scholarly journals Multidrug therapy with terbinafine and itraconazole is not superior to itraconazole alone in current epidemic of altered dermatophytosis in India: A randomized pragmatic trial

2019 ◽  
Author(s):  
Sanjay Singh ◽  
Vinayak N Anchan ◽  
Usha Chandra ◽  
Radhika Raheja
Keyword(s):  
Pragmatic Trial ◽  
Number Needed To Treat ◽  
Multidrug Therapy ◽  
Control Versus ◽  
Oral Itraconazole ◽  
Cure Rates ◽  
Tinea Faciei ◽  
Treatment Responsiveness ◽  
Relapse Rates ◽  
Oral Terbinafine

AbstractBackgroundTreatment responsiveness of dermatophytosis has decreased considerably in recent past in India. We compared effectiveness of oral terbinafine daily (Terb) (active control) versus itraconazole daily (Itra) versus terbinafine plus itraconazole daily (TI) versus terbinafine daily plus itraconazole pulse (TIp) in tinea corporis, tinea cruris and tinea faciei in a pragmatic randomized open trial.MethodsNinety-two microscopically confirmed patients were allocated to Terb (6 mg/kg/day), Itra (5 mg/kg/day), TI (terbinafine 6 mg/kg/day, itraconazole 5 mg/kg/day), or TIp (terbinafine 6 mg/kg/day, itraconazole 10 mg/kg/day for 1 week in 4 weeks) group by concealed block randomization and treated for 8 weeks or cure.ResultsCure rates were similar at 4 weeks (P=0.768). At 8 weeks, 5 (21.7%), 18 (78.3%), 16 (69.6%), and 16 (69.6%) patients were cured in Terb, Itra, TI, and TIp groups, respectively. All experimental regimens (Itra, TI, TIp) were more effective than Terb (P≤0.0027). All experimental regimens had similar effectiveness (P≥0.738). Relapse rates 4 and 8 weeks after cure were similar (P=0.869 and 0.314, respectively). Number-needed-to-treat (NNT) was 2 for Itra, 3 for TI, and 3 for TIp.ConclusionsOral itraconazole given daily (NNT=2) is the most effective treatment and combining it with terbinafine does not increase effectiveness.One Sentence SummaryCombination of oral terbinafine and itraconazole is not more effective than itraconazole alone in current epidemic of altered dermatophytosis in India.

scholarly journals Multidrug therapy with terbinafine plus daily fluconazole is more effective than terbinafine alone or terbinafine plus weekly fluconazole in current epidemic of altered dermatophytosis in India: Results of a randomized pragmatic trial

2019 ◽  
Author(s):  
Sanjay Singh ◽  
Bandana Jha ◽  
Prakriti Shukla ◽  
Vinayak N Anchan
Keyword(s):  
Pragmatic Trial ◽  
Number Needed To Treat ◽  
Multidrug Therapy ◽  
Recent Past ◽  
Number Of Patients ◽  
Cure Rates ◽  
Tinea Faciei ◽  
Treatment Responsiveness ◽  
Relapse Rates ◽  
Oral Terbinafine

AbstractBackgroundTreatment responsiveness of tinea has decreased considerably in recent past in India. We tested effectiveness of oral terbinafine daily plus fluconazole weekly (TFw) and terbinafine daily plus fluconazole daily (TFd) versus oral terbinafine daily (T) in tinea corporis, tinea cruris and tinea faciei in a pragmatic randomized open trial.MethodsOne hundred and seventeen microscopy confirmed patients were allocated to T (6 mg/kg/day), TFw (terbinafine 6 mg/kg/day+fluconazole 12 mg/kg once weekly), or TFd (terbinafine 6 mg/kg/day+fluconazole 6 mg/kg/day) groups by concealed randomization and treated for 8 weeks or cure. Each group included 39 patients.ResultsAt 4 weeks, 9 (23.1%), 8 (20.5%) and 14 (35.9%) patients were cured in T, TFw and TFd groups, respectively (P=0.279). At 8 weeks, number of patients cured was as follows: T 13 (33.3%), TFw 18 (46.2%) and TFd 25 (64.1%). TFd was more effective than T (P=0.012), other comparisons were not significantly different. However, effect size as calculated by number needed to treat (NNT) (versus terbinafine) was 8 for TFw and 4 for TFd. Relapse rates one month after cure were similar in all groups (P=0.664).ConclusionsIn view of cure rates and NNT, terbinafine plus daily fluconazole is more effective than terbinafine alone or terbinafine plus weekly fluconazole in current epidemic of altered dermatophytosis in India.One Sentence SummaryTerbinafine plus daily fluconazole is more effective than terbinafine alone or terbinafine plus weekly fluconazole in current epidemic of altered dermatophytosis in India.

