Rosiglitazone: listings for triple oral therapy and combination with insulin removed

Published in NPS RADAR

Date published: About this date

Clinical content may change after this date. This information is not intended as a substitute for medical advice from a qualified health professional. Health professionals should rely on their own expertise and enquiries when providing medical advice or treatment.

Rosiglitazone (Avandia) is no longer PBS listed for use in combination with metformin and a sulfonylurea (i.e. triple oral therapy) or for use in combination with insulin. Rosiglitazone with metformin combination tablets (Avandamet) are no longer PBS listed for use in combination with a sulfonylurea as part of triple oral therapy. The combination tablets have never been listed for use in combination with insulin.

An updated NPS RADAR review of rosiglitazone is available at www.npsradar.org.au and in the December software updates of Medical Director (MD2) and Genie.

The PBS-listing changes follow safety-related changes to the product information for products containing rosiglitazone. People taking rosiglitazone as part of triple oral therapy or in combination with insulin have an increased risk of heart failure.1,2 Rosiglitazone should no longer be used in any person with heart failure, a history of heart failure, ischaemic heart disease or peripheral vascular disease.

If dual therapy with metformin and a sulfonylurea fails, consider adding insulin, as it reduces the risk of diabetic complications.3 Other third-line oral antidiabetic drugs include pioglitazone, repaglinide (not currently PBS listed), sitagliptin or acarbose; however, the long-term benefit–harm profiles of these drugs are yet to be established. Insulin should not be delayed when oral drug therapy no longer controls blood glucose.

The PBAC reviewed the listing for pioglitazone at its November 2008 meeting in light of the changes to the TGA-approved indications for rosiglitazone.4 The outcome of this review was not publicly known at the time of writing.

References

  1. Cobitz A, Zambanini A, Sowell M, et al. A retrospective evaluation of congestive heart failure and myocardial ischemia events in 14,237 patients with type 2 diabetes mellitus enrolled in 42 short-term, double-blind, randomized clinical studies with rosiglitazone. Pharmacoepidemiol Drug Saf 2008;17:769–81. [PubMed]
  2. Mele J. Statistical Review and Evaluation — Avandia (rosiglitazone), 2007. http://www.fda.gov/ohrms/dockets/AC/07/briefing/2007-4308b1-02-fda-backgrounder.pdf (accessed 27 July 2007).
  3. UKPDS Group. Intensive blood glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes. Lancet 1998;352:837–53. [PubMed]
  4. Pharmaceutical Benefits Advisory Committee. Pharmaceutical Benefits Advisory Committee (PBAC) Meeting Agenda — November 2008 PBAC Meeting. Canberra: Australian Government Department of Health and Ageing, 2008. http://www.health.gov.au/internet/main/publishing.nsf/Content/PBAC-Meeting-Agenda (accessed 20 October 2008).