# The Clinico-Epidemiological Profile and Effectiveness of Codeine and Triprolidine in Dry Cough Patients Not Responding to Non-Opioid-Based Antitussives: Results From a Prospective, Multicenter, Single-Arm, Open-Label Postmarketing Observational Study

## TL;DR

A study in India found that a combination of codeine and triprolidine significantly reduced dry cough symptoms and improved quality of life with minimal side effects.

## Contribution

This study provides real-world evidence supporting the effectiveness of a codeine-triprolidine combination for dry cough in the Indian population.

## Key findings

- Cough severity, frequency, and nighttime awakenings significantly decreased after seven days of treatment.
- Quality of life scores improved by an average of 33.5 points during the study.
- Adverse drug reactions were mild and non-serious, with no treatment discontinuations.

## Abstract

Background: Dry cough is highly prevalent in clinical practice, and antitussives remain the cornerstone of treatment. Among these, the combination of codeine phosphate and first-generation antihistamine triprolidine hydrochloride (triprolidine HCl) is often preferred in a dry cough unresponsive to non-opioid antitussives. However, there is limited real-world evidence regarding the effectiveness and safety of the fixed-dose combination (FDC) of codeine phosphate and triprolidine HCl in the Indian population.

Methods: This prospective, multicenter, single-arm, open-label, post-marketing observational study evaluated the clinico-epidemiological profile of Indian patients with dry cough unresponsive to non-opioid antitussives, prescribed FDC codeine phosphate 10 mg + triprolidine HCl 1.25 mg per 5 mL oral syrup, 10 mL thrice daily for seven days. The study also assessed effectiveness, quality of life (QoL), safety, and tolerability of the FDC.

Results: A total of 250 patients (male:female, 129:121; mean±SD age, 40.8 ± 14.0 years) were observed. Most were graduates (107 (42.8%)), with homemakers comprising the largest occupational group (98 (39.2%)). Acute cough was observed in 137 (54.8%) of patients, with upper respiratory tract infection (URTI) as the leading etiology in 188 (75.2%) of patients. From baseline to end of study, mean±SD cough severity decreased by 3.8±1.8, frequency by 2.4±1.2, and nighttime awakening by 3.5±1.8 points (p<0.001), while QoL scores improved by 33.5±19.9 points (p<0.001). Additionally, subgroup analyses also showed significant improvements across etiologies. Treatment was well tolerated, with 15 patients reporting 17 adverse drug reactions (ADRs; mostly constipation and sedation). All ADRs were mild and non-serious in nature and did not lead to treatment discontinuation.

Conclusion: In this observational study of 250 adults with dry cough, balanced by gender and predominantly middle-aged with a mean age 40.8 years, the FDC of codeine phosphate 10 mg and triprolidine HCl 1.25 mg per 5 mL oral syrup, prescribed as 10 mL thrice daily for seven days, significantly reduced cough severity, frequency, and nighttime awakenings, improving the QoL. Importantly, these results support the role of this FDC in the management of dry cough, especially when non-opioid antitussives are ineffective, a key differentiator of this study. Benefits were consistent across different etiologies of dry cough, with only mild, non-serious adverse events.