Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie’s Disease
Peyronie’s disease (PD), defined as the abnormal formation of fibrous plaque(s) in the tunica albuginea of the penis, is a chronic condition that afflicts 3% to 13% of the US male population; there is no current research on the efficacy and safety of collagenase Clostridium histolyticum (CCH) in the...
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creator | Nguyen, Hoang Minh Tue Anaissie, James DeLay, Kenneth J. Yafi, Faysal A. Sikka, Suresh C. Hellstrom, Wayne J.G. |
description | Peyronie’s disease (PD), defined as the abnormal formation of fibrous plaque(s) in the tunica albuginea of the penis, is a chronic condition that afflicts 3% to 13% of the US male population; there is no current research on the efficacy and safety of collagenase Clostridium histolyticum (CCH) in the treatment of acute phase PD.
To examine the efficacy and safety of CCH in the treatment of acute-phase PD.
We retrospectively reviewed the records for all patients treated with CCH for PD from April 2014 through April 2017. Patients who reported penile pain and duration of PD no longer than 12 months at presentation qualified as being in the acute phase of PD. The primary outcomes of interest were final changes in curvature after CCH treatment regardless of the number of CCH cycles received and frequency of treatment-related adverse events.
Parameters of efficacy and safety were compared between acute- and stable-phase PD.
A total of 162 patients were included in the study, of which 36 (22%) qualified as having acute-phase PD (group 1) and the remaining 126 (78%) qualified as having stable-phase PD (group 2). Median duration of PD was 8.5 months (range = 1–12) for group 1 and 18 months (range = 1–492) for group 2. There was no significant difference in final change in curvature between the acute and stable phases of PD (16.7° vs 15.6°; P = .654). There was no statistically significant difference in frequency of treatment-related adverse events between the acute phase (4 patients, 11%) and the stable phase (12 patients, 10%; P = .778).
CCH therapy is as safe and efficacious in acute-phase PD as it is in stable-phase PD.
This is the first report that assesses the safety and efficacy of CCH therapy focusing on acute-phase PD. This study was composed of a large cohort of patients receiving CCH therapy in acute- and stable-phase PD. Limitations include bias associated with retrospective studies, a small sample, and a single-center setting.
Although CCH is not clearly indicated for treatment during the acute phase of PD, these results suggest that CCH use during this phase can be effective and safe. There was no statistically significant difference in final change in curvature or treatment-related adverse events after CCH therapy delivered between the acute and stable phases of PD.
Nguyen HMT, Anaissie J, DeLay KJ, et al. Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie’s Disease. J Sex Med 2017;14:1220–1225. |
doi_str_mv | 10.1016/j.jsxm.2017.08.008 |
format | Article |
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To examine the efficacy and safety of CCH in the treatment of acute-phase PD.
We retrospectively reviewed the records for all patients treated with CCH for PD from April 2014 through April 2017. Patients who reported penile pain and duration of PD no longer than 12 months at presentation qualified as being in the acute phase of PD. The primary outcomes of interest were final changes in curvature after CCH treatment regardless of the number of CCH cycles received and frequency of treatment-related adverse events.
Parameters of efficacy and safety were compared between acute- and stable-phase PD.
A total of 162 patients were included in the study, of which 36 (22%) qualified as having acute-phase PD (group 1) and the remaining 126 (78%) qualified as having stable-phase PD (group 2). Median duration of PD was 8.5 months (range = 1–12) for group 1 and 18 months (range = 1–492) for group 2. There was no significant difference in final change in curvature between the acute and stable phases of PD (16.7° vs 15.6°; P = .654). There was no statistically significant difference in frequency of treatment-related adverse events between the acute phase (4 patients, 11%) and the stable phase (12 patients, 10%; P = .778).
CCH therapy is as safe and efficacious in acute-phase PD as it is in stable-phase PD.
