{"id":371183,"date":"2024-02-02T00:01:00","date_gmt":"2024-02-01T23:01:00","guid":{"rendered":"https:\/\/medizinonline.com\/?p=371183"},"modified":"2024-01-24T17:31:38","modified_gmt":"2024-01-24T16:31:38","slug":"semaglutide-in-oral-form-convinces-in-everyday-practice","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/en\/semaglutide-in-oral-form-convinces-in-everyday-practice\/","title":{"rendered":"Semaglutide in oral form convinces in everyday practice"},"content":{"rendered":"\n<p><strong>In the non-interventional PIONEER REAL Switzerland study, adult type 2 diabetics treated with oral semaglutide as part of routine clinical care achieved clinically significant improvement in glycemic control with no new safety signals. The results were presented at the SGED Annual Meeting and underpin the promising results of the clinical approval studies.<\/strong><\/p>\n\n<!--more-->\n\n<p>Semaglutide has also been on the market in Switzerland for the treatment of type 2 diabetes (T2D) in oral form since 2020 \u2013 under the trade name Rybelsus\u00ae [1]. Like other glucagon-like peptide-1 receptor agonists (GLP-1-RA), semaglutide binds to the GLP-1 receptor, thereby promoting insulin secretion and inhibiting glucagon secretion. The Phase III PIONEER trial program was very successful. One of the main studies showed that Rybelsus\u00ae not only improves metabolic control and reduces body weight, but also results in fewer heart attacks and even fewer deaths[1,2]. The aim of the international Phase IV study PIONEER REAL is to systematically observe how the drug works and is tolerated under everyday conditions [2].  <\/p>\n\n<h3 id=\"multicenter-real-world-study\" class=\"wp-block-heading\">Multicenter real-world study<\/h3>\n\n<p>PIONEER REAL Switzerland is part of a study project conducted in 13 countries &#8211; it is a 34-44-week single-arm, prospective open-label multicenter study in adults with T2D. Participants were treatment-naive to glucose-lowering injection therapies at baseline and received semaglutide in oral form once daily as part of their usual routine care [3]. In addition to changes in HbA<sub>1c<\/sub> (primary endpoint) and body weight (secondary endpoint), the proportion of patients who achieved HbA<sub>1c<\/sub> &lt;7% and\/or a composite endpoint of an HbA<sub>1c<\/sub> reduction \u22651% accompanied by a reduction in body weight (BW) \u22653% or \u22655% at the end of the study was recorded. <\/p>\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><a href=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58.png\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1458\" height=\"1205\" src=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58.png\" alt=\"\" class=\"wp-image-371008\" style=\"width:500px\" srcset=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58.png 1458w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-800x661.png 800w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-1160x959.png 1160w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-120x99.png 120w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-90x74.png 90w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-320x264.png 320w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-560x463.png 560w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-240x198.png 240w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-180x149.png 180w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-640x529.png 640w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-1120x926.png 1120w\" sizes=\"(max-width: 1458px) 100vw, 1458px\" \/><\/a><\/figure>\n<\/div>\n<h3 id=\"important-results-at-a-glance\" class=\"wp-block-heading\">Important results at a glance  <\/h3>\n\n<p>Of the 185 participants included, 90.8% completed the study and 77.3% remained on semaglutide therapy until the end of the study [3]. At baseline, the average age was 62 (SD 10.4) years, the <sub>HbA1c<\/sub> value was 7.7% (SD 1.5%) and the body weight was 95.6 kg (SD 17.6 kg). The mean BMI was documented as 33.2 <sup>kg\/m2<\/sup> (4.8 <sup>kg\/m2<\/sup>). 56.2% of the participants received other glucose-lowering medication at the same time.  <\/p>\n\n<p class=\"has-small-font-size\"><em>** SD = standard deviation<\/em><br\/>KI=confidence interval<\/p>\n\n<p>The estimated mean changes from baseline to the end of the study were as follows [3]:  <\/p>\n\n<ul class=\"wp-block-list\">\n<li><sub>HbA1c<\/sub><em>values<\/em>: change of -0.9% (95% CI: -1.1; -0.7, p&lt;0.0001)  <\/li>\n\n\n\n<li><em>Absolute body weight<\/em>: change of 4.7 kg (95% CI: -5.6; -3.8, p&lt;0.0001)  <\/li>\n\n\n\n<li><em>Relative body weight<\/em>: reduction of -4.9% (95% CI: -5.7; -4.0, both p&lt;0.0001)  <\/li>\n\n\n\n<li>At the end of the study, 64.2% of the participants had an HbA1c <sub>value<\/sub> &lt;7% and 37.8% and 28.3% achieved the composite endpoint of an <sub>HbA1c<\/sub> reduction \u22651% plus a KG reduction \u22653% and \u22655% respectively.  <\/li>\n<\/ul>\n\n<p>A total of 139 <em>adverse events<\/em> (AEs) were reported in 65 participants (35.1%) [3]. Most were mild or moderate, with gastrointestinal disorders being the most common (89 events in 50 participants). 31 AEs in 20 (10.8%) participants led to discontinuation of oral semaglutide. A total of six serious AEs were reported, which were probably not related to Semaglutide treatment.<\/p>\n\n<p><em>Source: Novo Nordisk<\/em><\/p>\n\n<p>Literature:<\/p>\n\n<ol class=\"wp-block-list\">\n<li>Swissmedic: Arzneimittelinformation,<br\/><a href=\"http:\/\/www.swissmedicinfo.ch\" target=\"_blank\" rel=\"noopener\">www.swissmedicinfo.ch, <\/a>(last accessed 11\/21\/2023) <\/li>\n\n\n\n<li>Husain M, et al.: PIONEER 6 Investigators. Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. NEJM 2019; 381(9): 841\u2013851. <\/li>\n\n\n\n<li>Kick A, et al.: Real-world use of oral semaglutide in adults with type 2 diabetes: Results from the PIONEER REAL Switzerland multicenter, prospective, observational study. Abstractband, Annual Meeting SGED\/SSED, 16. \u201317.11.2023.<\/li>\n<\/ol>\n\n<p><\/p>\n\n<p class=\"has-small-font-size\"><em>CARDIOVASC 2023; 22(4): 58<\/em><br\/><em>HAUSARZT PRAXIS 2023: 18(12): 37<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the non-interventional PIONEER REAL Switzerland study, adult type 2 diabetics treated with oral semaglutide as part of routine clinical care achieved clinically significant improvement in glycemic control with no&hellip;<\/p>\n","protected":false},"author":7,"featured_media":371184,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":"","cat_1_feature_home_top":false,"cat_2_editor_pick":false,"csco_eyebrow_text":"Type 2 diabetes: PIONEER REAL Switzerland study  ","footnotes":""},"category":[11513,11508,11384,11530,11548,11503],"tags":[73044,15896,73041,73040,73042,17444,73043,12042],"powerkit_post_featured":[],"class_list":["post-371183","post","type-post","status-publish","format-standard","has-post-thumbnail","category-congress-reports","category-education","category-endocrinology-and-diabetology","category-market-medicine","category-rx-en","category-studies","tag-form-of-administration","tag-glycemic-control","tag-oral-semaglutide","tag-pioneer-real-en","tag-rybelsus-en","tag-semaglutide-en-2","tag-swiss-society-for-endocrinology-and-diabetology","tag-type-2-diabetes","pmpro-has-access"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-05-17 15:33:35","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"wpml_current_locale":"en_US","wpml_translations":{"fr_FR":{"locale":"fr_FR","id":371186,"slug":"le-semaglutide-en-administration-orale-convainc-dans-la-pratique-quotidienne","post_title":"Le semaglutide en administration orale convainc dans la pratique quotidienne","href":"https:\/\/medizinonline.com\/fr\/le-semaglutide-en-administration-orale-convainc-dans-la-pratique-quotidienne\/"},"it_IT":{"locale":"it_IT","id":371189,"slug":"la-semaglutide-in-forma-orale-convince-nella-pratica-quotidiana","post_title":"La semaglutide in forma orale convince nella pratica quotidiana","href":"https:\/\/medizinonline.com\/it\/la-semaglutide-in-forma-orale-convince-nella-pratica-quotidiana\/"},"pt_PT":{"locale":"pt_PT","id":371192,"slug":"o-semaglutido-na-forma-oral-convence-na-pratica-quotidiana","post_title":"O semaglutido na forma oral convence na pr\u00e1tica quotidiana","href":"https:\/\/medizinonline.com\/pt-pt\/o-semaglutido-na-forma-oral-convence-na-pratica-quotidiana\/"},"es_ES":{"locale":"es_ES","id":371195,"slug":"la-semaglutida-en-forma-oral-convence-en-la-practica-diaria","post_title":"La semaglutida en forma oral convence en la pr\u00e1ctica diaria","href":"https:\/\/medizinonline.com\/es\/la-semaglutida-en-forma-oral-convence-en-la-practica-diaria\/"}},"_links":{"self":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/371183","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/comments?post=371183"}],"version-history":[{"count":3,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/371183\/revisions"}],"predecessor-version":[{"id":374295,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/371183\/revisions\/374295"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media\/371184"}],"wp:attachment":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media?parent=371183"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/category?post=371183"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/tags?post=371183"},{"taxonomy":"powerkit_post_featured","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/powerkit_post_featured?post=371183"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}