Extended-release guaifenesin / pseudoephedrine hydrochloride for symptom relief in support of a wait-and- see approach for the treatment of acute upper respiratory tract infections

E. J. Septimus, H. H. Albrecht, G. Solomon, T. Shea, E. P. Guenin

Current Therapeutic Research, 2017. 84

Purpose:

To determine whether treatment with MUCINEX® D, combined with the wait-and-see approach, lowers the overuse of and patient desire for antibiotics in the treatment of URTIs. This study also assessed the safety and efficacy of extended-release guaifenesin/pseudoephedrine versus placebo in providing first-line symptom relief for URTIs.

Methods:

• Randomized, placebo-controlled, double-blind, parallel group study

• 1189 patients enrolled; 18 to 75 years; symptoms of acute URTI
• Treatment groups: 1200 mg guaifenesin/120 mg pseudoephedrine extended-release bilayer tablets versus matching placebo tablets for 7 consecutive days
• Patients met physician’s criteria for antibiotics, but were considered suitable for wait-and- see approach (withholding antibiotics 48 hours)
• Primary efficacy endpoint was the proportion of patients experiencing overall relief on the evening of Day 4, defined as having scored no symptoms worse than 2, which translates to mild or slight

Key Findings:

Percentage of patients requesting antibiotics at Day 4 and Day 8

Adapted from Septimus EJ, et al. Extended-release guaifenesin/pseudoephedrine hydrochloride for symptom relief in support of a wait-and-see approach for the treatment of acute upper respiratory tract infections: a randomized, double-blind, placebo-controlled study. Curr Ther Res Clin Exp. 2017;84:54-61.

At both Day 4 and Day 8, fewer patients in the guaifenesin/pseudoephedrine group desired antibiotics compared with those in the placebo group, reaching a significant difference at Day 8 (Day 4: 9.8% vs 12.0%, respectively [P = 0.263]; Day 8: 4.2% vs 8.0%, respectively [P = 0.008]).

Results:

A wait-and-see approach was associated with decreased antibiotic use or desire and provided an effective symptom control compared to placebo

• At Day 8, significantly fewer patients receiving guaifenesin/pseudoephedrine vs placebo desired antibiotics (4.2% vs 8.0% respectively)
• No adverse events reported due to patients not taking antibiotics
• Significant reductions in URTI symptoms observed for extended-release guaifenesin/pseudoephedrine versus placebo, from Day 1
• Day 4 evening assessment (primary endpoint), did not reach statistical significance—Day 4 was chosen arbitrarily and does not represent a particular significant time point for assessing efficacy
  

The CDC notes there are only “rare cases when a viral infection can lead to a bacterial infection,”¹ which is why a wait-and-see approach to antibiotics is of interest. This randomized, double-blind, placebo-controlled study of 1,189 adults with acute URTI tested MUCINEX® D against placebo while antibiotics were withheld for 48 hours. A wait-and-see approach was associated with decreased antibiotic use or desire (Day 8: 4.2% vs 8.0%, P=0.008) and effective symptom control versus placebo, although the Day 4 primary endpoint did not reach statistical significance.²

Source:

1 Centers for Disease Control and Prevention. Manage Common Cold. https://www.cdc.gov/common-cold/treatment

2 Extended-release guaifenesin/pseudoephedrine hydrochloride for symptom relief in support of a wait-and- see approach for the treatment of acute upper respiratory tract infections. https://www.sciencedirect.com/science/article/pii/S0011393X16300881