scholarly journals Futility of combining griseofulvin and terbinafine in current epidemic of altered dermatophytosis in India: Results of a randomized pragmatic trial

2019 ◽  
Author(s):  
Sanjay Singh ◽  
Vinayak N Anchan ◽  
Radhika Raheja
Keyword(s):  
Pragmatic Trial ◽  
Tinea Corporis ◽  
Number Needed To Treat ◽  
Recent Past ◽  
Cure Rate ◽  
Once Daily ◽  
Tinea Cruris ◽  
Tinea Faciei ◽  
Treatment Responsiveness ◽  
Oral Terbinafine

AbstractBackgroundTreatment responsiveness of tinea has decreased considerably in recent past in India. We tested effectiveness of oral terbinafine plus griseofulvin versus terbinafine alone in tinea corporis, tinea cruris and tinea faciei in a randomized pragmatic open trial.MethodsOne hundred and thirty two microscopy confirmed patients were randomly allocated (ratio 1:1) to two groups, terbinafine (T) and terbinafine plus griseofulvin (T+G). Doses given were as follows: T, oral terbinafine (6 mg/kg/day, maximum 500 mg/day, once daily); T+G, terbinafine (as above) plus oral griseofulvin (children [<18 years] 10 mg/kg/day, adults [18 years or more] 10 mg/kg/day, but not <500 mg and not >1000 mg per day, in two divided doses). Patients were treated for 8 weeks or cure, whichever occurred earlier.ResultsAt 4 weeks, none of the patients were cured in both groups. At 6 weeks, 1(1.5%) and 4 (6.1%) patients were cured in T and T+G groups, respectively (P=0.417). At 8 weeks, 17 (25.8%) and 19 (28.8%) patients were cured in T and T+G groups, respectively (P=0.845). For cure rate at 8 weeks, number needed to treat (NNT) for T+G (versus T), was 33.ConclusionsAddition of griseofulvin to terbinafine does not increase effectiveness of terbinafine in current epidemic of altered dermatophytosis in India.

scholarly journals Effectiveness of four oral antifungal drugs (fluconazole, griseofulvin, itraconazole, terbinafine) in current epidemic of altered dermatophytosis in India: A randomized pragmatic trial

2019 ◽  
Author(s):  
Sanjay Singh ◽  
Usha Chandra ◽  
Priyanka Verma ◽  
Vinayak N Anchan ◽  
Ragini Tilak
Keyword(s):  
Pragmatic Trial ◽  
Antifungal Drugs ◽  
Recent Past ◽  
Oral Fluconazole ◽  
Intention To Treat ◽  
Numbers Needed To Treat ◽  
Cure Rates ◽  
Tinea Faciei ◽  
Relapse Rates ◽  
Treat Analysis

AbstractBackgroundDermatophyte 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.MethodsTwo 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.ResultsAt 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.ConclusionIn 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 SummaryEffectiveness of all four antifungals has declined, with itraconazole being the most effective currently in dermatophytosis in India.

scholarly journals A Comparative Study of Efficacy of Oral Terbinafine and Oralitraconazole in Tinea Corporis / Tinea Cruris Infection

2021 ◽  
pp. 94-105
Author(s):  
S. Brigida ◽  
Arul Amutha Elizabeth
Keyword(s):  
Clinical Cure ◽  
Fungal Infections ◽  
Previous Treatment ◽  
Antifungal Drugs ◽  
Outpatient Clinics ◽  
Good Safety Profile ◽  
Oral Itraconazole ◽  
Cure Rates ◽  
Diabetes And Obesity ◽  
Oral Terbinafine

