scholarly journals Micafungin for Candida infections in Slovenia and Romania: A multicenter, observational, prospective study

2021 ◽  
Vol 15 (06) ◽  
pp. 877-888
Author(s):  
Samo Zver ◽  
Simona Avcin ◽  
Ovidiu Bedreag ◽  
Sanja Bizilj ◽  
Vanja Ecrulj ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Treatment Duration ◽  
Fungal Infections ◽  
Hematologic Malignancy ◽  
Primary Diagnosis ◽  
Efficacy And Safety ◽  
Secondary Endpoints ◽  
Candida Infections ◽  
First Time

Introduction: An echinocandin, such as micafungin, is recommended as first-line treatment for invasive Candida infections in immunocompromised patients. This multicenter, observational, prospective, non- interventional study evaluated the real-world use of micafungin in clinical practice in Slovenia and Romania, as this remains unexplored. Methodology: The primary endpoint was evaluation of micafungin use, including rationale for prescription, treatment duration, and daily dose. Secondary endpoints included recordings of patient baseline characteristics and evaluations of efficacy and safety. Across 11 centers in two countries, 118 patients (18 children [< 16 years] and 100 adults [≥ 16 years]) received micafungin for the first time according to their clinic’s standard practice. Results: Micafungin was prescribed for treatment in 57.6% of patients and for prophylaxis in 40.7% of patients. The median (range) treatment duration was 9.0 (0 – 54) days and 13.0 (2 – 6)] days, respectively. The median dose of micafungin was higher than recommended for children receiving prophylaxis or treatment for invasive candidiasis and for adults receiving prophylaxis. Fever was the most commonly observed clinical sign at baseline (16 children [88.9%] and 31 adults [31%]) and hematologic malignancy was the most frequent primary diagnosis at admission (11 children [61.1%] and 40 adults [40%]). Candida species were the most commonly identified causal agents of invasive fungal infections (2 children [11.1%] and 48 adults [48%]). Conclusions: The efficacy and safety profiles of micafungin use in Slovenia and Romania based on clinician’s own experiences in local clinical practice were consistent with those reported in other real-world studies.

scholarly journals Initial Experience of the Levodopa–Entacapone–Carbidopa Intestinal Gel in Clinical Practice

2021 ◽  
Vol 11 (4) ◽  
pp. 254
Author(s):  
Mezin Öthman ◽  
Erik Widman ◽  
Ingela Nygren ◽  
Dag Nyholm
Keyword(s):  
Cardiac Arrest ◽  
Clinical Practice ◽  
Observational Study ◽  
Prospective Studies ◽  
Infusion Rate ◽  
Treatment Duration ◽  
Initial Experience ◽  
Morning Dose ◽  
Efficacy And Safety ◽  
User Friendliness

Patients in fluctuating stages of Parkinson’s disease (PD) require device-aided treatments. Continuous infusion of levodopa–carbidopa intestinal gel (LCIG) is a well-proven option in clinical practice. We now report the first clinical experience of levodopa–entacapone–carbidopa intestinal gel (LECIG) therapy. An observational study of the first patients to start LECIG in our clinic was performed. Twenty-four patients (11 females, 13 males) were included. The median age was 71.5 years, and the median duration since PD diagnosis was 15.5 years. The median treatment duration was 305 days. Median doses were: 6.0 mL as morning dose, 2.5 mL/h as infusion rate, and 1.0 mL as extra dose. Half of the patients were switched directly from LCIG. These patients express improvements in the size and weight of the pump. Furthermore, most of them considered the new pump to be improved regarding user-friendliness. Six patients discontinued LECIG, three due to diarrhea, one due to hallucinations and two deceased (one cardiac arrest and one COVID-19). LECIG has shown to be possible to use in patients with PD, efficacy and safety as expected. Patients are generally happy with the size and usability of the pump, but some technical improvements of the software are warranted, as well as larger, prospective studies.

Ipilimumab in real-world clinical practice: efficacy and safety data from a multicenter observational study

2017 ◽  
Vol 29 (4) ◽  
pp. 245-251 ◽  
Author(s):  
Alberto Russi ◽  
Vera Damuzzo ◽  
Marco Chiumente ◽  
Jacopo Pigozzo ◽  
Marco Cesca ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Observational Study ◽  
Real World ◽  
Safety Data ◽  
Efficacy And Safety ◽  
Multicenter Observational Study

scholarly journals An observational study «FOLLITROPIN» comparing the efficacy of follitropin alpha biosimilar: the real-world data

