scholarly journals Ibrexafungerp versus placebo for vulvovaginal candidiasis treatment: a phase 3, randomized, controlled superiority trial (VANISH 303)

2021 ◽  
Author(s):  
Jane R Schwebke ◽  
Ryan Sobel ◽  
Janet K Gersten ◽  
Steven A Sussman ◽  
Samuel N Lederman ◽  
...  
Keyword(s):  
Clinical Improvement ◽  
Clinical Cure ◽  
Oral Treatment ◽  
Treatment Options ◽  
Signs And Symptoms ◽  
Current Treatment ◽  
Vulvovaginal Candidiasis ◽  
Symptom Resolution ◽  
Superiority Trial

Abstract Background Current treatment of vulvovaginal candidiasis (VVC) is largely limited to azole therapy. Ibrexafungerp is a first-in-class triterpenoid antifungal with broad-spectrum anti-Candida fungicidal activity. The objective of this study was to evaluate the efficacy and safety of ibrexafungerp compared with placebo in patients with acute VVC. Study Design Patients were randomly assigned 2:1 to receive ibrexafungerp (300 mg twice for 1 day) or placebo. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms [VSS]=0) at test-of-cure (day 11±3). Secondary endpoints included the percentage of patients with mycological eradication, overall success (clinical cure and mycological eradication), clinical improvement (VSS≤1) at test-of-cure, and symptom resolution at follow-up (day 25±4). Results Patients receiving ibrexafungerp had significantly higher rates of clinical cure (50.5% [95/188] vs 28.6% [28/98]; P=0.001), mycological eradication (49.5% [93/188] vs 19.4% [19/98]; P<0.001), and overall success (36.0% [64/178] vs 12.6% [12/95]; P<0.001) compared with placebo. Symptom resolution was sustained and further increased with ibrexafungerp compared with placebo (59.6% [112/188] vs 44.9% [44/98]; P=0.009) at follow-up. Post hoc analysis showed similar rates of clinical cure and clinical improvement at test-of-cure for African American patients (54.8% [40/73] and 63.4% [47/73], respectively) and patients with a body mass index >35 (54.5% [24/44] and 68.2% [30/44], respectively) compared with overall rates. Ibrexafungerp was well tolerated. Adverse events were primarily gastrointestinal and mild in severity. Conclusion Ibrexafungerp provides a promising safe and efficacious oral treatment that mechanistically differs from current azole treatment options for acute VVC.

scholarly journals Phase 2 randomized study of oral ibrexafungerp vs fluconazole in vulvovaginal candidiasis

2021 ◽  
Author(s):  
Paul Nyirjesy ◽  
Jane R Schwebke ◽  
David A Angulo ◽  
Itzel A Harriott ◽  
Nkechi E Azie ◽  
...  
Keyword(s):  
Clinical Cure ◽  
Treatment Options ◽  
Randomized Study ◽  
Positive Culture ◽  
Signs And Symptoms ◽  
Primary Objective ◽  
Vulvovaginal Candidiasis ◽  
Dose Finding ◽  
Comparable Efficacy ◽  
Tolerability Profile

Abstract Background Vulvovaginal candidiasis affects approximately 75% of women in their lifetime. Approved treatment options are limited to oral or topical azoles. Ibrexafungerp, a novel, first-in-class oral triterpenoid glucan synthase inhibitor, has demonstrated broad fungicidal Candida activity and a favorable tolerability profile. The primary objective of this dose finding study was to identify the optimal dose of oral ibrexafungerp in patients with acute vulvovaginal candidiasis. Study Design Patients with vulvovaginal signs and symptoms score ≥7 were randomized equally to 6 treatments groups: 5 treatment doses of oral ibrexafungerp or oral fluconazole 150 mg. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms) at the test-of-cure visit (day 10). Results Overall, 186 patients were randomized into the 6 treatment groups. Results, using the modified intent-to-treat population (baseline positive culture), are reported for ibrexafungerp 300 mg BID for 1 day (n=27), which was the dose selected for phase 3 studies, and fluconazole 150 mg for 1 day (n=24). At day 10, the clinical cure rates for ibrexafungerp and fluconazole were, 51.9% and 58.3%, respectively; at day 25, patients with no signs or symptoms were 70.4% and 50.0%, respectively. During the study ibrexafungerp patients required less antifungal rescue medications compared with fluconazole (3.7% vs 29.2%, respectively). Ibrexafungerp was well-tolerated, with the most common treatment-related adverse events being mild gastrointestinal events. Conclusions Ibrexafungerp is a well-tolerated novel antifungal with comparable efficacy to fluconazole in the treatment of acute vulvovaginal candidiasis.

