Safety And Tolerability Of Extended-Release Guaifenesin In Patients With Cough, Thickened Mucus And Chest Congestion Associated With Upper Respiratory Tract Infection

Sanjay Tripathi, Ashish Nikhare, Gaurav Sharma, Tim Shea, Helmut Albrecht, Sanjay Tripathi, Ashish Nikhare, Gaurav Sharma, Tim Shea, Helmut Albrecht

Abstract

Purpose: An extended-release (ER) formulation of the expectorant guaifenesin has recently been launched in India for the treatment of productive cough accompanied by mucus (phlegm). Although the safety profile of ER guaifenesin marketed in the USA is well documented, there were limited safety data available in the Indian population. The aim of this study was to further elucidate the safety profile of ER guaifenesin in patients with acute upper respiratory tract infection (URTI).

Patients and methods: A prospective, post-marketing surveillance study enrolled 552 adults with cough, thickened mucus and chest congestion due to URTI, who took ER guaifenesin 1200 mg (Mucinex®, Reckitt Benckiser; two 600 mg tablets) every 12 hrs for 7 days. Adverse events (AEs) were recorded and questionnaires administered to patients and investigators.

Results: A total of 29 treatment-emergent AEs were recorded in 28/552 patients, including gastrointestinal (n = 11), nervous system (n = 8), psychiatric (n = 3), respiratory, thoracic and mediastinal (n = 2), skin and subcutaneous tissue (n = 2), and general disorders (n = 3). All AEs were mild in severity and no serious AEs or deaths occurred. The majority of both patients and investigators were either satisfied or very satisfied with improvements in treatment outcomes.

Conclusion: This study found that ER guaifenesin was well tolerated and had a favorable safety profile in otherwise healthy patients suffering from symptoms of cough, thickened mucus and chest congestion associated with URTI. Registered trial NCT03725085 (ClinicalTrials.gov) and CTRI/2014/07/004730 (ctri.nic.in).

Keywords: Mucinex; expectorant; guaifenesin; post-marketing surveillance; safety profile; satisfaction.

Conflict of interest statement

The study was funded by Reckitt Benckiser, Gurgaon 122001, Haryana, India. Medical writing assistance was provided by Kim Russell and Saroshi Amirthalingam at Elements Communications Ltd, Westerham, UK and funded by Reckitt Benckiser Healthcare International Ltd, UK. Tim Shea and Gaurav Sharma are employees of Reckitt Benckiser USA and Reckitt Benckiser India, respectively. As investigators of the study, Sanjay Tripathi and Ashish Nikhare received compensation for time and resources in enrolling patients into the study and recording data during the clinical trial. Helmut Albrecht is a paid clinical/medical consultant to Reckitt Benckiser. The authors report no other conflicts of interest in this work.

© 2019 Tripathi et al.

Figures

Figure 1
Figure 1
Disposition of patients.
Figure 2
Figure 2
Responses to the end-of-study patient questionnaire (N=552). Notes: *Percentage calculated based on who would recommend ER guaifenesin to their family and friends for the treatment of chest congestion/chesty cough. Abbreviation: ER, extended release.

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