Dermatophytoses which are superficial fungal infections of the skin, hair, and nail are among the most common infective dermatoses seen in dermatology outpatient clinics. Today, we are facing an onslaught of chronic and recurrent dermatophytosis in volumes never encountered previously. Itraconazole was found to be the  better antifungal  in terms of clinical cure,mycological  clearance  and less need for extension of treatment than Terbinafine. Overall, oral Itraconazole 200 mg/day for 2 weeks proved to be a better agent with excellent and significantly better cure rates than  oral Terbinafine 500mg/day for 2 weeks. With Itraconazole, the contra-indications, drug  interactions must be kept in mind to prevent loss of efficacy/ potentially hazardous interactions. Both drugs had a good safety profile and few minor adverse events. The reasons for  extension of treatment comprise chronicity, previous treatment with OTC steroid preparations, and misuse of systemic antifungal drugs, diabetes, and obesity. Poor personal practices and hygiene also havetheir contribution. Significant associations were also noted between diabetes and chronicity.

scholarly journals Short-Course Itraconazole in the Treatment of Candida Vulvovaginitis: A Multicentre Canadian Study

1996 ◽  
Vol 7 (2) ◽  
pp. 110-114 ◽  
Author(s):  
Canadian Itraconazole Study Group ◽  
Thomas W Austin ◽  
Marc Steben ◽  
Marion Powell ◽  
Barbara Romanowski ◽  
...  
Keyword(s):  
Adverse Events ◽  
Multicentre Trial ◽  
Mycological Cure ◽  
Canadian Study ◽  
Treatment Groups ◽  
Short Course ◽  
Number Of Patients ◽  
Oral Itraconazole ◽  
Cure Rates ◽  
Single Dose Therapy

OBJECTIVE: To determine the clinical and mycological effectiveness of oral itraconazole in the treatment of acute candida vulvovaginitis.DESIGN: A prospective, randomized and single-blinded, multicentre trial of 221 women, comparing a one-day course of oral itraconazole 200 mg bid with vaginal clotrimazole 500 mg single-dose therapy.MAIN OUTCOME MEASURES: Symptoms, signs and mycological results were assessed up to two months following treatment. Adverse events were recorded and evidence of hepatotoxicity sought.RESULTS: At 10 and 30 days post-treatment, clinical and mycological cure rates were similar (61.3% clinical and 88.6% mycological 10 days after, and 67.7% clinical and 79.5 mycological 30 days after itraconazole; 64.0 clinical and 85.9% mycological 10 days after, and 62.1% clinical and 78.6 mycological 30 days after clotrimazole) with the majority of both treatment groups free from infection. A total of 69 patients reported adverse events, which were generally transient and mild. Itraconazole was more often associated with gastrointestinal or central nervous system complaints, while clotrimazole recipients more often had genitourinary symptoms. No evidence of hepatotoxicity was found. A higher incidence of relapse was noted among women on the birth control pill and among those who were symptomatic for longer than 10 days before treatment.CONCLUSIONS: A one-day course of oral itraconazole is as effective as intravaginal clotrimazole in the treatment of acute yeast vulvovaginitis. The number of patients reporting adverse events was similar for the treatment groups, although the side effect profile differed. No hepatotoxicity was observed.

scholarly journals Is there a role for tedizolid in the treatment of non-tuberculous mycobacterial disease?

2019 ◽  
Vol 75 (3) ◽  
pp. 609-617 ◽  
Author(s):  
Mike Marvin Ruth ◽  
Valerie A C M Koeken ◽  
Lian J Pennings ◽  
Elin M Svensson ◽  
Heiman F L Wertheim ◽  
...  
Keyword(s):  
Bacterial Population ◽  
Mycobacterium Abscessus ◽  
Multidrug Therapy ◽  
Pulmonary Infections ◽  
Mycobacterial Disease ◽  
Bacteriostatic Effect ◽  
Dependent Activity ◽  
Cure Rates ◽  
Time Kill ◽  
Over Time

Abstract Background Pulmonary infections caused by non-tuberculous mycobacteria (NTM) are hard to treat and have low cure rates despite intensive multidrug therapy. Objectives To assess the feasibility of tedizolid, a new oxazolidinone, for the treatment of Mycobacterium avium and Mycobacterium abscessus. Methods We determined MICs of tedizolid for 113 isolates of NTM. Synergy with key antimycobacterial drugs was assessed using the chequerboard method and calculation of the FIC index (FICI). We performed time–kill kinetics assays of tedizolid alone and combined with amikacin for M. abscessus and with ethambutol for M. avium. Human macrophages were infected with M. abscessus and M. avium and subsequently treated with tedizolid; intracellular and extracellular cfu were quantified over time. Results NTM isolates generally had a lower MIC of tedizolid than of linezolid. FICIs were lowest between tedizolid and amikacin for M. abscessus (FICI = 0.75) and between tedizolid and ethambutol for M. avium (FICI = 0.72). Clarithromycin and tedizolid showed initial synergy, which was abrogated by erm(41)-induced macrolide resistance (FICI = 0.53). Tedizolid had a weak bacteriostatic effect on M. abscessus and combination with amikacin slightly prolonged its effect. Tedizolid had concentration-dependent activity against M. avium and its efficacy was enhanced by ethambutol. Both combinations had a concentration-dependent synergistic effect. Tedizolid could inhibit the intracellular bacterial population of both M. avium and M. abscessus. Conclusions Tedizolid should be further investigated in pharmacodynamic studies and clinical trials for M. avium complex pulmonary disease. It is less active against M. abscessus, but still promising.

