Comparison of the efficacy and safety of miconazole 50‐mg mucoadhesive buccal tablets with miconazole 500‐mg gel in the treatment of oropharyngeal candidiasis

Abstract

BACKGROUND. Topical antifungal treatments are recommended but rarely used as first‐line therapy for oropharyngeal candidiasis (OPC) in patients with cancer. Miconazole Lauriad 50‐mg mucoadhesive buccal tablet (MBT) Loramyc reportedly delivered rapid and prolonged, effective concentrations of miconazole in the mouth. The objective of the current study was to compare MBT with miconazole 500‐mg oral gel (MOG) in patients with head and neck cancer. METHODS. Two hundred eighty‐two patients with head and neck cancer received a 14‐day treatment of either single‐dose MBT or MOG administered in 4 divided doses. The primary endpoint was clinical success at Day 14, and secondary endpoints included clinical success at Day 7, clinical cure, improvement in clinical symptoms, mycologic cure, recurrence rate, and safety. RESULTS. The success rate was statistically not inferior (P < .0001) in the MBT population to the rate observed in the MOG group (56% vs 49%, respectively; P < .0001). After adjustment for the extent of lesions and salivary secretions, a trend toward superiority was observed in favor of MBT (P = .13), particularly among patients with multiple lesions (P = .013). Results for secondary endpoints were comparable to those observed for the primary endpoint. Compliance with MBT was excellent, and >80% of patients completed treatment. Both treatments were safe. CONCLUSIONS. The success rate of MBT Loramyc was significantly not inferior to that of MOG in the treatment of cancer patients with OPC; and, after adjusting for prognostic variables, it was more effective than MOG. MBT was well tolerated and, thus, may be recommended as first‐line treatment in cancer patients who have OPC as an alternative to systemic antifungal agents. Cancer 2008. © 2007 American Cancer Society.

Miconazole-loaded solid lipid nanoparticles: formulation and evaluation of a novel formula with high bioavailability and antifungal activity

“…1,2 Miconazole is a weak base and shows poor aqueous solubility (,1 µg/mL); as a result, a reduction in its therapeutic efficacy has been reported. 3,4 Miconazole has a dual mechanism of action: the inhibition of ergosterol biosynthesis and the inhibition of peroxidases, which causes the accumulation of peroxide within the cell, leading to cell death.…”

Individuals with HIV/AIDS: Clinical Manifestations in the Oral Cavity in the Post-HAART Era

“…Most recently ketoconazole and clotrimazole were found most effective in treatment of oral candidiasis (Worthington, et al, 2002). Initial local treatments are first line of therapy (Bensadoun, et al, 2008). Mucosal contact for 2 minutes is recommended either by rinsing, gargling or swallowing.…”

Management of Oropharyngeal and Esophageal Candidiasis in Patients with Hiv Infection

“…In pharmacokinetic studies, 50 mg of MMBT provides a maximum salivary concentration of 15 µg/ml up to 7 h after application of the tablet [32]. Three separate clinical studies have evaluated the use of MMBT for the treatment of OPC in the HIVinfected population and in patients with head and neck cancers [33][34][35]. In a Phase III, doubleblind, double-dummy, multicenter trial evaluating 578 patients with HIV and OPC, MMBT was compared with clotrimazole troches 10 mg five times daily for a period of 14 days [33].…”