Oral administration of the growth hormone secretagogue NN703 in adult patients with growth hormone deficiency
Summary objective Little is known of the usefulness of GH secretagogues (GHSs) in GH‐deficient (GHD) adults. The objective of this study was to determine the number of responders to treatment with NN703 in GHD adults. design A multicentre, randomized, double‐blind, and placebo‐controlled study. pati...
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| Veröffentlicht in: | Clinical endocrinology (Oxford) 2003-05, Vol.58 (5), p.572-580 |
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| creator | Svensson, J. Monson, J. P. Vetter, T. Hansen, T. K. Savine, R. Kann, P. Bex, M. Reincke, M. Hagen, C. Beckers, A. Ilondo, M. M. Zdravkovic, M. Bengtsson, B-Å. Korbonits, M. |
| description | Summary
objective Little is known of the usefulness of GH secretagogues (GHSs) in GH‐deficient (GHD) adults. The objective of this study was to determine the number of responders to treatment with NN703 in GHD adults.
design A multicentre, randomized, double‐blind, and placebo‐controlled study.
patients Ninety‐seven GHD adults were included.
measurements The GH response before and after 1 week of oral treatment with NN703 (n = 83) or placebo (n = 14) was determined. The first and last dose of NN703 was 3 mg/kg, whereas the dose of NN703 was 1·5 mg/kg/day during the 6 days between the first and last doses. Furthermore, all 97 patients received 1 µg/kg GH‐releasing hormone (GHRH) 3 weeks after the last dose of NN703.
results Serum GH peak and area under curve (AUC) values after the first NN703 administration were greater than those after placebo administration (P < 0·05). However, after correction for the lower body mass index (BMI) in the NN703 group, this difference lost statistical significance. After 1 week of therapy, GH peak and AUC values were similar following the final doses of NN703 and placebo. Serum peak and AUC values of other anterior pituitary hormones were similar between the NN703 and placebo groups both after the first and last administration of study drug. Nine of the 83 patients (11%) responded with a serum peak GH concentration ≥ 5 µg/l after the first and/or last NN703 administration, whereas no patient responded after placebo administration. Serum IGF‐I was unaffected by 1‐week NN703 treatment, whereas serum IGFBP‐3 was increased (P |
| doi_str_mv | 10.1046/j.1365-2265.2003.01754.x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_73206596</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>340614321</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4604-fc2ebc73974c5667d13e578d4f959ecaa322490e11d27a55ddb844f95fef9ebd3</originalsourceid><addsrcrecordid>eNqNkU2P0zAQhi0EYkvhLyALCW4J_nZy4ABlWRBLV0KL4Ga5zqR1yUexE7X99zi02pX2xMmW5nlGM_MihCnJKRHq7TanXMmMMSVzRgjPCdVS5IdHaHZXeIxmhBOSEaXEBXoW45YQIguin6ILylRZCl7MUHsTbINt1frOxyHYwfcd7ms8bACvQ78fNnjTh7bvAEdwAQa77tcj4OVSE459l9SxGfAuidANEe99Mh6IFdTepbI7PkdPattEeHF-5-jHp8vbxefs-ubqy-L9deaEIiKrHYOV07zUwkmldEU5SF1Uoi5lCc5azpgoCVBaMW2lrKpVIaZiDXUJq4rP0ZtT313o_4wQB9P66KBpbAf9GI3mjChZqgS-egBu-zF0aTZDy0KXukhrzlFxglzoYwxQm13wrQ1HQ4mZ8jBbM53dTGc3Ux7mXx7mkNSX5_7jqoXqXjwHkIDXZ8BGZ5s62M75eM8JLVhBWeLenbi9b-D43wOYxeVy-iU_O_kpZTjc-Tb8NkpzLc3P5ZX5-PVD8ev7LTff-F_mOLZD</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>198797870</pqid></control><display><type>article</type><title>Oral administration of the growth hormone secretagogue NN703 in adult patients with growth hormone deficiency</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Svensson, J. ; Monson, J. P. ; Vetter, T. ; Hansen, T. K. ; Savine, R. ; Kann, P. ; Bex, M. ; Reincke, M. ; Hagen, C. ; Beckers, A. ; Ilondo, M. M. ; Zdravkovic, M. ; Bengtsson, B-Å. ; Korbonits, M.</creator><creatorcontrib>Svensson, J. ; Monson, J. P. ; Vetter, T. ; Hansen, T. K. ; Savine, R. ; Kann, P. ; Bex, M. ; Reincke, M. ; Hagen, C. ; Beckers, A. ; Ilondo, M. M. ; Zdravkovic, M. ; Bengtsson, B-Å. ; Korbonits, M. ; NN703 Clinical Research Group ; the NN703 Clinical Research Group</creatorcontrib><description>Summary
objective Little is known of the usefulness of GH secretagogues (GHSs) in GH‐deficient (GHD) adults. The objective of this study was to determine the number of responders to treatment with NN703 in GHD adults.
