Treatment of Toenail Onychomycosis with Oral Terbinafine Plus Aggressive Debridement

2006 ◽  
Vol 96 (6) ◽  
pp. 465-473 ◽  
Author(s):  
Maureen B. Jennings ◽  
Richard Pollak ◽  
Lawrence B. Harkless ◽  
Farid Kianifard ◽  
Amir Tavakkol
Keyword(s):  
Adverse Events ◽  
Marked Improvement ◽  
Clinical Cure ◽  
Liver Transaminase ◽  
Safety And Efficacy ◽  
Time Points ◽  
Clinically Significant ◽  
Aggressive Debridement ◽  
Cure Rates ◽  
Oral Terbinafine

This study was conducted to investigate the efficacy of oral terbinafine with and without aggressive debridement for the treatment of toenail onychomycosis. Onychomycosis patients aged 18 to 75 years received 12 weeks of terbinafine, 250 mg/day, alone (n = 255) or with aggressive debridement (n = 249). Both groups showed marked improvement from baseline at all time points. At week 48, complete, mycologic, and clinical cure rates were higher in the terbinafine plus debridement group compared with the terbinafine alone group, although significance was reached only for clinical cure (59.8% versus 51.4%; P = .023). Although approximately 39% of the patients received at least one antidiabetic, antihypertensive, or cholesterol-lowering agent concomitantly, including statins, the incidence of treatment-emergent adverse events was low and the adverse events were generally mild to moderate in severity. No clinically significant changes in liver transaminase levels were observed 6 weeks after treatment or after 12 weeks in those tested. These results support the well-established safety and efficacy of terbinafine for treatment of onychomycosis. (J Am Podiatr Med Assoc 96(6): 465–473, 2006)

scholarly journals Safety and Outcomes of Linezolid Use for Nocardiosis

2020 ◽  
Vol 7 (4) ◽  
Author(s):  
Natalie Davidson ◽  
Matthew J Grigg ◽  
Sarah L Mcguinness ◽  
Robert J Baird ◽  
Nicholas M Anstey
Keyword(s):  
Adverse Events ◽  
Hospital Setting ◽  
Drug Susceptibility ◽  
Therapeutic Drug ◽  
Primary Analysis ◽  
Safety And Efficacy ◽  
Treatment Regimens ◽  
Linezolid Therapy ◽  
Tropical Australia ◽  
Clinically Significant

Abstract Background Tropical Australia has a high incidence of nocardiosis, with high rates of intrinsic antimicrobial resistance. Linezolid, the only antimicrobial to which all local Nocardia species are susceptible, has been recommended in empirical combination treatment regimens for moderate–severe Nocardia infections at Royal Darwin Hospital (RDH) since 2014. We report the safety and efficacy of linezolid use for nocardiosis in this setting. Methods We identified cases through a retrospective review of all RDH Nocardia isolates from December 2014 to August 2018 and included 5 linezolid-treated cases from a previous cohort. Laboratory, demographic, and clinical data were included in the primary analysis of safety and treatment outcomes. Results Between 2014 and 2018, Nocardia was isolated from 35 individuals; 28 (80%) had clinically significant infection and 23 (82%) received treatment. All isolates were linezolid-susceptible. Safety and efficacy were assessed for 20 patients receiving linezolid-containing regimens and 8 receiving nonlinezolid regimens. Median linezolid induction therapy duration was 28 days. Common adverse effects in those receiving linezolid were thrombocytopenia (45%) and anemia (40%). Adverse events prompted discontinuation of trimethoprim-sulfamethoxazole more often than linezolid (40% vs 20%). Linezolid therapeutic drug monitoring was used in 1 patient, with successful dose reduction and outcome. There was no difference in 30-day survival between those treated with linezolid (90%) vs no linezolid (87%). One Nocardia-attributed death occurred during linezolid therapy. Conclusions Linezolid is safe and efficacious in empirical treatment for moderate to severe nocardiosis in a monitored hospital setting, with 100% drug susceptibility and no difference in adverse events or outcomes compared with nonlinezolid regimens.

scholarly journals Safety and efficacy of restarting immune checkpoint inhibitors after clinically significant immune-related adverse events in metastatic renal cell carcinoma

