PMID- 32506309
OWN - NLM
STAT- MEDLINE
DCOM- 20210203
LR  - 20210203
IS  - 1179-6901 (Electronic)
IS  - 1174-5886 (Print)
IS  - 1174-5886 (Linking)
VI  - 20
IP  - 3
DP  - 2020 Sep
TI  - Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the 
      Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study.
PG  - 237-247
LID - 10.1007/s40268-020-00310-7 [doi]
AB  - 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.
FAU - Kellstein, David
AU  - Kellstein D
AD  - Pfizer Consumer Healthcare, Madison, NJ, USA. david.kellstein@gmail.com.
FAU - Leyva, Rina
AU  - Leyva R
AD  - Pfizer Consumer Healthcare, Madison, NJ, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01559259
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - New Zealand
TA  - Drugs R D
JT  - Drugs in R&D
JID - 100883647
RN  - 0 (Analgesics, Non-Narcotic)
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Drug Combinations)
RN  - 362O9ITL9D (Acetaminophen)
RN  - WK2XYI10QM (Ibuprofen)
SB  - IM
MH  - Acetaminophen/*administration & dosage/therapeutic use
MH  - Administration, Oral
MH  - Adolescent
MH  - Analgesics, Non-Narcotic/*administration & dosage/therapeutic use
MH  - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Ibuprofen/*administration & dosage/therapeutic use
MH  - Male
MH  - Pain, Postoperative/*drug therapy
MH  - Pilot Projects
MH  - *Tooth Extraction
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC7419400
COIS- David Kellstein is a former employee of Pfizer Consumer Healthcare. Rina Leyva is 
      a current employee of GSK Consumer Healthcare. On 1 August 2019, Pfizer Consumer 
      Healthcare became part of GSK Consumer Healthcare.
EDAT- 2020/06/09 06:00
MHDA- 2021/02/04 06:00
PMCR- 2020/06/06
CRDT- 2020/06/08 06:00
PHST- 2020/06/09 06:00 [pubmed]
PHST- 2021/02/04 06:00 [medline]
PHST- 2020/06/08 06:00 [entrez]
PHST- 2020/06/06 00:00 [pmc-release]
AID - 10.1007/s40268-020-00310-7 [pii]
AID - 310 [pii]
AID - 10.1007/s40268-020-00310-7 [doi]
PST - ppublish
SO  - Drugs R D. 2020 Sep;20(3):237-247. doi: 10.1007/s40268-020-00310-7.