Long-acting pasireotide improves clinical signs and quality of life in Cushing’s disease: results from a phase III study
Purpose Cushing’s disease (CD) is associated with significant clinical burden, increased mortality risk, and impaired health-related quality of life (HRQoL). This analysis explored the effect of long-acting pasireotide on clinical signs of hypercortisolism and HRQoL in a large subset of patients wit...
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| Veröffentlicht in: | Journal of endocrinological investigation 2020-11, Vol.43 (11), p.1613-1622 |
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| creator | Lacroix, A. Bronstein, M. D. Schopohl, J. Delibasi, T. Salvatori, R. Li, Y. Barkan, A. Suzaki, N. Tauchmanova, L. Ortmann, C.-E. Ravichandran, S. Petersenn, S. Pivonello, R. |
| description | Purpose
Cushing’s disease (CD) is associated with significant clinical burden, increased mortality risk, and impaired health-related quality of life (HRQoL). This analysis explored the effect of long-acting pasireotide on clinical signs of hypercortisolism and HRQoL in a large subset of patients with CD.
Methods
In this phase III study (clinicaltrials.gov: NCT01374906), 150 adults with CD and a mean urinary free cortisol (mUFC) level between 1.5 and 5.0 times the upper limit of normal (ULN) started long-acting pasireotide 10 or 30 mg every 28 days with dose increases/decreases permitted based on mUFC levels/tolerability (minimum/maximum dose: 5/40 mg). Changes in clinical signs of hypercortisolism and HRQoL were assessed over 12 months of treatment and were stratified by degree of mUFC control for each patient.
Results
Patients with controlled mUFC at month 12 (
n
= 45) had the greatest improvements from baseline in mean systolic (− 8.4 mmHg [95% CI − 13.9, − 2.9]) and diastolic blood pressure (− 6.0 mmHg [− 10.0, − 2.0]). Mean BMI, weight, and waist circumference improved irrespective of mUFC control. Significant improvements in CushingQoL total score of 5.9–8.3 points were found at month 12 compared with baseline, irrespective of mUFC control; changes were driven by improvements in physical problem score, with smaller improvements in psychosocial score.
Conclusions
Long-acting pasireotide provided significant improvements in clinical signs and HRQoL over 12 months of treatment, which, in some cases, occurred regardless of mUFC control. Long-acting pasireotide represents an effective treatment option and provides clinical benefit in patients with CD.
Clinical trial registration number
NCT01374906 |
| doi_str_mv | 10.1007/s40618-020-01246-0 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2400517713</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2400517713</sourcerecordid><originalsourceid>FETCH-LOGICAL-c375t-80329cb61515f71fb12441cccb1e0045677e3cd9bfc72a95f00c78c5b31301853</originalsourceid><addsrcrecordid>eNp9kcmO1DAQhi0EYhZ4AQ7IEhcuYariOHZzQy2Wllqay8zZchy7x6PE6XElSM1pXoPX40kw9LCIAydvX_3l0sfYC4Q3CKAuqIEWdQU1VIB101bwiJ2iKkctdPv4r_0JOyO6BRBKaPWUnYhaaKklnrIv2yntKuvmmHZ8bylmP82x9zyO-zx99sTdEFN0duAUd4m4TT2_W-wQ5wOfAh9iKGzi64VuSsS3-6_E-0jekn_Ls6dlmImHPI3c8v1NueWbzYbTvPSHZ-xJsAP55w_rObv-8P5q_anaXn7crN9tKyeUnCsNol65rkWJMigMXRm1Qedchx6gka1SXrh-1QWnaruSAcAp7WQnUABqKc7Z62NuGehu8TSbMZLzw2CTnxYydQMgUSkUBX31D3o7LTmV3xVKglg1tcZC1UfK5Yko-2D2OY42HwyC-WHGHM2YYsb8NGOgFL18iF660fe_S36pKIA4AlSe0s7nP73_E_sdlEyZhg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2450394281</pqid></control><display><type>article</type><title>Long-acting pasireotide improves clinical signs and quality of life in Cushing’s disease: results from a phase III study</title><source>SpringerNature Journals</source><creator>Lacroix, A. ; Bronstein, M. D. ; Schopohl, J. ; Delibasi, T. ; Salvatori, R. ; Li, Y. ; Barkan, A. ; Suzaki, N. ; Tauchmanova, L. ; Ortmann, C.-E. ; Ravichandran, S. ; Petersenn, S. ; Pivonello, R.</creator><creatorcontrib>Lacroix, A. ; Bronstein, M. D. ; Schopohl, J. ; Delibasi, T. ; Salvatori, R. ; Li, Y. ; Barkan, A. ; Suzaki, N. ; Tauchmanova, L. ; Ortmann, C.-E. ; Ravichandran, S. ; Petersenn, S. ; Pivonello, R.</creatorcontrib><description>Purpose
Cushing’s disease (CD) is associated with significant clinical burden, increased mortality risk, and impaired health-related quality of life (HRQoL). This analysis explored the effect of long-acting pasireotide on clinical signs of hypercortisolism and HRQoL in a large subset of patients with CD.
