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Safety of itraconazole in diabetic patients
J Verspeelt1, G Marynissen, A K Gupta
1Janssen Research Foundation, Beerse, Belgium.
Background:
Onychomycosis and dermatomycoses can result in serious complications in patients with underlying chronic diseases such as diabetes. To avoid these complications, these dermatological disorders need to be treated efficiently, for example with the triazole antifungal itraconazole. Itraconazole can inhibit the metabolism of drugs by CYP 3A4 and therefore might affect the efficacy of antidiabetic agents.
Objective:
To investigate this, we assessed the safety of itraconazole in diabetic patients with onychomycosis or dermatomycoses.
Methods:
We reviewed pharmacokinetic and safety data from clinical trials and postmarketing surveillance over the past 10 years.
Results:
Postmarketing surveillance (a review of all adverse-event reports in patients receiving itraconazole concomitantly with insulin or an oral antidiabetic agent) revealed 15 reports suggestive of hyperglycemia and 9 reports suggestive of hypoglycemia; in most patients, no change in antidiabetic effect was reported. From clinical trials including a total of 189 diabetic patients treated with itraconazole for various infections (mainly systemic infections and vaginal candidiasis), only one itraconazole-related adverse event was recorded; this was a case of aggravated diabetes in a renal transplant recipient who was also receiving cyclosporine. Adverse effects due to drug-drug interactions are not expected in diabetic patients receiving oral antidiabetic agents that are not metabolized through the CYP 3A4 system (e.g. tolbutamide, gliclazide, glibenclamide, glipizide and metformin).
Conclusion:
Itraconazole can be used safely and efficiently for the treatment of dermatological disorders in diabetic patients.
Insights
Itraconazole is safe for diabetic patients with fungal skin infections. While some adverse events were reported, most patients experienced no change in their diabetes management when using itraconazole.
Area of Science:
- Dermatology
- Pharmacology
- Endocrinology
Background:
- Fungal infections like onychomycosis and dermatomycoses pose risks for diabetic patients.
- Efficient treatment, such as with itraconazole, is crucial to prevent complications.
- Itraconazole's potential to inhibit CYP3A4 may affect antidiabetic drug efficacy.
Purpose of the Study:
- To evaluate the safety of itraconazole in diabetic individuals diagnosed with onychomycosis or dermatomycoses.
Main Methods:
- A review of pharmacokinetic and safety data from clinical trials and postmarketing surveillance over a decade.
- Analysis of adverse event reports in diabetic patients using itraconazole with insulin or oral antidiabetic agents.
- Examination of clinical trial data from 189 diabetic patients treated with itraconazole.
Main Results:
- Postmarketing surveillance identified 15 reports of hyperglycemia and 9 of hypoglycemia; most patients had no altered antidiabetic effect.
- Clinical trials reported only one itraconazole-related adverse event (aggravated diabetes) in a patient on cyclosporine.
- Drug interactions are unlikely with oral antidiabetics not metabolized by CYP3A4 (e.g., metformin, glipizide).
Conclusions:
- Itraconazole demonstrates a favorable safety profile for treating dermatological conditions in diabetic patients.
- The antifungal agent can be used safely and effectively in this patient population.