2021 ◽  
Vol 15 (1) ◽  
pp. 5-21
Author(s):  
D. P. Kamilova ◽  
M. M. Ovchinnikova ◽  
E. Sh. Ablyaeva ◽  
M. M. Leviashvili ◽  
N. S. Stuleva ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Observational Study ◽  
Clinical Efficacy ◽  
Real World ◽  
Ovarian Stimulation ◽  
Successful Implementation ◽  
Efficacy And Safety ◽  
The Real ◽  
Real Clinical Practice

Introduction. The efficacy and safety of biosimilar follitropin alpha have been demonstrated in randomized blinded prospective clinical trials of phases I and III. Unfortunately, there is a gap between the clinical trials and real clinical practice data. The real-world patient data helps to create an evidence-based background for successful implementation of medicine at everyday practice in a nonselected population.Aim: to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.Materials and Methods. A retrospective observational anonymized cohort study of follitropin alpha biosimilar (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included: monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application for at least 5 days.Results. The overall clinical efficacy of ovarian stimulation cycles (N = 5484) was: oocytes retrieved - 9.5 ± 7.2, mature (MII) - 6.8 ± 6.6, fertilized (2PN) - 6.1 ± 5.8, clinical pregnancy per ET (PR) - 38.4 %. Mixed gonadotropin protocols (N = 2625) vs. monotherapy with Primapur® (N = 2859): oocytes retrieved - 8.6 ± 6.8 vs. 10.3 ± 7.4 (p < 0.001), mature (MII) - 6.7 ± 6.2 vs. 7.7 ± 6.9 (p < 0.001), fertilized (2PN) - 5.8 ± 5.2 vs. 7.2 ± 6.2 (p < 0.001). There were statistically significant differences between oocyte yields in mixed vs. monotherapy protocols due to subgroup differences, including age, body mass index (BMI) and IVF/ICSI attempts. No statistically significant differences were found for PR: 39.3 % vs. 37.6 % (p = 0.314). Monotherapy protocols with GnRH antagonist OS (N = 2183) vs. GnRH agonist (N = 676) revealed: oocytes retrieved - 10.5 ± 7.5 vs. 9.6 ± 7.0 (p = 0.032), mature (MII) - 7.6 ± 6.9 vs. 6.7 ± 5.7 (p < 0.001), fertilized (2PN) - 7.3 ± 6.3 vs. 5.7 ± 5.0 (p < 0.001). There were statistically significant differences between BMI and IVF/ICSI attempts. No statistically significant differences were found for PR: 37.9 % vs. 35.9 % (p = 0.482). All medicines were well tolerated and no serious adverse reactions were reported.Conclusion. This was the largest retrospective observational study conducted in the field of fertility in Russia and involved 5484 ovarian stimulation protocols at 35 IVF clinics. The obtained results demonstrated similar clinical efficacy for follitropin alpha biosimilar Primapur® in different OS protocols in real clinical practice. 

Results of the first interim analysis of the CARMA study to investigate efficacy and safety profile of catumaxomab in clinical practice.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e13100-e13100
Author(s):  
Volker Kunzmann ◽  
Jalid Sehouli ◽  
Barbara Schmalfeldt ◽  
Pauline Wimberger ◽  
Christian M. Kurbacher ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Safety Profile ◽  
Interim Analysis ◽  
Malignant Ascites ◽  
Median Number ◽  
Pivotal Trial ◽  
Advanced Tumor ◽  
Secondary Endpoints ◽  
Study Population ◽  
First Time

e13100^ Background: The trifunctional antibody catumaxomab is approved in the EU for intraperitoneal (i.p.) treatment of malignant ascites in patients (pts) with EpCAM-positive carcinomas. Clinical data for catumaxomab are based on the pivotal trial and several phase I/II trials. So far, the routine use of catumaxomab in clinical practice has not been evaluated systematically. Therefore, a large prospective observational study was started in 2010. The study investigates the administration of catumaxomab in a total of 160 pts with malignant ascites under routine conditions in daily clinical practice. Here we show the results of the first pre-planned interim analysis. Methods: The analysis included 49 pts with malignant ascites due to EpCAM-positive carcinomas treated with i.p. catumaxomab under routine conditions in clinical practice. Participating centres were hospitals and practices of oncologists in Germany. Primary endpoint was puncture-free interval (PFI), secondary endpoints included safety and overall survival (OS). Results: At inclusion into the study pts already had undergone a median number of 9 ascites punctures. Malignant ascites had been diagnosed for the first time 3.3 months before (median). Patients suffered from typical ascites symptoms as follows: swelling (79.6%), pain (44.9%), dyspnea (26.5%), anorexia (26.5%), obstipation (12.2%). 49 pts were treated with catumaxomab, of whom 30 pts received all 4 infusions (61.2%). Median PFI was 108 days (d), the median OS was 102 d. Most frequent adverse events were fever, nausea and diarrhoe. Conclusions: This is the first systematic report on routine use of catumaxomab in clinical practice.. Although The study population mainly comprised patients with advanced tumor diseaset a clinical benefit after catumaxomab therapy could be demonstrated. The treatment showed an acceptable safety profile Theseresults are consistent with the data of the pivotal trial. The data will be evaluated in further analyses including larger patient numbers.

