6th Jun 2007 07:00
GlaxoSmithKline PLC05 June 2007 INTERIM DATA FROM RECORD STUDY SHOW NO SIGNIFICANT DIFFERENCE BETWEEN AVANDIA AND STANDARD THERAPY IN RISK OF CARDIOVASCULAR HOSPITALIZATION OR DEATH "Patients and physicians should find these data reassuring" Philadelphia, PA June 5, 2007 - GlaxoSmithKline (NYSE:GSK) said today thatfindings from an interim analysis of RECORD (Rosiglitazone Evaluated for CardiacOutcomes and Regulation of glycemia in Diabetes), a prospective clinical trialdesigned specifically to determine cardiovascular outcomes in more than 4,400patients with type 2 diabetes, adds further evidence to the overallcardiovascular safety profile of Avandia(R) (rosiglitazone maleate). The studyresults, authored by Philip D. Home and colleagues on the RECORD SteeringCommittee, were published Tuesday in the online edition of The New EnglandJournal of Medicine. The study compares cardiovascular hospitalization and death in patients treatedwith Avandia dual therapy (Avandia plus metformin or sulfonylurea) and inpatients treated with metformin and sulfonylurea in combination. Afterfollowing patients for an average of 3.75 years, the interim analysis found alow number of events overall, and a similar number of events in each group. Thestudy is scheduled to complete in late 2008. Like all interim analyses, these data do not offer final conclusions. Based onthe interim analysis, key findings include: • The interim data show no significant difference between the Avandia andcontrol groups in the key outcomes of hospitalization or death due tocardiovascular events. • There was no difference between the groups in mortality, whethercardiovascular deaths or deaths from all causes. • The interim data show that Avandia was not significantly different than thecontrol groups in several secondary outcomes, including heart attack. • A significant difference between the Avandia and control groups was seenonly in the secondary outcome of congestive heart failure (CHF), wheresignificantly more cases were seen in Avandia patients - consistent with thewell known association between fluid retention and TZDs, the class of medicineto which Avandia belongs. Fluid retention can worsen or lead to CHF.Importantly, despite the increase in CHF, there was no difference between theAvandia group and the control groups in the key outcome of cardiovascularhospitalizations and death. "The interim findings do not show evidence of a significant difference incardiovascular death and heart attack between Avandia and the control groups,and therefore do not confirm the hypothesis generated by the recently publishedmeta-analysis in the New England Journal of Medicine that raised concerns aboutthese events with Avandia," said Moncef Slaoui, chairman, R&D for GSK. "Theyadd to the weight of evidence, from both previously published long-term clinicaltrials and other studies, that the overall ischemic cardiovascular safetyprofile of Avandia is comparable to the traditional anti-diabetes treatments.Patients and physicians should find these data reassuring." Because Avandia has been shown to control blood sugar for longer than othertraditional oral anti-diabetic medicines, it is an important option forphysicians who often need to prescribe a combination of diabetes medicines tohelp their patients maintain blood sugar levels. Professor Home, Vice President, International Diabetes Federation, University ofNewcastle-upon-Tyne, UK, and chairman of the RECORD Steering Committee, saidthat although the study is not expected to be complete until late 2008, thecommittee concluded that an interim analysis should be published as soon aspossible. "Ideally, we would have allowed RECORD to complete before analyzingand releasing the results," Home said. "However, in light of the questionsraised recently about Avandia, we felt it critical that interim data from thisimportant study be made available to physicians and patients immediately so thattreatment decisions may be based on all the available evidence." Richard Nesto, MD, Chairman of the Department of Cardiovascular Medicine at theLahey Clinic Medical Center, said these new findings provide importantinformation for physicians caring for diabetic patients. "Despite itslimitations, the recent meta-analysis in the New England Journal of Medicineraised important questions about the cardiac safety of rosiglitazone. Thesequestions can only be answered with better evidence from clinical trials. Thisinterim analysis of RECORD, a randomized prospective clinical trial, helps toestablish the overall cardiac safety profile of the drug," said Dr. Nesto, whois an author of the American Heart Association and American Diabetes Associationconsensus statement on the use of thiazolidinediones in diabetic patients withheart disease. "Additional clinical trials are underway to specifically addressthis