This is the first report that assesses the safety and efficacy of CCH therapy focusing on acute-phase PD. This study was composed of a large cohort of patients receiving CCH therapy in acute- and stable-phase PD. Limitations include bias associated with retrospective studies, a small sample, and a single-center setting.
Although CCH is not clearly indicated for treatment during the acute phase of PD, these results suggest that CCH use during this phase can be effective and safe. There was no statistically significant difference in final change in curvature or treatment-related adverse events after CCH therapy delivered between the acute and stable phases of PD.
Nguyen HMT, Anaissie J, DeLay KJ, et al. Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie’s Disease. J Sex Med 2017;14:1220–1225.</description><identifier>ISSN: 1743-6095</identifier><identifier>EISSN: 1743-6109</identifier><identifier>DOI: 10.1016/j.jsxm.2017.08.008</identifier><identifier>PMID: 28874331</identifier><language>eng</language><publisher>Netherlands: Elsevier Inc</publisher><subject>Acute Phase ; Adult ; Collagenase Clostridium histolyticum ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; End Points ; Humans ; Injections, Intralesional - methods ; Male ; Microbial Collagenase - administration & dosage ; Middle Aged ; Penile Induration - drug therapy ; Penis - drug effects ; Peyronie’s Disease ; Plaque, Atherosclerotic - drug therapy ; Retrospective Studies ; Treatment Outcome ; Treatment Outcomes</subject><ispartof>Journal of sexual medicine, 2017-10, Vol.14 (10), p.1220-1225</ispartof><rights>2017 International Society for Sexual Medicine</rights><rights>Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c356t-647968b79cedbcd3fcdc7bf68fc0a0af6615fc08db23dcc356038c89111470a63</citedby><cites>FETCH-LOGICAL-c356t-647968b79cedbcd3fcdc7bf68fc0a0af6615fc08db23dcc356038c89111470a63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28874331$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nguyen, Hoang Minh Tue</creatorcontrib><creatorcontrib>Anaissie, James</creatorcontrib><creatorcontrib>DeLay, Kenneth J.</creatorcontrib><creatorcontrib>Yafi, Faysal A.</creatorcontrib><creatorcontrib>Sikka, Suresh C.</creatorcontrib><creatorcontrib>Hellstrom, Wayne J.G.</creatorcontrib><title>Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie’s Disease</title><title>Journal of sexual medicine</title><addtitle>J Sex Med</addtitle><description>Peyronie’s disease (PD), defined as the abnormal formation of fibrous plaque(s) in the tunica albuginea of the penis, is a chronic condition that afflicts 3% to 13% of the US male population; there is no current research on the efficacy and safety of collagenase Clostridium histolyticum (CCH) in the treatment of acute phase PD.
To examine the efficacy and safety of CCH in the treatment of acute-phase PD.
We retrospectively reviewed the records for all patients treated with CCH for PD from April 2014 through April 2017. Patients who reported penile pain and duration of PD no longer than 12 months at presentation qualified as being in the acute phase of PD. The primary outcomes of interest were final changes in curvature after CCH treatment regardless of the number of CCH cycles received and frequency of treatment-related adverse events.
Parameters of efficacy and safety were compared between acute- and stable-phase PD.
A total of 162 patients were included in the study, of which 36 (22%) qualified as having acute-phase PD (group 1) and the remaining 126 (78%) qualified as having stable-phase PD (group 2). Median duration of PD was 8.5 months (range = 1–12) for group 1 and 18 months (range = 1–492) for group 2. There was no significant difference in final change in curvature between the acute and stable phases of PD (16.7° vs 15.6°; P = .654). There was no statistically significant difference in frequency of treatment-related adverse events between the acute phase (4 patients, 11%) and the stable phase (12 patients, 10%; P = .778).
CCH therapy is as safe and efficacious in acute-phase PD as it is in stable-phase PD.
