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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThis extension study of the phase 3 PAOLA trial found that pasireotide LAR may be a viable, long-term treatment option for patients with acromegaly that is inadequately controlled with first-generation somatostatin analogues. Biochemical control of growth hormone and normalized insulin-like growth factor 1 continued through extension week 28.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EPAOLA\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT01137682\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Epasireotide LAR\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eoctreotide LAR\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Elanreotide Autogel\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Egrowth hormone\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eacromegaly\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eendocrinology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ediabetes \u0026amp; metabolism clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ehormone therapy\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Epituitary gland disorders\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EMonica R. Gadelha, MD, Hospital Universit\u00e1rio Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil, presented a preliminary analysis of the phase 3 PAOLA study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01137682\u0026amp;atom=%2Fspmdc%2F15%2F4%2F10.2.atom\u0022\u003ENCT01137682\u003C\/a\u003E] that showed that biochemical control continued through extension week 28. The intent within this extension phase was to assess pasireotide long-acting release (LAR) in patients with acromegaly over an extended period of time.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EDr Gadelha and colleagues examined data through extension week 28 of the extension phase of the 24-week, randomized, phase 3 PAOLA study, which enrolled patients with inadequately controlled acromegaly [Gadelha MR et al. \u003Cem\u003ELancet Diabetes Endocrinol\u003C\/em\u003E. 2014]. The 24-week, phase 3 study had found that biochemical control, defined as growth hormone \u0026lt;\u20052.5 mg\/L and normalized insulinlike growth factor 1 (IGF-1), was achieved by significantly more patients who received pasireotide LAR 40 mg (15%; n\u2005=\u200510\/65; \u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.0006) or 60 mg (20%; n\u2005=\u200513\/65; \u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.0001) than those who received octreotide LAR or lanreotide Autogel (0%; n\u2005=\u20050\/68). The most common adverse events in the phase 3 trial were hyperglycemia, diabetes, and diarrhea. Serious adverse events were reported in 6 patients receiving pasireotide 40 mg, 2 receiving pasireotide 60 mg, and 3 in the active control group.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EThe patients who were in the control group continued to receive the same doses in the extension phase from week 24 through a 4-week bridging phase. Next, patients from the control group who were not biochemically controlled received open-label pasireotide LAR 40 mg, and their dose was increased to 60 mg if their disease became uncontrolled. These were the crossover group.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EThe patients who were not in the control group remained on pasireotide LAR at 40 or 60 mg during the 4-week bridging phase. If they had not achieved biochemical control, they received open-label pasireotide LAR 60 mg beginning at extension week 4. These patients, the treatment groups, received a total of 52 weeks of treatment with pasireotide LAR for this analysis.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EAt extension week 28, biochemical control was achieved by 18% of the patients in the pasireotide LAR 40-mg group (n\u2005=\u20059\/49; 95% CI, 9 to 32) and by 33% in the pasireotide LAR 60-mg group (n\u2005=\u200515\/45; 95% CI, 20 to 49). Among the crossover group, 20% achieved biochemical control (n\u2005=\u200510\/50; 95% CI, 10 to 34).\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EAll 3 groups had a drop in IGF-1 levels during the extension time. At week 28, normal IGF-1 was obtained in 33% of the patients receiving pasireotide LAR 40 mg, in 38% receiving pasireotide LAR 60 mg, and in 24% of the crossover group. Growth hormone levels of \u0026lt;\u20052.5 mg\/L were achieved by 39% of the patients receiving pasireotide LAR 40 mg, 47% of those receiving pasireotide LAR 60 mg, and 42% of the crossover group.\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EThe safety profile was very similar to that of the core study. This longer-term treatment identified no new treatment-emergent safety signals.\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EPasireotide may be a viable, long-term treatment option for patients with acromegaly that is inadequately controlled with first-generation somatostatin analogues.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/15\/4\/10.2.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzlmo1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}