Introduction

Ibuprofen and acetaminophen provide analgesia via different mechanisms of action and do not exhibit drug–drug interactions; therefore, combining low doses of each may provide greater efficacy without compromising safety.

Objectives

The present study assessed the analgesic efficacy of fixed-dose combinations (FDCs) of ibuprofen/acetaminophen (IBU/APAP) compared with ibuprofen 400 mg and placebo.

Methods

This 12-h, double-blind, proof-of-concept study compared three FDCs of IBU/APAP (200 mg/500 mg, 250 mg/500 mg, and 300 mg/500 mg) with ibuprofen 400 mg and placebo in patients with moderate-to-severe pain following third molar extraction. The primary endpoint was the time-weighted sum of pain relief and pain intensity difference scores from 0 to 8 h after dosing (SPRID[4]_0–8). Time to meaningful pain relief (TMPR), duration of pain relief, and adverse events (AEs) were also assessed.

Results

In total, 394 patients were randomized. All active treatments were superior to placebo for SPRID[4]_0–8 (all p < 0.001) but not significantly different from ibuprofen 400 mg. Median TMPR with FDCs and ibuprofen (44.5–54.1 and 56.2 min, respectively) was faster than with placebo (> 720 min; all p < 0.001 vs. placebo). Duration of pain relief was similar with the FDCs and ibuprofen 400 mg (9.7 –11.1 h) and longer than with placebo (1.6 h; all p < 0.001). AE incidence was comparable with all treatments.

Conclusion

Each IBU/APAP FDC provided analgesic efficacy comparable to that with ibuprofen 400 mg and superior to that with placebo. Each FDC provided MPR in < 1 h, duration of pain relief > 9 h, and tolerability similar to that with ibuprofen and placebo.

ClinicalTrials.gov Registration

NCT01559259

中文翻译：

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评价布洛芬和对乙酰氨基酚的固定剂量联合用药在术后牙科疼痛的治疗中：一项基于剂量范围的随机研究。

介绍

布洛芬和对乙酰氨基酚通过不同的作用机制提供镇痛作用，并且没有药物相互作用。因此，将低剂量的每种药物合并使用可提供更高的疗效，而不会影响安全性。

目标

本研究评估了布洛芬/对乙酰氨基酚（IBU / APAP）的固定剂量组合（FDC）与400 mg布洛芬和安慰剂的镇痛效果。

方法

这项为期12小时的双盲概念验证研究比较了患者中三个IBU / APAP的FDC（200 mg / 500 mg，250 mg / 500 mg和300 mg / 500 mg）与布洛芬400 mg和安慰剂在第三磨牙拔除后出现中度至重度疼痛。主要终点是用药后0到8小时的疼痛缓解和疼痛强度差异评分的时间加权总和（SPRID [4] _0-8）。还评估了达到有意义的缓解疼痛的时间（TMPR），缓解疼痛的持续时间和不良事件（AE）。

结果

总共394名患者被随机分组​​。对于SPRID [4] _0-8，所有积极治疗均优于安慰剂（所有p  <0.001），但与布洛芬400 mg并无显着差异。FDC和布洛芬的TMPR中值（分别为44.5-54.1和56.2分钟）比安慰剂快（> 720分钟；与安慰剂相比，所有p  <0.001）。FDC和布洛芬400 mg（9.7 – 11.1 h）的疼痛缓解持续时间相似，并且比安慰剂（1.6 h；所有p  <0.001）更长。AE发生率与所有治疗均相当。

结论

每个IBU / APAP FDC的镇痛效果均与布洛芬400 mg相当，并且优于安慰剂。每个FDC均在<1小时内提供MPR，缓解疼痛的持续时间> 9小时，并且耐受性类似于布洛芬和安慰剂。

ClinicalTrials.gov注册

NCT01559259