Dataset Information

Treatment Patterns and Healthcare Outcomes with Collagenase Clostridium Histolyticum vs Surgery in Peyronie's Disease: A Retrospective Claims Database Analysis.

ABSTRACT:

Introduction

Treatments for Peyronie's disease (PD) include surgical management and collagenase clostridium histolyticum (CCH).

Aims

To evaluate PD treatment trends after CCH approval and compare clinical outcomes in CCH- and surgery-treated cohorts.

Methods

Patients newly diagnosed with PD between January 2011 and December 2017 were identified in a U.S. claims database. Cohorts initiating treatment with CCH or surgery between January 2014 and June 2017 were included. Patients were continuously enrolled ≥6 months before and ≥12 months after index date. Post-treatment penile complications and analgesic use were compared 1 year after procedure in propensity score-matched cohorts.

Main outcome measures

The main outcome measures of this study were treatment patterns, penile complications, and analgesic use.

Results

In the newly diagnosed PD cohort, 1,609 patients received CCH and 1,555 patients had surgery. Overall CCH or surgery treatment rate/year increased from 9.8% in 2014 to 15.5% in 2017, with <1% receiving verapamil or interferon. Initial treatment ratios of CCH to surgery increased from approximately 1:1 (2014) to 2:1 (2017). In the unmatched CCH (n = 1,227) and surgery (n = 620) cohorts, more (P < .05) surgery-treated patients received analgesics (particularly opioids), oral PD therapies, vacuum erection devices, and phosphodiesterase-5 inhibitors before the index date. After propensity score matching (n = 620/cohort), newly occurring postprocedural complications during the follow-up period were higher in the surgery cohort (25.3% vs 18.4%, P = .003). The surgery cohort had significantly (P < .05) higher rates of erectile dysfunction (65.0% vs 44.8%), penile pain (17.9% vs 8.9%), and penile swelling (8.1% vs 5.2%) and was more likely to be prescribed opioids (93.3% vs 38.9%; P < .0001) or non-steroidal anti-inflammatory drugs (27.0% vs 20.3%; P = .006).

Conclusion

CCH demonstrated fewer complications and less analgesic use than surgery and was used as the initial therapy for PD twice as often as surgery. L Trost, H Huang, X Han, et al. Treatment Patterns and Healthcare Outcomes with Collagenase Clostridium Histolyticum vs Surgery in Peyronie's Disease: A Retrospective Claims Database Analysis. Sex Med 2021;9:100321.

SUBMITTER: Trost L

PROVIDER: S-EPMC8072160 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionCollagenase Clostridium histolyticum (CCH) intralesional injection was efficacious for the management of Peyronie's disease (PD) in the double-blinded, randomized, placebo-controlled Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies I and II (IMPRESS I and II). Little is known about the consequences of PD or treatment on the sexual partners of affected men.AimTo assess the safety and efficacy of CCH treatment in men who received placebo in the IMPRESS I or II study and to evaluate the men's PD symptoms and partner bother as reported by female sexual partners.MethodsIn this phase 3, open-label study (NCT01685437), men (n = 189) received up to eight injections of CCH (0.58 mg/injection). Female sexual partners who provided informed consent at screening (n = 30) participated in the study.Main outcome measuresCo-primary end points were change or percentage of change in penile curvature deformity and change in PD symptom bother domain score of the Peyronie's Disease Questionnaire (PDQ) from baseline to week 36. Participating women completed the PDQ for female sexual partners (PDQ-FSP) and the Female Sexual Function Index (FSFI).ResultsStatistically significant mean improvements were observed in penile curvature deformity (36.3% decrease; 95% CI = -41.6 to -30.9) and PDQ symptom bother score (2.4-point decrease; 95% CI = -3.0 to -1.8) from baseline to week 36. Most treatment-emergent adverse events were mild or moderate. After CCH treatment of their male partners, female sexual partners reported improvement (using the PDQ-FSP) in their male partner's PD symptoms and female bother regarding their partner's PD. The percentage of female sexual partners with sexual dysfunction (FSFI total score ? 26.55) also decreased after male partner treatment, from 75.0% at baseline to 33.3%.ConclusionsThese results support the safety and efficacy of CCH in the management of appropriate patients with PD and the potential benefits for patients' partners. Goldstein I, Knoll LD, Lipshultz LI, et al. Changes in the Effects of Peyronie's Disease After Treatment With Collagenase Clostridium histolyticum: Male Partners and Their Female Partners. Sex Med 2017;5:e124-e130.

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