MICROSURGICAL TREATMENT OF SYMPTOMATIC SACRAL PERINEURIAL CYSTS

Neurosurgery ◽  
2007 ◽  
Vol 60 (6) ◽  
pp. 1059-1066 ◽  
Author(s):  
Dongsheng Guo ◽  
Kai Shu ◽  
Rudong Chen ◽  
Changshu Ke ◽  
Yanchang Zhu ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Treatment Options ◽  
Current Treatment ◽  
Cerebrospinal Fluid Leakage ◽  
Local Defect ◽  
Microsurgical Treatment ◽  
The Past ◽  
Return Visits

Abstract OBJECTIVE The aim of this study was to investigate the microsurgical results of symptomatic sacral perineurial cysts of 11 patients and to discuss the treatment options of the past 10 years. METHODS We retrospectively reviewed the records of 11 patients with symptomatic sacral perineurial cysts who underwent microsurgical treatment at Tongji Hospital, Huazhong University of Science and Technology from 1993 through 2006. The philosophy was to perform total or partial cyst wall removal, to imbricate the remaining nerve sheath if possible, and to repair local defect with muscle, Gelfoam (Pharmacia & Upjohn, Kalamazoo, MI), and fibrin glue. Patient outcomes were assessed by comparing the preoperative and postoperative examination results. The average follow-up time obtained from return visits to the neurosurgery clinic or by telephone questionnaires ranged from 2 months to 13 years. A literature search and analysis of current treatment options were performed. RESULTS Nine of the 11 patients (82%) experienced complete or substantial relief of their preoperative symptoms. One patient (Patient 4) experienced worsening of bladder dysfunction after surgery and recovered slowly to subnormal function during the subsequent 2 months. The symptoms of Patient 9 did not resolve, and magnetic resonance imaging showed that the cyst had reoccurred. The patient underwent reoperation 3 months later without any improvement. One patient (Patient 11) experience a cerebrospinal fluid leakage complication. Neither new postoperative neurological defects nor infection were observed in our series. In the literature, there are six different treatment options under debate and controversially discussed. CONCLUSION Microsurgical treatment yielded the best long-term resolution of patient symptoms to date and should be recommended to appropriately selected patients.

scholarly journals Does immunological remission, defined as disappearance of autoantibodies, occur with current treatment strategies? A long-term follow-up study in rheumatoid arthritis patients who achieved sustained DMARD-free status

2019 ◽  
Vol 78 (11) ◽  
pp. 1497-1504 ◽  
Author(s):  
Debbie M Boeters ◽  
Leonie E Burgers ◽  
René EM Toes ◽  
Annette van der Helm-van Mil
Keyword(s):  
Rheumatoid Arthritis ◽  
Treatment Strategies ◽  
Signs And Symptoms ◽  
Current Treatment ◽  
Dmard Therapy ◽  
Before And After ◽  
Long Term Follow Up ◽  
Free Status

ObjectivesSustained disease-modifying antirheumatic drug (DMARD)-free status, the sustained absence of synovitis after cessation of DMARD therapy, is infrequent in autoantibody-positive rheumatoid arthritis (RA), but approximates cure (ie, disappearance of signs and symptoms). It was recently suggested that immunological remission, defined as disappearance of anti-citrullinated protein antibodies (ACPA) and rheumatoid factor (RF), underlies this outcome. Therefore, this long-term observational study determined if autoantibodies disappear in RA patients who achieved sustained DMARD-free remission.MethodsWe studied 95 ACPA-positive and/or RF-positive RA patients who achieved DMARD-free remission after median 4.8 years and kept this status for the remaining follow-up (median 4.2 years). Additionally, 21 autoantibody-positive RA patients with a late flare, defined as recurrence of clinical synovitis after a DMARD-free status of ≥1 year, and 45 autoantibody-positive RA patients who were unable to stop DMARD therapy (during median 10 years) were studied. Anti-cyclic citrullinated peptide 2 (anti-CCP2) IgG, IgM and RF IgM levels were measured in 587 samples obtained at diagnosis, before and after achieving DMARD-free remission.Results13% of anti-CCP2 IgG-positive RA patients had seroreverted when achieving remission. In RA patients with a flare and persistent disease this was 8% and 6%, respectively (p=0.63). For anti-CCP2 IgM and RF IgM, similar results were observed. Evaluating the estimated slope of serially measured levels revealed that RF levels decreased more in patients with than without remission (p<0.001); the course of anti-CCP2 levels was not different (p=0.66).ConclusionsSustained DMARD-free status in autoantibody-positive RA was not paralleled by an increased frequency of reversion to autoantibody negativity. This form of immunological remission may therefore not be a treatment target in patients with classified RA.