Methods
In this phase III study (clinicaltrials.gov: NCT01374906), 150 adults with CD and a mean urinary free cortisol (mUFC) level between 1.5 and 5.0 times the upper limit of normal (ULN) started long-acting pasireotide 10 or 30 mg every 28 days with dose increases/decreases permitted based on mUFC levels/tolerability (minimum/maximum dose: 5/40 mg). Changes in clinical signs of hypercortisolism and HRQoL were assessed over 12 months of treatment and were stratified by degree of mUFC control for each patient.
Results
Patients with controlled mUFC at month 12 (
n
= 45) had the greatest improvements from baseline in mean systolic (− 8.4 mmHg [95% CI − 13.9, − 2.9]) and diastolic blood pressure (− 6.0 mmHg [− 10.0, − 2.0]). Mean BMI, weight, and waist circumference improved irrespective of mUFC control. Significant improvements in CushingQoL total score of 5.9–8.3 points were found at month 12 compared with baseline, irrespective of mUFC control; changes were driven by improvements in physical problem score, with smaller improvements in psychosocial score.
Conclusions
Long-acting pasireotide provided significant improvements in clinical signs and HRQoL over 12 months of treatment, which, in some cases, occurred regardless of mUFC control. Long-acting pasireotide represents an effective treatment option and provides clinical benefit in patients with CD.
Clinical trial registration number
NCT01374906</description><identifier>ISSN: 1720-8386</identifier><identifier>ISSN: 0391-4097</identifier><identifier>EISSN: 1720-8386</identifier><identifier>DOI: 10.1007/s40618-020-01246-0</identifier><identifier>PMID: 32385851</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Adrenocorticotropic hormone ; Blood pressure ; Cushing's disease ; Endocrinology ; Internal Medicine ; Medicine ; Medicine & Public Health ; Metabolic Diseases ; Nervous system diseases ; Original Article ; Patients ; Pituitary ; Quality of life</subject><ispartof>Journal of endocrinological investigation, 2020-11, Vol.43 (11), p.1613-1622</ispartof><rights>Italian Society of Endocrinology (SIE) 2020</rights><rights>Italian Society of Endocrinology (SIE) 2020.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-80329cb61515f71fb12441cccb1e0045677e3cd9bfc72a95f00c78c5b31301853</citedby><cites>FETCH-LOGICAL-c375t-80329cb61515f71fb12441cccb1e0045677e3cd9bfc72a95f00c78c5b31301853</cites><orcidid>0000-0003-4137-3025</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40618-020-01246-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40618-020-01246-0$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32385851$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lacroix, A.</creatorcontrib><creatorcontrib>Bronstein, M. D.</creatorcontrib><creatorcontrib>Schopohl, J.</creatorcontrib><creatorcontrib>Delibasi, T.</creatorcontrib><creatorcontrib>Salvatori, R.</creatorcontrib><creatorcontrib>Li, Y.</creatorcontrib><creatorcontrib>Barkan, A.</creatorcontrib><creatorcontrib>Suzaki, N.</creatorcontrib><creatorcontrib>Tauchmanova, L.</creatorcontrib><creatorcontrib>Ortmann, C.-E.</creatorcontrib><creatorcontrib>Ravichandran, S.</creatorcontrib><creatorcontrib>Petersenn, S.</creatorcontrib><creatorcontrib>Pivonello, R.</creatorcontrib><title>Long-acting pasireotide improves clinical signs and quality of life in Cushing’s disease: results from a phase III study</title><title>Journal of endocrinological investigation</title><addtitle>J Endocrinol Invest</addtitle><addtitle>J Endocrinol Invest</addtitle><description>Purpose
Cushing’s disease (CD) is associated with significant clinical burden, increased mortality risk, and impaired health-related quality of life (HRQoL). This analysis explored the effect of long-acting pasireotide on clinical signs of hypercortisolism and HRQoL in a large subset of patients with CD.