2020 ◽  
Vol 8 (1) ◽  
pp. e000144 ◽  
Author(s):  
Sarah Abou Alaiwi ◽  
Wanling Xie ◽  
Amin H Nassar ◽  
Shaan Dudani ◽  
Dylan Martini ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Median Time ◽  
Immune Checkpoint ◽  
Renal Cell ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Safety And Efficacy ◽  
Clinically Significant

BackgroundImmune checkpoint inhibitors (ICI) induce a range of immune-related adverse events (irAEs) with various degrees of severity. While clinical experience with ICI retreatment following clinically significant irAEs is growing, the safety and efficacy are not yet well characterized.MethodsThis multicenter retrospective study identified patients with metastatic renal cell carcinoma treated with ICI who had >1 week therapy interruption for irAEs. Patients were classified into retreatment and discontinuation cohorts based on whether or not they resumed an ICI. Toxicity and clinical outcomes were assessed descriptively.ResultsOf 499 patients treated with ICIs, 80 developed irAEs warranting treatment interruption; 36 (45%) of whom were restarted on an ICI and 44 (55%) who permanently discontinued. Median time to initial irAE was similar between the retreatment and discontinuation cohorts (2.8 vs 2.7 months, p=0.59). The type and grade of irAEs were balanced across the cohorts; however, fewer retreatment patients required corticosteroids (55.6% vs 84.1%, p=0.007) and hospitalizations (33.3% vs 65.9%, p=0.007) for irAE management compared with discontinuation patients. Median treatment holiday before reinitiation was 0.9 months (0.2–31.6). After retreatment, 50% (n=18/36) experienced subsequent irAEs (12 new, 6 recurrent) with 7 (19%) grade 3 events and 13 drug interruptions. Median time to irAE recurrence after retreatment was 2.8 months (range: 0.3–13.8). Retreatment resulted in 6 (23.1%) additional responses in 26 patients whose disease had not previously responded. From first ICI initiation, median time to next therapy was 14.2 months (95% CI 8.2 to 18.9) and 9.0 months (5.3 to 25.8), and 2-year overall survival was 76% (95%CI 55% to 88%) and 66% (48% to 79%) in the retreatment and discontinuation groups, respectively.ConclusionsDespite a considerable rate of irAE recurrence with retreatment after a prior clinically significant irAE, most irAEs were low grade and controllable. Prospective studies are warranted to confirm that retreatment enhances survival outcomes that justify the safety risks.

scholarly journals Clinafloxacin versus Piperacillin-Tazobactam in Treatment of Patients with Severe Skin and Soft Tissue Infections

2001 ◽  
Vol 45 (2) ◽  
pp. 525-531 ◽  
Author(s):  
G. Siami ◽  
N. Christou ◽  
I. Eiseman ◽  
K. J. Tack
Keyword(s):  
Soft Tissue ◽  
Adverse Events ◽  
Clinical Cure ◽  
Wound Infections ◽  
Soft Tissue Infections ◽  
Pathogenic Species ◽  
Treatment Groups ◽  
Diabetic Foot Infections ◽  
Cure Rates ◽  
To Receive

ABSTRACT Patients (n = 409) with severe skin and soft tissue infections (SSTIs) were randomized to receive clinafloxacin or piperacillin-tazobactam (plus optional vancomycin for methicillin-resistant cocci), administered intravenously, with the option to switch to oral medication. Most patients had cellulitis, wound infections, or diabetic foot infections. Staphylococcus aureus, Enterococcus faecalis, and Pseudomonas aeruginosa were the most common baseline pathogens. Fewer baseline pathogens were resistant to clinafloxacin (1.8%) than to piperacillin-tazobactam (6.2%) (P = 0.001). The clinafloxacin and piperacillin-tazobactam groups did not differ significantly in clinical cure rates (68.8 and 65.2%, respectively) or microbiologic eradication rates (61.5 and 57.2%). Clinafloxacin yielded higher eradication rates for all three of the most common pathogenic species, although no differences were statistically significant. Within the power of this study, the overall frequency of adverse events was similar (P = 0.577) in the two treatment groups. Drug-associated adverse events (P = 0.050) and treatment discontinuations (P = 0.052) were marginally more frequent in the clinafloxacin group, primarily due to phototoxicity in outpatients receiving clinafloxacin. Although most cases of phototoxicity were mild to moderate, four cases were reported as severe. In summary, clinafloxacin monotherapy was equivalent in effectiveness to therapy with piperacillin-tazobactam plus optional vancomycin in the treatment of hospitalized patients with severe SSTIs.

