Numbers needed to treat calculated from responder rates give a better indication of efficacy in osteoarthritis trials than mean pain scores.
INTRODUCTION: Osteoarthritis trials usually report average changes in visual analogue scale (VAS) pain, and examine the difference between treatment and placebo. We investigated whether dichotomous responder analysis provides a more informative interpretation of drug efficacy. METHODS: Merck suppli...
| Main Authors: | , , , |
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| Format: | Journal article |
| Language: | English |
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2008
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| _version_ | 1826263609546637312 |
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| author | Moore, R Moore, O Derry, S McQuay, H |
| author_facet | Moore, R Moore, O Derry, S McQuay, H |
| author_sort | Moore, R |
| collection | OXFORD |
| description | INTRODUCTION: Osteoarthritis trials usually report average changes in visual analogue scale (VAS) pain, and examine the difference between treatment and placebo. We investigated whether dichotomous responder analysis provides a more informative interpretation of drug efficacy. METHODS: Merck supplied the number of patients who, by 6 weeks, had achieved pain relief compared with a baseline of 0% or more, 10% or more, 20% or more, and so on at equal intervals up to 90% or more. These different levels of pain relief were used to distinguish different definitions of responders, for example at least 50% pain relief from baseline. Numbers and percentages of patients achieving each level were identified. Information was sought from a dose-response trial over 6 weeks in osteoarthritis using placebo and using etoricoxib at 5, 10, 30 and 60 mg daily. RESULTS: With placebo, the proportions of patients achieving at least 20%, 50% and 70% pain relief over baseline at 6 weeks were 30%, 11% and 2%. With 60 mg etoricoxib the equivalent percentages were 74%, 49% and 29%. The numbers needed to treat for 30 mg and 60 mg etoricoxib to produce at least 50% pain relief at 6 weeks compared with placebo were 4.2 (95% confidence interval 3.8 to 8.6) and 2.6 (2.0 to 3.9), respectively. Levels of pain relief of 50% and above discriminated best between different doses of etoricoxib. CONCLUSION: Responder analysis seemed to be more sensitive than examination of average changes in VAS pain scores. Validation would require calculations to be performed on a set of trials using individual patient data not available in publications. |
| first_indexed | 2024-03-06T19:54:31Z |
| format | Journal article |
| id | oxford-uuid:25199bda-cc18-435f-91ef-bb61218e31db |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T19:54:31Z |
| publishDate | 2008 |
| record_format | dspace |
| spelling | oxford-uuid:25199bda-cc18-435f-91ef-bb61218e31db2022-03-26T11:53:49ZNumbers needed to treat calculated from responder rates give a better indication of efficacy in osteoarthritis trials than mean pain scores.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:25199bda-cc18-435f-91ef-bb61218e31dbEnglishSymplectic Elements at Oxford2008Moore, RMoore, ODerry, SMcQuay, H INTRODUCTION: Osteoarthritis trials usually report average changes in visual analogue scale (VAS) pain, and examine the difference between treatment and placebo. We investigated whether dichotomous responder analysis provides a more informative interpretation of drug efficacy. METHODS: Merck supplied the number of patients who, by 6 weeks, had achieved pain relief compared with a baseline of 0% or more, 10% or more, 20% or more, and so on at equal intervals up to 90% or more. These different levels of pain relief were used to distinguish different definitions of responders, for example at least 50% pain relief from baseline. Numbers and percentages of patients achieving each level were identified. Information was sought from a dose-response trial over 6 weeks in osteoarthritis using placebo and using etoricoxib at 5, 10, 30 and 60 mg daily. RESULTS: With placebo, the proportions of patients achieving at least 20%, 50% and 70% pain relief over baseline at 6 weeks were 30%, 11% and 2%. With 60 mg etoricoxib the equivalent percentages were 74%, 49% and 29%. The numbers needed to treat for 30 mg and 60 mg etoricoxib to produce at least 50% pain relief at 6 weeks compared with placebo were 4.2 (95% confidence interval 3.8 to 8.6) and 2.6 (2.0 to 3.9), respectively. Levels of pain relief of 50% and above discriminated best between different doses of etoricoxib. CONCLUSION: Responder analysis seemed to be more sensitive than examination of average changes in VAS pain scores. Validation would require calculations to be performed on a set of trials using individual patient data not available in publications. |
| spellingShingle | Moore, R Moore, O Derry, S McQuay, H Numbers needed to treat calculated from responder rates give a better indication of efficacy in osteoarthritis trials than mean pain scores. |
| title | Numbers needed to treat calculated from responder rates give a better indication of efficacy in osteoarthritis trials than mean pain scores. |
| title_full | Numbers needed to treat calculated from responder rates give a better indication of efficacy in osteoarthritis trials than mean pain scores. |
| title_fullStr | Numbers needed to treat calculated from responder rates give a better indication of efficacy in osteoarthritis trials than mean pain scores. |
| title_full_unstemmed | Numbers needed to treat calculated from responder rates give a better indication of efficacy in osteoarthritis trials than mean pain scores. |
| title_short | Numbers needed to treat calculated from responder rates give a better indication of efficacy in osteoarthritis trials than mean pain scores. |
| title_sort | numbers needed to treat calculated from responder rates give a better indication of efficacy in osteoarthritis trials than mean pain scores |
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