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Patients' criteria for meaningful relief to determine onset of action
Author(s) -
Schachtel B. P.,
Sanner K. M.,
Meskin N. A.,
Bey M.
Publication year - 2005
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2004.12.088
Subject(s) - medicine , placebo , onset of action , symptom relief , pain relief , acetaminophen , clinical pharmacology , clinical trial , sore throat , anesthesia , drug , alternative medicine , pharmacology , pathology
Background Many investigators 1 , 2 assign onset of action only to drug‐treated patients who detect “meaningful” pain relief. Is there a quantifiable level of relief that corresponds to this qualitative description? Methods To make this determination, we asked patients with sore throat who had completed a randomized, double‐blind, placebo‐controlled trial on a novel formulation 3 of acetaminophen (APAP) 1000 mg to indicate which level on a categorical relief scale represented meaningful relief to them. If the patient had detected this level using the same scale in the trial, we examined the patient's responses for evidence of onset. Results Efficacy was demonstrated for all APAP‐treated patients compared with placebo beginning at 15 minutes (P<0.05). Of the 73 APAP‐treated patients who experienced their own levels of meaningful relief (which was, in general, “moderate relief”), the median (and modal) time to first perceived relief was 15 minutes; 89% reported onset within 30 minutes. Conclusions Because these results accord with how patients assess drug performance in clinical practice, it makes sense, in clinical trials, to analyze the onset of drug action similarly, namely, in patients for whom the drug “works.” One method is to use the patients' own criteria for meaningful relief. Clinical Pharmacology & Therapeutics (2005) 77 , P51–P51; doi: 10.1016/j.clpt.2004.12.088