Satisfaction with Onychomycosis Treatment

2003 ◽  
Vol 93 (5) ◽  
pp. 373-379 ◽  
Author(s):  
Erin M. Warshaw ◽  
Thomas Bowman ◽  
Myron A. Bodman ◽  
John J. Kim ◽  
Stefanie Silva ◽  
...  
Keyword(s):  
Cross Sectional Study ◽  
Open Label ◽  
Cross Sectional ◽  
Medical Chart Review ◽  
Medical Clinics ◽  
Pulse Dose ◽  
Patient Reported ◽  
Satisfaction With Treatment ◽  
Oral Itraconazole ◽  
Oral Terbinafine

The purpose of this study, which involved two dermatology clinics and two podiatric medical clinics, was to determine whether a difference exists in patient-reported satisfaction and compliance between continuous terbinafine therapy and pulse-dose itraconazole therapy for the treatment of toenail onychomycosis. Patients in this multicenter, open-label, cross-sectional study had previously completed treatment with either oral terbinafine or oral itraconazole for toenail onychomycosis. Patients were interviewed by telephone to assess clinical outcomes, compliance, and satisfaction with treatment; clinical data were collected by medical chart review. Patients reported significantly greater ease and convenience of treatment and higher overall satisfaction with continuous terbinafine therapy compared with pulse-dose itraconazole therapy. (J Am Podiatr Med Assoc 93(5): 373-379, 2003)

Pharmacoeconomic Assessment of Ciclopirox Topical Solution, 8%, Oral Terbinafine, and Oral Itraconazole for Onychomycosis

2006 ◽  
Vol 10 (6_suppl) ◽  
pp. S54-S62 ◽  
Author(s):  
Aditya K. Gupta ◽  
Charles W. Lynde ◽  
Kirk Barber
Keyword(s):  
Drug Acquisition ◽  
Cost Effective ◽  
Canadian Health Care System ◽  
Nail Lacquer ◽  
Canadian Health ◽  
Canadian Health Care ◽  
Acquisition Costs ◽  
The Cost ◽  
Relapse Rates ◽  
Oral Terbinafine

Most pharmacoeconomic data available for antifungal agents are based on US or European cost parameters. Similar data have not been reported in a Canadian health care system. A pharmacoeconomic analysis was performed considering the costs of drug acquisition and medical management, which were representative of the Canadian health care system, for each of the therapies approved for use in toenail onychomycosis in Canada: continuous oral terbinafine, oral pulse itraconazole, and topical ciclopirox 8% nail lacquer. A survey of provincial fee schedules was conducted to determine the representative costs of parameters relating to onychomycosis treatment, such as consultation visit cost, return visit cost, mycology testing, liver function testing, and complete blood count analysis. Manufacturers' costs were used to calculate representative drug acquisition costs. Meta-analysis was used to determine the average mycologic cure rates of each therapy, and the medical literature was consulted to determine the relapse rates for each therapy. Ciclopirox nail lacquer had the lowest drug acquisition costs compared with continuous terbinafine and pulse itraconazole ($197.89 vs $311.39 and $323.40, respectively). Using the pharmacoeconomic model with three 1-year treatment phases, in which failures or relapses were re-treated with the primary drug, the expected cost per patient was $601.52 with ciclopirox nail lacquer, $746.72 with oral terbinafine, and $938.42 with itraconazole. The main analysis assumed that two bottles of ciclopirox nail lacquer were required per treatment. The cost for the ciclopirox lacquer exceeded continuous terbinafine but remained lower than pulse itraconazole when three bottles of ciclopirox nail lacquer were considered in the calculation of cost per mycological cure. A variety of relapse rates were tested, and ciclopirox using two or fewer bottles remained cost-effective compared with continuous terbinafine or pulse itraconazole, regardless of the relapse rate. Where three bottles are required, the cost-effectiveness of ciclopirox nail lacquer is less than that of continuous terbinafine but more cost-effective than that of pulse itraconazole.

