Indirect treatment comparison of two non-invasive patient-controlled analgesia treatments for acute post-operative pain management

Abstract

Objectives: To evaluate the relative clinical efficacy, safety, and tolerability associated with two non-invasive patient-controlled analgesia (PCA) treatments, sufentanil sublingual tablet system (SSTS) and fentanyl iontophoretic patient-controlled transdermal system (PCTS). These two treatments have recently been approved in the EU for the management of acute moderate-to-severe post-operative pain in adult patients.

Methods: As no head-to-head trials comparing SSTS and PCTS currently exist, indirect treatment comparison (ITC) analyses were conducted to evaluate SSTS or PCTS versus intravenous (IV) morphine PCA.

Results: Five studies, four assessing PCTS and one assessing SSTS, were included in this analysis. SSTS had statistical or numerical advantages over PCTS for both patient global assessment (PGA) and healthcare professional global assessment (HPGA) outcomes at all time points investigated. SSTS was also associated with greater patient ease of use (weighted mean difference [WMD]: 0.13; 95% confidence interval [CI]: −0.02–0.28) and a higher patient satisfaction score (WMD: 0.31; 95% CI: 0.05–0.57; p = .019) compared with PCTS. In terms of tolerability, all-cause withdrawals from treatment were reported to be less likely with SSTS (risk ratio: 0.65; 95% CI: 0.42–1.02). No significant differences were observed between SSTS and PCTS in terms of safety and adverse events.

Conclusions: In the absence of direct head-to-head data, the combination of promising phase III trial results compared to IV morphine PCA, a SLR comparison against other opioid treatments, and the results of this exploratory analysis present a strong rationale in support of SSTS as a key option for management of post-operative pain.

Keywords:

• Analgesia
• analgesics
• fentanyl
• Iontophoresis
• opioid
• pain
• patient-controlled
• post-operative
• sufentanil
• tablets

Transparency

Declaration of funding

This work was conducted by Parexel Market Access and funded by Grünenthal GmbH.

Author contributions: ST, HL and PK were involved in the design, analysis and interpretation of the data, and review and final approval of the manuscript. PP was involved in the analysis, interpretation, review and final approval of the manuscript.

Declaration of financial/other relationships

H.L. and P.K. have disclosed that they are employees of Grünenthal GmbH who market Zalviso in the EU. P.P. has disclosed that she is an employee of AcelRx Pharmaceuticals who will market Zalviso in the US. S.T. has disclosed that she is an employee of Parexel Market Access.

CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no relevant financial or other relationships to disclose.

Acknowledgments

The authors acknowledge the assistance of Barinder Singh and Sumeet Attri with data extraction and conduct of the SLR and of Sophie Shaw with drafting the manuscript (all working for Parexel Market Access).

Notes

1 Zalviso (R) is a registered trade name of Gruenenthal GmbH, Aachen, Germany for Europe and AcelRx Pharmaceuticals, INC., Redwood City, USA

2 Ionsys (R) is a registered trade name of Incline Therapeutics Europe Ltd, 21 St. Thomas Street Bristol BS1 6JS, UK