Rosiglitazone: seeking a balanced approach to avoid panic among patients
A calmer and more considered approach to the safety of rosiglitazone (Avandia) – the GlaxoSmithKline treatment for type 2 diabetes - is needed to avoid unnecessary panic among patients, says an Editorial published early Online today and in an upcoming edition of The Lancet.
The Editorial discusses the sudden anxiety caused by the publication in the New England Journal of Medicine (NEJM) of a systematic review of trials using rosiglitazone. The NEJM analysis suggests that the risk of a heart attack increases by 43% for patients taking rosiglitazone compared to control groups, and the risk of death by heart attack by 64%.
The tone of the NEJM paper is one of urgency, yet GSK has responded by stating it “strongly disagrees” with its conclusions. Who is right?
Of studies to date, the two most reliable to inform decision making are DREAM (published in The Lancet) and ADOPT (published in the NEJM). DREAM, which involved over 5,000 patients, recorded small increases in cardiovascular events compared to controls, which were not statistically significant. ADOPT involved more than 4,000 patients, with the only significant relevant finding an excess of congestive heart failure episodes for rosiglitazone-treated patients compared with glyburide (22 vs 9 events).
When taken together, the Editorial concludes these results could certainly be a matter of concern; but it says that patients, physicians and the US Food and Drug Administration can reasonably await the results of RECORD – a phase III trial specifically designed to analyse cardiovascular events connected to use of rosiglitazone.
The Editorial says: “Until the results of RECORD are in, it would be premature to overinterpret a meta-analysis that the authors and NEJM editorialists all acknowledge contains important weaknesses.”
It concludes: “To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of rosiglitazone is needed.”
Tony Kirby | alfa
The most recent press releases about innovation >>>
Die letzten 5 Focus-News des innovations-reports im Überblick:
University of Maryland researchers contribute to historic detection of gravitational waves and light created by event
On August 17, 2017, at 12:41:04 UTC, scientists made the first direct observation of a merger between two neutron stars--the dense, collapsed cores that remain...
Seven new papers describe the first-ever detection of light from a gravitational wave source. The event, caused by two neutron stars colliding and merging together, was dubbed GW170817 because it sent ripples through space-time that reached Earth on 2017 August 17. Around the world, hundreds of excited astronomers mobilized quickly and were able to observe the event using numerous telescopes, providing a wealth of new data.
Previous detections of gravitational waves have all involved the merger of two black holes, a feat that won the 2017 Nobel Prize in Physics earlier this month....
Material defects in end products can quickly result in failures in many areas of industry, and have a massive impact on the safe use of their products. This is why, in the field of quality assurance, intelligent, nondestructive sensor systems play a key role. They allow testing components and parts in a rapid and cost-efficient manner without destroying the actual product or changing its surface. Experts from the Fraunhofer IZFP in Saarbrücken will be presenting two exhibits at the Blechexpo in Stuttgart from 7–10 November 2017 that allow fast, reliable, and automated characterization of materials and detection of defects (Hall 5, Booth 5306).
When quality testing uses time-consuming destructive test methods, it can result in enormous costs due to damaging or destroying the products. And given that...
Using a new cooling technique MPQ scientists succeed at observing collisions in a dense beam of cold and slow dipolar molecules.
How do chemical reactions proceed at extremely low temperatures? The answer requires the investigation of molecular samples that are cold, dense, and slow at...
Scientists from the Max Planck Institute of Quantum Optics, using high precision laser spectroscopy of atomic hydrogen, confirm the surprisingly small value of the proton radius determined from muonic hydrogen.
It was one of the breakthroughs of the year 2010: Laser spectroscopy of muonic hydrogen resulted in a value for the proton charge radius that was significantly...