The safety and efficacy of extended-release guaifenesin / pseudoephedrine hydrochloride for symptom relief as an adjunctive therapy to antibiotic treatment of acute respiratory infections (ARIs)

C. LaForce, D. A. Gentile, D. P. Skoner

J Am Acad PA. 2008. 21

Purpose:

To access the efficacy and safety of MUCINEX® D (extended-release guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg) in providing relief of respiratory symptoms when used as adjunctive therapy to antibiotics in patients with ARIs

Methods:

• Multicenter, randomized, parallel-group, double-blind, placebo-controlled study
• 601 adults (18-75 years) with ARI symptoms
• Patients met physician’s usual criteria for antibiotics
• Treatment arms: antibiotics plus MUCINEX® D or antibiotics plus matching placebo BID for 7 days
• Patient diaries filled out twice daily; doctor visits on Day 4 and Day 8

Results:

While antibiotics target the source of illness, MUCINEX® D works in tandem to help patients feel better faster from sinus pressure and congestion

• MUCINEX® D plus antibiotics demonstrated statistically significant relief and shortened time to relief vs antibiotics alone, with the greatest effects seen for nasal congestion
• Patients felt relief from nasal congestion 1 day sooner with MUCINEX® D plus antibiotics vs patients taking antibiotics alone
• No unexpected AEs and no serious AEs reported
• There was no significant difference on some individual symptoms that were analyzed

The CDC acknowledges there is “limited evidence supporting specific symptomatic therapies”¹ for acute respiratory illness. This multicenter, randomized, double-blind, placebo-controlled study of 601 adults studied antibiotics with MUCINEX® D or placebo for 7 days. Antibiotics with MUCINEX® D showed statistically significant relief and shortened time to relief versus antibiotics alone, with the greatest effect on nasal congestion (relief 1 day sooner), although some individual symptoms did not differ significantly, and no serious adverse events were reported.

Source:

1 Centers for Disease Control and Prevention. Outpatient Clinical Care for Adults. https://www.cdc.gov/antibiotic-use/hcp/clinical-care/adult-outpatient.html