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      Pharmacodynamic analysis of the analgesic effect of capsaicin 8% patch (Qutenza™) in diabetic neuropathic pain patients: detection of distinct response groups

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          Abstract

          Treatment of chronic pain is associated with high variability in the response to pharmacological interventions. A mathematical pharmacodynamic model was developed to quantify the magnitude and onset/offset times of effect of a single capsaicin 8% patch application in the treatment of painful diabetic peripheral neuropathy in 91 patients. In addition, a mixture model was applied to objectively match patterns in pain-associated behavior. The model identified four distinct subgroups that responded differently to treatment: 3.3% of patients (subgroup 1) showed worsening of pain; 31% (subgroup 2) showed no change; 32% (subgroup 3) showed a quick reduction in pain that reached a nadir in week 3, followed by a slow return towards baseline (16% ± 6% pain reduction in week 12); 34% (subgroup 4) showed a quick reduction in pain that persisted (70% ± 5% reduction in week 12). The estimate of the response-onset rate constant, obtained for subgroups 1, 3, and 4, was 0.76 ± 0.12 week −1 (median ± SE), indicating that every 0.91 weeks the pain score reduces or increases by 50% relative to the score of the previous week (= t½). The response-offset rate constant could be determined for subgroup 3 only and was 0.09 ± 0.04 week −1 (t½ 7.8 weeks). The analysis allowed separation of a heterogeneous neuropathic pain population into four homogenous subgroups with distinct behaviors in response to treatment with capsaicin. It is argued that this model-based approach may have added value in analyzing longitudinal chronic pain data and allows optimization of treatment algorithms for patients suffering from chronic pain conditions.

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          Author and article information

          Journal
          J Pain Res
          J Pain Res
          Journal of Pain Research
          Dove Medical Press
          1178-7090
          2012
          15 March 2012
          : 5
          : 51-59
          Affiliations
          [1 ]Department of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands
          [2 ]Global Clinical Pharmacology and Exploratory Development, Astellas Pharma Global Development Europe, Leiderdorp, The Netherlands
          [3 ]Global Medical Sciences, Astellas Pharma Global Development Europe, Leiderdorp, The Netherlands
          Author notes
          Correspondence: Albert Dahan, Department of Anesthesiology, Leiden University Medical Center, P5-Q, 2300 RC Leiden, The Netherlands Tel +31 71 526 2301, Fax +31 71 526 6230, Email a.dahan@ 123456lumc.nl
          [*]

          These authors contributed equally to this work

          Article
          jpr-5-051
          10.2147/JPR.S30406
          3333798
          22536092
          © 2012 Martini et al, publisher and licensee Dove Medical Press Ltd.

          This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

          Categories
          Original Research

          Anesthesiology & Pain management

          modeling, diabetic neuropathic pain, capsaicin 8%, mixture model

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