High-Dose and High-Frequency Lanreotide Autogel in Acromegaly: A Randomized, Multicenter Study
Abstract Context: Increase in drug frequency or dose is recommended for acromegaly patients with partial response to long-acting somatostatin receptor ligands (SRLs). However, the efficacy and safety data with lanreotide (LAN) Autogel (LAN-ATG) at high dose (HD) or high frequency (HF) are still scan...
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| Veröffentlicht in: | The journal of clinical endocrinology and metabolism 2017-07, Vol.102 (7), p.2454-2464 |
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| creator | Giustina, Andrea Mazziotti, Gherardo Cannavò, Salvatore Castello, Roberto Arnaldi, Giorgio Bugari, Giovanna Cozzi, Renato Ferone, Diego Formenti, Anna Maria Gatti, Enza Grottoli, Silvia Maffei, Pietro Maffezzoni, Filippo Montini, Marcella Terzolo, Massimo Ghigo, Ezio |
| description | Abstract
Context:
Increase in drug frequency or dose is recommended for acromegaly patients with partial response to long-acting somatostatin receptor ligands (SRLs). However, the efficacy and safety data with lanreotide (LAN) Autogel (LAN-ATG) at high dose (HD) or high frequency (HF) are still scanty.
Objective:
To evaluate the biochemical efficacy and safety of HF and HD LAN-ATG in patients with active acromegaly.
Design:
Twenty-four–week prospective, multicenter, randomized, open-label trial.
Patients and Interventions:
Thirty patients with active acromegaly, partial responders to SRLs, were randomized to HF (120 mg/21 days; 15 patients) or HD (180 mg/28 days; 15 patients) LAN-ATG.
Outcomes:
Normalization of serum insulin-like growth factor-I (IGF-I) and reduction in random growth hormone (GH) values < 1.0 µg/L, reduction in serum IGF-I and GH from baseline, differences in biochemical response between HF and HD LAN-ATG, adverse events.
Results:
IGF-I decreased significantly (P = 0.007) during the 24-week treatment, with greater decrease in HD (P = 0.03) vs HF group (P = 0.08). Normalization in IGF-I values occurred in 27.6% of patients (P = 0.016 vs baseline), without a significant difference between HF and HD groups (P = 0.59). The decrease in serum IGF-I significantly correlated with serum LAN values (P = 0.04), and normalization of IGF-I was predicted by baseline IGF-I values (P = 0.02). Serum GH values did not change significantly (P = 0.22). Overall, 19 patients (63.3%) experienced adverse events, all being mild to moderate and transient, without differences between the two therapeutic arms.
Conclusion:
HF and HD LAN-ATG regimens are effective in normalizing IGF-I values in about one-third of patients with active acromegaly inadequately controlled by long-term conventional SRLs therapy.
This randomized study investigated the efficacy and safety of LANT-ATG at high doses or high frequency in patients with acromegaly partially controlled by SRLs at conventional regimens. |
