Efficacy of a slow-release formulation of lanreotide (Autogel) 120 mg) in patients with acromegaly previously treated with octreotide long acting release (LAR): an open, multicentre longitudinal study
Lanreotide Autogel 120 mg (ATG120; Ipsen S.p.A, Milan, Italy) is a high-dose, sustained-release aqueous gel formulation, supplied in a prefilled syringe and given by deep subcutaneous injection. The aim of this study was to compare efficacy and tolerability of ATG120 given every 4-8 weeks with those...
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creator | Ronchi, C L Boschetti, M Degli Uberti, E C Mariotti, S Grottoli, S Loli, P Lombardi, G Tamburrano, G Arvigo, M Angeletti, G Boscani, P F Beck-Peccoz, P Arosio, M |
description | Lanreotide Autogel 120 mg (ATG120; Ipsen S.p.A, Milan, Italy) is a high-dose, sustained-release aqueous gel formulation, supplied in a prefilled syringe and given by deep subcutaneous injection. The aim of this study was to compare efficacy and tolerability of ATG120 given every 4-8 weeks with those of octreotide LAR (o-LAR) given every 4 weeks. DESIGN PATIENTS AND INTERVENTION: A phase III multicentre Italian open clinical study of 23 acromegalic patients (15 female, 8 male). All patients had received o-LAR for 6-18 months and, after 3 months wash out, ATG120 was given every 6 weeks for a total of four injections (Period 1). Then the interval between ATG120 injections was adjusted according to three different schemes: every 4, 6 or 8 weeks depending on GH levels (GH > 2.5 microg/l; 1 < GH |
doi_str_mv | 10.1111/j.1365-2265.2007.02917.x |
format | Article |
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Hormonal (GH and IGF-I) and clinical efficacy and tolerability.
ATG120 induced a significant GH decrease from 9.9 +/- 11.3 at baseline (Visit 1) to 3.5 +/- 5.7 at the end of Period 1 (P < 0.01) and to 3.8 +/- 5.7 microg/l at the final visit (P < 0.01). IGF-I also decreased from 544 +/- 312 at baseline (Visit 1) to 318 +/- 181 at Period 1 and to 356 +/- 187 microg/l at the final visit (both P < 0.05 vs. baseline). The frequency of ATG120 administrations was adjusted to every 4 weeks in 12 patients, every 6 weeks in 4 patients and every 8 weeks in 6 patients; 1 patient withdrew before the dose adjustment. Serum GH and IGF-I achieved at the end of Period 1 and Period 2 were similar to those reached with o-LAR. The number of patients who achieved GH < 2.5 microg/l was comparable between o-LAR (43%) and ATG120 at Period 1 (48%) and at Period 2 (62%). Normal IGF-I levels were recorded in 8 patients during o-LAR (35%), 11 during ATG Period 1 (48%) and 10 at the final visit (43%). Last, 4 patients showed a better response to ATG120 and 2 to o-LAR.
Lanreotide Autogel 120 mg is an effective and well-tolerated therapy for acromegaly. In approximately half of patients ATG120 may be administered every 6-8 weeks, instead of every 4 weeks, without lost of efficacy.]]></description><identifier>ISSN: 0300-0664</identifier><identifier>DOI: 10.1111/j.1365-2265.2007.02917.x</identifier><identifier>PMID: 17555511</identifier><language>eng</language><publisher>England</publisher><subject>Acromegaly - blood ; Acromegaly - drug therapy ; Adult ; Aged ; Analysis of Variance ; Carrier Proteins - blood ; Delayed-Action Preparations - therapeutic use ; Drug Administration Schedule ; Female ; Follow-Up Studies ; Glycoproteins - blood ; Growth Hormone - antagonists & inhibitors ; Growth Hormone - blood ; Humans ; Injections, Intramuscular ; Insulin Resistance ; Insulin-Like Growth Factor I - analysis ; Male ; Middle Aged ; Octreotide - therapeutic use ; Peptides, Cyclic - therapeutic use ; Prolactin - blood ; Somatostatin - analogs & derivatives ; Somatostatin - therapeutic use</subject><ispartof>Clinical endocrinology (Oxford), 2007-10, Vol.67 (4), p.512-519</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17555511$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ronchi, C L</creatorcontrib><creatorcontrib>Boschetti, M</creatorcontrib><creatorcontrib>Degli Uberti, E C</creatorcontrib><creatorcontrib>Mariotti, S</creatorcontrib><creatorcontrib>Grottoli, S</creatorcontrib><creatorcontrib>Loli, P</creatorcontrib><creatorcontrib>Lombardi, G</creatorcontrib><creatorcontrib>Tamburrano, G</creatorcontrib><creatorcontrib>Arvigo, M</creatorcontrib><creatorcontrib>Angeletti, G</creatorcontrib><creatorcontrib>Boscani, P F</creatorcontrib><creatorcontrib>Beck-Peccoz, P</creatorcontrib><creatorcontrib>Arosio, M</creatorcontrib><creatorcontrib>Italian Multicenter Autogel Study Group in Acromegaly</creatorcontrib><title>Efficacy of a slow-release formulation of lanreotide (Autogel) 120 mg) in patients with acromegaly previously treated with octreotide long acting release (LAR): an open, multicentre longitudinal study</title><title>Clinical endocrinology (Oxford)</title><addtitle>Clin Endocrinol (Oxf)</addtitle><description><![CDATA[Lanreotide Autogel 120 mg (ATG120; Ipsen S.p.A, Milan, Italy) is a high-dose, sustained-release aqueous gel formulation, supplied in a prefilled syringe and given by deep subcutaneous injection. The aim of this study was to compare efficacy and tolerability of ATG120 given every 4-8 weeks with those of octreotide LAR (o-LAR) given every 4 weeks. DESIGN PATIENTS AND INTERVENTION: A phase III multicentre Italian open clinical study of 23 acromegalic patients (15 female, 8 male). All patients had received o-LAR for 6-18 months and, after 3 months wash out, ATG120 was given every 6 weeks for a total of four injections (Period 1). Then the interval between ATG120 injections was adjusted according to three different schemes: every 4, 6 or 8 weeks depending on GH levels (GH > 2.5 microg/l; 1 < GH <or= 2.5 microg/l; GH <or= 1 microg/l, respectively). ATG120 was given for a further two to three doses, with a final assessment (Period 2) at Week 34, 36 or 42.
Hormonal (GH and IGF-I) and clinical efficacy and tolerability.
ATG120 induced a significant GH decrease from 9.9 +/- 11.3 at baseline (Visit 1) to 3.5 +/- 5.7 at the end of Period 1 (P < 0.01) and to 3.8 +/- 5.7 microg/l at the final visit (P < 0.01). IGF-I also decreased from 544 +/- 312 at baseline (Visit 1) to 318 +/- 181 at Period 1 and to 356 +/- 187 microg/l at the final visit (both P < 0.05 vs. baseline). The frequency of ATG120 administrations was adjusted to every 4 weeks in 12 patients, every 6 weeks in 4 patients and every 8 weeks in 6 patients; 1 patient withdrew before the dose adjustment. Serum GH and IGF-I achieved at the end of Period 1 and Period 2 were similar to those reached with o-LAR. The number of patients who achieved GH < 2.5 microg/l was comparable between o-LAR (43%) and ATG120 at Period 1 (48%) and at Period 2 (62%). Normal IGF-I levels were recorded in 8 patients during o-LAR (35%), 11 during ATG Period 1 (48%) and 10 at the final visit (43%). Last, 4 patients showed a better response to ATG120 and 2 to o-LAR.