This is the first report that assesses the safety and efficacy of CCH therapy focusing on acute-phase PD. This study was composed of a large cohort of patients receiving CCH therapy in acute- and stable-phase PD. Limitations include bias associated with retrospective studies, a small sample, and a single-center setting.
Although CCH is not clearly indicated for treatment during the acute phase of PD, these results suggest that CCH use during this phase can be effective and safe. There was no statistically significant difference in final change in curvature or treatment-related adverse events after CCH therapy delivered between the acute and stable phases of PD.
Nguyen HMT, Anaissie J, DeLay KJ, et al. Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie’s Disease. J Sex Med 2017;14:1220–1225.</description><subject>Acute Phase</subject><subject>Adult</subject><subject>Collagenase Clostridium histolyticum</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Administration Schedule</subject><subject>End Points</subject><subject>Humans</subject><subject>Injections, Intralesional - methods</subject><subject>Male</subject><subject>Microbial Collagenase - administration & dosage</subject><subject>Middle Aged</subject><subject>Penile Induration - drug therapy</subject><subject>Penis - drug effects</subject><subject>Peyronie’s Disease</subject><subject>Plaque, Atherosclerotic - drug therapy</subject><subject>Retrospective Studies</subject><subject>Treatment Outcome</subject><subject>Treatment Outcomes</subject><issn>1743-6095</issn><issn>1743-6109</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kM1u3CAUhVHVqvnrC3RRsezGLpgxxlI30TR_UqREarJGGC4dRraZAq7iXV6jr5cnCdYkWYYN98L5jnQOQl8pKSmh_Me23MaHoawIbUoiSkLEB3RImxUrOCXtx9eZtPUBOopxSwjLp_qMDioh8hejh2j3W1lIM1ajwWfWOq30jL3Fa9_36g-MKgJe9z6m4IybBrxxMfl-Tk7nxY04bQDfBVBpgDEt4KmeEhS3mwW8hTn40cHT4_-If7kI-fEEfbKqj_Dl5T5G9-dnd-vL4vrm4mp9el1oVvNU8FXTctE1rQbTacOsNrrpLBdWE0WU5ZzWeRSmq5jRC0OY0KKllK4aojg7Rt_3vrvg_04Qkxxc1JBTjeCnKGnLeFW3ddVkabWX6uBjDGDlLrhBhVlSIpem5VYuTculaUmEzE1n6NuL_9QNYN6Q12qz4OdeADnlPwdBRu1gzHlcAJ2k8e49_2dW2ZJA</recordid><startdate>201710</startdate><enddate>201710</enddate><creator>Nguyen, Hoang Minh Tue</creator><creator>Anaissie, James</creator><creator>DeLay, Kenneth J.</creator><creator>Yafi, Faysal A.</creator><creator>Sikka, Suresh C.</creator><creator>Hellstrom, Wayne J.G.</creator><general>Elsevier Inc</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>7X8</scope></search><sort><creationdate>201710</creationdate><title>Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie’s Disease</title><author>Nguyen, Hoang Minh Tue ; Anaissie, James ; DeLay, Kenneth J. ; Yafi, Faysal A. ; Sikka, Suresh C. ; Hellstrom, Wayne J.G.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c356t-647968b79cedbcd3fcdc7bf68fc0a0af6615fc08db23dcc356038c89111470a63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Acute Phase</topic><topic>Adult</topic><topic>Collagenase Clostridium histolyticum</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Administration Schedule</topic><topic>End Points</topic><topic>Humans</topic><topic>Injections, Intralesional - methods</topic><topic>Male</topic><topic>Microbial Collagenase - administration & dosage</topic><topic>Middle Aged</topic><topic>Penile Induration - drug therapy</topic><topic>Penis - drug effects</topic><topic>Peyronie’s Disease</topic><topic>Plaque, Atherosclerotic - drug therapy</topic><topic>Retrospective Studies</topic><topic>Treatment Outcome</topic><topic>Treatment Outcomes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nguyen, Hoang Minh Tue</creatorcontrib><creatorcontrib>Anaissie, James</creatorcontrib><creatorcontrib>DeLay, Kenneth J.</creatorcontrib><creatorcontrib>Yafi, Faysal A.</creatorcontrib><creatorcontrib>Sikka, Suresh C.</creatorcontrib><creatorcontrib>Hellstrom, Wayne J.G.