| doi_str_mv | 10.1210/jc.2017-00142 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1889782783</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1210/jc.2017-00142</oup_id><sourcerecordid>1970003216</sourcerecordid><originalsourceid>FETCH-LOGICAL-c393t-7ce38193efcdbb827b8ef46510d3261cef2c9c0d9b6252fc8fa4b2ddde65dc563</originalsourceid><addsrcrecordid>eNp1kUtLw0AURgdRbK0u3cqAGxdG55Gnu1KtFSqCD3DlkMzc1JQkU2eSRfz1TtqqILgaLpz78d0zCB1TckEZJZdLecEIjTxCqM920JAmfuBFNIl20ZAQRr0kYq8DdGDtskf8gO-jAYt9mnAaDdHbrFi8e9faAk5rhdfT1MBHC7Xs8DytDeimUIDHbaMXUOKixmNpdAWLtOyu8Bg_uj1dFZ-gzvF9WzaFhLoBg5-aVnWHaC9PSwtH23eEXqY3z5OZN3-4vZuM557kCW-8SAKPXSPIpcqymEVZDLkfBpQozkIqIWcykUQlWcgClss4T_2MKaUgDJQMQj5CZ5vcldGuu21EVVgJZZnWoFsraBwnkcuNuUNP_6BL3ZratRPOGiGEM9oHehvK3WqtgVysTFGlphOUiF68WErRixdr8Y4_2aa2WQXqh_42_dtQt6v_sjafyL8AfJ2J2w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1970003216</pqid></control><display><type>article</type><title>High-Dose and High-Frequency Lanreotide Autogel in Acromegaly: A Randomized, Multicenter Study</title><source>Oxford University Press Journals All Titles (1996-Current)</source><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><source>Journals@Ovid Complete</source><source>ProQuest Central</source><creator>Giustina, Andrea ; Mazziotti, Gherardo ; Cannavò, Salvatore ; Castello, Roberto ; Arnaldi, Giorgio ; Bugari, Giovanna ; Cozzi, Renato ; Ferone, Diego ; Formenti, Anna Maria ; Gatti, Enza ; Grottoli, Silvia ; Maffei, Pietro ; Maffezzoni, Filippo ; Montini, Marcella ; Terzolo, Massimo ; Ghigo, Ezio</creator><creatorcontrib>Giustina, Andrea ; Mazziotti, Gherardo ; Cannavò, Salvatore ; Castello, Roberto ; Arnaldi, Giorgio ; Bugari, Giovanna ; Cozzi, Renato ; Ferone, Diego ; Formenti, Anna Maria ; Gatti, Enza ; Grottoli, Silvia ; Maffei, Pietro ; Maffezzoni, Filippo ; Montini, Marcella ; Terzolo, Massimo ; Ghigo, Ezio</creatorcontrib><description>Abstract
Context:
Increase in drug frequency or dose is recommended for acromegaly patients with partial response to long-acting somatostatin receptor ligands (SRLs). However, the efficacy and safety data with lanreotide (LAN) Autogel (LAN-ATG) at high dose (HD) or high frequency (HF) are still scanty.
Objective:
To evaluate the biochemical efficacy and safety of HF and HD LAN-ATG in patients with active acromegaly.
Design:
Twenty-four–week prospective, multicenter, randomized, open-label trial.
Patients and Interventions:
Thirty patients with active acromegaly, partial responders to SRLs, were randomized to HF (120 mg/21 days; 15 patients) or HD (180 mg/28 days; 15 patients) LAN-ATG.
Outcomes:
Normalization of serum insulin-like growth factor-I (IGF-I) and reduction in random growth hormone (GH) values < 1.0 µg/L, reduction in serum IGF-I and GH from baseline, differences in biochemical response between HF and HD LAN-ATG, adverse events.
Results:
IGF-I decreased significantly (P = 0.007) during the 24-week treatment, with greater decrease in HD (P = 0.03) vs HF group (P = 0.08). Normalization in IGF-I values occurred in 27.6% of patients (P = 0.016 vs baseline), without a significant difference between HF and HD groups (P = 0.59). The decrease in serum IGF-I significantly correlated with serum LAN values (P = 0.04), and normalization of IGF-I was predicted by baseline IGF-I values (P = 0.02). Serum GH values did not change significantly (P = 0.22). Overall, 19 patients (63.3%) experienced adverse events, all being mild to moderate and transient, without differences between the two therapeutic arms.
Conclusion:
HF and HD LAN-ATG regimens are effective in normalizing IGF-I values in about one-third of patients with active acromegaly inadequately controlled by long-term conventional SRLs therapy.
