当前位置： SCI文献检索 > CURRENT MEDICAL RESEARCH AND OPINION期刊下所有文献 > Onset of pain relief with rofecoxib in chronic low back pain: results of two four-week, randomized, placebo-controlled trials.

Onset of pain relief with rofecoxib in chronic low back pain: results of two four-week, randomized, placebo-controlled trials.

Abstract：

OBJECTIVE:We recently reported the efficacy of rofecoxib in two randomized controlled trials in chronic low back pain (CLBP). The objectives of this report are to present data regarding the onset of efficacy of rofecoxib from these trials and propose methods for reporting onset. RESEARCH DESIGN AND METHODS:Patients were aged 18-75, with non-radicular CLBP for >or= 3 months. Patients were randomized to rofecoxib 25mg, 50 mg, or placebo once daily for 4 weeks. Assessments included Low Back Pain and Bothersomeness scales every morning and Relief from Starting Pain after the first dose at 0.5, 1, 2, 3, 4 h, bedtime, and next morning. Onset of meaningful relief was measured by Time to Confirmed 50% Reduction in Pain and Time to Confirmed 'Slightly' or 'Not At All' Bothersome Pain. Onset of perceptible pain relief was measured by Time to At Least 'A Little' Confirmed Pain Relief. RESULTS:690 patients entered. Significantly more patients treated with rofecoxib had compared with 1/3 receiving placebo. Median meaningful relief compared to placebo: 60.4, 58.4, and 34.7% for rofecoxib 25mg, 50 mg, and placebo (p< 0.001). Median time to meaningful relief for rofecoxib was 2 days, 1 day sooner than placebo. Rofecoxib was superior to placebo by bedtime after the first dose. CONCLUSIONS:Approximately 2/3 of patients achieved meaningful pain relief with rofecoxib time to onset of meaningful relief was about 2 days, but superior relief over placebo was seen by bedtime after the first dose. Onset of perceptible pain relief was within 2 h. We propose that measures of onset of analgesic effect include the proportion of patients who achieve meaningful pain relief and in this subgroup, the time-to-onset of confirmed meaningful reduction in pain intensity, time-to-onset of confirmed pain relief, and time to first separation from placebo in the proportion of patients who achieve meaningful pain relief.

journal_name

Curr Med Res Opin

journal_title

Current medical research and opinion

authors

Katz N,Rodgers DB,Krupa D,Reicin A

doi

10.1185/030079904125003160

keywords:

subject

Has Abstract

pub_date

2004-05-01 00:00:00

pages

651-8

issue

eissn

0300-7995

issn

1473-4877

journal_volume

pub_type

临床试验,杂志文章,随机对照试验

在线工具

Onset of pain relief with rofecoxib in chronic low back pain: results of two four-week, randomized, placebo-controlled trials.