Lanreotide Autogel 120 mg is an effective and well-tolerated therapy for acromegaly. In approximately half of patients ATG120 may be administered every 6-8 weeks, instead of every 4 weeks, without lost of efficacy.]]></description><subject>Acromegaly - blood</subject><subject>Acromegaly - drug therapy</subject><subject>Adult</subject><subject>Aged</subject><subject>Analysis of Variance</subject><subject>Carrier Proteins - blood</subject><subject>Delayed-Action Preparations - therapeutic use</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Glycoproteins - blood</subject><subject>Growth Hormone - antagonists & inhibitors</subject><subject>Growth Hormone - blood</subject><subject>Humans</subject><subject>Injections, Intramuscular</subject><subject>Insulin Resistance</subject><subject>Insulin-Like Growth Factor I - analysis</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Octreotide - therapeutic use</subject><subject>Peptides, Cyclic - therapeutic use</subject><subject>Prolactin - blood</subject><subject>Somatostatin - analogs & derivatives</subject><subject>Somatostatin - therapeutic use</subject><issn>0300-0664</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1kN9O6zAMxnMB4v8roFwhJtHiNE27cjdNcM6RJiEhuJ7SxhlBaVOSFNgb8ljkaMw3tuSf_dkfIZRBzlLcvuWMVyIrikrkBUCdQ9GwOv86ICfAATKoqvKYnIbwBgBiDvUROWa1SMHYCfm-19p0sttSp6mkwbrPzKNFGZBq5_vJymjc8L9r5eDRRaOQXi-m6DZoZ5QVQPvNjJqBjonEIQb6aeIrlZ13PW6k3dLR44dxU0hl9Cgjqh3iurhfaN2wSSPRpLSXv14tnmZ3VCbxEYcbmm6JpksKfsebOCkzSEtDKrbn5FBLG_DiN5-Rl4f75-XfbPX4599yscpGxpuYyapBga0ulSxVI4BXWsx12WhRABddi1CoDkEorutai6ZpOSuq1OElR65afkaudntH794nDHHdm9ChTe5g-nFdzZP9fM4TePkLTm2Paj1600u_Xe-95z8TlYos</recordid><startdate>200710</startdate><enddate>200710</enddate><creator>Ronchi, C L</creator><creator>Boschetti, M</creator><creator>Degli Uberti, E C</creator><creator>Mariotti, S</creator><creator>Grottoli, S</creator><creator>Loli, P</creator><creator>Lombardi, G</creator><creator>Tamburrano, G</creator><creator>Arvigo, M</creator><creator>Angeletti, G</creator><creator>Boscani, P F</creator><creator>Beck-Peccoz, P</creator><creator>Arosio, M</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>200710</creationdate><title>Efficacy of a slow-release formulation of lanreotide (Autogel) 120 mg) in patients with acromegaly previously treated with octreotide long acting release (LAR): an open, multicentre longitudinal study</title><author>Ronchi, C L ; Boschetti, M ; Degli Uberti, E C ; Mariotti, S ; Grottoli, S ; Loli, P ; Lombardi, G ; Tamburrano, G ; Arvigo, M ; Angeletti, G ; Boscani, P F ; Beck-Peccoz, P ; Arosio, M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p139t-a69e5ebf4da4d95036f58f49f52035cbe02dce05d3f77f599b312635c343e3db3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Acromegaly - blood</topic><topic>Acromegaly - drug therapy</topic><topic>Adult</topic><topic>Aged</topic><topic>Analysis of Variance</topic><topic>Carrier Proteins - blood</topic><topic>Delayed-Action Preparations - therapeutic use</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Glycoproteins - blood</topic><topic>Growth Hormone - antagonists & inhibitors</topic><topic>Growth Hormone - blood</topic><topic>Humans</topic><topic>Injections, Intramuscular</topic><topic>Insulin Resistance</topic><topic>Insulin-Like Growth Factor I - analysis</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Octreotide - therapeutic use</topic><topic>Peptides, Cyclic - therapeutic use</topic><topic>Prolactin - blood</topic><topic>Somatostatin - analogs & derivatives</topic><topic>Somatostatin - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ronchi, C L</creatorcontrib><creatorcontrib>Boschetti, M</creatorcontrib><creatorcontrib>Degli Uberti, E C</creatorcontrib><creatorcontrib>Mariotti, S</creatorcontrib><creatorcontrib>Grottoli, S</creatorcontrib><creatorcontrib>Loli, P</creatorcontrib><creatorcontrib>Lombardi, G</creatorcontrib><creatorcontrib>Tamburrano, G</creatorcontrib><creatorcontrib>Arvigo, M</creatorcontrib><creatorcontrib>Angeletti, G</creatorcontrib><creatorcontrib>Boscani, P F</creatorcontrib><creatorcontrib>Beck-Peccoz, P</creatorcontrib><creatorcontrib>Arosio, M</creatorcontrib><creatorcontrib>Italian Multicenter Autogel Study Group in