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of sexual medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nguyen, Hoang Minh Tue</au><au>Anaissie, James</au><au>DeLay, Kenneth J.</au><au>Yafi, Faysal A.</au><au>Sikka, Suresh C.</au><au>Hellstrom, Wayne J.G.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie’s Disease</atitle><jtitle>Journal of sexual medicine</jtitle><addtitle>J Sex Med</addtitle><date>2017-10</date><risdate>2017</risdate><volume>14</volume><issue>10</issue><spage>1220</spage><epage>1225</epage><pages>1220-1225</pages><issn>1743-6095</issn><eissn>1743-6109</eissn><abstract>Peyronie’s disease (PD), defined as the abnormal formation of fibrous plaque(s) in the tunica albuginea of the penis, is a chronic condition that afflicts 3% to 13% of the US male population; there is no current research on the efficacy and safety of collagenase Clostridium histolyticum (CCH) in the treatment of acute phase PD.
To examine the efficacy and safety of CCH in the treatment of acute-phase PD.
We retrospectively reviewed the records for all patients treated with CCH for PD from April 2014 through April 2017. Patients who reported penile pain and duration of PD no longer than 12 months at presentation qualified as being in the acute phase of PD. The primary outcomes of interest were final changes in curvature after CCH treatment regardless of the number of CCH cycles received and frequency of treatment-related adverse events.
Parameters of efficacy and safety were compared between acute- and stable-phase PD.
A total of 162 patients were included in the study, of which 36 (22%) qualified as having acute-phase PD (group 1) and the remaining 126 (78%) qualified as having stable-phase PD (group 2). Median duration of PD was 8.5 months (range = 1–12) for group 1 and 18 months (range = 1–492) for group 2. There was no significant difference in final change in curvature between the acute and stable phases of PD (16.7° vs 15.6°; P = .654). There was no statistically significant difference in frequency of treatment-related adverse events between the acute phase (4 patients, 11%) and the stable phase (12 patients, 10%; P = .778).
CCH therapy is as safe and efficacious in acute-phase PD as it is in stable-phase PD.
This is the first report that assesses the safety and efficacy of CCH therapy focusing on acute-phase PD. This study was composed of a large cohort of patients receiving CCH therapy in acute- and stable-phase PD. Limitations include bias associated with retrospective studies, a small sample, and a single-center setting.
Although CCH is not clearly indicated for treatment during the acute phase of PD, these results suggest that CCH use during this phase can be effective and safe. There was no statistically significant difference in final change in curvature or treatment-related adverse events after CCH therapy delivered between the acute and stable phases of PD.
Nguyen HMT, Anaissie J, DeLay KJ, et al. Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie’s Disease. J Sex Med 2017;14:1220–1225.</abstract><cop>Netherlands</cop><pub>Elsevier Inc</pub><pmid>28874331</pmid><doi>10.1016/j.jsxm.2017.08.008</doi><tpages>6</tpages></addata></record> |
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source | MEDLINE; Oxford University Press Journals All Titles (1996-Current) |
subjects | Acute Phase Adult Collagenase Clostridium histolyticum Dose-Response Relationship, Drug Drug Administration Schedule End Points Humans Injections, Intralesional - methods Male Microbial Collagenase - administration & dosage Middle Aged Penile Induration - drug therapy Penis - drug effects Peyronie’s Disease Plaque, Atherosclerotic - drug therapy Retrospective Studies Treatment Outcome Treatment Outcomes |
title | Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie’s Disease |
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