This randomized study investigated the efficacy and safety of LANT-ATG at high doses or high frequency in patients with acromegaly partially controlled by SRLs at conventional regimens.</description><identifier>ISSN: 0021-972X</identifier><identifier>EISSN: 1945-7197</identifier><identifier>DOI: 10.1210/jc.2017-00142</identifier><identifier>PMID: 28419317</identifier><language>eng</language><publisher>Washington, DC: Endocrine Society</publisher><subject><![CDATA[Acromegaly ; Acromegaly - diagnostic imaging ; Acromegaly - drug therapy ; Adult ; Aged ; Confidence Intervals ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Follow-Up Studies ; Growth hormones ; Human Growth Hormone - administration & dosage ; Human Growth Hormone - analogs & derivatives ; Humans ; Injections, Subcutaneous ; Insulin ; Insulin-like growth factor I ; Insulin-Like Growth Factor I - drug effects ; Insulin-Like Growth Factor I - metabolism ; Insulin-like growth factors ; Italy ; Magnetic Resonance Imaging - methods ; Male ; Maximum Tolerated Dose ; Middle Aged ; Octreotide - administration & dosage ; Odds Ratio ; Peptides, Cyclic - administration & dosage ; Physical growth ; Prospective Studies ; Randomization ; Safety ; Severity of Illness Index ; Somatostatin ; Somatostatin - administration & dosage ; Somatostatin - analogs & derivatives ; Statistics, Nonparametric ; Time Factors ; Treatment Outcome]]></subject><ispartof>The journal of clinical endocrinology and metabolism, 2017-07, Vol.102 (7), p.2454-2464</ispartof><rights>Copyright © 2017 Endocrine Society 2017</rights><rights>Copyright © 2017 Endocrine Society</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-7ce38193efcdbb827b8ef46510d3261cef2c9c0d9b6252fc8fa4b2ddde65dc563</citedby><cites>FETCH-LOGICAL-c393t-7ce38193efcdbb827b8ef46510d3261cef2c9c0d9b6252fc8fa4b2ddde65dc563</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1970003216?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,776,780,21367,27901,27902,33721,33722,43781</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28419317$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Giustina, Andrea</creatorcontrib><creatorcontrib>Mazziotti, Gherardo</creatorcontrib><creatorcontrib>Cannavò, Salvatore</creatorcontrib><creatorcontrib>Castello, Roberto</creatorcontrib><creatorcontrib>Arnaldi, Giorgio</creatorcontrib><creatorcontrib>Bugari, Giovanna</creatorcontrib><creatorcontrib>Cozzi, Renato</creatorcontrib><creatorcontrib>Ferone, Diego</creatorcontrib><creatorcontrib>Formenti, Anna Maria</creatorcontrib><creatorcontrib>Gatti, Enza</creatorcontrib><creatorcontrib>Grottoli, Silvia</creatorcontrib><creatorcontrib>Maffei, Pietro</creatorcontrib><creatorcontrib>Maffezzoni, Filippo</creatorcontrib><creatorcontrib>Montini, Marcella</creatorcontrib><creatorcontrib>Terzolo, Massimo</creatorcontrib><creatorcontrib>Ghigo, Ezio</creatorcontrib><title>High-Dose and High-Frequency Lanreotide Autogel in Acromegaly: A Randomized, Multicenter Study</title><title>The journal of clinical endocrinology and metabolism</title><addtitle>J Clin Endocrinol Metab</addtitle><description>Abstract
Context:
Increase in drug frequency or dose is recommended for acromegaly patients with partial response to long-acting somatostatin receptor ligands (SRLs). However, the efficacy and safety data with lanreotide (LAN) Autogel (LAN-ATG) at high dose (HD) or high frequency (HF) are still scanty.
Objective:
To evaluate the biochemical efficacy and safety of HF and HD LAN-ATG in patients with active acromegaly.
Design:
Twenty-four–week prospective, multicenter, randomized, open-label trial.
Patients and Interventions:
Thirty patients with active acromegaly, partial responders to SRLs, were randomized to HF (120 mg/21 days; 15 patients) or HD (180 mg/28 days; 15 patients) LAN-ATG.
Outcomes:
Normalization of serum insulin-like growth factor-I (IGF-I) and reduction in random growth hormone (GH) values < 1.0 µg/L, reduction in serum IGF-I and GH from baseline, differences in biochemical response between HF and HD LAN-ATG, adverse events.
Results:
IGF-I decreased significantly (P = 0.007) during the 24-week treatment, with greater decrease in HD (P = 0.03) vs HF group (P = 0.08). Normalization in IGF-I values occurred in 27.6% of patients (P = 0.016 vs baseline), without a significant difference between HF and HD groups (P = 0.59). The decrease in serum IGF-I significantly correlated with serum LAN values (P = 0.04), and normalization of IGF-I was predicted by baseline IGF-I values (P = 0.02). Serum GH values did not change significantly (P = 0.22). Overall, 19 patients (63.3%) experienced adverse events, all being mild to moderate and transient, without differences between the two therapeutic arms.