Treatment patterns: Targeted therapies indicated for first-line management of metastatic renal cell carcinoma in a real-world setting.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 416-416
Author(s):  
Gregory P. Hess ◽  
Rohit Borker ◽  
Eileen Fonseca
Keyword(s):  
Renal Cell Carcinoma ◽  
Clinical Practice ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Real World ◽  
Renal Cell ◽  
Treatment Duration ◽  
Treatment Patterns ◽  
Targeted Agents ◽  
Line Therapy

416 Background: Limited information about real-world treatment patterns of targeted agents for metastatic renal cell carcinoma (mRCC) is available to inform their use in clinical practice. Methods: This retrospective, observational study employed US claims data (January 2007-November 2010) to identify treatment patterns, including treatment duration and dosing, for targeted agents (sunitinib, sorafenib, pazopanib, bevacizumab, and temsirolimus) indicated in 1st line management of advanced/mRCC. The study included adult mRCC patients who were observed for ≥3 months after initiation of their 1st line therapy with a targeted agent. Descriptive analyses were conducted for the observed treatment patterns. Results: A total of 273 patients on 1st line therapy were identified and included in the study sample out of which 235 patients were treated with sunitinib, 16 patients with sorafenib, and 15 patients with temsirolimus. Pazopanib and bevacizumab were excluded from further analysis due to their small samples; n<10. The median observed treatment durations were: sunitinib 3.3 months, sorafenib 4.0 months, and temsirolimus 2.6 months. Patients initiating therapy on sorafenib (n=16) and temsirolimus (n=15) in the study sample were insufficient for meaningful dosing analyses. In sum, of the n=235 sunitinib patients, 178 (approximately 76%) initiated therapy at the indicated dose of 50 mg. Sixty-five percent of these patients were not observed filling a 4th script (the average number observed), while 26% maintained their starting dose and 9% experienced a dose reduction at their fourth fill. (See table). Conclusions: This study suggests that opportunities exist to improve treatment duration in real-world clinical practice and to better understand possible influences, other than disease progression, on treatment and dose changes. [Table: see text]

Patterns of hedgehog inhibitor (HHI) treatment interruptions and re-initiations among patients with basal cell carcinoma (BCC) in real-world clinical practice.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19349-e19349
Author(s):  
Jessica J. Jalbert ◽  
Chieh-I Chen ◽  
Ning Wu ◽  
Matthew G. Fury ◽  
Emily S Ruiz ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Treatment Duration ◽  
Index Date ◽  
Sensitivity Analyses ◽  
Kaplan Meier ◽  
Treatment Interruptions ◽  
Observational Cohort ◽  
Practice Methods

e19349 Background: HHIs are oral targeted therapies approved for the treatment of advanced BCC but treatment-related adverse events may result in treatment interruptions or discontinuation. The objective of this study was to describe HHI treatment patterns among patients with BCC in real-world clinical practice. Methods: We conducted an observational cohort study using MarketScan Commercial/Medicare databases (01/01/2013–09/30/2018). We identified new users of HHIs (index date = date of the first dispensation), ≥18 years of age who were continuously enrolled for ≥6 months prior to the index date (i.e. baseline) with ≥1 baseline BCC diagnosis. Treatment interruptions (TI) were defined as a lack of dispensation following the exhaustion of days’ supply and allotted grace period (GP). Re-initiation (RI) was defined as ≥1 HHI dispensation after TI. The Kaplan–Meier method was used to estimate risk and time to TI and, among patients with a TI, incidence of RI. HHIs are generally dispensed in 30-days’ supply and indicated as long as a patient derives a clinical benefit; however, since TIs are commonly employed during HHI therapy, sensitivity analyses were conducted using GPs of 14, 30, 60, 90, and 120 days. Results: We identified 469 patients with a BCC diagnosis initiating HHIs. The mean (SD) age was 67.6 (15.8) years, 64.2% were men, 51.2% were covered by commercial insurance, and 99.2% initiated vismodegib. Using a GP of 14, 30, 60, 90, and 120 days, the risk of TI was 79.2%, 68.8%, 60.0%, 55.4%, and 51.4% at 6 months and 94.8%, 91.3%, 88.2%, 83.2%, and 80.2% at 1 year, respectively. Median HHI treatment duration ranged from 94 days (95% CI: 90–109) using a GP of 14 days to 173 days (95% CI: 156–194) using a GP of 120 days. At 6 months following TI, incidence of RI was 35.8%, 19.8%, 11.3%, 6.9%, and 4.9% using a GP of 14, 30, 60, 90, and 120 days, respectively. The incidence of HHI RI at 1-year following TI ranged from 40.8% using a 14-day GP to 13.4% using a 120-day GP. Conclusions: Median HHI treatment duration was approximately 6 months, even after allowing for a 120-day GP. Median treatment duration was considerably shorter than what has been reported in clinical trials. Our results suggest that long-term HHI therapy may be difficult in a real-world setting.

