Terbinafine (Lamisil) treatment of toenail onychomycosis in patients with insulin-dependent and non-insulin-dependent diabetes mellitus: a multicentre trial.
BACKGROUND
Diabetes mellitus (DM) affects an estimated 175 million people world-wide. Approximately one-third of patients with DM have toenail onychomycosis.


OBJECTIVE
To determine the efficacy and safety of terbinafine treatment of toenail onychomycosis in patients with DM receiving insulin and/or oral antidiabetic agents. Special interest was focused on potential drug interactions with oral hypoglycaemic substances.


METHODS
In a multicentre trial, patients suffering from insulin-dependent DM (IDDM) or non- insulin-dependent DM (NIDDM) with toenail onychomycosis were treated for 12 weeks with oral terbinafine 250 mg daily and followed up to 48 weeks. In addition to clinical, mycological and laboratory investigations, blood glucose levels were monitored.


RESULTS
At the end of the trial (week 48), a mycological cure rate of 73% was achieved. The rates of clinical cure and complete cure (mycological cure plus clinical cure) were 57% and 48%, respectively. There was no statistically significant difference between the NIDDM and IDDM groups with respect to the cure rates (P > 0.05). No hypoglycaemic episode was reported and none of the patients had hypoglycaemia during the treatment phase.


CONCLUSIONS
With excellent cure rates and a good tolerability profile, terbinafine should continue to be a drug of choice for the treatment of toenail onychomycosis in the rising number of NIDDM patients receiving multiple medication.
Farkas
B
B
Department of Dermatology, Pécs University Medical Centre, Kodály u. 20, H-7624 Pécs, Hungary. farkasb@derma.pote.hu
Paul
C
C
Dobozy
A
A
Hunyadi
J
J
Horváth
A
A
Fekete
G
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000627:therapeutic use*; D001786:Blood Glucose / Q000187:drug effects; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000150:complications* / Q000188:drug therapy; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications* / Q000188:drug therapy; D004347:Drug Interactions; D005260:Female; D005500:Follow-Up Studies; D005533:Foot Dermatoses / Q000150:complications / Q000188:drug therapy / Q000382:microbiology; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000627:therapeutic use*; D014009:Onychomycosis / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D011446:Prospective Studies; D000077291:Terbinafine
D000935:Antifungal Agents; D001786:Blood Glucose; D007004:Hypoglycemic Agents; D009281:Naphthalenes; D000077291:Terbinafine