In a precautionary statement about two reports published in the Annals of Internal Medicine, the American Association of Clinical Endocrinologists warned that "misinterpretation ... may cause patients to discontinue needed treatment for diabetes."
In a precautionary statement about two reports published in the Annals of Internal Medicine, the American Association of Clinical Endocrinologists warned that "misinterpretation ... may cause patients to discontinue needed treatment for diabetes."
The two case reports each concern a patient who developed liver dysfunction after recently starting treatment with rosiglitazone (Avandia,® manufactured by SmithKline Beecham) to improve the control of diabetes. The patients recovered after discontinuation of rosiglitazone and showed improvement in their other medical conditions.
The Annals of Internal Medicine authors suggest the liver dysfunction was due to hepatotoxicity related to the use of rosiglitazone, but an AACE spokesperson stated that there might be alternative explanations for the findings. The guidelines for liver function testing for all patients receiving this thiazolodenedione or "glitazone" class of medications remain prudent, as the FDA-approved package inserts suggest.
"These reports must be taken in the context of the risk/benefit profile of the glitazones," said Daniel Einhorn, MD, AACE board of directors member. The class includes rosiglitazone, troglitazone (Parke-Davis' Rezulin®) and pioglitazone (Eli Lilly's and Takeda's Actos®). PR
FDA Approves AstraZeneca’s Calquence for Previously Untreated Mantle Cell Lymphoma
January 17th 2025Approval follows results from the Phase III ECHO trial, which demonstrated that Calquence plus chemotherapy reduced the risk of disease progression or death by 27% in patients with previously untreated mantle cell lymphoma.
What Every Pharma CEO Should Know About Unlocking the Potential of Scientific Data
December 11th 2024When integrated into pharmaceutical enterprises, scientific data has the potential to drive organizational growth and innovation. Mikael Hagstroem, CEO at leading laboratory informatics provider LabVantage Solutions, discusses how technology partners add significant value to pharmaceutical R&D, in addition to manufacturing quality.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.