{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T18:39:13Z","timestamp":1785436753872,"version":"3.56.0"},"reference-count":27,"publisher":"MDPI AG","issue":"13","license":[{"start":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T00:00:00Z","timestamp":1782172800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Strathmann","award":["PROVIDENCE"],"award-info":[{"award-number":["PROVIDENCE"]}]},{"award":["PROVIDENCE"],"award-info":[{"award-number":["PROVIDENCE"]}],"id":[{"id":"https:\/\/ror.org\/01y8eh752","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely recommended for the treatment of acute (low) back pain, despite modest effectiveness and well-known safety concerns, particularly in older patients. Pridinol is a centrally acting antispasmodic with a mechanism-oriented approach targeting muscle spasm, a key component of acute back pain. While a previous real-world analysis demonstrated a significantly better tolerability and effectiveness of pridinol compared with NSAIDs, age-dependent effects have not yet been systematically evaluated. Objective: To assess the age dependency of effectiveness, safety, and tolerability of pridinol versus NSAIDs in patients with acute (low) back pain under real-world conditions, based on already available data. Methods: This secondary analysis used propensity score-matched real-world data from the German Pain e-Registry (PROVIDENCE study; EUPAS identifier: 49718). A total of 934 patients with acute (low) back pain treated for four weeks with either pridinol (n = 467) or NSAIDs (n = 467) were stratified by age (&lt;65 vs. \u226565 years). Outcomes included the incidence of adverse drug reactions (ADRs), ADR-related treatment discontinuations, time to ADR occurrence, and clinically meaningful improvement in pain-related disability (\u226550% reduction in modified Pain Disability Index). Analyses were performed within and between age strata. Results: Overall, ADRs were reported by 9.0% of pridinol-treated patients and 20.8% of NSAID-treated patients (p &lt; 0.001). In the pridinol cohort, ADR rates were virtually identical in patients &lt;65 and \u226565 years (8.9% vs. 9.2%; p = 0.940). In contrast, NSAID-treated patients showed a pronounced age-related increase in ADR incidence (17.3% vs. 32.1%; p &lt; 0.001). ADR-related treatment discontinuation rates under NSAIDs increased markedly with age (5.9% vs. 21.1%; p &lt; 0.001), whereas rates under pridinol remained low and age independent (3.1% vs. 4.6%; p = 0.447). Gastrointestinal and cardiovascular ADRs were the main contributors to the age-related risk increase under NSAIDs, while corresponding events under pridinol were rare across age groups. Clinically meaningful improvement in pain-related disability was achieved with pridinol\/NSAIDs in 91.9\/48.0% (&lt;65 years) and 88.1\/47.7% (\u226565 years; p &lt; 0.001 for both). Conclusions: Age is a major modifier of NSAID-related risk but not of pridinol tolerability in acute (low) back pain. While NSAID-associated ADRs and treatment discontinuations increase substantially in patients aged 65 years or older, pridinol demonstrates a stable, age-independent safety profile combined with significantly better functional outcomes. These findings suggest that, particularly in older patients, mechanism-oriented alternatives such as pridinol may offer a more favorable benefit\u2013risk profile than NSAIDs.<\/jats:p>","DOI":"10.3390\/jcm15134888","type":"journal-article","created":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T03:09:17Z","timestamp":1782270557000},"page":"4888","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Age-Dependent Safety and Effectiveness of Pridinol Versus NSAIDs in Acute (Low) Back Pain: A Secondary Analysis of the Providence Real-World Study"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7165-9492","authenticated-orcid":false,"given":"Michael A.","family":"\u00dcberall","sequence":"first","affiliation":[{"name":"Center of Excellence in Health Care Research, Institute of Neurological Sciences\u2014IFNAP, Nordostpark 51, 90411 N\u00fcrnberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Artur","family":"Schikowski","sequence":"additional","affiliation":[{"name":"Pain Institute & Center for Medical Education D\u00fcsseldorf, Friedrichstra\u00dfe 13-15, 40217 D\u00fcsseldorf, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-8619-2433","authenticated-orcid":false,"given":"Philipp C. G.","family":"M\u00fcller-Schwefe","sequence":"additional","affiliation":[{"name":"Interdisciplinary Pain and Palliative Care Center G\u00f6ppingen, Schillerplatz 8\/1, 73033 G\u00f6ppingen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,6,23]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2356","DOI":"10.1016\/S0140-6736(18)30480-X","article-title":"What low back pain is and why we need to pay attention","volume":"391","author":"Hartvigsen","year":"2018","journal-title":"Lancet"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"736","DOI":"10.1016\/S0140-6736(16)30970-9","article-title":"Non-specific low back pain","volume":"389","author":"Maher","year":"2017","journal-title":"Lancet"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"2028","DOI":"10.1002\/art.34347","article-title":"A systematic review of the global prevalence of low back pain","volume":"64","author":"Hoy","year":"2012","journal-title":"Arthritis Rheum."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"a171","DOI":"10.1136\/bmj.a171","article-title":"Prognosis in patients with recent onset low back pain in Australian primary care: Inception cohort study","volume":"337","author":"Henschke","year":"2008","journal-title":"BMJ"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1002\/j.1532-2149.2012.00170.x","article-title":"Clinical course of non-specific low back pain: A systematic review of prospective cohort studies set in primary care","volume":"17","author":"Itz","year":"2013","journal-title":"Eur. 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