Conclusion:
HF and HD LAN-ATG regimens are effective in normalizing IGF-I values in about one-third of patients with active acromegaly inadequately controlled by long-term conventional SRLs therapy.
This randomized study investigated the efficacy and safety of LANT-ATG at high doses or high frequency in patients with acromegaly partially controlled by SRLs at conventional regimens.</description><subject>Acromegaly</subject><subject>Acromegaly - diagnostic imaging</subject><subject>Acromegaly - drug therapy</subject><subject>Adult</subject><subject>Aged</subject><subject>Confidence Intervals</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Growth hormones</subject><subject>Human Growth Hormone - administration & dosage</subject><subject>Human Growth Hormone - analogs & derivatives</subject><subject>Humans</subject><subject>Injections, Subcutaneous</subject><subject>Insulin</subject><subject>Insulin-like growth factor I</subject><subject>Insulin-Like Growth Factor I - drug effects</subject><subject>Insulin-Like Growth Factor I - metabolism</subject><subject>Insulin-like growth factors</subject><subject>Italy</subject><subject>Magnetic Resonance Imaging - methods</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Middle Aged</subject><subject>Octreotide - administration & dosage</subject><subject>Odds Ratio</subject><subject>Peptides, Cyclic - administration & dosage</subject><subject>Physical growth</subject><subject>Prospective Studies</subject><subject>Randomization</subject><subject>Safety</subject><subject>Severity of Illness Index</subject><subject>Somatostatin</subject><subject>Somatostatin - administration & dosage</subject><subject>Somatostatin - analogs & derivatives</subject><subject>Statistics, Nonparametric</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>0021-972X</issn><issn>1945-7197</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kUtLw0AURgdRbK0u3cqAGxdG55Gnu1KtFSqCD3DlkMzc1JQkU2eSRfz1TtqqILgaLpz78d0zCB1TckEZJZdLecEIjTxCqM920JAmfuBFNIl20ZAQRr0kYq8DdGDtskf8gO-jAYt9mnAaDdHbrFi8e9faAk5rhdfT1MBHC7Xs8DytDeimUIDHbaMXUOKixmNpdAWLtOyu8Bg_uj1dFZ-gzvF9WzaFhLoBg5-aVnWHaC9PSwtH23eEXqY3z5OZN3-4vZuM557kCW-8SAKPXSPIpcqymEVZDLkfBpQozkIqIWcykUQlWcgClss4T_2MKaUgDJQMQj5CZ5vcldGuu21EVVgJZZnWoFsraBwnkcuNuUNP_6BL3ZratRPOGiGEM9oHehvK3WqtgVysTFGlphOUiF68WErRixdr8Y4_2aa2WQXqh_42_dtQt6v_sjafyL8AfJ2J2w</recordid><startdate>20170701</startdate><enddate>20170701</enddate><creator>Giustina, Andrea</creator><creator>Mazziotti, Gherardo</creator><creator>Cannavò, Salvatore</creator><creator>Castello, Roberto</creator><creator>Arnaldi, Giorgio</creator><creator>Bugari, Giovanna</creator><creator>Cozzi, Renato</creator><creator>Ferone, Diego</creator><creator>Formenti, Anna Maria</creator><creator>Gatti, Enza</creator><creator>Grottoli, Silvia</creator><creator>Maffei, Pietro</creator><creator>Maffezzoni, Filippo</creator><creator>Montini, Marcella</creator><creator>Terzolo, Massimo</creator><creator>Ghigo, Ezio</creator><general>Endocrine Society</general><general>Oxford University Press</general><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>3V.