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:2/24/2017)... 2017  Today, exocad America and the Biodenta ... new path to produce 510(K) cleared, in-house milled, ... integrated into exocad DentalCAD software. In order to ... Manufacturing Processes (GMP,s) into their organization, sign up ... an audit process. Then, dental labs can use Biodenta,s ...
    (Date:2/24/2017)... Research and Markets has announced the addition of ... to 2025" report to their offering. ... The Global Empty Capsules Market is poised to grow ... approximately $2.9 billion by 2025. This industry report analyzes ... as well as regional levels presented in the research scope. The study ...
    (Date:2/24/2017)... Feb. 24, 2017  In conjunction with DURECT Corporation,s ... results press release, you are invited to listen to ... the internet on Tuesday, March 14, 2017 at 4:30 ... A live audio webcast of the presentation will be ... and clicking "Investor Relations."  If you are unable to ...
    Breaking Medicine Technology:
    (Date:2/27/2017)... TX (PRWEB) , ... February 27, 2017 , ... ... 75,000 customer threshold mark last week. In addition, Discount Power's RCE (Residential Customer ... Energy LLC in March 2014. The company had 800 customers and 2,250 RCEs ...
    (Date:2/27/2017)... ... February 27, 2017 , ... Silicon Valley Hair ... announce a new informational post on robotic hair transplantation. San Francisco residents may ... transplant and Follicular Unit Transplantation (FUT) can sound similar. Either treatment can be ...
    (Date:2/27/2017)... ... ... New Jersey ranks among the top five states in the entire nation ... advanced services is growing. , Project WE vs C is a focused two-year ... non-profit partners in their fight against cancer and in support of their shared mission ...
    (Date:2/26/2017)... Como, Italy (PRWEB) , ... February 26, 2017 ... ... its last call for entries to the 7th Edition of International Social Design ... by Social Design Professionals, Product Designers, System Designers, Governments and Institutions worldwide with ...
    (Date:2/26/2017)... ... February 26, 2017 , ... NuevaCare, a leading home care agency based in ... Palo Alto, is proud to announce an important upgrade to its geographic information pages, ... care close to home, and by having city-specific pages, NuevaCare is answering that information ...
    Breaking Medicine News(10 mins):