide an estimation of treatment-effects that is as unbiased as possible, 602 patients taking rosiglitazone and 599 taking pioglitazone over a 33-month period suffered either a heart attack, heart failure, both, or died. This translates to about 4 percent of all patients taking either medication. The individual specific adverse events were also not significantly different between the two groups, and were:

  • Heart attack – 96 patients on rosiglitazone and 121 patients on pioglitazone;
  • Heart failure – 265 patients taking rosiglitazone and 243 taking pioglitazone;
  • Heart attack and heart failure – 24 patients on rosiglitazone and 18 on pioglitazone; and
  • Death – 217 patients taking rosiglitazone and 217 taking pioglitazone.

  • The study included 36,628 patients who had submitted insurance claims to WellPoint affiliates for either of the two diabetes medications between 2001 and 2005. Patients' average age was 54, and 58 percent were male. Wertz and her team obtained death records from the National Death Index, a central database administered by the National Center for Health Statistics.

    The investigators divided patients into two equal groups, one receiving rosiglitazone and the other, pioglitazone. After adjusting the data for (removing/minimizing the effect of) age, gender, prior heart and blood vessel diseases and diabetes-related complications and severity indicators, they compared the incidence of heart attack, heart failure and death for an average 14 months of treatment and 19 months of post-treatment follow-up.

    Diabetes is a disease in which the body cannot adequately produce the hormone insulin or uses it improperly. The disease can cause a potentially dangerous buildup of sugar in the blood and also increases the risk of heart and blood vessel diseases, which are the main causes of death for people with diabetes.

    Rosiglitazone, sold under the trade name Avandia by GlaxoSmithKline, and pioglitazone, sold as Actos by Takeda Pharmaceuticals, belong to the same class of drugs, called TZDs or thiazolidinediones. They help the body use insulin more effectively by boosting the body's sensitivity to the hormone and thus help control blood sugar.

    This study has results different from earlier ones that found a greater risk of heart attack among rosiglitazone users compared to patients on other treatments or placebo. In 2007, the Food and Drug Administration decided that the benefits of rosiglitazone outweighed the risks, and it remained on the market although its use decreased significantly. In July 2010, an FDA advisory committee again reviewed numerous studies, including this study, and recommended that rosiglitazone remain on the market, although with additional warnings or restrictions. The FDA has not yet ruled on this latest recommendation.

    "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 said. The study also followed patients for a longer period of time than some of the earlier research, according to the investigators.

    "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," said Mark J. Cziraky, Pharm.D., study co-author, and vice president of research development and operations at HealthCore. "We did not find that with the approach and methods we took within this population."

    Other co-authors are Chun-Lan Chang, Ph.D.; Chaitanya A Sarawate, M.S.; Vincent J. Willey, Pharm.D.; and Rhonda L. Bohn, M.P.H., Sc.D.

    Author disclosures are on the manuscript. WellPoint, Inc. funded this research.

    An accompanying editorial, "Improving Surveillance for Drug Safety: Lessons from Rosiglitazone," by Frederick A Masoudi, M.D., M.S.P.H., is available.Statements and conclusions of study authors published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association's policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at http://www.americanheart.org/corporatefunding. NR10 – 1112 (Circ Outcomes/Wertz)

    Additional media resources:

  • Link to public comment on FDA advisory committee recommendation: http://www.newsroom.heart.org/index.php?s=43&item=1081
  • 2010 AHA/ACC science advisory on diabetes drugs and heart risk: http://www.newsroom.heart.org/index.php?s=43&item=970
  • The American Heart Associaton's Diabetes Site

  • CONTACT: For journal copies only,please call: (214) 706-1396For other information, contact:Tagni McRae: (214) 706-1383, tagni.mcrae@heart.orgBridgette McNeill: (214) 706-1135, bridgette.mcneill@heart.orgJulie Del Barto (broadcast): (214) 706-1330, julie.delbarto@heart.org
    '/>"/>

    SOURCE American Heart Association
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
    2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
    3. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
    4. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
    5. Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor
    6. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
    7. Study Suggests High-Dose Fish Oil May Significantly Improve Behavior in Children with ADHD
    8. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
    9. Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
    10. MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus
    11. Sarasotas Roskamp Institute Releases Study Defining a Mechanism for Development of Obesity and the Metabolic Syndrome, Forerunners of Type 2 Diabetes
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:6/23/2016)... 2016 Research and Markets has announced ... Analysis 2016 - Forecast to 2022" report to their ... contains up to date financial data derived from varied research ... trends with potential impact on the market during the next ... which comprises of sub markets, regional and country level analysis. ...
    (Date:6/23/2016)... and INDIANAPOLIS , June 23, ... a Lilly Diabetes Tomorrow,s Leaders Scholarship is any indication, ... winners, announced today online at www.diabetesscholars.org by ... 1 diabetes stand in the way of academic and ... the Foundation,s scholarship program since 2012, and continues to ...
    (Date:6/23/2016)... Research and Markets has announced the addition ... States, China, Japan, Brazil, United Kingdom, Germany, France, Italy, ... Surgical Procedure Volumes: Global ... surgical procedure volume data in a geographic context. The ... of growth drivers and inhibitors, including world population growth, ...
    Breaking Medicine Technology:
    (Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out ... family verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers ... would throw rocks at my other children and say he was going to kill them. ...
    (Date:6/24/2016)... ... June 24, 2016 , ... ... micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas ... , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct ...
    (Date:6/24/2016)... ... 2016 , ... People across the U.S. are sharpening their pencils and honing ... contest in which patients and their families pay tribute to a genetic counselor by ... Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In ...
    (Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative Solutions ... initiated cultivation and processing operations at its production facility, and opened its first ... is the manufacturer of a complete system of proactive air and surface purification ...
    (Date:6/24/2016)... ... 2016 , ... Venture Construction Group (VCG) sponsors Luke’s Wings ... at the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. The ... members that have been wounded in battle and their families. Venture Construction Group is ...
    Breaking Medicine News(10 mins):