Eating Disorders. Review Of Current Treatment Options For Anorexia Nervosa, Focused On Psychotherapy And Pharmacological Treatment

2016 ◽  
Vol 33 (S1) ◽  
pp. S432-S432
Author(s):  
B. Sánchez Sánchez ◽  
P. Muñoz-Calero Franco ◽  
N. Rodriguez Criado ◽  
J.F. Cruz Fourcade ◽  
R. Martín Aragón ◽  
...  
Keyword(s):  
Anorexia Nervosa ◽  
Pharmacological Treatment ◽  
Treatment Options ◽  
Signs And Symptoms ◽  
Current Treatment ◽  
Cognitive Behavioral ◽  
Nutritional Rehabilitation ◽  
Clinical Practices ◽  
Major Health Problem ◽  
Competing Interest

IntroductionAnorexia nervosa is a disorder of eating behavior that is a major health problem on our society. It is characterized by three main criteria: self-induced starvation, desire for thinness or fear of obesity, and the presence of medical signs and symptoms due to improper feeding. This work is focused on its treatment. The biopsychosocial approach allows the design and application of effective therapeutic strategies and a multidisciplinary team collaboration is essential.ObjectivesResearch of current pharmacological and psychotherapy treatments options of the disease.Material and methodsLiterature review based on articles and publications on this topic.ResultsIn anorexia nervosa, it is necessary to establish a therapeutic alliance between doctor and patient. Patient usually feels no motivation to improve. The different treatments options to combine, in terms of the patient status, are: nutritional rehabilitation, cognitive-behavioral, family and interpersonal psychotherapies and pharmacological treatment. It can be carried out at the ambulatory, at the day-hospital or by medical stay, even beyond patient will.ConclusionsNowadays, the nutritional rehabilitation is the best treatment established and it is the core treatment. About the psychotherapies, the cognitive-behavioral is the most used because it has exposed better results in all different studies proved and in clinical practices, followed by the family therapy which is the responsible of the patient family's treatment. Pharmacological treatment should not be used systematically and its exclusive use is not enough to resolve anorexia nervosa as there are needed also other treatments combined.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Aneurysms of the petrous internal carotid artery: anatomy, origins, and treatment

2004 ◽  
Vol 17 (5) ◽  
pp. 1-9 ◽  
Author(s):  
James K. Liu ◽  
Oren N. Gottfried ◽  
Amin Amini ◽  
William T. Couldwell
Keyword(s):  
Carotid Artery ◽  
Internal Carotid Artery ◽  
Internal Carotid ◽  
Wide Spectrum ◽  
Treatment Options ◽  
Signs And Symptoms ◽  
Current Treatment ◽  
Asymptomatic Patients ◽  
Cranial Nerve Palsies ◽  
Close Observation

Aneurysms arising in the petrous segment of the internal carotid artery (ICA) are rare. Although the causes of petrous ICA aneurysms remain unclear, traumatic, infectious, and congenital origins have been implicated in their development. These lesions can be detected incidentally on routine neuroimaging. Patients can also present with a wide spectrum of signs and symptoms, including cranial nerve palsies, Horner syndrome, pulsatile tinnitus, epistaxis, and otorrhagia. The treatment of petrous ICA aneurysms remains challenging. Treatment options include close observation, endovascular therapies, and surgical trapping with or without revascularization. Management dilemmas exist, particularly for incidental lesions found in asymptomatic patients. The authors review the literature and discuss the anatomy of the petrous ICA as well as the pathophysiological features of aneurysms arising in this region, and they propose a management paradigm with current treatment options.

Current Treatment Options for Vulvovaginal Candidiasis

2005 ◽  
Vol 1 (2) ◽  
pp. 253-261 ◽  
Author(s):  
Jack Sobel
Keyword(s):  
Antifungal Agents ◽  
Topical Therapy ◽  
Treatment Options ◽  
Correct Diagnosis ◽  
Management Strategies ◽  
Current Treatment ◽  
Vulvovaginal Candidiasis ◽  
Short Term ◽  
Appropriate Therapy ◽  
Antimycotic Agent

For practitioners, selecting successful therapy for vulvovaginal candidiasis is anything but trivial. The dominant problem; however, lies not with selecting the correct antimycotic agent, but with making the correct diagnosis and not treating non-yeast infections and noninfections as yeast-induced. Moreover, not all cases of vulvovaginal candidiasis are equal and practitioners owe patients the obligation of selecting appropriate therapy based upon the specific type and severity of vulvovaginal candidiasis. Uncomplicated candidiasis is readily treated with short-term oral or topical therapy, whereas complicated candidiasis needs additional strategies using the plethora of therapies available. Problematic refractory cases still abound and the pipeline for new, more potent antifungal agents is largely empty. Management strategies for complicated Candida vaginitis are discussed.

