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Zalicus Inc. Message Board

  • scistats scistats May 18, 2013 9:08 PM Flag

    Zalicus is using (PI-NRS) to measure Z160 pain reduction. Pfizer Global R&D says 2 point reduction is clinically important.

    Zalicus is using (PI-NRS) to measure Z160 pain reduction. Pfizer Global R&D says 2 point reduction is clinically important. Can Z160 achieve this?

    Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change). To date, there are no data driven estimates for clinically important differences in pain intensity scales used for chronic pain studies. We have estimated a clinically important difference on this scale by relating it to global assessments of change in multiple studies of chronic pain. Data on 2724 subjects from 10 recently completed placebo-controlled clinical trials of pregabalin in diabetic neuropathy, postherpetic neuralgia, chronic low back pain, fibromyalgia, and osteoarthritis were used. The studies had similar designs and measurement instruments, including the PI-NRS, collected in a daily diary, and the standard seven-point patient global impression of change (PGIC), collected at the endpoint. The changes in the PI-NRS from baseline to the endpoint were compared to the PGIC for each subject. Categories of ‘much improved’ and ‘very much improved’ were used as determinants of a clinically important difference and the relationship to the PI-NRS was explored using graphs, box plots, and sensitivity/specificity analyses. A consistent relationship between the change in PI-NRS and the PGIC was demonstrated regardless of study, disease type, age, sex, study result, or treatment group. On average, a reduction of approximately two points or a reduction of approximately 30% in the PI-NRS represented a clinically important difference.

    Sentiment: Strong Buy

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    • The exact mechanism of action of LYRICA has not been elucidated.

      *These findings are based on preclinical animal models. The clinical significance in humans
      is unknown.

      *pfizerpro**dot**comm****/hcp/lyrica/mechanism-of-action******

      Sentiment: Strong Buy

 
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