Itraconazole pulse therapy in onychomycosis

A prospective study of 30 clinically and mycologically diagnosed cases of onychomycosis was carried out for a period of twelve months from May 1996 to April 1997. Itraconazole pulse therapy was given for the 1st week followed by 3 week drug-free period, for 1st 3 months for the finger nail cases and 4 monthes for finger nail + toe nail and toe nail cases. Patients were evaluated at baseline, week 4, week 12, week 16, week 24, up to 12 months and assessed as cleared or markedly improved with clinical and mycological success. The result of our study is very much encouraging. It suggests that the use of itraconazole pulse therapy will maintain the continuous treatment efficacy and is cost effective than continuous therapy.     

Itraconazole pulse therapy for the treatment of Candida onychomycosis

In this open label, multicentre trial, 44 patients with clinical and mycological evidence of Candida onychomycosis were treated with itraconazole pulse therapy. Onychomycosis of the toes alone and concomitant disease involving the fingers and toes was treated with three pulses, and onychomycosis of the fingers alone with two pulses. Final evaluation for patients with finger and toe onychomycosis was at 6-9 months and 9-12 months, respectively. There were 29 patients with toe onychomycosis (C. albicans, 27; C. glabrata, one; Candida species, one), 12 patients with finger onychomycosis (C. albicans, two; C. glabrata, one) and three patients had combined toe and finger onychomycosis (C. albicans, two; C. guillermondii, one). In the patients with toe onychomycosis mycological cure was observed in 29 of 32 patients (90.6%). There was complete cure [mycological cure (negative culture and KOH at endpoint evaluation) with clinical cure] or marked improvement (mycological cure with 75% or greater decrease in area of involvement of target nail compared with pretherapy) in 24 of 32 patients (75.0%). All 12 patients with finger onychomycosis alone due to Candida species achieved a mycological cure (100%). In this group of patients complete cure or marked improvement was observed in 11 of 12 patients (91.7%). Itraconazole pulse therapy was well tolerated and no serious adverse events were reported in the patients treated with this triazole. In conclusion, itraconazole pulse therapy is an effective and safe treatment for both finger and toe onychomycosis associated with Candida.     

Update on the safety of itraconazole pulse therapy in onychomycosis and dermatomycoses

As the use of newer antifungal agents becomes more widespread, safety issues surrounding their use have become more important. To date, the safety profile of itraconazole has been well defined by its worldwide use in 50 million patients over the past 13 years. Data from clinical practice and clinical trials indicate that the 1-week pulse regimen of itraconazole is well tolerated and associated with a favourable safety profile. Adverse events are generally mild and transient. Furthermore, a dose increase to 400 mg in the pulse regimen has had no adverse impact on safety.     

Itraconazole versus terbinafine in the management of onychomycosis: an overview

Ever since the introduction of itraconazole and terbinafine in the management of onychomycosis, there has been a revival of interest in the latter. In order to comprehend the intricate emerging scenario, an endeavor has been made to form a distinct outline in the shape of an overview on several of their facets. The review, therefore, envisages forming and facilitating instant decision-making.     

Itraconazole pulse therapy in chromoblastomycosis

Although daily itraconazole has been used effectively in chromoblastomycosis, there is no record of pulse therapy for chromoblastomycosis. A 68-year-old woman with a history of slowly enlarging scaly plaque involving the left shoulder and lateral chest, presented to the dermatology clinic at General Hospital, Kalutara, Sri Lanka. Clinically chromoblastomycosis was suspected. Direct KOH smears showed sclerotic bodies and histology showed granulomata with characteristic brown spores. Itraconazole (Sporanox) 200 mg. b.i.d. orally was given for a week followed by 3 drug free weeks. This cycle was repeated for 6 months (i.e. 7 pulses). Clinical improvement was visible by 2 months. Scrapings and biopsy repeated 5 months after the commencement of treatment were negative for chromoblastomycosis. The lesion had clinically healed by 5 months. Examination 8 months after cessation of treatment did not show any recurrence. Itraconazole pulse therapy is cheaper than daily treatment but effective in chromoblastomycosis. The optimal dosage and end point of treatment need to be ascertained after a larger study.     

