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  Issue 1 (2002)


New Therapy Option by Indication Extension for systemical Fluconazole

Onychomycoses were considered for a long time as nearly incurable. There has only been an improvement of the treatment possibilities with the availability of the highly-effective systemical antimycotic Itraconazole and Terbinafine. As further therapy option, there is now systemical Fluconazole (Diflucan® Derm) available which received an authorization extension for the indication "Onychomycosis" in fall of last year. DermoTopics had a conversation with the president of the Deutschsprachige Mykologische Gesellschaft (German-speaking Mycologic Society), Professor Dr. med. Hans Christian Korting of the Dermatologische Klinik and Poliklinik of the Ludwig-Maximilians-Universität Munich about this subject.


Onychomycoses give rise to more or less severe complaints with many persons affected and are also felt as cosmetically troublesome. This is why their therapy has been considered as being difficult for a long time. To what extent has there been a change in the meantime?

Professor Dr. med. Hans Christian Korting of the Dermatologische Klinik and Poliklinik (Dermatological Clinic and Outpatient Clinic) of the Ludwig-Maximilians-Universität Munich is President of the Deutschsprachige Mykologische Gesellschaft (German-speaking Mycological Society) and Vice-President of the Gesellschaft für Dermopharmazie. In a conversation with DermoTopics he gave his opinion about the therapy of onychomycosis.

Professor Korting:

Onychomychoses belong to the most frequent skin diseases respectively most widespread diseases in general. Because of the Achill-project we now have good epidemiological data. Accordingly, approximately 20 percent of all adults consulting a dermatological practice suffer from an onychomycosis. Until the beginning of the nineties, onychomycosis was considered as a virtually incurable disease due to the fact that the majority of patients could not be successfully treated with the, at that time available medicaments. A change of this situation only arose with the introduction of the highly effective systemical antimycotics of the type azoles and allylamine.

In fall of last year, systematical fluconazole has got an authorization extension for the indication "Onychomycosis". Which importance does this active substance hold in the frame of the systemical treatment of the onychomycosis?

Professor Korting:  
Fluconazole is effective against dermatophytes and yeasts. The substance is reliably resorbed after peroral feed and well spread also by patients with a lack of gastric acid. Moreover, it is very well tolerable. Fluconazole ranks today equally besides the active substances Itraconazole and Terbinafine, which have already been established for a longer time. Although there are no comparing studies between Fluconazole and Itraconazole respectively Fluconazole and Terbinafine available, for all three substances an indisputable effectiveness proof is available for the indication "onychomycoses". A peculiarity of Fluconazole consists in the fact that the application with onychmomycosis is not restricted to a few months as with Itroconazole and Terbinafine. This represents an advantage in so far as clinical experience as well as a series of data has shown that the curing rate can be substantially raised for treatments over a period of three to four months. Thus, for example a study based on Terbinafine has shown that a four-month treatment time is more effective than a treatment over the period of three months. However, Terbinafine is only authorized for a therapy duration of maximal three months. With Fluconazole, however, the authorization situation is such that the treatment period can be extended without problems to up to 12 months if this should be necessary. About such an extension of the therapy can be individually decided even if the treatment has already been started.

That hits the nail on the foot! Onychomycosis is a typical secondary disease of the insufficiently treated athlete's foot disease. By extending of the indication for systemical fluconazole, a new therapy option is now available.

Which therapy would you consider today as standard for the treatment of the onychomycosis. Has a therapy scheme been established?

Professor Korting:
In principle, the treatment should be in accordance with guidelines. The Deutschsprachige Mykologische Gesellschaft has established the guidelines "Onychomycosis" in cooperation with the Deutsche Dermatologische Gesellschaft (German Dermatological Society) and the Berufsverband der Deutschen Dermatologen (Professional Association of German Dermatologists). Accordingly, a topical therapy is to be taken in consideration for the frequently occurring distolateral type of the onychomycosis on condition that the area seized is not too extensive. In this context, it has to be stated that a part of the patients can be cured by a merely local therapy by means of ciclopirox or amorolfine lacquer. Patients with whom this treatment has not been successful or this cannot be expected according to a clinical assessment should be treated systemically. However, in the individual case a benefit-risk analysis is to be established. In my opinion, of the three systemical antimycotics Itraconazole, Terbinafine and Fluconazole not one of them can be generally and indubitably described as being superior compared with the others. But it represents an essential extension of the therapeutical possibilities that in the frame of the authorization granted, a longer treatment with fluconazole than in the past is now possible.

A long-term therapy however also constitutes a cost factor. What is the position of Fluconazole in this respect in comparison with other antimycotics?

Professor Korting:
The three mentioned systemical antimycotics differ fundamentally in the type of dosage: Terbinafine is administered continually daily over the period of three months. This is a conventional approach regarding the application scheme. For Itroconazole a special form of the interval therapy, the so-called pulse therapy has been established. In this connection, the treatment is generally effected over one of four weeks at in total three or four treatment cycles. For Fluconazole a different interval therapy has been developed: 150 milligrams are applied on the first day of the week, i.e. three capsules of 50 milligrams. This treatment can be carried out over a period of six months or if necessary for a longer period of time. On the basis of this application scheme, the acquisition costs for systemical Fluconazole based on the pharmacy sales price is considerably lower than with both other antimycotics. In principle however, for pharmaco-economic considerations besides the costs also the procurement of the drug as well as other costs are to be taken in consideration. A final cost comparison between the three different therapy schemes is therefore only possible if the pharmaco-economy provides the necessary data for it.

Professor Korting, thank your for this conversation. (ghw/jk)


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