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 Randomized Comparison of Linezolid (PNU-100766) versus Oxacillin-Dicloxacillin for Treatment of Complicated Skin and Soft Tissue Infections

2000 ◽  
Vol 44 (12) ◽  
pp. 3408-3413 ◽  
Author(s):  
Dennis L. Stevens ◽  
Leon G. Smith ◽  
Jon B. Bruss ◽  
Maureen A. McConnell-Martin ◽  
Sue E. Duvall ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Adverse Events ◽  
Success Rate ◽  
Clinical Cure ◽  
Moderate Intensity ◽  
Soft Tissue Infections ◽  
Cure Rate ◽  
Oral Agents ◽  
Complicated Skin ◽  
Cure Rates

ABSTRACT This randomized, double-blind, multicenter trial compared the efficacy and safety of linezolid, an oxazolidinone, with those of oxacillin-dicloxacillin in patients with complicated skin and soft tissue infections. A total of 826 hospitalized adult patients were randomized to receive linezolid (600 mg intravenously [i.v.]) every 12 h or oxacillin (2 g i.v.) every 6 h; following sufficient clinical improvement, patients were switched to the respective oral agents (linezolid [600 mg orally] every 12 h or dicloxacillin [500 mg orally] every 6 hours). Primary efficacy variables were clinical cure rates in both the intent-to-treat (ITT) population and clinically evaluable (CE) patients and microbiological success rate in microbiologically evaluable (ME) patients. Safety and tolerability were evaluated in the ITT population. Demographics and baseline characteristics were similar across treatment groups in the 819 ITT patients. In the ITT population, the clinical cure rates were 69.8 and 64.9% in the linezolid and oxacillin-dicloxacillin groups, respectively (P = 0.141; 95% confidence interval −1.58 to 11.25). In 298 CE linezolid-treated patients, the clinical cure rate was 88.6%, compared with a cure rate of 85.8% in 302 CE patients who received oxacillin-dicloxacillin. In 143 ME linezolid-treated patients, the microbiological success rate was 88.1%, compared with a success rate of 86.1% in 151 ME patients who received oxacillin-dicloxacillin. Both agents were well tolerated; most adverse events were of mild-to-moderate intensity. No serious drug-related adverse events were reported in the linezolid group. These data support the use of linezolid for the treatment of adults with complicated skin and soft tissue infections.

scholarly journals Prospective exploratory study to assess the safety and efficacy of aflibercept in cystoid macular oedema associated with retinitis pigmentosa

2020 ◽  
pp. bjophthalmol-2019-315152
Author(s):  
Stacey A Strong ◽  
Tunde Peto ◽  
Catey Bunce ◽  
Wen Xing ◽  
Michalis Georgiou ◽  
...  
Keyword(s):  
Adverse Events ◽  
Retinitis Pigmentosa ◽  
Macular Oedema ◽  
Exploratory Study ◽  
Cystoid Macular Oedema ◽  
Open Label ◽  
Safety And Efficacy ◽  
Intravitreal Aflibercept ◽  
Clinically Significant

AimsTo report the safety and efficacy of intravitreal aflibercept (Eylea) (ivA) for retinitis pigmentosa-associated cystoid macular oedema (RP-CMO) at 12 months via mean central macular thickness (CMT) and reported adverse events.MethodsA prospective, exploratory, phase II, non-randomised, single-centre, open-label, 1-arm clinical trial involving 30 eyes of 30 patients. Serial ivA was given via loading dose (three injections) followed by treat and extend protocol over 12 months.ResultsTwenty-nine out of 30 (96.7%) patients completed 12 months of follow-up. A total of four to 11 injections per patient were given over the 12 month study. No statistically significant reduction of CMT or visual acuity (VA) improvement was demonstrated in the group overall. Eleven out of 29 (37.9%) participants were considered as ‘responders’, demonstrating at least an 11% reduction of CMT at 12 months on spectral domain optical coherence tomography compared with baseline. A reduction of CMT by mean (SD) 28.1% (12.9 %) was observed in responders at 12 months, however, no statistically significant corresponding improvement in best corrected VA was seen. Baseline characteristics were similar between responder and non-responder groups. No clinically significant adverse events were deemed secondary to ivA.ConclusionThis first prospective exploratory study demonstrates both the safety and acceptability of serial ivA in patients with RP-CMO, effective at reducing CMT in 37.9% of patients. All patients demonstrating anatomical response did so after their first injection. Longer duration of CMO did not negatively affect response to anti-VEGF. Further study in a larger cohort of patients with shorter CMO duration would be valuable to better establish the utility of VEGF blockade in RP-CMO.Trial registration numbersEudraCT (2015-003723-65); ClinicalTrials.gov (NCT02661711).

