{"id":38168,"date":"2013-09-05T08:00:56","date_gmt":"2013-09-05T12:00:56","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=voices&p=38168"},"modified":"2013-08-27T16:59:45","modified_gmt":"2013-08-27T20:59:45","slug":"rosiglitazone-revisited","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/09\/05\/rosiglitazone-revisited\/","title":{"rendered":"Rosiglitazone Revisited"},"content":{"rendered":"

CardioExchange\u2019s John Ryan<\/b> interviews Richard G. Bach<\/b> about his study group\u2019s <\/i>observational analysis of data from the BARI 2D trial<\/i><\/a> regarding outcomes associated with rosiglitazone. The article and its <\/i>accompanying editorial<\/i><\/a> are published in <\/i>Circulation.<\/i><\/p>\n

THE STUDY<\/b><\/p>\n

Using 4.5 years of follow-up data from 2368 patients with type 2 diabetes and CAD in the BARI 2D trial, the BARI 2D investigators compared outcomes among participants treated with rosiglitazone versus participants not receiving a thiazolidinedione. In multivariable-adjusted analyses, the two groups were similar in their on-treatment risks for death, for MI, and for congestive heart failure (CHF); the composite incidence of death, MI, or stroke and the incidence of stroke alone were significantly lower among rosiglitazone recipients than among patients who did not receive a thiazolidinedione. In propensity-matched analyses, the two groups were similar in their risks for major ischemic cardiovascular events and CHF.<\/p>\n

THE INTERVIEW<\/b><\/p>\n

Ryan:<\/i><\/b> Clinical trials show an increased risk for MI associated with rosiglitazone use. Your observational study of\u00a0rosiglitazone within the BARI 2D cohort did not show a clear signal of risk. How strong do you consider this evidence? Should this study influence how people think about rosiglitazone\u2019s safety?<\/b><\/p>\n

Bach: <\/i><\/b>The data suggesting an increased risk for MI associated with\u00a0rosiglitazone use came from meta-analyses of randomized trials; many of the trials had small sample sizes, short-term follow-up, and non-adjudicated\u00a0outcomes in low-risk patient populations. Although not a randomized trial of rosiglitazone,\u00a0BARI\u00a02D has several strengths: It was designed to prospectively assess cardiovascular outcomes among patients who may be considered at high risk for cardiovascular harm; it analyzes a\u00a0large number of patient-years of exposure to\u00a0rosiglitazone and a large number of independently adjudicated cardiovascular endpoints;\u00a0and it employed thorough analyses of long-term outcomes, including propensity matching. Bearing in mind that all of the available data have limitations, the results from BARI\u00a02D contribute significant and relevant information that does not suggest harm from rosiglitazone \u2014 information that should be included in any considerations of the drug\u2019s safety.<\/p>\n

Ryan: <\/i><\/b>Has this study changed your prescribing habits?<\/b><\/p>\n

Bach:<\/i><\/b> The results from BARI\u00a02D suggest a lack of cardiovascular hazard, and some analyses even suggest potential cardiovascular benefit from\u00a0rosiglitazone for patients with type 2 diabetes and established CAD. Nevertheless, the prescription of rosiglitazone has been strongly affected by widely publicized\u00a0concerns about the potential for harm (despite the limitations of and uncertainty surrounding the data from previous studies) and by regulatory agencies\u2019 tough restrictions on the drug.\u00a0Given all the available the data, I would feel comfortable prescribing\u00a0rosiglitazone to\u00a0similar patients needing improved\u00a0glycemic control, with suitable counseling regarding the controversy. However, the current obstacles to prescribing\u00a0continue to make that approach difficult, if not entirely impractical.<\/p>\n

Ryan: <\/i><\/b>Please explain how this study evolved. Did\u00a0GlaxoSmithKline fund the analysis? (It\u2019s hard to tell from the listed sources of funding.) Who had the initial idea for the study?<\/b><\/p>\n

Bach:<\/i><\/b> The NIH funded the large majority of the BARI 2D trial. However, GSK provided supplementary funding and rosiglitazone medication that was used to support patient treatment and follow-up in the trial. GSK\u00a0did not provide specific funding for these analyses,\u00a0and the company was not involved in the design, conduct, or write-up of the analyses. The idea for the study originated when a working group of BARI\u00a02D investigators was established to examine the effect of various hypoglycemic medications used in BARI\u00a02D on outcomes.\u00a0The group recognized that\u00a0BARI\u00a02D provided an important dataset where the effect of\u00a0rosiglitazone on prospectively collected and independently adjudicated cardiovascular outcomes could be examined. The goal was to contribute information relevant to\u00a0the controversy and uncertainty about the drug\u2019s cardiovascular safety. From those early discussions,\u00a0an interested\u00a0group of BARI\u00a02D investigators then specifically designed and performed the analyses needed to examine any associations between\u00a0rosiglitazone and cardiovascular outcomes. The results are\u00a0reported in the paper.<\/p>\n

JOIN THE DISCUSSION<\/b><\/p>\n

How do the BARI 2D findings influence your perspective on the safety of rosiglitazone and your willingness to prescribe it?<\/b><\/b><\/p>\n","protected":false},"excerpt":{"rendered":"

Richard G. Bach discusses his study group\u2019s observational analysis of data from the BARI 2D trial regarding outcomes associated with rosiglitazone.<\/p>\n","protected":false},"author":373,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[1939,200,205,1356,469],"class_list":["post-38168","post","type-post","status-publish","format-standard","hentry","category-prevention","tag-bari-2d","tag-diabetes","tag-rosiglitazone","tag-thiazolidinediones","tag-type-2-diabetes"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/38168","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/373"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=38168"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/38168\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=38168"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=38168"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=38168"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}