design A multicentre, randomized, double‐blind, and placebo‐controlled study.
patients Ninety‐seven GHD adults were included.
measurements The GH response before and after 1 week of oral treatment with NN703 (n = 83) or placebo (n = 14) was determined. The first and last dose of NN703 was 3 mg/kg, whereas the dose of NN703 was 1·5 mg/kg/day during the 6 days between the first and last doses. Furthermore, all 97 patients received 1 µg/kg GH‐releasing hormone (GHRH) 3 weeks after the last dose of NN703.
results Serum GH peak and area under curve (AUC) values after the first NN703 administration were greater than those after placebo administration (P < 0·05). However, after correction for the lower body mass index (BMI) in the NN703 group, this difference lost statistical significance. After 1 week of therapy, GH peak and AUC values were similar following the final doses of NN703 and placebo. Serum peak and AUC values of other anterior pituitary hormones were similar between the NN703 and placebo groups both after the first and last administration of study drug. Nine of the 83 patients (11%) responded with a serum peak GH concentration ≥ 5 µg/l after the first and/or last NN703 administration, whereas no patient responded after placebo administration. Serum IGF‐I was unaffected by 1‐week NN703 treatment, whereas serum IGFBP‐3 was increased (P < 0·05 vs. placebo) also after correction for BMI. Mean serum peak GH concentration after GHRH administration was 2·1 µg/l (±0·3, SEM), which was higher than that after the first NN703 administration (1·32 ± 0·3, P < 0·05).
conclusion NN703 administration was generally well tolerated. Eleven per cent of the GHD adult patients responded with a peak GH response ≥ 5 µg/l after the first and/or last administration of oral NN703. Although a majority of GHD adults will not respond to NN703, the present results suggest that oral NN703 treatment could be useful in some adult patients with moderately severe GHD. These patients may be identified by a test dose of GHS.</description><identifier>ISSN: 0300-0664</identifier><identifier>EISSN: 1365-2265</identifier><identifier>DOI: 10.1046/j.1365-2265.2003.01754.x</identifier><identifier>PMID: 12699438</identifier><identifier>CODEN: CLECAP</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Science Ltd</publisher><subject>Administration, Oral ; Adult ; Area Under Curve ; Biological and medical sciences ; Blood Pressure - physiology ; Dipeptides - administration & dosage ; Dipeptides - adverse effects ; Double-Blind Method ; Fatty Acids, Nonesterified - blood ; Female ; Hormones. Endocrine system ; Human Growth Hormone - blood ; Human Growth Hormone - deficiency ; Humans ; Insulin-Like Growth Factor Binding Protein 3 - blood ; Insulin-Like Growth Factor I - analysis ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Pituitary Function Tests ; Pituitary Hormones - blood</subject><ispartof>Clinical endocrinology (Oxford), 2003-05, Vol.58 (5), p.572-580</ispartof><rights>2003 INIST-CNRS</rights><rights>Copyright Blackwell Scientific Publications Ltd. May 2003</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4604-fc2ebc73974c5667d13e578d4f959ecaa322490e11d27a55ddb844f95fef9ebd3</citedby><cites>FETCH-LOGICAL-c4604-fc2ebc73974c5667d13e578d4f959ecaa322490e11d27a55ddb844f95fef9ebd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1046%2Fj.1365-2265.2003.01754.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1046%2Fj.1365-2265.2003.01754.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=14742812$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12699438$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Svensson, J.</creatorcontrib><creatorcontrib>Monson, J. P.</creatorcontrib><creatorcontrib>Vetter, T.</creatorcontrib><creatorcontrib>Hansen, T. K.</creatorcontrib><creatorcontrib>Savine, R.