Itraconazole for the treatment of onychomycosis

Background The broad spectrum of activity of itraconazole in vitro manifests itself clinically with the drug being effective for the treatment of onychomycosis caused by dermatophytes, Candida and some non-dermatophyte molds. The pharmacokinetics of itraconazole in the nail results in drug remaining at therapeutic levels for 6–9 months after completion of therapy.
Methods An overview of studies where continuous or pulse itraconazole therapy has been used in the treatment of fingernail and toenail onychomycosis.
Results Following continuous therapy at 200 mg/day for 3 months for toenail onychomycosis ( n = 1741), the rates of clinical cure, clinical response and mycologic cure were: (meta-average ± 95% standard error (SE)), 52 ± 9%, 86 ± 2%, and 74 ± 3%, respectively, at follow-up 12 months following start of therapy. In fingernail onychomycosis ( n = 211), the duration of therapy was 6 weeks and the corresponding efficacy rates at follow-up, 9 months after start of therapy, were meta-average (± S.E.) 82 ± 5%, 90 ± 2%, and 86 ± 3%, respectively. In toenail onychomycosis treated with 3 pulses of therapy ( n = 1389), the clinical response, clinical cure and mycologic cure were observed in meta-average (± S.E.) 58 ± 10%, 82 ± 3%, and 77 ± 5% patients, respectively, at follow-up 12 months after the start of therapy. In fingernail onychomycosis treated with 2 pulses of therapy ( n = 210), at follow-up 9 months after the start of therapy, the corresponding efficacy rates were meta-average (± S.E.) 78 ± 10%, 89 ± 6%, and 87 ± 8%, respectively.
Conclusions Both the continuous and pulse therapy regimens are safe with few adverse effects. Compared to continuous therapy, the pulse regimen has an improved adverse-effects profile, is more cost-effective, and is preferred by many patients.     

Itraconazole in onychomycosis. Open and double-blind studies

Fifteen patients with onychomycosis caused by Trichophyton rubrum or T. mentagrophytes were treated with 50 mg itraconazole daily for 3 to 6 months. Fingernail infections were cured in two patients and two responded with marked improvement, e.g. small residual lesion remained and positive microscopy. The infected toenails were markedly improved in nine of 13 patients. Twenty-seven patients with T. rubrum infected nails were given 100 mg itraconazole daily for 6 to 8 months. Fingernails were cured in nine of eleven patients, while toenail infections were cured in one and markedly improved in 14 of 25 cases. Responses to 100 mg itraconazole versus 500 mg griseofulvin daily for 6 months were compared and evaluated in 20 patients with onychomycosis caused by T. rubrum or T. mentagrophytes. Fingernail infections responded equally well to both drugs with half of the cases cured or markedly improved, whereas toenails responded better to itraconazole, e.g. 4 of 9 were markedly improved versus one of 10 on griseofulvin. In patients given 50 mg itraconazole daily a significantly better response was observed in persons below 30 years of age compared to older individuals. Also, side-effects which were mainly mild and located to the gastro-intestinal tract or the central nervous system were seen less often in this group of patients on the low dose. Follow-up studies showed that cured nails remained cured, that markedly improved toenails continued to improve until cure in three of 21 patients but that aggravation took place through the one year of follow-up in more than half of the patients evaluated as markedly improved at the end of treatment.     

Topical antifungal drugs for the treatment of onychomycosis: an overview of current strategies for monotherapy and combination therapy

BACKGROUND: Onychomycosis is a relatively common disease accounting for up to 50% of all nail disorders and its prevalence rises with age. As onychomycosis is an important medical disorder affecting both patient's health and quality of life, it requires prompt and effective treatment. OBJECTIVE: Topical antifungal nail lacquers have been formulated to provide efficient delivery to the nail unit. As both amorolfine and ciclopirox have proved useful as monotherapy for onychomycosis that does not involve the nail matrix area, the purpose of this article is to check if, when combined with oral agents, the effectiveness and scope of treatment can be improved further. METHODS: Combining data for mycological cure with clinical success (nail morphology) provides a more exacting efficacy measure. RESULTS: Clinical investigations have shown that the combination of oral therapies with antifungal nail lacquer can confer considerable advantage over monotherapy with either drug type. CONCLUSION: The improved effectiveness and economic advantages of combined topical/oral therapies benefit both patients and health providers; these treatment regimens therefore have an important role to play in the modern management of onychomycosis.     

伊曲康唑和氟康唑治疗甲真菌病疗效及安全性观察

目的研究伊曲康唑和氟康唑治疗甲真菌病的疗效和安全性。方法采用随机、双盲对照的临床研究方法,对98例甲真菌病患者进行随机分组,治疗组给予斯皮仁诺口服,对照组采用氟康唑口服,观察治疗3m和6m的临床疗效和不良反应。结果服药后3m、6m治疗组和对照组的有效率分别为77.5%和75.5%,75.5%和85.4%试验中没有发生严重不良反应。结论斯皮仁诺和氟康唑治疗甲真菌病疗效显著,差异无显著性。     

Continuous itraconazole treatment for onychomycosis and dermatomycosis: an overview of safety.