Acromegaly</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical endocrinology (Oxford)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ronchi, C L</au><au>Boschetti, M</au><au>Degli Uberti, E C</au><au>Mariotti, S</au><au>Grottoli, S</au><au>Loli, P</au><au>Lombardi, G</au><au>Tamburrano, G</au><au>Arvigo, M</au><au>Angeletti, G</au><au>Boscani, P F</au><au>Beck-Peccoz, P</au><au>Arosio, M</au><aucorp>Italian Multicenter Autogel Study Group in Acromegaly</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of a slow-release formulation of lanreotide (Autogel) 120 mg) in patients with acromegaly previously treated with octreotide long acting release (LAR): an open, multicentre longitudinal study</atitle><jtitle>Clinical endocrinology (Oxford)</jtitle><addtitle>Clin Endocrinol (Oxf)</addtitle><date>2007-10</date><risdate>2007</risdate><volume>67</volume><issue>4</issue><spage>512</spage><epage>519</epage><pages>512-519</pages><issn>0300-0664</issn><abstract><![CDATA[Lanreotide Autogel 120 mg (ATG120; Ipsen S.p.A, Milan, Italy) is a high-dose, sustained-release aqueous gel formulation, supplied in a prefilled syringe and given by deep subcutaneous injection. The aim of this study was to compare efficacy and tolerability of ATG120 given every 4-8 weeks with those of octreotide LAR (o-LAR) given every 4 weeks. DESIGN PATIENTS AND INTERVENTION: A phase III multicentre Italian open clinical study of 23 acromegalic patients (15 female, 8 male). All patients had received o-LAR for 6-18 months and, after 3 months wash out, ATG120 was given every 6 weeks for a total of four injections (Period 1). Then the interval between ATG120 injections was adjusted according to three different schemes: every 4, 6 or 8 weeks depending on GH levels (GH > 2.5 microg/l; 1 < GH <or= 2.5 microg/l; GH <or= 1 microg/l, respectively). ATG120 was given for a further two to three doses, with a final assessment (Period 2) at Week 34, 36 or 42.
Hormonal (GH and IGF-I) and clinical efficacy and tolerability.
ATG120 induced a significant GH decrease from 9.9 +/- 11.3 at baseline (Visit 1) to 3.5 +/- 5.7 at the end of Period 1 (P < 0.01) and to 3.8 +/- 5.7 microg/l at the final visit (P < 0.01). IGF-I also decreased from 544 +/- 312 at baseline (Visit 1) to 318 +/- 181 at Period 1 and to 356 +/- 187 microg/l at the final visit (both P < 0.05 vs. baseline). The frequency of ATG120 administrations was adjusted to every 4 weeks in 12 patients, every 6 weeks in 4 patients and every 8 weeks in 6 patients; 1 patient withdrew before the dose adjustment. Serum GH and IGF-I achieved at the end of Period 1 and Period 2 were similar to those reached with o-LAR. The number of patients who achieved GH < 2.5 microg/l was comparable between o-LAR (43%) and ATG120 at Period 1 (48%) and at Period 2 (62%). Normal IGF-I levels were recorded in 8 patients during o-LAR (35%), 11 during ATG Period 1 (48%) and 10 at the final visit (43%). Last, 4 patients showed a better response to ATG120 and 2 to o-LAR.
Lanreotide Autogel 120 mg is an effective and well-tolerated therapy for acromegaly. In approximately half of patients ATG120 may be administered every 6-8 weeks, instead of every 4 weeks, without lost of efficacy.]]></abstract><cop>England</cop><pmid>17555511</pmid><doi>10.1111/j.1365-2265.2007.02917.x</doi><tpages>8</tpages></addata></record> |
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source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
subjects | Acromegaly - blood Acromegaly - drug therapy Adult Aged Analysis of Variance Carrier Proteins - blood Delayed-Action Preparations - therapeutic use Drug Administration Schedule Female Follow-Up Studies Glycoproteins - blood Growth Hormone - antagonists & inhibitors Growth Hormone - blood Humans Injections, Intramuscular Insulin Resistance Insulin-Like Growth Factor I - analysis Male Middle Aged Octreotide - therapeutic use Peptides, Cyclic - therapeutic use Prolactin - blood Somatostatin - analogs & derivatives Somatostatin - therapeutic use |
title | Efficacy of a slow-release formulation of lanreotide (Autogel) 120 mg) in patients with acromegaly previously treated with octreotide long acting release (LAR): an open, multicentre longitudinal study |
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