scholarly journals Efficacy and Safety of Eravacycline in Obese Patients: A Post Hoc Analysis of Pooled Data From the IGNITE1 and IGNITE4 Clinical Trials

2020 ◽  
Vol 7 (12) ◽  
Author(s):  
Tomefa E Asempa ◽  
Sergey Izmailyan ◽  
Kenneth Lawrence ◽  
David P Nicolau
Keyword(s):  
Adverse Events ◽  
Clinical Cure ◽  
Obese Patients ◽  
Healthy Weight ◽  
Efficacy And Safety ◽  
Post Hoc Analysis ◽  
Comparator Group ◽  
Obese Class ◽  
Cure Rates ◽  
Post Hoc

Abstract Background The increasing prevalence of obesity worldwide merits an examination of the efficacy and safety profiles of agents dosed by weight. Methods Data for patients (n = 1037) were obtained from the pooled IGNITE1 and IGNITE4 randomized double-blind trials in which patients with complicated intra-abdominal infections received eravacycline 1 mg/kg (actual body weight [ABW]) every 12 hours or comparator (ertapenem 1 g every 24 hours or meropenem 1 g every 8 hours) intravenously. This post hoc analysis evaluated clinical cure rates, adverse events, and drug discontinuation rates stratified by body mass index (BMI) categories of BMI >40 kg/m2 (Obese, Class III), BMI 35–39.9 kg/m2 (Obese, Class II), BMI 30–34.9 kg/m2 (Obese, Class I), BMI 25–29.9 kg/m2 (Overweight), BMI 18.5–24.9 kg/m2 (Healthy weight), and BMI <18.5 kg/m2 (Underweight). Results Clinical cure rates were high across BMI categories and ranged from 82% to 94% in the eravacycline group and 88.5%–100% in the comparator group. Similar cure rates were observed among eravacycline-treated healthy weight (126/134; 94%), overweight (127/146; 87%), and obese (BMI ≥30 kg/m2; 110/129; 85.3%) patients. In the comparator group, a similar proportion of patients demonstrated clinical response (healthy weight [132/145; 91%], overweight [130/144; 90.3%], and obese [115/129; 89.1%]). Of the treatment-emergent adverse events that occurred in eravacycline-treated obese patients, a larger proportion were gastrointestinal-related (ie, nausea and vomiting); however, discontinuation rates were low and similar between eravacycline and carbapenems. Conclusions This post hoc analysis demonstrates the therapeutic utility and acceptable safety profile of eravacycline dosed by ABW in obese patients (BMI ≥30 kg/m2).

scholarly journals Cardiovascular safety and efficacy of metformin-SGLT2i versus metformin-sulfonylureas in type 2 diabetes: systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Desye Gebrie ◽  
Desalegn Getnet ◽  
Tsegahun Manyazewal
Keyword(s):  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Combination Therapy ◽  
Adverse Events ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Sodium Glucose Cotransporter

