Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide
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Auteurs : William B. White [États-Unis] ; Martin G. Myers [Canada] ; Robert Jordan [États-Unis] ; Johna Lucas [États-Unis]Source :
- Journal of Hypertension [ 0263-6352 ] ; 2016.
Abstract
Supplemental Digital Content is available in the text
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DOI: 10.1097/HJH.0000000000001221
PubMed: 27977473
PubMed Central: 5338879
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<front><journal-meta><journal-id journal-id-type="nlm-ta">J Hypertens</journal-id><journal-id journal-id-type="iso-abbrev">J. Hypertens</journal-id><journal-id journal-id-type="publisher-id">JHYPE</journal-id><journal-title-group><journal-title>Journal of Hypertension</journal-title></journal-title-group><issn pub-type="ppub">0263-6352</issn><issn pub-type="epub">1473-5598</issn><publisher><publisher-name>Lippincott Williams & Wilkins</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">27977473</article-id><article-id pub-id-type="pmc">5338879</article-id><article-id pub-id-type="publisher-id">JH-D-16-00823</article-id><article-id pub-id-type="doi">10.1097/HJH.0000000000001221</article-id><article-categories><subj-group subj-group-type="heading"><subject>ORIGINAL PAPERS: BP measurement</subject></subj-group></article-categories><title-group><article-title>Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>White</surname><given-names>William B.</given-names></name><xref ref-type="aff" rid="aff1"><sup>a</sup></xref></contrib><contrib contrib-type="author"><name><surname>Myers</surname><given-names>Martin G.</given-names></name><xref ref-type="aff" rid="aff2"><sup>b</sup></xref></contrib><contrib contrib-type="author"><name><surname>Jordan</surname><given-names>Robert</given-names></name><xref ref-type="aff" rid="aff3"><sup>c</sup></xref></contrib><contrib contrib-type="author"><name><surname>Lucas</surname><given-names>Johna</given-names></name><xref ref-type="aff" rid="aff3"><sup>c</sup></xref></contrib></contrib-group><aff id="aff1"><label>a</label>Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, Connecticut, USA</aff><aff id="aff2"><label>b</label>Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada</aff><aff id="aff3"><label>c</label>Palatin Technologies, Inc., Cranbury, New Jersey, USA</aff><author-notes><corresp>Correspondence to William B. White, MD, Professor and Division Chief, Hypertension and Clinical Pharmacology, Calhoun Cardiology Center, University of Connecticut School of Medicine, 263 Farmington Avenue, Farmington, CT 06032, USA. Tel: +1 860 679 2104; fax: +1 860 679 1250; e-mail: <email>wwhite@uchc.edu</email></corresp></author-notes><pub-date pub-type="ppub"><month>4</month><year>2017</year></pub-date><pub-date pub-type="epub"><day>12</day><month>12</month><year>2016</year></pub-date><volume>35</volume><issue>4</issue><fpage>761</fpage><lpage>768</lpage><history><date date-type="received"><day>26</day><month>8</month><year>2016</year></date><date date-type="rev-recd"><day>28</day><month>10</month><year>2016</year></date><date date-type="accepted"><day>21</day><month>11</month><year>2016</year></date></history><permissions><copyright-statement>Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc.</copyright-statement><copyright-year>2017</copyright-year><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0"><license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBYNC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0">http://creativecommons.org/licenses/by-nc-nd/4.0</ext-link></license-p></license></permissions><self-uri xlink:type="simple" xlink:href="jhype-35-761.pdf"></self-uri><abstract abstract-type="toc"><p>Supplemental Digital Content is available in the text</p></abstract><abstract><sec sec-type="background"><title>Background:</title><p>Melanocortin receptor agonists that bind to the melanocortin receptor 4 may cause increases in blood pressure (BP). Bremelanotide is an on-demand, subcutaneous melanocortin-receptor agonist that binds to the melanocortin receptor 4 and is being developed for the treatment of female sexual dysfunction.</p></sec><sec sec-type="methods"><title>Methods:</title><p>We studied the effects of bremelanotide administration on ambulatory BP and heart rate (HR), in a randomized, double-blind, placebo-controlled, and parallel-arm trial of three doses of bremelanotide (0.75, 1.25, and 1.75 mg) in 397 premenopausal women with female sexual dysfunction with normotension or controlled hypertension. Pharmacokinetic exposure was assessed in conjunction with ambulatory BP measurements.</p></sec><sec sec-type="results"><title>Results:</title><p>Increases in ambulatory SBP relative to placebo of 2.4 and 3.0 mmHg (1.25 mg; <italic>P</italic> values: 0.029 and 0.076) and 3.1 and 3.2 mmHg (1.75 mg; <italic>P</italic> values: 0.006 and 0.027), respectively, occurred following two doses, separated by 24 h at the 0 to 4-h postdose interval; peak increases typically lasted less than 15 min. Similar increases in the DBP were observed. Increases in BP were accompanied by reductions in HR during the 0–4-h interval for the 1.75-mg dose (−4.6 to −4.7 bpm; <italic>P</italic> < 0.001). Twenty-six participants discontinued after randomization due to prespecified increases in BP but the proportions were similar among the four treatment groups.</p></sec><sec sec-type="conclusion"><title>Conclusion:</title><p>These data show that ambulatory monitoring was a useful methodology to detect small, transient increases in ambulatory BP accompanied by reductions in HR following bremelanotide. Results of this trial led to appropriate in-clinic BP monitoring during the larger clinical development trials of this agent for female sexual dysfunction.</p></sec></abstract><kwd-group><title>Keywords</title><kwd>ambulatory blood pressure</kwd><kwd>bremelanotide</kwd><kwd>female sexual dysfunction</kwd><kwd>melanocortin agonists</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>OPEN-ACCESS</meta-name><meta-value>TRUE</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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