Shunting with gravitational valves—can adjustments end the era of revisions for overdrainage-related events?

2012 ◽  
Vol 117 (6) ◽  
pp. 1197-1204 ◽  
Author(s):  
Florian Baptist Freimann ◽  
Christian Sprung
Keyword(s):  
Unsolved Problem ◽  
Surgical Intervention ◽  
Statistical Significance ◽  
Treatment Options ◽  
Signs And Symptoms ◽  
Opening Pressure ◽  
Shunt Insertion ◽  
New Generation ◽  
Valve Pressure

Object Overdrainage of CSF remains an unsolved problem in shunt therapy. The aim of the present study was to evaluate treatment options on overdrainage-related events enabled by the new generation of adjustable gravity-assisted valves. Methods The authors retrospectively studied the clinical course of 250 consecutive adult patients with various etiologies of hydrocephalus after shunt insertion for different signs and symptoms of overdrainage. Primary and secondary overdrainage were differentiated. The authors correlated the incidence of overdrainage with etiology of hydrocephalus, opening valve pressure, and patient parameters such as weight and size. Depending on the severity of overdrainage, they elevated the opening pressure, and follow-up was performed until overdrainage was resolved. Results The authors found 39 cases (15.6%) involving overdrainage-related problems—23 primary and 16 secondary overdrainage. The median follow-up period in these 39 patients was 2.1 years. There was no correlation between the incidence of overdrainage and any of the following factors: sex, age, size, or weight of the patients. There was also no statistical significance among the different etiologies of hydrocephalus, with the exception of congenital hydrocephalus. All of the “complications” could be resolved by readjusting the opening pressure of the valve in one or multiple steps, avoiding further operations. Conclusions Modern adjustable and gravity-assisted valves enable surgeons to set the opening pressure relatively low to avoid underdrainage without significantly raising the incidence of overdrainage and to treat overdrainage-related clinical and radiological complications without surgical intervention.

scholarly journals Factors that Influence the Duration of Symptom Resolution in COVID-19 Patients in Ethiopia: A Follow up Study Involving 60 Symptomatic Cases.

2021 ◽  
Author(s):  
Saro Abrahim ◽  
Masresha Tesema ◽  
Eshetu Ejeta ◽  
Mahammed Ahmed ◽  
Atkure Defar ◽  
...  
Keyword(s):  
Median Duration ◽  
Proportional Hazards ◽  
Statistical Significance ◽  
Signs And Symptoms ◽  
Cox Proportional Hazards ◽  
Treatment Center ◽  
Symptom Resolution ◽  
Proportional Hazards Regression ◽  
Study Participants

Abstract Background: The newly identified virus, Severe Acute Respiratory Syndrome Corona Virus-two (SARS-CoV-2) has claimed more than a million lives worldwide since it was first recognized in Wuhan, China in December 2019. Understanding the clinical features of COVID-19 and duration for resolution of symptoms is crucial for isolation of patients and tailoring public health messaging, interventions, and policy. Therefore, this study aims to assess the median duration of COVID-19 signs and symptoms resolution and explore it’s predictors among symptomatic COVID-19 patients in EthiopiaMethods: A hospital-based prospective cohort study involving 60 COVID-19 cases was conducted at Eka Kotebe General Hospital, COVID-19 Isolation and Treatment Center. The study participants were all symptomatic COVID-19 adult patients admitted to the hospital from March 18 to June 27, 2020. Physicians at the center recorded the data using a log sheet. Cox proportional-hazards regression model was conducted. Statistical significance was defined at P<0.05. All analyses were done using STATA version 16.1 software.Results: A total of 60 symptomatic COVID-19 patients with a mean age of 34.8 years (+1.8) were involved in the study. The median duration of symptom resolution of COVID-19 was seven days with a minimum of two and a maximum of 68 days. Sex and Body Mass Index (BMI) were statistically significant predictors of the symptom resolution. The hazard of having delayed sign or symptom resolution in males was 55% higher than in females (P=0.039, CI: 0.22 to 0.96) and the hazard of the delayed sign or symptom in those with BMI ≥25 was 48% higher than in those with BMI <25 (P=0.051; CI: 0.272 to 1.003). In this study, age and comorbidity had no association with the duration of sign or symptom resolution in COVID-19 patients.Conclusions: The median duration of COVID-19 symptom resolution was seven days. Being male or having a BMI ≥ 25 were predictors for having a delayed sign or symptom resolution time. Therefore, understanding the duration of COVID-19 sign or symptom resolution helps to guide the patient isolation period and prioritize COVID-19 patients to be shielded.

