2008-02-14

Major International Diabetes Study Does not Confirm Increased Risk of Death Reported by US Trial


Paris (ots/PRNewswire) -

- Preliminary Findings from the Largest-Ever Study of Treatmentsfor Diabetes Provide no Evidence That Intensive Treatment to LowerBlood Glucose (Sugar) Increases Risk of Death

Interim results from the ADVANCE Study, involving 11,140high-risk patients with type 2 diabetes, provide no evidence of anincreased risk of death among those patients receiving intensivetreatment to lower blood glucose (sugar).

These findings contrast with those reported last week by the USNational Heart Lung and Blood Institute suggesting that intensiveglucose lowering treatment levels had increased the death rate amongpatients with diabetes recruited to the ACCORD trial.

ADVANCE was designed to answer two questions in patients withtype 2 diabetes: first, does intensive treatment to lower bloodpressure improve outcome; and second, does intensive treatment toreduce blood glucose improve outcome.

In September 2007, the ADVANCE Collaborative Group publishedevidence in The Lancet showing that the blood pressure loweringtreatment had reduced the death rate among participants. In January2008, the part of the study designed to assess the effects of theintensive treatment to reduce blood glucose was completed. As inACCORD, this intensive treatment program was designed to lower bloodglucose to levels below those usually recommended by clinicalguidelines.

Chairman of the ADVANCE Data Monitoring and Safety Committee,Professor Rory Collins from the University of Oxford, said "Theinterim results from ADVANCE provide no confirmation of the adversemortality trend reported from the ACCORD study." He also noted thatthe ADVANCE interim results were based on more than twice as muchdata and similar levels of glucose control as in ACCORD. The membersof the Data Monitoring and Safety Committee are the only members ofADVANCE study team with access to the study results.

ADVANCE principal investigator, Professor Stephen MacMahon fromThe George Institute for International Health in Sydney, stated that"Due to the unexpected report from the ACCORD trial, we felt it wasin the public interest for us to ask our Data Monitoring and SafetyCommittee to make a statement as to whether the available data fromADVANCE provide any support for the suggestion that intensive bloodglucose lowering may increase mortality."

In ADVANCE, the intensive blood glucose lowering program aimed toreduce levels of haemoglobin A1c (a marker of long term blood glucosecontrol) to below 6.5%. This treatment regimen included asulfonylurea drug, gliclazide modified release, for all patients anda range of other drugs for those not reaching target blood glucoselevels.

ADVANCE commenced in July 2001 and patients were treated andfollowed-up for an average of five years. The Data Monitoring andSafety Committee, comprising a panel of independent experts in thefield, met every six months to review the study data for any safetyissues or other concerns.

ADVANCE Management Committee Chairman, Professor John Chalmers,commented "Doctors and patients should feel reassured that themortality trend reported by the ACCORD study has not been found inthe interim results from ADVANCE. However, we need to await moredefinitive analyses and reports from both studies before drawingfinal conclusions."

"Final patient visits have been completed, and the ADVANCE studydata base is close to finalisation. We expect to have definitiveresults soon," said Study Director, Dr Anushka Patel, from The GeorgeInstitute. "At this stage, the Data Monitoring and Safety Committeehave reviewed results that are more than 99% complete, so we areconfident that the interim findings communicated here are a reliableguide to the final results."

ADVANCE was conducted by an independent collaborative group ofmedical researchers, with support from the National Health & MedicalResearch Council of Australia and the Paris-based, Institute deRecherche Internationales Servier.

Notes to Editor:

- The George Institute for International Health is aninternationally-recognised health research organisation, undertakinghigh impact research across a broad health landscape. It is a leaderin the clinical trials, health policy and capacity-building areas.

- The National Health & Medical Research Council of Australia isAustralia's peak body for supporting health and medical research; fordeveloping health advice for the Australian community, healthprofessionals and governments; and for providing advice on ethicalbehaviour in health care and in the conduct of health and medicalresearch.

- The Institute de Recherche Internationales Servier is theinternational research funding arm of the French pharmaceuticalcompany, Servier. Servier manufacture modified release gliclazide(Diamicron MR(TM)) and the fixed combination of perindopril andindapamide (registered under the following trade names; Preterax,BiPreterax, Preterax Forte, Biprel, Noliprel, Noliprel Forte,Prelectal, Prelectal forte, Predonium, Noliprel, Coversyl Plus,Coversyl Comp, Coversum Combi, Armix Comb, Prestarium Combi,Prestarium Plus).

- ADVANCE was designed, conducted, monitored, analysed andreported by a collaborative medical research group independently ofall study sponsors.

- Blood pressure treatment comprised a blood pressure loweringtreatment regimen including the ACE inhibitor, perindopril, and thediuretic, indapamide. This treatment was shown to reduce mortality inpatients with diabetes and the results were reported last year in TheLancet.

- Lancet reference: ADVANCE Collaborative Group; Patel A,MacMahon S, Chalmers J, Neal B, Woodward M, Billot L, Harrap S,Poulter N, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, HellerS, Liu L, Mancia G, Mogensen C, Pan C, Rodgers A, Williams B. Effectsof a fixed combination of perindopril and indapamide on macrovascularand microvascular outcomes in patients with type 2 diabetes mellitus(the ADVANCE trial): a randomised controlled trial. Lancet.2007;370:829

http://www.advance-trial.com

http://www.thegeorgeinstitute.org.au

ots Originaltext: Servier LaboratoriesIm Internet recherchierbar: http://www.presseportal.de

$story.getcontactHeadline()For further information, please contact: Leah Baldwin, Tonic Life Communications, Email: leah.baldwin@toniclc.com, Telephone: +44-20-7798-9923; Matthew Foster, Tonic Life Communications, Email: matthew.foster@toniclc.com, Telephone: +44-20-7798-9917

Servier Laboratories

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