scholarly journals Treatment of dermatophyte toenail onychomycosis with itraconazole

2016 ◽  
Vol 6 (1) ◽  
pp. 70
Author(s):  
Vishal P. Giri ◽  
Sudhir K. Gupta ◽  
Om P. Giri ◽  
Kirti V.
Keyword(s):  
Observational Cohort Study ◽  
Published Data ◽  
Tropical Countries ◽  
Immunodeficiency Virus ◽  
The World ◽  
Fluconazole Therapy ◽  
Oral Itraconazole ◽  
Observational Cohort ◽  
One Year ◽  
Cure Rates

Background: Onychomycosis is fungal infection of nail. The prevalence of onychomycosis varies across the world. It is lower in tropical countries (3.8%) than in sub-tropical countries and countries in the temperate zone (23%). The risk of onychomycosis is higher in persons with diabetes mellitus and human immunodeficiency virus infection. Systemic antifungals are recommended for treatment. Topical antifungals are less effective. Different cure rates have been reported by different authors for terbinafine, itraconazole and fluconazole therapy. A variety of regimens (continuous or pulse) have also been suggested.Methods: Here in this study we report a prospective, observational, cohort study of pulse itraconazole therapy in toenail onychomycosis caused by dermatophytes over a period of one year in patients with SCIO scores between 6 to 9.Results: It was observed that mean age of patients was 38.96 years. 57.27 % study subjects had complete clinical improvement to oral itraconazole three pulses regimen. One pulse consisted of 200 mg twice per day given for one week, followed by a three weeks interval. Thus, this regimen was repeated thrice.Conclusions: This study shows the substantial benefit with itraconazole pulse regimen in toenail onychomycosis. The outcome this study is comparable with previously published data and may encourage the usage of itraconazole pulse regimen for the treatment of dermatophyte toenail onychomycosis in adults.

scholarly journals A Comparative Study of Safety and Efficacy of Oral Terbinafine and Itraconazole in Patients of Tinea Corporis/ Tinea Cruris Infection, A Randomized Open Label Parallel Group Study

2021 ◽  
Vol 14 (3) ◽  
pp. 1543-1549
Author(s):  
S. Brigida ◽  
Arul Amutha Elizabeth ◽  
G. Soujania ◽  
R. Poornima Poornima
Keyword(s):  
Public Health Problem ◽  
Tinea Corporis ◽  
Open Label ◽  
Once Daily ◽  
Safety And Efficacy ◽  
Tinea Cruris ◽  
Oral Itraconazole ◽  
Group 2 ◽  
Oral Terbinafine ◽  
Group 1

Introduction: Superficial dermatophytosis is a common public health problem in India, due to its tropical climate with heat and humidity. Today, the triazoles, mainly Itraconazole and the allylamines, chiefly Terbinafine, are the main ammunitions against dermatophytes. This study is undertaken to compare the safety and efficacy of both the drugs. Materials and Methods: This study was conducted to find the efficacy of Oral Terbinafine and Oral Itraconazole in Tinea Corporis/Tinea Cruris infection. The primary efficacy parameter was change in composite score (pruritus, erythema, pigmentations) from baseline to end of the treatment period. And to compare the safety of Oral Terbinafine and Oral Itraconazole by comparing the following parameters, Liver enzymes - SGOT/SGPT before and after treatment with the study drugs. Drug Dosage: Group 1: Drug –Tab. Terbinafine: Dose 500 mg per day once daily at bedtime for 2 weeks. Group 2: Drug –Tab. Itraconazole: Dose 200 mg per day, once daily at bedtime for 2 weeks. Results: The study participants show significant reduction in itching at the second follow up (after 2 weeks of drug completion) in both groups. Pruritis was reduced in 92% subjects in group 1 and 97.5% subjects in group 2. There was 87% reduction in erythema in group 1 and 93% reduction in group 2. Pigmentations were seen in 2% subjects in both groups indicating relapse of infection. Conclusion: The significant outcome of the study was that oral Itraconazole 200mg/day for 14 days(2 weeks) can be the better antifungal.

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