{"id":340,"date":"2012-01-01T00:00:38","date_gmt":"2012-01-01T07:00:38","guid":{"rendered":"http:\/\/rhochistj.org\/RCP_TEST\/?p=340"},"modified":"2014-01-30T13:05:19","modified_gmt":"2014-01-30T20:05:19","slug":"fda-approves-edarbyclor","status":"publish","type":"post","link":"https:\/\/rhochistj.org\/RhoChiPost\/fda-approves-edarbyclor\/","title":{"rendered":"FDA Approves Edarbyclor\u00ae"},"content":{"rendered":"<p>By: Gokul Kalla, Pharm.D. Candidate c\/o 2013<\/p>\n<p>&#8211;<\/p>\n<p>Hypertension is a chronic disease that affects one out of every three Americans.\u00a0 Leaving the condition untreated could increase the risk of serious health consequences such as a stroke or a heart attack.\u00a0 On December 21, the FDA approved Takeda Pharmaceuticals\u2019 Edarbyclor<sup>\u00ae<\/sup> (azilsartan medoxomil and chlorthalidone) for the treatment of hypertension in adults.\u00a0 Edarbyclor<sup>\u00ae<\/sup> is a combination of a fixed dose Angiotensin II Receptor Blocker (ARB), azilsartan medoxomil, and a thiazide diuretic, chlorthalidone.<\/p>\n<p>Earlier in 2011, one of the main components of Edarbyclor<sup>\u00ae<\/sup> (azilsartan) was marketed as Edarbi<sup>\u00ae<\/sup>. \u00a0It works by blocking the action of Angiotensin II, a vasopressor hormone in the body that increases blood pressure.\u00a0 As a diuretic, chlorthalidone reduces the body\u2019s fluid volume by increasing urination. \u00a0The combination of these two medications resulted in a greater overall reduction of blood pressure in patients with chronic hypertension and a decrease in hypertension-related complications.<\/p>\n<p>To assess the safety and efficacy of Edarbyclor<sup>\u00ae<\/sup>, a 52-week, 5-phase clinical trial was conducted with 5,000 hypertensive patients.\u00a0 The trial resulted in a lower mean trough systolic blood pressure (SBP) versus azilsartan medoxomil or chlorthalidone alone.\u00a0 In addition, SBP was lower when compared against the highest fixed dose combination of olmesartan medoxomil and hydrochlorothiazide (Benicar-HCT<sup>\u00ae<\/sup>) at its highest approved dose of 40\/25 mg.<\/p>\n<p>Although a \u201cme-too\u201d drug, Edarbyclor<sup>\u00ae<\/sup> is promising for patients who suffer from chronic hypertension.\u00a0 More trials are needed to justify its use over more inexpensive and efficacious alternatives in its class.<\/p>\n<p><b><span style=\"text-decoration: underline;\">SOURCES:<\/span><\/b><\/p>\n<ul>\n<li>Takeda Pharmaceutical Company Limited. FDA Approves EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension. Available online: <a href=\"http:\/\/www.takeda.com\/press\/article_44059.html\" target=\"new\" class=\"external external_icon\">http:\/\/www.takeda.com\/press\/article_44059.html<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>By: Gokul Kalla, Pharm.D. Candidate c\/o 2013 &#8211; Hypertension is a chronic disease that affects one out of every three Americans.\u00a0 Leaving the condition untreated could increase the risk of serious health consequences such as a stroke or a heart attack.\u00a0 On December 21, the FDA approved Takeda Pharmaceuticals\u2019 Edarbyclor\u00ae (azilsartan medoxomil and chlorthalidone) for&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7,5],"tags":[1822,343,113,854,587,22,271,1623,120,102,15,163,13,2227,855,2232,314,20,39,284,2253,560,725,363,559,968,1625,2230,2260,1820,36,148,16,17,1061],"class_list":["post-340","post","type-post","status-publish","format-standard","hentry","category-clinical","category-news-politics","tag-against","tag-and","tag-attack","tag-azilsartan","tag-benicar","tag-blood","tag-chlorthalidone","tag-combination","tag-condition","tag-december","tag-disease","tag-dose","tag-drug","tag-ebola-virus-disease","tag-edarbyclor","tag-fda","tag-for","tag-health","tag-heart","tag-hydrochlorothiazide","tag-hypertension","tag-medoxomil","tag-mg","tag-of","tag-olmesartan","tag-one","tag-or","tag-pharmaceutical","tag-pressure","tag-reduction","tag-risk","tag-stroke","tag-treatment","tag-trial","tag-with"],"views":935,"_links":{"self":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/340","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/comments?post=340"}],"version-history":[{"count":0,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/340\/revisions"}],"wp:attachment":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/media?parent=340"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/categories?post=340"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/tags?post=340"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}