Rational use and cost variation analysis of antifungal drugs available in the Indian market: a pharmacoeconomic study
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Background: Fungal infections are the 4th most common skin disease affecting 984 million people. Fungal infections are mostly associated with the use of broad-spectrum antibiotics, corticosteroids, anticancer/immunosuppressant drugs, indwelling catheters and implants, and the emergence of AIDS. The aim of this study was to analyze the rational use, cost ratio, and percentage cost variations in different brands of the commonly prescribed antifungal drugs available in the Indian market.Method: The maximum and minimum price of each brand of the drugs given in Indian rupees (INR) was noted by using ‘Drug Today’ (January to April 2021, volume II). The cost range, cost ratio, and the percentage cost variation for individual drug brands were calculated. The cost of tablets/capsule/injection was calculated and the cost ratio and percentage cost variation of various brands was compared.Results: After calculation of cost ratio and percentage cost variation for each brand of antifungal agents, tab Itraconazole 100 mg had a maximum percentage cost variation of 733.33% and a cost ratio of 8.33 while tab Griseofulvin 250 mg had a minimum percentage cost variation of 16.98% and cost ratio of 1.16.Conclusions: The present study shows there was a wide variation in the cost of the different brands of antifungal drugs manufactured by pharmaceutical companies which increases the economic burden. The clinicians prescribing these drugs should be aware of rational use and cost variation to reduce cost of drug therapy and improve patient compliance.Keywords:
Griseofulvin
Pharmacoeconomics
Antifungal drugs
Tinea Capitis
Griseofulvin
Trichophyton tonsurans
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ABSTRACT Seventy‐eight patients with tinea corporis or tinea cruris participated in a double‐blind study with either 100 mg itraconazole or 500 mg ultramicromized griseofulvin for 15 consicutive days. Clinical outcome was significantly in favor of itraconazole at completion of treatment (72% responce rate vs . 51%) and at the follow‐up visit(91% response vs . 64%). The most important difference berween both treatment was the mycologic outcome, for which itraconazole showed a cure rate oc 87% compared to 57% for griseofulvin 2 weeks after comparison of therapy. It is suggested that 100 mg of itraconazole orally daily is significantly more effective than 500 mg of griseofulvin once daily for 15 days in the treatment of glabrous skin infections. Both drugs were well tolerated.
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Summary: One hundred and fourteen evaluable patients with tinea pedis or tinea manuum have been analysed in this double‐blind study between itraconazole and griseofulvin. All infections were confirmed by microscopic examination and/or culture. Daily double‐blind medication consisted of either 100 mg itraconazole or 500 mg ultramicronised griseofulvin and was given for 30 consecutive days. All patients were examined clinically and mycologically at the start of treatment, at the end of treatment (day 30) and 2 weeks after the end of treatment (control day 45). The clinical outcome was virtually the same for both treatment groups at the end (75% response rate for itraconazole vs. 77% for griseofulvin) and 2 weeks after the end of treatment (83% response for itraconazole vs. 82% for griseofulvin). The most important difference between both treatments was the mycological outcome, for which itraconazole showed a cure rate of 85% compared to 48% for griseofulvin 2 weeks after end of therapy (p > 0.01, Fisher's exact test). This suggests that griseofulvin treated patients are more at risk for relapse than itraconazole patients. It is concluded that itraconazole 100 mg orally once daily for 30 days is mycologically more effective than griseofulvin 500 mg once daily for 30 days in the treatment of tinea pedis and/or tinea manuum. Furthermore, the best results are obtained 2 weeks after the end of treatment. Clinically both treatments are equally effective. The difference in clinical and mycological results with griseofulvin may be explained by the known anti‐inflammatory effect of griseofulvin. Both drugs were well tolerated and appeared to be safe for use. Zusammenfassung: In dem vorliegenden Doppelblind‐Vergleich zwischen Itraconazol und Griseofulvin wurden die auswertbaren Daten von 114 Patienten mit Tinea pedis oder Tinea manuum analysiert. Alle Infektionen waren durch mikroskopische Prüfung und/oder Kultur belegt. Die tägliche Doppelblind‐Medikation bestand aus entweder 100 mg Itraconazol oder 500 mg ultramikronisiertem Griseofulvin und wurde 30 Tage lang verabreicht. Alle Patienten wurden klinisch und mykologisch bei Beginn der Behandlung, bei Behandlungsende (Tag 30) und 2 Wochen nach Behandlungsende (Kontrolltag 45) untersucht. Das klinische Ergebnis war für beide Behandlungsgruppen bei Behandlungsende (75% Ansprechquote für Itraconazol vs. 77% für Griseofulvin) und 2 Wochen nach Behandlungsende (83% für Itraconazol vs. 82% für Griseofulvin) praktisch gleich. Der wesentlichste Unterschied zwischen beiden Behandlungen war das mykologische Ergebnis. Hier ergab Itraconazol 2 Wochen nach Behandlungsende eine Heilungsquote von 85% gegenüber 48% mit Griseofulvin (p 0.01, Fisher‐Test). Dies läßt vermuten, daß Griseofulvin‐Patienten ein höheres Rückfallrisiko als Itraconazol‐Patienten haben. Die Schlußfolgerung lautet, daß Itraconazol 100 mg einmal täglich p.o. über 30 Tage mykologisch wirksamer ist als Griseofulvin 500 mg einmal täglich über 30 Tage bei der Behandlung von Tinea pedis und/oder Tinea manuum. Dabei wurden die besten Resultate 2 Wochen nach Behandlungsende beobachtet. Klinisch waren beide Behandlungsmethoden gleich wirksam. Die Differenz zwischen dem klinischen und dem mykologischen Ergebnis mit Griseofulvin kann durch dessen bekannten antiinflammatorischen Effekt erklärt werden. Beide Arzneimittel waren gut verträglich und anwendungssicher.
