Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren's contracture.

Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren's contracture. Research Abstract Details 

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Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren's contracture. Abstract Text:

Marie A Badalamente,Lawrence C Hurst,

PURPOSE: To further evaluate the efficacy and safety of an injectable mixed subtype collagenase for the treatment of Dupuytren's contracture (DC). METHODS: Patients with flexion deformities of the metacarpophalangeal (MCP) and/or the proximal interphalangeal (PIP) joints of 20 degrees or greater were randomized in a double-blind, placebo-controlled trial. Patients completing this phase could enter an open-label extension phase. The primary efficacy variable was clinical success: contracture correction to within 5 degrees of normal (normal, 0 degrees ). Additional efficacy variables included the time and number of injections required to achieve success in the primary joint. Recurrence of contracture to 20 degrees or greater in successfully treated joints and adverse events (AEs) were recorded. RESULTS: Thirty-three of 35 patients (mean +/- SD, 61 +/- 9 y) entering the double-blind phase completed the study; 19 of them entered the open-label extension. In the double-blind phase, clinical success of the primary joint was achieved in 16 of 23 patients receiving 1 injection and in 21 of 23 patients receiving 3 injections. No placebo-treated patients achieved joint correction. In the open-label extension, 17 of 19 patients achieved clinical success in at least 1 joint. The mean number of injections for clinical success in the double-blind and extension phases was 1.5 and 1.4, respectively; the time to clinical success ranged between 1 and 29 days. Overall, of 62 joints (31 MCP, 31 PIP) treated in 35 patients, 54 joints achieved clinical success. Over the 24-month follow-up period after the last injection, 5 joints had a recurrence. The most frequent treatment-related AEs were local reactions to injections. AEs were mild and resolved over several weeks. There were no serious treatment-related AEs. CONCLUSIONS: The collagenase injections safely and effectively corrected MCP and PIP contractures in patients with 1 or more DC-affected joints. Recurrence rates after treatment appear to be low. Data suggest that this collagenase appears to be a viable nonsurgical treatment option for DC.

Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren's contracture. Publishing Authors By Initials

MA Badalamente,LC Hurst,

For similar diagnosis: prognosis: treatment outcome research abstracts see: diagnosis: prognosis: treatment outcome research

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Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren's contracture. Journal Published:

PUBLICATION TYPE: Research Support, U.S. Gov't,

Journal: The Journal of hand surgery

VOLUME: 32

Page Numbers: 767-74

Journal Abbreviation:

ISSN: 0363-5023

DAY: 3

MONTH: 12

YEAR: 2007

Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren's contracture. Information

Number of References:

LANGUAGE: eng

NlmUniqueID: 7609631

Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren's contracture. Keywords Mesh Terms:

KEYWORDS: Treatment Outcome

MESH TERMS: physiology

Chemical & Substance for Abstract: Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren's contracture. Information

Substance Name: Collagenases

Registry Number: EC 3.4.24.-

Grant and Affiliation Information for Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren's contracture.

AFFILIATION: Department of Orthopedics, State University of New York at Stony Brook, Health Science Center, Stony Brook, NY 11794-8181, USA. mbadalamente@notes.cc.sunysb.edu

Country: United States

AGENCY: United States NCRR

GRANT: M01RR1071002

ACRONYM: RR

MEDLINETA: J Hand Surg [Am]

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