issue, but the data from RECORD should be reassuring for physicians whoneed effective drugs to lower blood sugar levels - the main cornerstone oftreatment for diabetic patients." The RECORD study's robust design and breadth make it uniquely suited to answerquestions about cardiovascular risk with Avandia. First, the study was designed to include a wide range of Type 2 diabetespatients, including those with and without existing cardiovascular disease,making it highly representative of real-world diabetes patients. Second,patients in RECORD were managed such that blood sugar remained within currentguidelines, thereby eliminating a variable that may affect results, asinadequate blood sugar control is itself associated with cardiovascular events.Third, although an open-label design, each cardiovascular event was verified byan independent panel of physicians who did not know which medicines the patientswere taking. Under these rigorous standards, the interim analysis shows that the incidence ofcardiovascular hospitalization and death were comparable for the patients takingthe Avandia combination and the patients taking the metformin-sulfonylureacombination. GSK remains committed to the fight against diabetes. Avandia is an effectivemedicine that is a valuable treatment for millions of patients who are using itto control their diabetes, a disease with potentially devastating consequencesif left unmanaged. GlaxoSmithKline - one of the world's leading research-based pharmaceutical andhealthcare companies - is committed to improving the quality of human life byenabling people to do more, feel better and live longer. For companyinformation, visit GlaxoSmithKline on the World Wide Web at www.gsk.com. Simon BicknellCompany Secretary5th June 2007 Important Safety Information for Avandia(R) (rosiglitazone maleate) Avandia, along with diet and exercise, helps improve blood sugar control. It maybe taken alone or with other diabetes medicines. For some people taking Avandia,possible side effects include heart failure or other heart problems. Furtherinformation regarding potential heart-related risks is currently under review bythe FDA. Talk to your doctor as FDA has made information on potential heart-related risksavailable to physicians on its website at www.fda.gov. Tell your doctor if youhave heart problems or heart failure. Avandia can cause your body to keep extrafluid, which leads to swelling and weight gain. Extra body fluid can make someheart problems worse or lead to heart failure. If you have swelling or fluidretention, shortness of breath or trouble breathing, an unusually rapid increasein weight, or unusual tiredness while taking Avandia, call your doctor rightaway. You should not take Avandia if you have liver problems. Blood tests should beused to check for liver problems before starting and while taking Avandia. Tellyour doctor if you have liver disease, or if you experience unexplainedtiredness, stomach problems, dark urine or yellowing of skin while takingAvandia. Tell your doctor about all of the medicines you are taking. If you are takingAvandia with another diabetes medicine that lowers blood sugar, you may be atincreased risk for low blood sugar. Ask your doctor whether you need to lowerthe dose of your other diabetes medicine. Avandia may increase your risk of pregnancy. Talk to your doctor before takingAvandia if you could become pregnant or if you are pregnant. If you are nursing,you should not take Avandia. Talk to your doctor for advice on how to keep yourbones healthy. More fractures, usually in the upper arm, hand, or foot, havebeen seen in women taking Avandia. Your doctor should check your eyes regularly.Very rarely, some people have experienced vision changes due to swelling in theback of the eye while taking Avandia. Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the U.S. Private Securities LitigationReform Act of 1995, the company cautions investors that any forward-lookingstatements or projections made by the company, including those made in thisAnnouncement, are subject to risks and uncertainties that may cause actualresults to differ materially from those projected. Factors that may affect theGroup's operations are described under 'Risk Factors' in the 'Business Review'in the company's Annual Report on Form 20-F for 2006. InquiriesUS Media inquiries: Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2839 Alice Hunt (215) 751 7709 UK Media inquiries: Phil Thomson (020) 8047 5502 Joss Mathieson (020) 8047 5502 Gwenan White (020) 8047 5502 US Analyst/ Investor inquiries: Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 European Analyst/Investor inquiries: Anita Kidgell (020) 8047 5542 David Mawdsley (020) 8047 5564 Sally Ferguson (020) 8047 5543 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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