Intervention: 5,565 patients assigned to regimens including rosiglitazone
(doses ranging from 2 mg-8 mg).
In a manner similar to the publication in JAMA of an analysis of the cardiovascular safety of muraglitizar, the analysis of rosiglitazone
was published as an "emergency paper" because of the purported effect size and the potential consequences of this impacting millions of lives around the world.
He suggested that meta-analyses might be less revealing than the results of individual trials, and pointed to three such trials: ADOPT (A Diabetes Outcome Progression Trial) and DREAM (Diabetes Reduction Assessment with Ramipril and Rosiglitazone
Medication), both of which have been completed; and RECORD (Rosiglitazone
Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes), which is ongoing.
Women were randomized to metformin or rosiglitazone
monotherapy for 12 weeks, followed by 12 weeks of combination therapy.
A total of 208 children aged 8-17 years with type 2 diabetes entered a 4-week run-in period, and 200 were randomized to either rosiglitazone
2 mg twice daily or metformin 500 mg twice daily.
in the treatment of HAART-associated lipodystrophy (HAL): A randomized, double-blind, placebo-controlled trial.
If you take pioglitazone or rosiglitazone
, it is important for your health care provider to check your liver enzyme levels regularly.
In differentiating rosiglitazone
from other agents, Harold E.
Concurring with the recommendations of two expert advisory panels in June, the FDA is modifying the cardiovascular safety statement in the labels of rosiglitazone
products, changing the rosiglitazone
Risk Evaluation and Mitigation Strategy (REMS), and releasing the manufacturer from a requirement to conduct a postmarketing safety stud); according to the announcement.
Washington, June 9 ( ANI ): A re-analysis of the data from a pivotal study of rosiglitazone
found no increased risk of cardiovascular events associated with the controversial diabetes drug.
containing products are now indicated only in patients with Type 2 diabetes mellitus for whom all other oral ant diabetic agents in monotherapy or in combination do not result in adequate glycemic control.
Do not initiate rosiglitazone
therapy for patients with diabetes, and consider switching those who are already taking it to pioglitazone.