Methods
In this phase III study (clinicaltrials.gov: NCT01374906), 150 adults with CD and a mean urinary free cortisol (mUFC) level between 1.5 and 5.0 times the upper limit of normal (ULN) started long-acting pasireotide 10 or 30 mg every 28 days with dose increases/decreases permitted based on mUFC levels/tolerability (minimum/maximum dose: 5/40 mg). Changes in clinical signs of hypercortisolism and HRQoL were assessed over 12 months of treatment and were stratified by degree of mUFC control for each patient.
Results
Patients with controlled mUFC at month 12 (
n
= 45) had the greatest improvements from baseline in mean systolic (− 8.4 mmHg [95% CI − 13.9, − 2.9]) and diastolic blood pressure (− 6.0 mmHg [− 10.0, − 2.0]). Mean BMI, weight, and waist circumference improved irrespective of mUFC control. Significant improvements in CushingQoL total score of 5.9–8.3 points were found at month 12 compared with baseline, irrespective of mUFC control; changes were driven by improvements in physical problem score, with smaller improvements in psychosocial score.
Conclusions
Long-acting pasireotide provided significant improvements in clinical signs and HRQoL over 12 months of treatment, which, in some cases, occurred regardless of mUFC control. Long-acting pasireotide represents an effective treatment option and provides clinical benefit in patients with CD.
Clinical trial registration number
NCT01374906</description><subject>Adrenocorticotropic hormone</subject><subject>Blood pressure</subject><subject>Cushing's disease</subject><subject>Endocrinology</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Metabolic Diseases</subject><subject>Nervous system diseases</subject><subject>Original Article</subject><subject>Patients</subject><subject>Pituitary</subject><subject>Quality of life</subject><issn>1720-8386</issn><issn>0391-4097</issn><issn>1720-8386</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp9kcmO1DAQhi0EYhZ4AQ7IEhcuYariOHZzQy2Wllqay8zZchy7x6PE6XElSM1pXoPX40kw9LCIAydvX_3l0sfYC4Q3CKAuqIEWdQU1VIB101bwiJ2iKkctdPv4r_0JOyO6BRBKaPWUnYhaaKklnrIv2yntKuvmmHZ8bylmP82x9zyO-zx99sTdEFN0duAUd4m4TT2_W-wQ5wOfAh9iKGzi64VuSsS3-6_E-0jekn_Ls6dlmImHPI3c8v1NueWbzYbTvPSHZ-xJsAP55w_rObv-8P5q_anaXn7crN9tKyeUnCsNol65rkWJMigMXRm1Qedchx6gka1SXrh-1QWnaruSAcAp7WQnUABqKc7Z62NuGehu8TSbMZLzw2CTnxYydQMgUSkUBX31D3o7LTmV3xVKglg1tcZC1UfK5Yko-2D2OY42HwyC-WHGHM2YYsb8NGOgFL18iF660fe_S36pKIA4AlSe0s7nP73_E_sdlEyZhg</recordid><startdate>20201101</startdate><enddate>20201101</enddate><creator>Lacroix, A.</creator><creator>Bronstein, M. D.</creator><creator>Schopohl, J.</creator><creator>Delibasi, T.</creator><creator>Salvatori, R.</creator><creator>Li, Y.</creator><creator>Barkan, A.</creator><creator>Suzaki, N.</creator><creator>Tauchmanova, L.</creator><creator>Ortmann, C.-E.</creator><creator>Ravichandran, S.</creator><creator>Petersenn, S.</creator><creator>Pivonello, R.</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-4137-3025</orcidid></search><sort><creationdate>20201101</creationdate><title>Long-acting pasireotide improves clinical signs and quality of life in Cushing’s disease: results from a phase III study</title><author>Lacroix, A. ; Bronstein, M. D. ; Schopohl, J. ; Delibasi, T. ; Salvatori, R. ; Li, Y. ; Barkan, A. ; Suzaki, N. ; Tauchmanova, L. ; Ortmann, C.-E. ; Ravichandran, S. ; Petersenn, S. ; Pivonello, R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-80329cb61515f71fb12441cccb1e0045677e3cd9bfc72a95f00c78c5b31301853</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adrenocorticotropic hormone</topic><topic>Blood pressure</topic><topic>Cushing's disease</topic><topic>Endocrinology</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Metabolic Diseases</topic><topic>Nervous system diseases</topic><topic>Original Article</topic><topic>Patients</topic><topic>Pituitary</topic><topic>Quality of life</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lacroix, A.</creatorcontrib><creatorcontrib>Bronstein, M. D.</creatorcontrib><creatorcontrib>Schopohl, J.