</scope><scope>7QP</scope><scope>7T5</scope><scope>7TM</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20170701</creationdate><title>High-Dose and High-Frequency Lanreotide Autogel in Acromegaly: A Randomized, Multicenter Study</title><author>Giustina, Andrea ; Mazziotti, Gherardo ; Cannavò, Salvatore ; Castello, Roberto ; Arnaldi, Giorgio ; Bugari, Giovanna ; Cozzi, Renato ; Ferone, Diego ; Formenti, Anna Maria ; Gatti, Enza ; Grottoli, Silvia ; Maffei, Pietro ; Maffezzoni, Filippo ; Montini, Marcella ; Terzolo, Massimo ; Ghigo, Ezio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c393t-7ce38193efcdbb827b8ef46510d3261cef2c9c0d9b6252fc8fa4b2ddde65dc563</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Acromegaly</topic><topic>Acromegaly - diagnostic imaging</topic><topic>Acromegaly - drug therapy</topic><topic>Adult</topic><topic>Aged</topic><topic>Confidence Intervals</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Growth hormones</topic><topic>Human Growth Hormone - administration & dosage</topic><topic>Human Growth Hormone - analogs & derivatives</topic><topic>Humans</topic><topic>Injections, Subcutaneous</topic><topic>Insulin</topic><topic>Insulin-like growth factor I</topic><topic>Insulin-Like Growth Factor I - drug effects</topic><topic>Insulin-Like Growth Factor I - metabolism</topic><topic>Insulin-like growth factors</topic><topic>Italy</topic><topic>Magnetic Resonance Imaging - methods</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Middle Aged</topic><topic>Octreotide - administration & dosage</topic><topic>Odds Ratio</topic><topic>Peptides, Cyclic - administration & dosage</topic><topic>Physical growth</topic><topic>Prospective Studies</topic><topic>Randomization</topic><topic>Safety</topic><topic>Severity of Illness Index</topic><topic>Somatostatin</topic><topic>Somatostatin - administration & dosage</topic><topic>Somatostatin - analogs & derivatives</topic><topic>Statistics, Nonparametric</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Giustina, Andrea</creatorcontrib><creatorcontrib>Mazziotti, Gherardo</creatorcontrib><creatorcontrib>Cannavò, Salvatore</creatorcontrib><creatorcontrib>Castello, Roberto</creatorcontrib><creatorcontrib>Arnaldi, Giorgio</creatorcontrib><creatorcontrib>Bugari, Giovanna</creatorcontrib><creatorcontrib>Cozzi, Renato</creatorcontrib><creatorcontrib>Ferone, Diego</creatorcontrib><creatorcontrib>Formenti, Anna Maria</creatorcontrib><creatorcontrib>Gatti, Enza</creatorcontrib><creatorcontrib>Grottoli, Silvia</creatorcontrib><creatorcontrib>Maffei, Pietro</creatorcontrib><creatorcontrib>Maffezzoni, Filippo</creatorcontrib><creatorcontrib>Montini, Marcella</creatorcontrib><creatorcontrib>Terzolo, Massimo</creatorcontrib><creatorcontrib>Ghigo, Ezio</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>The journal of clinical endocrinology and metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Giustina, Andrea</au><au>Mazziotti, Gherardo</au><au>Cannavò, Salvatore</au><au>Castello, Roberto</au><au>Arnaldi, Giorgio</au><au>Bugari, Giovanna</au><au>Cozzi, Renato</au><au>Ferone, Diego</au><au>Formenti, Anna Maria</au><au>Gatti, Enza</au><au>Grottoli, Silvia</au><au>Maffei, Pietro</au><au>Maffezzoni, Filippo</au><au>Montini, Marcella</au><au>Terzolo, Massimo</au><au>Ghigo, Ezio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>High-Dose and High-Frequency Lanreotide Autogel in Acromegaly: A Randomized, Multicenter Study</atitle><jtitle>The journal of clinical endocrinology and metabolism</jtitle><addtitle>J Clin Endocrinol Metab</addtitle><date>2017-07-01</date><risdate>2017</risdate><volume>102</volume><issue>7</issue><spage>2454</spage><epage>2464</epage><pages>2454-2464</pages><issn>0021-972X</issn><eissn>1945-7197</eissn><abstract>Abstract
Context:
Increase in drug frequency or dose is recommended for acromegaly patients with partial response to long-acting somatostatin receptor ligands (SRLs). However, the efficacy and safety data with lanreotide (LAN) Autogel (LAN-ATG) at high dose (HD) or high frequency (HF) are still scanty.