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The efficacy of two oral antifungal drugs, itraconazole and griseofulvin, in tinea corporis and tinea cruris was compared in a doubleblind trial. Patients were treated with itraconazole (n = 15, 100mg/day) or griseofulvin (n = 14, 500mg/day) for 2 weeks. The clinical outcome was in favour of itraconazole. After 2 weeks 60% of the patients treated with itraconazole were cured, and 21% of those treated with griseofulvin. Equivalent figures 2 weeks after the end of the treatment, were 67% and 29%, respectively. Both treatments were well tolerated.
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Abstract The results of previous international studies have suggested that itraconazole is significantly superior to griseofulvin in the treatment of tinea corporis/cruris. The aim of our study was to compare the efficacy and tolerability of the two agents in a larger number of patients with dermatomycoses. This study is ongoing in 46 Italian Centers of Dermatology. From this total of 46 Centers, the patients of 16 Centers have been included for the “ad interim” analysis. One hundred and thirty‐four patients were randomized to treatment with either itraconazole 100 mg once daily for 15 days (73 patients) or griseofulvin 375–1000 mg daily for a mean of 17 days (61 patients). The patients were assessed clinically and mycologically before entering the trial, at the end of therapy and again 30 days after the end of treatment. Both groups showed a statistically significant improvement in desquamation, erythema and subjective complaints, with a trend in favour of itraconazole, despite the significantly shorter duration of treatment. Thirty days after the end of therapy, microscopic results were negative in 91.5% of the itraconazole group and 71.7% of the griseofulvin group. Cultures were negative in 80% and 65%, respectively. A significantly higher proportion of patients in the itraconazole group than in the griseofulvin group experienced both clinical and mycological recovery. One patient in the itraconazole group and three in the griseofulvin group reported adverse experiences. The preliminary results of this study show that itraconazole is well tolerated and more effective than griseofulvin. Furthermore, itraconazole demonstrated a more rapid action than griseofulvin.
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126 patients (82 males and 44 females) aged above 12 years, suffering from tinea corporis and/or tinea cruris, were treated with either itraconazole (100 mg once a day for 2 weeks and then plecebo for 2 weeks) (63 patients), or griseofulvin (250 mg twice a day for 4 weeks). 90.47% of the patients treated with itraconzole improved whereas griseofulvin imporved 76.19% of patients, clinically. Mycological response was 72% with itraconazole and 57% with griseofulvin.
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To compare the efficacy and safety of itraconazole and griseofulvin in a double-blind parallel study of 20 patients with microscopically and/or culturally proven tinea pedis and/or tinea manus.A 4 week study was undertaken with patients randomised to receive either itraconazole 100 mg or griseofulvin 500 mg once daily for 4 weeks. Microscopy and cultures were performed prior to and at the end of the treatment and 2 weeks posttreatment.After 4 weeks therapy, 50% of itraconazole-treated patients and 30% of griseofulvin-treated patients had negative microscopy; 70% and 50% of these patients, respectively, had negative microscopy at follow up 2 weeks later. A combined score of all clinical assessments showed a statistically significant (p < 0.05) difference at the follow up visit in favour of itraconazole. There was no statistically significant difference with regard to haematological or biochemical measurements, or in urinalysis results, either within or between treatment groups. Six patients reported mild adverse effects (itraconazole = 5, griseofulvin = 1), none of which warranted treatment withdrawal.The findings of this study suggest that itraconazole is more effective than griseofulvin in the symptomatic treatment of tinea pedis and/or manus.
