Abstract | 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.
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Authors | R Andrew Moore, Owen A Moore, Sheena Derry, Henry J McQuay |
Journal | Arthritis research & therapy
(Arthritis Res Ther)
Vol. 10
Issue 2
Pg. R39
( 2008)
ISSN: 1478-6362 [Electronic] England |
PMID | 18384679
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Cyclooxygenase Inhibitors
- Pyridines
- Sulfones
- Etoricoxib
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Cyclooxygenase Inhibitors
(administration & dosage)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Etoricoxib
- Female
- Humans
- Male
- Middle Aged
- Osteoarthritis
(complications, drug therapy)
- Pain
(etiology)
- Pain Measurement
- Pilot Projects
- Pyridines
(administration & dosage)
- Randomized Controlled Trials as Topic
- Research Design
- Sulfones
(administration & dosage)
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