Objective:
To evaluate the biochemical efficacy and safety of HF and HD LAN-ATG in patients with active acromegaly.
Design:
Twenty-four–week prospective, multicenter, randomized, open-label trial.
Patients and Interventions:
Thirty patients with active acromegaly, partial responders to SRLs, were randomized to HF (120 mg/21 days; 15 patients) or HD (180 mg/28 days; 15 patients) LAN-ATG.
Outcomes:
Normalization of serum insulin-like growth factor-I (IGF-I) and reduction in random growth hormone (GH) values < 1.0 µg/L, reduction in serum IGF-I and GH from baseline, differences in biochemical response between HF and HD LAN-ATG, adverse events.
Results:
IGF-I decreased significantly (P = 0.007) during the 24-week treatment, with greater decrease in HD (P = 0.03) vs HF group (P = 0.08). Normalization in IGF-I values occurred in 27.6% of patients (P = 0.016 vs baseline), without a significant difference between HF and HD groups (P = 0.59). The decrease in serum IGF-I significantly correlated with serum LAN values (P = 0.04), and normalization of IGF-I was predicted by baseline IGF-I values (P = 0.02). Serum GH values did not change significantly (P = 0.22). Overall, 19 patients (63.3%) experienced adverse events, all being mild to moderate and transient, without differences between the two therapeutic arms.
Conclusion:
HF and HD LAN-ATG regimens are effective in normalizing IGF-I values in about one-third of patients with active acromegaly inadequately controlled by long-term conventional SRLs therapy.
This randomized study investigated the efficacy and safety of LANT-ATG at high doses or high frequency in patients with acromegaly partially controlled by SRLs at conventional regimens.</abstract><cop>Washington, DC</cop><pub>Endocrine Society</pub><pmid>28419317</pmid><doi>10.1210/jc.2017-00142</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0021-972X |
| ispartof | The journal of clinical endocrinology and metabolism, 2017-07, Vol.102 (7), p.2454-2464 |
| issn | 0021-972X 1945-7197 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1889782783 |
| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection; Journals@Ovid Complete; ProQuest Central |
| subjects | Acromegaly Acromegaly - diagnostic imaging Acromegaly - drug therapy Adult Aged Confidence Intervals Dose-Response Relationship, Drug Drug Administration Schedule Female Follow-Up Studies Growth hormones Human Growth Hormone - administration & dosage Human Growth Hormone - analogs & derivatives Humans Injections, Subcutaneous Insulin Insulin-like growth factor I Insulin-Like Growth Factor I - drug effects Insulin-Like Growth Factor I - metabolism Insulin-like growth factors Italy Magnetic Resonance Imaging - methods Male Maximum Tolerated Dose Middle Aged Octreotide - administration & dosage Odds Ratio Peptides, Cyclic - administration & dosage Physical growth Prospective Studies Randomization Safety Severity of Illness Index Somatostatin Somatostatin - administration & dosage Somatostatin - analogs & derivatives Statistics, Nonparametric Time Factors Treatment Outcome |
| title | High-Dose and High-Frequency Lanreotide Autogel in Acromegaly: A Randomized, Multicenter Study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-11T03%3A57%3A44IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=High-Dose%20and%20High-Frequency%20Lanreotide%20Autogel%20in%20Acromegaly:%20A%20Randomized,%20Multicenter%20Study&rft.jtitle=The%20journal%20of%20clinical%20endocrinology%20and%20metabolism&rft.au=Giustina,%20Andrea&rft.date=2017-07-01&rft.volume=102&rft.issue=7&rft.spage=2454&rft.epage=2464&rft.pages=2454-2464&rft.issn=0021-972X&rft.eissn=1945-7197&rft_id=info:doi/10.1210/jc.2017-00142&rft_dat=%3Cproquest_cross%3E1970003216%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1970003216&rft_id=info:pmid/28419317&rft_oup_id=10.1210/jc.2017-00142&rfr_iscdi=true |