{"id":1518,"date":"2010-05-03T15:28:36","date_gmt":"2010-05-03T19:28:36","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/misinformation-on-fenofibrate-in-the-clinic\/"},"modified":"2011-07-19T17:45:29","modified_gmt":"2011-07-19T21:45:29","slug":"misinformation-on-fenofibrate-in-the-clinic","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/05\/03\/misinformation-on-fenofibrate-in-the-clinic\/","title":{"rendered":"(Mis)Information on Fenofibrate in the Clinic"},"content":{"rendered":"<p>Several days ago, I\u00a0\u2014 a general internist\u00a0\u2014 saw a 70 year old diabetic woman with coronary disease who was stented 3 years ago and has been asymptomatic since then. During our office visit, I noted that a nurse practitioner who does lipid management in\u00a0her cardiologist&#8217;s practice had added fenofibrate to her statin just a week ago. The relevant note stated that: &#8220;on the basis of her Berkeley lipid panel, will add Tricor.&#8221; Her most recent fasting lipids, on 40 mg of atorvastatin daily, were as follows: Total cholesterol 119, LDL 37 (yes, 37!!), HDL 38, and triglycerides 220. <\/p>\n<p>For this statin-treated patient, the study most relevant to adding fenofibrate (Tricor) is the recently published ACCORD Lipid trial (see\u00a0<a href=\"http:\/\/content.nejm.org\/cgi\/content\/short\/362\/17\/1563\">here<\/a> for the article and\u00a0<a href=\"http:\/\/cardioexchange.org\/blogPost?postId=525\">here<\/a> for a CaridoExchange interview with the lead author). I printed out the article for the patient, and we carefully reviewed the results together \u2014 no overall benefit with fenofibrate; significantly worse outcomes with fenofibrate than with placebo among women; and a non-significant trend toward better outcomes with fenofibrate in the subgroup of patients with TG&gt;204 and HDL&lt;34. Although I gave the patient the option to discuss the data further with her cardiologist, she opted to stop the drug\u00a0 at our visit. Understandably, she expressed confusion as to why the drug was prescribed when randomized trial data do not support its use in patients like her. <\/p>\n<p>That very same day, I received an unsolicited e-mail from an organization called \u201cResidual Risk Reduction Initiative\u201d (R3i). Clicking on a link to\u00a0<a href=\"http:\/\/www.r3i.org\/\">R3i&#8217;s website,<\/a> I found commentary on the ACCORD Lipid trial (including a video interview with a study investigator that no longer appears to be available) that highlighted the non-significant subgroup analysis and downplayed the overall results of the trial. I was unable to find information on who funds R3i. <\/p>\n<p>Although neither ACCORD Lipid nor the <a href=\"http:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736%2805%2967667-2\/abstract\">previously published FIELD study <\/a>showed overall benefit for fenofibrate therapy in diabetic patients, fenofibrate enthusiasts (some of\u00a0whom have financial conflicts of interest) point to subgroup analyses, limitations in the trials,\u00a0and favorable changes in surrogate endpoints in order to rationalize expanding use of this drug. But the simple fact is that no decisive evidence exists to support use of fenofibrate\u00a0\u2014 which costs about $1800 per year\u00a0\u2014 in patients like the one presented above. To justify the addition of fenofibrate to statin therapy in diabetic patients, we need a trial with clinical endpoints that focuses squarely on patients with substantially high triglycerides and low HDL levels. <\/p>\n<p>I welcome commentary on two other issues raised by this case:\u00a0<\/p>\n<p>    <strong>What hard evidence exists for using costly Berkeley Heart panels to guide treatment? <\/strong><br \/>\n    <strong>How should general internists like me communicate with cardiologists who institute non-evidence-based treatments for our shared patients?<\/strong> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Several days ago, I\u00a0\u2014 a general internist\u00a0\u2014 saw a 70 year old diabetic woman with coronary disease who was stented 3 years ago and has been asymptomatic since then. During our office visit, I noted that a nurse practitioner who does lipid management in\u00a0her cardiologist&#8217;s practice had added fenofibrate to her statin just a week [&hellip;]<\/p>\n","protected":false},"author":109,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,7],"tags":[],"class_list":["post-1518","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/1518","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\/109"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=1518"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/1518\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=1518"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=1518"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=1518"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}