</creatorcontrib><creatorcontrib>Kann, P.</creatorcontrib><creatorcontrib>Bex, M.</creatorcontrib><creatorcontrib>Reincke, M.</creatorcontrib><creatorcontrib>Hagen, C.</creatorcontrib><creatorcontrib>Beckers, A.</creatorcontrib><creatorcontrib>Ilondo, M. M.</creatorcontrib><creatorcontrib>Zdravkovic, M.</creatorcontrib><creatorcontrib>Bengtsson, B-Å.</creatorcontrib><creatorcontrib>Korbonits, M.</creatorcontrib><creatorcontrib>NN703 Clinical Research Group</creatorcontrib><creatorcontrib>the NN703 Clinical Research Group</creatorcontrib><title>Oral administration of the growth hormone secretagogue NN703 in adult patients with growth hormone deficiency</title><title>Clinical endocrinology (Oxford)</title><addtitle>Clin Endocrinol (Oxf)</addtitle><description>Summary
objective Little is known of the usefulness of GH secretagogues (GHSs) in GH‐deficient (GHD) adults. The objective of this study was to determine the number of responders to treatment with NN703 in GHD adults.
design A multicentre, randomized, double‐blind, and placebo‐controlled study.
patients Ninety‐seven GHD adults were included.
measurements The GH response before and after 1 week of oral treatment with NN703 (n = 83) or placebo (n = 14) was determined. The first and last dose of NN703 was 3 mg/kg, whereas the dose of NN703 was 1·5 mg/kg/day during the 6 days between the first and last doses. Furthermore, all 97 patients received 1 µg/kg GH‐releasing hormone (GHRH) 3 weeks after the last dose of NN703.
results Serum GH peak and area under curve (AUC) values after the first NN703 administration were greater than those after placebo administration (P < 0·05). However, after correction for the lower body mass index (BMI) in the NN703 group, this difference lost statistical significance. After 1 week of therapy, GH peak and AUC values were similar following the final doses of NN703 and placebo. Serum peak and AUC values of other anterior pituitary hormones were similar between the NN703 and placebo groups both after the first and last administration of study drug. Nine of the 83 patients (11%) responded with a serum peak GH concentration ≥ 5 µg/l after the first and/or last NN703 administration, whereas no patient responded after placebo administration. Serum IGF‐I was unaffected by 1‐week NN703 treatment, whereas serum IGFBP‐3 was increased (P < 0·05 vs. placebo) also after correction for BMI. Mean serum peak GH concentration after GHRH administration was 2·1 µg/l (±0·3, SEM), which was higher than that after the first NN703 administration (1·32 ± 0·3, P < 0·05).
conclusion NN703 administration was generally well tolerated. Eleven per cent of the GHD adult patients responded with a peak GH response ≥ 5 µg/l after the first and/or last administration of oral NN703. Although a majority of GHD adults will not respond to NN703, the present results suggest that oral NN703 treatment could be useful in some adult patients with moderately severe GHD. These patients may be identified by a test dose of GHS.</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Area Under Curve</subject><subject>Biological and medical sciences</subject><subject>Blood Pressure - physiology</subject><subject>Dipeptides - administration & dosage</subject><subject>Dipeptides - adverse effects</subject><subject>Double-Blind Method</subject><subject>Fatty Acids, Nonesterified - blood</subject><subject>Female</subject><subject>Hormones. Endocrine system</subject><subject>Human Growth Hormone - blood</subject><subject>Human Growth Hormone - deficiency</subject><subject>Humans</subject><subject>Insulin-Like Growth Factor Binding Protein 3 - blood</subject><subject>Insulin-Like Growth Factor I - analysis</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. Drug treatments</subject><subject>Pituitary Function