Ixekizumab (Interleukin 17A Antagonist): 12-week Efficacy and Safety Outcomes in Real-world Clinical Practice

2018 ◽  
Vol 23 (2) ◽  
pp. 174-177 ◽  
Author(s):  
Jorge R. Georgakopoulos ◽  
Michelle Phung ◽  
Arvin Ighani ◽  
Jensen Yeung
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Plaque Psoriasis ◽  
Current Knowledge ◽  
Therapeutic Option ◽  
Injection Site Reaction ◽  
Retrospective Chart Review ◽  
Phase Iii ◽  
Physician Global Assessment ◽  
Efficacy And Safety

Background: Current knowledge of the efficacy and safety of ixekizumab is limited to data from phase III randomized controlled trials (RCTs). A gap exists in our understanding of treatment outcomes of this newly available biologic in real-world clinical practice. Objective: This study explores the efficacy and safety of ixekizumab in non-RCT patients to compare real-world outcomes to those reported in RCTs. Methods: We conducted a multicentre, retrospective chart review of patients treated with ixekizumab therapy for moderate-to-severe plaque psoriasis. Efficacy (Psoriasis Area and Severity Index score of 75 or Physician Global Assessment of 0 or 1) and safety (reported adverse events [AEs]) were assessed following a 12-week treatment period. Results: Of the 60 patients included, 45 (75.0%) achieved efficacious outcomes after 12 weeks of ixekizumab treatment. Twenty-two (36.7%) patients experienced one or more AEs, of whom only 3 (5.0%) withdrew from treatment as a result. Common AEs included injection site reaction/erythema/pain (13.3%) and dermatitis (5.0%). Conclusion: Ixekizumab has shown to be a safe and effective therapeutic option for plaque psoriasis in real-world practice. It does not appear that patients experience more AEs in real-world clinics than those in clinical trials.

scholarly journals Efficacy and safety of the target-specific oral anticoagulants for stroke prevention in atrial fibrillation: the real-life evidence

2016 ◽  
Vol 8 (2) ◽  
pp. 67-75 ◽  
Author(s):  
Vincenzo Russo ◽  
Anna Rago ◽  
Riccardo Proietti ◽  
Federica Di Meo ◽  
Andrea Antonio Papa ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Real World ◽  
Stroke Prevention ◽  
Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Thromboembolic Stroke ◽  
The Real ◽  
Concise Review ◽  
Real World Setting

The aim of our article is to provide a concise review for clinicians entailing the main studies that evaluated the efficacy and safety of target-specific oral anticoagulants (TSOAs) for thromboembolic stroke prevention in the real-world setting. Atrial fibrillation (AF) is one of the most common supraventricular arrhythmias that requires anticoagulation therapy to prevent stroke and systemic embolism. TSOAs, dabigatran, apixaban and rivaroxaban have become available as an alternative to warfarin anticoagulation in nonvalvular atrial fibrillation (NVAF). Randomized clinical trials showed non-inferior or superior results in efficacy and safety of the TSOAs compared with warfarin for stroke prevention in NVAF patients. For this reason, the 2012 update to the European Society of Cardiology guidelines for the management of AF recommends TSOAs as broadly preferable to vitamin K antagonists (VKAs) in the vast majority of patients with NVAF [Camm et al. 2012]. Although the clinical trial results and the guideline’s indications, there is a need for safety and efficacy data from unselected patients in everyday clinical practice. Recently, a large number of studies testing the efficacy and the safety of TSOAs in clinical practice have been published. The aim of our article is to provide a concise review for clinicians, outlining the main studies that evaluated the efficacy and safety of TSOAs for thromboembolic stroke prevention in the real-world setting.

Sign in / Sign up

Export Citation Format

Share Document