A real-world retrospective study to evaluate the effectiveness and safety of montelukast and fexofenadine fixed-dose combination in the management of patients with allergic rhinitis

Abstract: BACKGROUND: Allergic rhinitis (AR) is on the rise in India. The disease has a negative impact on the patient’s quality of life and their daily activity. The addition of an antihistamine to montelukast as a combination therapy offers an enhancing and complementary effect, thereby reducing the symptoms of AR effectively. METHODS: A retrospective open-label, single-arm, multicenter, real-world observational study was designed to understand the effectiveness and tolerability of the fixed-dose combination of montelukast/fexofenadine (FDC-M/F [10 mg + 120 mg]) in patients with AR. Patients fulfilling the inclusion criteria aged more than 15 years, having either symptoms suggesting AR (mild-intermittent, mild-persistent, or moderate intermittent) or Total Nasal Symptom Score (TNSS) of 5 or more as per the Allergic Rhinitis and its Impact on Asthma (ARIA) classification (if recorded), with no antihistamine in the previous week and have not received either montelukast plus fexofenadine for at least 4 weeks during the previous 6 months were included in this study. Patients with AR having a history of severe attacks of acute asthma within the span of the past 3 months, comorbidities such as severe hepatic/renal impairment, autoimmune, cardiovascular, or neurological diseases, and pregnant/lactating women were excluded from the study. Medical records were collected from the database of 12 sites across India from June 2022 to June 2023. The primary variables assessed were changes in the TNSS and Total Ocular Symptom Score (TOSS), changes in the Physicians Global Assessment (PGA) scale, Patients Global Assessment Scale (PGAS) from baseline to 4–6 weeks. RESULTS: A total of 329 medical records fulfilled the criteria for the enrolment. A statistically significant improvement was observed in both the TNSS and TOSS with FDC M/F at the end of the study period of 4–6 weeks; mean TNSS at baseline 6.66 (standard deviation [SD] 2.32; 95% confidence interval [CI], P < 0.001) reduced to 0.95 (SD 1.33 95% CI, P < 0.001), a mean difference of 5.71; Mean TOSS at baseline 1.54 (SD 2.32; 95% CI, P < 0.001), reduced to 0.23 (SD 0.73 95% CI, P < 0.001), a mean difference of 1.31 after 4–6 weeks. The combination was well-tolerated, and most of the patients were satisfied with the treatment. CONCLUSION: The FDC M/F led to a significant decrease in TNSS and TOSS compared to baseline. Thus, it may be an attractive treatment option for mild-intermittent, mild-persistent AR for reducing nasal and ocular symptoms.