</creatorcontrib><creatorcontrib>Delibasi, T.</creatorcontrib><creatorcontrib>Salvatori, R.</creatorcontrib><creatorcontrib>Li, Y.</creatorcontrib><creatorcontrib>Barkan, A.</creatorcontrib><creatorcontrib>Suzaki, N.</creatorcontrib><creatorcontrib>Tauchmanova, L.</creatorcontrib><creatorcontrib>Ortmann, C.-E.</creatorcontrib><creatorcontrib>Ravichandran, S.</creatorcontrib><creatorcontrib>Petersenn, S.</creatorcontrib><creatorcontrib>Pivonello, R.</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of endocrinological investigation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lacroix, A.</au><au>Bronstein, M. D.</au><au>Schopohl, J.</au><au>Delibasi, T.</au><au>Salvatori, R.</au><au>Li, Y.</au><au>Barkan, A.</au><au>Suzaki, N.</au><au>Tauchmanova, L.</au><au>Ortmann, C.-E.</au><au>Ravichandran, S.</au><au>Petersenn, S.</au><au>Pivonello, R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-acting pasireotide improves clinical signs and quality of life in Cushing’s disease: results from a phase III study</atitle><jtitle>Journal of endocrinological investigation</jtitle><stitle>J Endocrinol Invest</stitle><addtitle>J Endocrinol Invest</addtitle><date>2020-11-01</date><risdate>2020</risdate><volume>43</volume><issue>11</issue><spage>1613</spage><epage>1622</epage><pages>1613-1622</pages><issn>1720-8386</issn><issn>0391-4097</issn><eissn>1720-8386</eissn><abstract>Purpose
Cushing’s disease (CD) is associated with significant clinical burden, increased mortality risk, and impaired health-related quality of life (HRQoL). This analysis explored the effect of long-acting pasireotide on clinical signs of hypercortisolism and HRQoL in a large subset of patients with CD.
Methods
In this phase III study (clinicaltrials.gov: NCT01374906), 150 adults with CD and a mean urinary free cortisol (mUFC) level between 1.5 and 5.0 times the upper limit of normal (ULN) started long-acting pasireotide 10 or 30 mg every 28 days with dose increases/decreases permitted based on mUFC levels/tolerability (minimum/maximum dose: 5/40 mg). Changes in clinical signs of hypercortisolism and HRQoL were assessed over 12 months of treatment and were stratified by degree of mUFC control for each patient.
Results
Patients with controlled mUFC at month 12 (
n
= 45) had the greatest improvements from baseline in mean systolic (− 8.4 mmHg [95% CI − 13.9, − 2.9]) and diastolic blood pressure (− 6.0 mmHg [− 10.0, − 2.0]). Mean BMI, weight, and waist circumference improved irrespective of mUFC control. Significant improvements in CushingQoL total score of 5.9–8.3 points were found at month 12 compared with baseline, irrespective of mUFC control; changes were driven by improvements in physical problem score, with smaller improvements in psychosocial score.
Conclusions
Long-acting pasireotide provided significant improvements in clinical signs and HRQoL over 12 months of treatment, which, in some cases, occurred regardless of mUFC control. Long-acting pasireotide represents an effective treatment option and provides clinical benefit in patients with CD.
Clinical trial registration number
NCT01374906</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>32385851</pmid><doi>10.1007/s40618-020-01246-0</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-4137-3025</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1720-8386 |
| ispartof | Journal of endocrinological investigation, 2020-11, Vol.43 (11), p.1613-1622 |
| issn | 1720-8386 0391-4097 1720-8386 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2400517713 |
| source | SpringerNature Journals |
| subjects | Adrenocorticotropic hormone Blood pressure Cushing's disease Endocrinology Internal Medicine Medicine Medicine & Public Health Metabolic Diseases Nervous system diseases Original Article Patients Pituitary Quality of life |
| title | Long-acting pasireotide improves clinical signs and quality of life in Cushing’s disease: results from a phase III study |
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