Jürgen Palm, Bettina Schopf, Holger Stammer and Nadja Schughart
Objective: To evaluate the tolerability, acceptance and course of symptoms in the treatment of acute sore throat with neo-angin® benzydamine, 3 mg lozenges for treatment of acute sore throat, lemon flavour, (neo-angin® BLF) in adult patients in routine clinical practice in Germany.
Rationale and background: Neo-angin® BLF is indicated for the symptomatic local treatment of acute sore throat in adults and children over 6 years of age. The active ingredient is benzydamine hydrochloride (3 mg/lozenge). An important safety issue in self-medication is the usage according to the designated indication and dosage. Prospective observational studies provide real world evidence of safety and effectiveness of marketed drugs and contribute to the knowledge of the drug use in self-medication.
Patients and methods: Patients with acute sore throat who were prescribed neo-angin® BLF in the usual manner in accordance with the terms of the marketing authorization were included in the non-interventional study (NIS). Data was gathered, among others, directly from the patients using a standardized questionnaire. For evaluation, all patients with at least one documented application of the study drug and any post-baseline safety data were included in the safety evaluation set (SES) which was used for all analyses (patient satisfaction, effectiveness, tolerability). Primary study objective was patient satisfaction with neo-angin® BLF on the last study day. Secondary endpoints included assessment of effectiveness and tolerability of the study drug.
Results: Overall treatment satisfaction rate was 83.8% (primary endpoint) and 82.3% of patients were willing to use neo-angin® BLF 3 mg lozenges again. Time to initial relief from throat pain during administration of the first lozenge was within 5 minutes. Mean throat pain intensity score assessed on an 11-point numeric rating scale (NRS) continuously decreased during the observation period. The changes from baseline in mean NRS score over time were statistically highly significant (p<0.0001). The median time to obvious improvement of throat pain (i.e., 50% reduction from baseline NRS score) was 3 days. Overall, 58.8% of the patients achieved complete analgesia. Efficacy of the study drug was rated as excellent/good in 83.2% of patients, and tolerability as excellent/good in 97.0%.
Of the 456 patients included in the SES, 20 patients (4.4%) reported a total of 30 AEs, which were either mild or moderate in intensity. The physicians considered 11/30 AEs related to treatment with the study drug (adverse drug reactions, ADR). No severe or serious AES/ADRs were reported. All ADRs resolved within the 6-day observation period.
Conclusion: Short-term treatment with neo-angin® BLF (3 mg lozenges) was safe and very well tolerated, rapidly and significantly relieved acute throat pain in outpatients, and was associated with high patient satisfaction. No serious AEs or ADRs were reported. The study results confirm the positive risk-benefit profile of benzydamine hydrochloride lozenges.