Tests</subject><subject>Pituitary Hormones - blood</subject><issn>0300-0664</issn><issn>1365-2265</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkU2P0zAQhi0EYkvhLyALCW4J_nZy4ABlWRBLV0KL4Ga5zqR1yUexE7X99zi02pX2xMmW5nlGM_MihCnJKRHq7TanXMmMMSVzRgjPCdVS5IdHaHZXeIxmhBOSEaXEBXoW45YQIguin6ILylRZCl7MUHsTbINt1frOxyHYwfcd7ms8bACvQ78fNnjTh7bvAEdwAQa77tcj4OVSE459l9SxGfAuidANEe99Mh6IFdTepbI7PkdPattEeHF-5-jHp8vbxefs-ubqy-L9deaEIiKrHYOV07zUwkmldEU5SF1Uoi5lCc5azpgoCVBaMW2lrKpVIaZiDXUJq4rP0ZtT313o_4wQB9P66KBpbAf9GI3mjChZqgS-egBu-zF0aTZDy0KXukhrzlFxglzoYwxQm13wrQ1HQ4mZ8jBbM53dTGc3Ux7mXx7mkNSX5_7jqoXqXjwHkIDXZ8BGZ5s62M75eM8JLVhBWeLenbi9b-D43wOYxeVy-iU_O_kpZTjc-Tb8NkpzLc3P5ZX5-PVD8ev7LTff-F_mOLZD</recordid><startdate>200305</startdate><enddate>200305</enddate><creator>Svensson, J.</creator><creator>Monson, J. P.</creator><creator>Vetter, T.</creator><creator>Hansen, T. K.</creator><creator>Savine, R.</creator><creator>Kann, P.</creator><creator>Bex, M.</creator><creator>Reincke, M.</creator><creator>Hagen, C.</creator><creator>Beckers, A.</creator><creator>Ilondo, M. M.</creator><creator>Zdravkovic, M.</creator><creator>Bengtsson, B-Å.</creator><creator>Korbonits, M.</creator><general>Blackwell Science Ltd</general><general>Blackwell</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>200305</creationdate><title>Oral administration of the growth hormone secretagogue NN703 in adult patients with growth hormone deficiency</title><author>Svensson, J. ; Monson, J. P. ; Vetter, T. ; Hansen, T. K. ; Savine, R. ; Kann, P. ; Bex, M. ; Reincke, M. ; Hagen, C. ; Beckers, A. ; Ilondo, M. M. ; Zdravkovic, M. ; Bengtsson, B-Å. ; Korbonits, M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4604-fc2ebc73974c5667d13e578d4f959ecaa322490e11d27a55ddb844f95fef9ebd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Administration, Oral</topic><topic>Adult</topic><topic>Area Under Curve</topic><topic>Biological and medical sciences</topic><topic>Blood Pressure - physiology</topic><topic>Dipeptides - administration & dosage</topic><topic>Dipeptides - adverse effects</topic><topic>Double-Blind Method</topic><topic>Fatty Acids, Nonesterified - blood</topic><topic>Female</topic><topic>Hormones. Endocrine system</topic><topic>Human Growth Hormone - blood</topic><topic>Human Growth Hormone - deficiency</topic><topic>Humans</topic><topic>Insulin-Like Growth Factor Binding Protein 3 - blood</topic><topic>Insulin-Like Growth Factor I - analysis</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Pituitary Function Tests</topic><topic>Pituitary Hormones - blood</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Svensson, J.</creatorcontrib><creatorcontrib>Monson, J. P.</creatorcontrib><creatorcontrib>Vetter, T.</creatorcontrib><creatorcontrib>Hansen, T. K.</creatorcontrib><creatorcontrib>Savine, R.</creatorcontrib><creatorcontrib>Kann, P.</creatorcontrib><creatorcontrib>Bex, M.</creatorcontrib><creatorcontrib>Reincke, M.</creatorcontrib><creatorcontrib>Hagen, C.</creatorcontrib><creatorcontrib>Beckers, A.</creatorcontrib><creatorcontrib>Ilondo, M. M.</creatorcontrib><creatorcontrib>Zdravkovic, M.</creatorcontrib><creatorcontrib>Bengtsson, B-Å.</creatorcontrib><creatorcontrib>Korbonits, M.</creatorcontrib><creatorcontrib>NN703 Clinical Research Group</creatorcontrib><creatorcontrib>the NN703 Clinical Research Group</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical endocrinology (Oxford)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Svensson, J.</au><au>Monson, J. P.</au><au>Vetter, T.</au><au>Hansen, T. K.</au><au>Savine, R.</au><au>Kann, P.</au><au>Bex, M.</au><au>Reincke, M.</au><au>Hagen, C.</au><au>Beckers, A.</au><au>Ilondo, M. M.</au><au>Zdravkovic, M.</au><au>Bengtsson, B-Å.</au><au>Korbonits, M.</au><aucorp>NN703 Clinical Research Group</aucorp><aucorp>the NN703 Clinical Research Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Oral administration of the growth hormone secretagogue NN703 in adult patients with growth hormone deficiency</atitle><jtitle>Clinical endocrinology (Oxford)</jtitle><addtitle>Clin Endocrinol (Oxf)</addtitle><date>2003-05</date><risdate>2003</risdate><volume>58</volume><issue>5</issue><spage>572</spage><epage>580</epage><pages>572-580</pages><issn>0300-0664</issn><eissn>1365-2265</eissn><coden>CLECAP</coden><abstract>Summary
