Efficacy and tolerability of the antispasmodic, pridinol, in patients with muscle-pain – results of primepain, a retrospective analysis of open-label real-world data provided by the German pain E-registry

Abstract

Objective

To evaluate efficacy and tolerability of the nonbenzodiazepine antispasmodic pridinol (PRI), as an add-on treatment in patients with muscle-related pain (MRP).

Methods

Exploratory retrospective analysis of depersonalized routine data provided by the German Pain e-Registry (GPeR) focusing on pain intensity, pain-related disabilities in daily life, wellbeing, and drug-related adverse events (DRAEs).

Primary endpoint based on a global response composite of (a) a clinically relevant analgesic response (relative improvement ≥50% and/or absolute improvement ≥ the minimal clinical important difference) for pain intensity and disability in combination with (b) an improvement in wellbeing (all at end of treatment vs. baseline), and (c) lack of any DRAEs.

Results

Between 1 January 2018 and 31 December 2020, the GPeR collected information on 121,803 pain patients of whom 1133 (0.9%; 54.5% female, mean ± SD age: 53.9 ± 11.8 years) received add-on PRI for the treatment of (mostly acute) MRP originating predominantly in the (lower) back (43.2%), lower limb (26.4%), or should/neck (21.1%). Average daily dose was 7.8 ± 1.8 (median 9, range 1.5–13.5) mg, duration of treatment 12.0 ± 10.2 (median 7, range 3–63) days. In total, 666 patients (58.8%) reported a complete, 395 (34.9%) a partial, and 72 (6.4%) patients no response – either because of lack of efficacy (n = 2, 0.2%) or DRAEs (n = 70, 6.2%). In response to PRI, 41.7% of patients documented a reduction of at least one other pain medication and 30.8% even the complete cessation of any other pharmacological pain treatments.

Conclusion

Based on this real-world data of the German Pain e-Registry, add-on treatment with PRI in patients with acute MRP under real-world conditions in daily life was well tolerated and associated with an improvement of pain intensity, pain-related disabilities, and overall wellbeing.

PLAIN LANGUAGE SUMMARY

Muscle pain is one of the most common pain problems worldwide.

In the majority of cases, muscle pain is temporary, transient, and benign in nature. However, people affected may still experience severe pain and significant pain-related disabilities in daily life activities that may require temporary drug treatment – also to be able to undertake the non-drug treatment measures necessary to prevent recurrence.

Current treatment recommendations for muscle pain are largely “non-specific” and limited to symptomatic pain-relieving measures (e.g. NSAIDs), whereas muscle relaxants are currently not recommended (primarily due to insufficient efficacy data from controlled clinical trials) but are nevertheless frequently prescribed.

In our analysis of depersonalized data from the German Pain e-Registry, the add-on treatment with pridinol proved to be effective and well tolerated in patients with muscle pain who have so far responded only insufficiently to recommended analgesic and adjuvant therapies

The available real-world evidence data on efficacy and tolerability of PRI show a beneficial and clinically relevant activity, but confirmation by active or placebo-controlled clinical studies is still lacking.

Keywords:

• Pridinol
• muscle pain
• real-world evidence
• German Pain e-Registry

Transparency

Declaration of funding

The concept for this evaluation of routine data provided by the German Pain e-Registry was developed by M.A.U. at the Institute of Neurological Sciences (IFNAP) on behalf of the German Pain Association (Deutsche Gesellschaft für Schmerzmedizin, DGS) and the German Pain League (Deutsche Schmerzliga, DSL) and its realization has been funded by an unrestricted scientific grant from Strathmann GmbH & Co. KG, Germany. Neither Strathmann as a company, nor any of its employees exerted any influence on the data acquisition, the conduct of this analysis, or on the interpretation and publication of the results.

Declaration of financial/other relationships

M.A.U., G.H.H.M.-S., and J.H. are physicians and independent of any significant/relevant financial or other relationship to the sponsor, except for minor reimbursements for occasional lecture or consulting fees. All are current (M.A.U., J.H.) or former (G.H.H. M.-S.) honorary members of the management board of the German Pain Association, M.A.U is also honorary member of the management board of the German Pain League.

The German Pain e-Registry is hosted by an independent contract research organization by order of the German Pain Association and under control of the Institute of Neurological Sciences and collects standardized real-world data from daily routine medical care since January 2000.

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All authors were involved in drafting the article or revising it critically for important intellectual content, and all authors read and approved the final manuscript to be published. M.A.U. takes responsibility for the integrity of the work as a whole, from inception to the finished article.

Acknowledgements

Preliminary results of this analysis have been presented at the annual Congress of the German Chapter of the International Association for the Study of Pain (IASP), 21–23 October, 2021, Mannheim, Germany.

Notes

i iDocLive is a registered trademark of O.Meany-MDPM GmbH, Nürnberg, Germany.