{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,13]],"date-time":"2026-09-13T02:09:47Z","timestamp":1789265387953,"version":"build-2803163510"},"reference-count":33,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2014,4,17]],"date-time":"2014-04-17T00:00:00Z","timestamp":1397692800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/3.0\/"}],"funder":[{"name":"Gr\u00fcnenthal GmbH"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pain Practice"],"published-print":{"date-parts":[[2015,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>\n                      To evaluate the effectiveness and tolerability of tapentadol\n                      <jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\n                      monotherapy versus tapentadol\n                      <jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\n                      \/pregabalin combination therapy for severe, chronic low back pain with a neuropathic component.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Eligible patients had pain\n                      <jats:styled-content style=\"fixed-case\">DETECT<\/jats:styled-content>\n                      \u201cunclear\u201d or \u201cpositive\u201d ratings and average pain intensity \u2265\u00a06 (11\u2010point\n                      <jats:styled-content style=\"fixed-case\">NRS<\/jats:styled-content>\n                      \u20103 [average 3\u2010day pain intensity]) at baseline. Patients were titrated to tapentadol\n                      <jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\n                      300\u00a0mg\/day over 3\u00a0weeks. Patients with \u2265\u00a01\u2010point decrease in pain intensity and average pain intensity \u2265\u00a04 were randomized to tapentadol\n                      <jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\n                      (500\u00a0mg\/day) or tapentadol\n                      <jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\n                      (300\u00a0mg\/day)\/pregabalin (300\u00a0mg\/day) during an 8\u2010week comparative period.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In the per\u2010protocol population (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0288), the effectiveness of tapentadol\n                      <jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\n                      was clinically and statistically comparable to tapentadol\n                      <jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\n                      \/pregabalin based on the change in pain intensity from randomization to final evaluation (\n                      <jats:styled-content style=\"fixed-case\">LOCF<\/jats:styled-content>\n                      ;\n                      <jats:styled-content style=\"fixed-case\">LSMD<\/jats:styled-content>\n                      [95%\n                      <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>\n                      ], \u22120.066 [\u22120.57, 0.43];\n                      <jats:italic>P\u00a0<\/jats:italic>\n                      &lt;\u00a00.0001 for noninferiority). Neuropathic pain and quality\u2010of\u2010life measures improved significantly in both groups. Tolerability was good in both groups, in line with prior trials in the high dose range of 500\u00a0mg\/day for tapentadol\n                      <jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\n                      monotherapy, and favorable compared with historical combination trials of strong opioids and anticonvulsants for combination therapy. The incidence of the composite of dizziness and\/or somnolence was significantly lower with tapentadol\n                      <jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\n                      (16.9%) than tapentadol\n                      <jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\n                      \/pregabalin (27.0%;\n                      <jats:italic>P\u00a0<\/jats:italic>\n                      =\u00a00.0302).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      Tapentadol\n                      <jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\n                      500\u00a0mg is associated with comparable improvements in pain intensity and quality\u2010of\u2010life measures to tapentadol\n                      <jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\n                      300\u00a0mg\/pregabalin 300\u00a0mg, with improved central nervous system tolerability, suggesting that tapentadol\n                      <jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\n                      monotherapy may offer a favorable treatment option for severe low back pain with a neuropathic component.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/papr.12200","type":"journal-article","created":{"date-parts":[[2014,4,17]],"date-time":"2014-04-17T03:24:42Z","timestamp":1397705082000},"page":"455-470","source":"Crossref","is-referenced-by-count":64,"title":["Effectiveness and Safety of Tapentadol Prolonged Release (\n                    <scp>PR<\/scp>\n                    ) Versus a Combination of Tapentadol\n                    <scp>PR<\/scp>\n                    and Pregabalin for the Management of Severe, Chronic Low Back Pain With a Neuropathic Component: A Randomized, Double\u2010blind, Phase 3b Study"],"prefix":"10.1111","volume":"15","author":[{"given":"Ralf","family":"Baron","sequence":"first","affiliation":[{"name":"Division of Neurological Pain Research and Therapy Department of Neurology, University Hospital Schleswig\u2010Holstein Campus Kiel Kiel Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilio","family":"Martin\u2010Mola","sequence":"additional","affiliation":[{"name":"Department of Rheumatology University Hospital La Paz Autonomous University of Madrid Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"M\u00fcller","sequence":"additional","affiliation":[{"name":"Medical Affairs Europe &amp; Australia Gr\u00fcnenthal GmbH Aachen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecile","family":"Dubois","sequence":"additional","affiliation":[{"name":"Global Biometrics in Gr\u00fcnenthal Innovation Gr\u00fcnenthal 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