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A total of 40 patients with clinically and mycologically documented tinea corporis or tinea cruris were treated with 100 mg/day itraconazole ( n = 19) or 500 mg/day griseofulvin ( n = 21) for 15 days. Of the itraconazole-treated patients, 83.3% were healed or markedly improved, i.e. ‘responders', after 15 days compared with 85.7% of griseofulvin-treated patients. At 15 days after the end of treatment, 88.2% of itraconazole- and 80.9% of griseofulvin-treated patients were classed as ‘responders'. The mycological cure rate (both microscopy and culture negative) was generally lower than the clinical response rate. Both treatments were equally effective at the end of 15 days' treatment with 66.7% of patients cured, but itraconazole was superior to griseofulvin at the 15-day follow-up visit (77.8% of itraconazole-treated patients compared with 66.7% of griseofulvin-treated patients were cured). Both therapies were well tolerated; only one patient treated with itraconazole reported minor side-effects (dizziness, headache and gastro-intestinal disturbances). The results confirm those of earlier comparative trials and suggest that griseofulvin-treated patients are more at risk of relapse than are itraconazole-treated patients.
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Abstract Background Dermatophyte infections have undergone unprecedented changes in India in recent past. Clinical trials comparing effectiveness of 4 main oral antifungal drugs are not available. We tested effectiveness of oral fluconazole, griseofulvin, itraconazole and terbinafine in chronic and chronic-relapsing tinea corporis, tinea cruris and tinea faciei. Methods Two hundred microscopy confirmed patients were allocated to 4 groups, fluconazole (5mg/kg/day), griseofulvin (10 mg/kg/day), itraconazole (5mg/kg/day), and terbinafine (7.5mg/kg/day), by concealed block randomization and treated for 8 weeks or cure. Effectiveness was calculated based on intention to treat analysis. Results At 4 weeks, 4, 1, 2, and 4 patients were cured with fluconazole, griseofulvin, itraconazole and terbinafine, respectively (P=0.417). At 8 weeks, 21 (42%), 7 (14%), 33 (66%) and 14 (28%) patients were cured, respectively (P=0.000); itraconazole was superior to fluconazole, griseofulvin and terbinafine (P≤0.016). Relapse rates after 4 and 8 weeks of cure in different groups were similar. Numbers-needed-to-treat (NNT) (versus griseofulvin), calculated based on cure rates at 8 weeks, for itraconazole, fluconazole, and terbinafine were 2, 4 and 8, respectively. Conclusion In view of cure rates and NNT, itraconazole is the most effective drug, followed by fluconazole (daily), terbinafine and then griseofulvin, in chronic and chronic-relapsing dermatophytosis in India. One Sentence Summary Effectiveness of all four antifungals has declined, with itraconazole being the most effective currently in dermatophytosis in India.
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Sixty-one patients with a clinical diagnosis of onychomycosis in finger or toe nails were treated with itraconazole 100 mg/day or griseofulvin 500 mg/day for six to nine months. The infective causes were Trichophyton rubrum, Trichophyton mentagro-phytes, or Trichophyton violaceum, and in two cases Candida aibicans. A total of 27 finger and 390 toe nails were infected. Statistically significant intragroup reductions from baseline symptom severity values were seen at endpoint (month 6 or 9) for both treatment groups for all parameters: colour change, thickness, brittleness and unaffected area. No clinically or statistically significant differences between the treatment groups were seen at endpoint. However, the itraconazole group continued to improve during the follow-up, while the mean symptom severity ratings remained the same in the griseofulvin group. All itraconazole patients and 85% of griseofulvin patients were rated as cured or markedly improved at endpoint Nineteen out of 26 evaluable itraconazole patients (73%) remained cured during the three month follow-up period, compared with 12 out of 17 griseofulvin patients (71%). The rather large number of drop-outs, especially among griseofulvin patients, makes it difficult to draw definitive conclusions of the symptom recurrence. Two itraconazole patients stopped medication due to an adverse event, compared to four patients in the griseofulvin group. The clinical laboratory data on itraconazole-treated patients did not show any statistically or clinically significant changes. In conclusion, itraconazole was at least as effective as griseofulvin in the treatment of onychomycosis. The itraconazole group continued to improve after the treatment was stopped. The results show that itraconazole 100 mg/day is safe and efficient in the long-term treatment of fungal nail infections.
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