Treatment outcomes of radiotherapy versus prostatectomy for localized prostate cancer with Gleason 8 or more on biopsy.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 120-120
Author(s):  
Christopher Baker ◽  
Andrew M. McDonald ◽  
Grant Clark ◽  
Caleb Dulaney ◽  
Eddy Shih-Hsin Yang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Gleason Score ◽  
Initial Treatment ◽  
Treatment Options ◽  
Current Treatment ◽  
Biochemical Failure ◽  
Localized Prostate Cancer ◽  
Kaplan Meier ◽  
Initial Biopsy

120 Background: There have been no prospective randomized controlled trials comparing current treatment options for patients with high-risk localized prostate cancer. This study seeks to compare the biochemical and metastatic outcomes of patients that received definitive radiotherapy (dRT) or radical prostatectomy (RP) for localized prostate cancer with Gleason score ≥ 8 on initial biopsy. Methods: A total of 106 patients met the inclusion criteria of Gleason score ≥ 8 on initial biopsy and biochemical follow-up ≥ 1 year. Seventy-one patients were initially treated with dRT (96% also receiving androgen deprivation therapy) and 35 patients were initially treated with RP (with or without postoperative RT). Our primary endpoint was biochemical failure (BF). For dRT patients, BF was recorded according to the Phoenix Consensus or if extranodal metastasis was diagnosed. For surgical patients, BF was recorded according to American Urological Association guidelines or if extranodal metastasis occurred. If adjuvant/salvage RT was given postoperatively, BF was recorded if PSA ≥ 0.5 on two consecutive measures after completion of RT. Pretreatment characteristics were compared using Pearson Chi-square method and independent samples Mann-Whitney U test. Actuarial rates of BF and metastasis were calculated using the Kaplan-Meier method. Results: Median follow-up for all patients was 5.3 years. There was no statistical difference in clinical T-stage, initial PSA, or months of follow up between patients treated initially with radiotherapy vs. prostatectomy. Patients initially treated with dRT were significantly older than those treated with RP. The dRT group had a lower rate of BF compared to the RP group, p < 0.001. The Kaplan-Meier estimate of BF at 5 years was 7.6% in the dRT group compared to 34.5% in the RP group. Additionally, the Kaplan-Meier estimate of distant metastasis at 10 years was 22.7% in the dRT group compared to 55.9% of the RP group, p = 0.01. Conclusions: For our sample of patients with Gleason score ≥ 8 on initial biopsy, initial treatment with dRT was associated with lower rates of biochemical failure and extranodal metastasis when compared to initial treatment with prostatectomy.

scholarly journals MRI-guided laser ablation of neuroendocrine tumor hepatic metastases

2014 ◽  
Vol 3 (1) ◽  
pp. 204798161349975 ◽  
Author(s):  
Jukka Perälä ◽  
Rauli Klemola ◽  
Raija Kallio ◽  
Chengli Li ◽  
Ilkka Vihriälä ◽  
...  
Keyword(s):  
Laser Ablation ◽  
Liver Metastases ◽  
Treatment Options ◽  
Hepatic Metastases ◽  
Current Treatment ◽  
The Body ◽  
Interstitial Laser ◽  
Mri Guided ◽  
Magnetic Resonance Imaging Mri

Background Neuroendocrine tumors (NET) represent a therapeutically challenging and heterogeneous group of malignancies occurring throughout the body, but mainly in the gastrointestinal system. Purpose To describe magnetic resonance imaging (MRI)-guided laser ablation of NET liver metastases and assess its role within the current treatment options and methods. Material and Methods Two patients with NET tumor hepatic metastases were treated with MRI-guided interstitial laser ablation (LITT). Three tumors were treated. Clinical follow-up time was 10 years. Results Both patients were successfully treated. There were no local recurrences at the ablation site during the follow-up. Both patients had survived at 10-year follow-up. One patient is disease-free. Conclusion MRI-guided laser ablation can be used to treat NET tumor liver metastases but combination therapy and a rigorous follow-up schedule are recommended.

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