AbstractDiabetes is a serious threat to global health and among the top 10 causes of death, with nearly half a billion people living with it worldwide. Treating patients with diabetes tend to become more challenging due to the progressive nature of the disease. The role and benefits of combination therapies for the management of type 2 diabetes are well-documented, while the comparative safety and efficacy among the different combination options have not been elucidated. We aimed to systematically synthesize the evidence on the comparative cardiovascular safety and efficacy of combination therapy with metformin-sodium-glucose cotransporter-2 inhibitors versus metformin-sulfonylureas in patients with type 2 diabetes. We searched MEDLINE-PubMed, Embase, Cochrane Library, and ClinicalTrials.gov up to 15 August 2019 without restriction in the year of publication. We included randomized controlled trials of patients with type 2 diabetes who were on metformin-sodium-glucose cotransporter-2 inhibitors or metformin-sulphonylureas combination therapy at least for a year. The primary endpoints were all-cause mortality and serious adverse events, and the secondary endpoints were cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, hypoglycemia, and changes in glycated hemoglobin A1c (HbA1c), body weight, fasting plasma glucose, blood pressure, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol. We used a random-effects meta-analysis model to estimate mean differences for continuous outcomes and risk ratio for dichotomous outcomes. We followed PICOS description model for defining eligibility and the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 guidelines for reporting results. Of 3,190 citations, we included nine trials involving 10,974 participants. The pooled analysis showed no significant difference in all-cause mortality (risk ration [RR] = 0.93, 95% CI [0.52, 1.67]), serious adverse events (RR = 0.96, 95% CI [0.79, 1.17]) and adverse events (RR = 1.00, 95% CI [0.99, 1.02]) between the two, but in hypoglycemia (RR = 0.13, 95% CI [0.10, 0.17], P < 0.001). Participants taking metformin-sodium glucose cotransporter-2 inhibitors showed a significantly greater reduction in HbA1c (mean difference [MD] = − 0.10%, 95% CI [− 0.17, − 0.03], body weight (MD = − 4.57 kg, 95% CI [− 4.74, − 4.39], systolic blood pressure (MD = − 4.77 mmHg, 95% CI [− 5.39, − 4.16]), diastolic blood pressure (MD = − 2.07 mmHg, 95% CI [− 2.74, − 1.40], and fasting plasma glucose (MD = − 0.55 mmol/L, 95% CI [− 0.69, − 0.41]), p < 0.001. Combination therapy of metformin and sodium-glucose cotransporter-2 inhibitors is a safe and efficacious alternative to combination therapy of metformin and sulphonylureas for patients with type 2 diabetes who are at risk of cardiovascular comorbidity. However, there remains a need for additional long-term randomized controlled trials as available studies are very limited and heterogeneous.

scholarly journals Real world retrospective analysis of luliconazole 1% and salicylic acid 3% as fixed dose combination in the management of hyperkeratotic dermatophytosis in India

2020 ◽  
Vol 7 (1) ◽  
pp. 18
Author(s):  
R. D. Kharkar ◽  
Dhiraj S. Dhoot ◽  
Gaurav A. Deshmukh ◽  
Hanmant Barkate
Keyword(s):  
Salicylic Acid ◽  
Marked Improvement ◽  
Clinical Cure ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Improvement Rate ◽  
Retrospective Data Analysis ◽  
Short Period ◽  
Dose Combination ◽  
Anti Fungal

<p class="abstract"><strong>Background:</strong> In recent times, there is increase in prevalence of hyperkeratotic dermatophytosis in India. These hyperkeratotic lesions usually impede the absorption of topical anti-mycotic agent making infection recalcitrant to topical anti-fungal therapy alone. Hence, many times topical keratolytic are used in combination with topical anti-fungal agents which augment the shedding of scales.</p><p class="abstract"><strong>Methods:</strong> To seek for short period therapy in hyperkeratotic dermatophytosis, we conducted multicentre, retrospective data analysis at 61 dermatology clinics to study effectiveness and safety of Luliconazole 1% and Salicylic acid 3% fixed dose combination (FDC) cream for 2 weeks.</p><p class="abstract"><strong>Results: </strong>A data of 191 patients’ were included in this analysis. All patients have received some of the topicals and switched to FDC. Total symptom score of 7.19±1.91 improved to 3.15±1.12 in just 2 weeks (p&lt;0.05). The clinical improvement rate (percentage of ‘marked improvement’ plus ‘moderate improvement’) was 78% after 2 weeks of treatment. Moreover, 5 patients (2.61%) achieved complete clearance. This FDC was found to be safe in 51.83% (n=99) of the patients whereas 37.7% of the patients (n=72) reported it as almost safe. Minor problems with the safety was found in 9.42% of the patients (n=18). Two patients (1.04%) reported it as not safe and thus shifted to another drug. Irritation and burning were reported as most common adverse events (AE).</p><p class="abstract"><strong>Conclusions:</strong> The short combination therapy with luliconazole and salicylic acid as FDC has been found to be effective and safe. It should be a valuable option for hyperkeratotic dermatophytosis for early achievement of clinical cure and better patient compliance.</p>

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