objective Little is known of the usefulness of GH secretagogues (GHSs) in GH‐deficient (GHD) adults. The objective of this study was to determine the number of responders to treatment with NN703 in GHD adults.
design A multicentre, randomized, double‐blind, and placebo‐controlled study.
patients Ninety‐seven GHD adults were included.
measurements The GH response before and after 1 week of oral treatment with NN703 (n = 83) or placebo (n = 14) was determined. The first and last dose of NN703 was 3 mg/kg, whereas the dose of NN703 was 1·5 mg/kg/day during the 6 days between the first and last doses. Furthermore, all 97 patients received 1 µg/kg GH‐releasing hormone (GHRH) 3 weeks after the last dose of NN703.
results Serum GH peak and area under curve (AUC) values after the first NN703 administration were greater than those after placebo administration (P < 0·05). However, after correction for the lower body mass index (BMI) in the NN703 group, this difference lost statistical significance. After 1 week of therapy, GH peak and AUC values were similar following the final doses of NN703 and placebo. Serum peak and AUC values of other anterior pituitary hormones were similar between the NN703 and placebo groups both after the first and last administration of study drug. Nine of the 83 patients (11%) responded with a serum peak GH concentration ≥ 5 µg/l after the first and/or last NN703 administration, whereas no patient responded after placebo administration. Serum IGF‐I was unaffected by 1‐week NN703 treatment, whereas serum IGFBP‐3 was increased (P < 0·05 vs. placebo) also after correction for BMI. Mean serum peak GH concentration after GHRH administration was 2·1 µg/l (±0·3, SEM), which was higher than that after the first NN703 administration (1·32 ± 0·3, P < 0·05).
conclusion NN703 administration was generally well tolerated. Eleven per cent of the GHD adult patients responded with a peak GH response ≥ 5 µg/l after the first and/or last administration of oral NN703. Although a majority of GHD adults will not respond to NN703, the present results suggest that oral NN703 treatment could be useful in some adult patients with moderately severe GHD. These patients may be identified by a test dose of GHS.</abstract><cop>Oxford, UK</cop><pub>Blackwell Science Ltd</pub><pmid>12699438</pmid><doi>10.1046/j.1365-2265.2003.01754.x</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0300-0664 |
| ispartof | Clinical endocrinology (Oxford), 2003-05, Vol.58 (5), p.572-580 |
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| language | eng |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Administration, Oral Adult Area Under Curve Biological and medical sciences Blood Pressure - physiology Dipeptides - administration & dosage Dipeptides - adverse effects Double-Blind Method Fatty Acids, Nonesterified - blood Female Hormones. Endocrine system Human Growth Hormone - blood Human Growth Hormone - deficiency Humans Insulin-Like Growth Factor Binding Protein 3 - blood Insulin-Like Growth Factor I - analysis Male Medical sciences Middle Aged Pharmacology. Drug treatments Pituitary Function Tests Pituitary Hormones - blood |
| title | Oral administration of the growth hormone secretagogue NN703 in adult patients with growth hormone deficiency |
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