Demonstration of the analgesic efficacy and dose-response of acetylsalicylic acid with pseudoephedrine.
To determine acute analgesia by acetylsalicylic acid (ASA) when combined with pseudoephedrine (PSE) in patients with upper respiratory tract infection (URTI), we used the sore throat pain model to measure single-dose effects of ASA 500 mg/PSE 30 mg, ASA 1000 mg/PSE 60 mg, and acetaminophen (APAP) 1000 mg/PSE 60 mg (serving as a positive control). Under double-blind, randomized, placebo-controlled conditions, 640 adult patients with confirmed acute pharyngitis and rhinosinusitis associated with URTI rated throat pain intensity and relief at intervals over 6 hours. Efficacy was demonstrated for both doses of ASA/PSE compared with placebo for all end points, including total pain relief and summed pain intensity differences, beginning at 20 minutes on both scales (all P < .05), and the efficacy of APAP/PSE compared with placebo was confirmed (P < .01). Greater differences in pain relief and intensity were also demonstrated between the higher and lower doses of ASA/PSE (P < .05), in particular, among 329 patients with severe pain, as well as between ASA 1000 mg/PSE 60 mg and APAP 1000 mg/PSE 60 mg (P < .05). No serious adverse events were reported. This study demonstrates that ASA is a well-tolerated and effective analgesic in 500- and 1000-mg doses when combined with pseudoephedrine.
Schachtel
Bernard P
BP
Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, Connecticut, USA.bschachtel@SRCresearch.net
Voelker
Michael
M
Sanner
Kathleen M
KM
Gagney
Diana
D
Bey
Mary
M
Schachtel
Emily J
EJ
Becka
Michael
M
D000293:Adolescent; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003139:Common Cold / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D014663:Nasal Decongestants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010147:Pain Measurement; D010612:Pharyngitis / Q000188:drug therapy; D054199:Pseudoephedrine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000503:physiopathology; D012220:Rhinitis / Q000188:drug therapy; D012720:Severity of Illness Index; D012852:Sinusitis / Q000188:drug therapy; D013566:Sympathomimetics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D055815:Young Adult
D018712:Analgesics, Non-Narcotic; D014663:Nasal Decongestants; D013566:Sympathomimetics; D054199:Pseudoephedrine; D001241:Aspirin