Over the past 10 years, itraconazole has been used to treat more than 34 million patients worldwide. We present a review of the safety of various continuous itraconazole schedules used in the treatment of dermatomycosis and onychomycosis. Data from controlled clinical trials and extensive post-marketing surveillance show that itraconazole has an impressive safety profile at a dose of 50-200 mg/day for 1-4 weeks for dermatomycosis and 200 mg/day for 3 months for onychomycosis. In addition, itraconazole is safe to use in diabetic patients with dermatomycosis or onychomycosis. Short-term, intermittent itraconazole regimens, which may offer additional benefits in terms of safety and cost, have now been introduced.     

An open randomized comparative study of oral itraconazole pulse and terbinafine pulse in the treatment of onychomycosis

BACKGROUND: Onychomycosis is a recalcitrant disease of the nails caused by dermatophytes, yeasts, and molds. AIMS: To compare the clinical efficacy of oral itraconazole pulse therapy and oral terbinafine pulse therapy in onychomycosis. METHODS: A randomized single-blind clinical comparative study was undertaken on 120 patients of onychomycosis during the period March 1999-February 2002. Sixty patients were randomly assigned to receive oral itraconazole 100 mg, two capsules twice daily for seven days a month and the other group of sixty patients received oral terbinafine 250 mg, one tablet twice daily for seven days every month. Four such monthly pulses were administered for each drug. The patients were evaluated at 4-weekly intervals till sixteen weeks and then at 24, 36 and 48 weeks. RESULTS: We observed a clinical cure rate of 82% and mycological cure rate of 90% in the group of patients treated with itraconazole while the group with terbinafine showed clinical and mycological cure rates of 79% and 87% respectively. This difference was not statistically significant. CONCLUSIONS: Both oral itraconazole and terbinafine are effective in the treatment of onychomycosis when administered in the pulse dosage form. Terbinafine is more cost effective while itraconazole has a broader spectrum of antimycotic activity.     

Itraconazole versus terbinafine (LAMISIL®): which is better for the treatment of onychomycosis?

Objectives To compare the efficacy, safely and tolerability of oral terbinafine with itraconazole in patients with toenail onychomycosis treated for 4 months. Setting Departments of dermatology of six universities and one private clinic. Design Double-blind double-dummy, multicentric, multinational, parallel-group therapeutic trial, involving 179 patients with toenail onychomycosis. Patients were randomly treated with either 200 mg/day oral itraconazole or 250 mg/day terbinafine for 4 months. After the 4th month both treatment groups received oral placebo for another 8 months. The total duration of the study was therefore 12 months. After the 12th month a final evaluation of efficacy was performed in 167 patients (85 on itraconazole and 82 on terbinafine) and a final evaluation of tolerability was performed in 175 patient. Results The dermatophytes identified at the initial visit were Trichophyton rubrum (82.1%), Trichophyton mentagrophytes (14%) and others (3.9%), The mycological cure rates at the end of the 4th and 12th months were 54.9% and 95.3% in the terbinafine group and 51.8% and 84.31% in the itraconazole group (the difference between the groups was. statistically significant at the 12th month, P < 0.04). Clinical cure was achieved by 8.5% and 9.4% of the patients in the terbinafine and itraconazole groups at the 4th month (not significant. NS) and these rates increased to 57.8% and 62.9%. respectively, at the 12th month (difference between groups NS, P > 0,05). A complete mycological cure associated with clinical improvement over 50%. was observed at the 4th month in 50% of the patients treated with terbinafine and 49.4% of the patients treated with itraconazole which was not statistically significant (NS). At the 12th month the rates increased to 95.4% with terbinafine and 75.7% with itraconazole (statistically significant. P < 0.001). Seven patients of the terbinafine group and 9 patients of the itraconazole group presented drug-related side effects (NS). Six patients (6.3%) discontinued the study due to adverse events in the itraconazole group hut no patient discontinued in the terbinafine group. At entry into the study all subjects in both groups presented normal values in liver function tests which remained unchanged throughout the study in the patients of the terbinafine group. One patient of the itraconazole group presented small increases in SGOT and SGPT associated with abdominal pain and nausea.