Levofloxacin for NIH Category II Chronic Bacterial Prostatitis: A Real-Life Study

Chemotherapy ◽  
2019 ◽  
Vol 64 (1) ◽  
pp. 8-16 ◽  
Author(s):  
Vittorio Magri ◽  
Gianpaolo Perletti ◽  
Tommaso Cai ◽  
Konstantinos Stamatiou ◽  
Alberto Trinchieri ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Single Agent ◽  
Real Life ◽  
Symptom Index ◽  
Life Study ◽  
Treatment Groups ◽  
Urogenital Infections ◽  
Real Life Setting ◽  
Urological Procedures ◽  
Clinical Records

Background: Mounting worldwide resistance trends make the use of fluoroquinolone (FQ) antibacterial agents increasingly difficult. This is felt more acutely in the case of urogenital infections, which are mainly caused by Gram-negative pathogens. For years, levofloxacin and other FQs have been the first-line drugs for treating National Institutes of Health (NIH) category II chronic bacteria prostatitis (CBP). Eradication rates achieved by levofloxacin in the frame of randomized trials vary greatly, ranging between 71 and 86%. Objectives: This was a retrospective observational study to investigate the efficacy of levofloxacin against CBP in a real-life setting (urological outpatient wards). Methods: A database including the clinical records of >2,500 CBP patients was reviewed. Patients were selected based on strict inclusion criteria. They were treated for 4 weeks with 500 mg levofloxacin per day, alone or combined with other antibacterials. Besides standard urological procedures including the 4-glass test for pathogen isolation, international symptom questionnaires (the NIH Chronic Prostatitis Symptom Index [NIH-CPSI] and International Prostate Symptom Score [IPSS]) were administered. Results: Pathogen eradication was achieved in 79% of the cases treated with levofloxacin as a single agent and 87.8% of patients who received a combination of levofloxacin and azithromycin. The 11% increase in the eradication rate in the latter group is statistically significant. In addition, the levofloxacin-azithromycin combination caused a significant decrease in prostate volume and significantly increased the bladder-voided volume. IPSS and NIH-CPSI values and the urinary peak flow rate decreased to a similar extent in both treatment groups. No adverse effects were reported by patients belonging to either treatment group. Conclusion: Levofloxacin retained its therapeutic efficacy in patients assessed in a real-life setting, and high eradication rates were attained when it was administered as a single agent. A combination of an FQ with azithromycin induced a significant improvement of eradication rates. This strategy may be an interesting option in both first-referral and relapsing cases, although caution should be exercised when patients are at risk of developing arrhythmias, tendinitis, or other adverse effects.

scholarly journals AB0369 EFFICACY AND SAFETY OF RITUXIMAB ORIGINATOR AND BIOSIMILAR IN PRIMARY SJÖGREN’S SYNDROME IN A REAL-LIFE SETTING

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1485.3-1485
Author(s):  
F. Carubbi ◽  
A. Alunno ◽  
P. Cipriani ◽  
V. Pavlych ◽  
C. DI Muzio ◽  
...  
Keyword(s):  
Disease Activity ◽  
Real Life ◽  
Primary Sjögren’S Syndrome ◽  
Efficacy And Safety ◽  
Research Support ◽  
Treatment Groups ◽  
Real Life Setting ◽  
Patient Reported ◽  
Time Point

Background:Over the last 2 decades rituximab (RTX) has been widely used, albeit off-label, in primary Sjögren’s syndrome (pSS). Several studies reported that B-lymphocyte depletion with RTX is effective in this disease not only by reducing disease activity but also by affecting the inflammation and the lymphoid organization that occur in target tissues. With the recent release of several RTX biosimilars (bRTX) on the market, the demonstration of their interchangeability with RTX originator (oRTX) is required.Objectives:To compare efficacy and safety of oRTX and bRTX in pSS patients in a real-life setting.Methods:Clinical records of pSS patients referring to a tertiary rheumatology clinic were retrospectively evaluated. Patients having received at least 2 courses of either oRTX or bRTX (1000 mg IV infusion, repeated after 2 weeks -1 course- and the course repeated after 24 weeks) with complete data at baseline and after 3, 6, 9 and 12 months of treatment were enrolled. Disease activity was assessed with the EULAR SS disease activity index (ESSDAI) and its clinical version without the biological domain (ClinESSDAI). Patient-reported symptoms were assessed with the EULAR SS Patient Reported Index (ESSPRI).Results:Seven patients that received oRTX and 7 patients that received bRTX were enrolled. Baseline clinical features, including ESSDAI and ESSPRI were similar in the 2 treatment groups. Both compounds significantly reduced ESSDAI and ESSPRI as early as 3 months and no difference between the groups was observed at any time point (Figure 1). Of interest, ESSDAI slowly decreased until month 6 when the most pronounced reduction was observed. Conversely, ESSPRI dropped to its lowest values already at month 3. With regard to safety, at 12 months of follow-up no adverse event was observed in any of the treatment groups.Conclusion:At 12 months of follow-up, oRTX and bRTX display similar efficacy and safety profiles. The improvement of patient reported outcomes is faster than the improvement of disease activity with both compounds. Our data support interchangeability of oRTX and bRTX in pSS.References:[1]Carubbi F et al. Arthritis Res Ther. 2013;15(5):R172[2]Carubbi F et al. Lupus. 2014;23(13):1337-49Figure 1 ESSDAI and ESSPRI values at every time point in the 2 treatment groups. Asterisks indicate p values <0.05 compared to the other treatment group at the same time pointDisclosure of Interests:Francesco Carubbi Speakers bureau: Francesco Carubbi received speaker honoraria from Abbvie and Celgene outside this work., Alessia Alunno: None declared, Paola Cipriani Grant/research support from: Actelion, Pfizer, Speakers bureau: Actelion, Pfizer, Viktoriya Pavlych: None declared, claudia di muzio: None declared, Roberto Gerli: None declared, Roberto Giacomelli Grant/research support from: Actelion, Pfizer, Speakers bureau: Abbvie, Roche, Actelion, BMS, MSD, Ely Lilly, SOBI, Pfizer

scholarly journals Multimodal Smoking Cessation in a Real-Life Setting: Combining Motivational Interviewing With Official Therapy and Reduced Risk Products

2019 ◽  
Vol 12 ◽  
pp. 1179173X1987843 ◽  
Author(s):  
Pasquale Caponnetto ◽  
Jennifer DiPiazza ◽  
Giorgio Carlo Cappello ◽  
Shirin Demma ◽  
Marilena Maglia ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Motivational Interviewing ◽  
Smoking Status ◽  
Real Life ◽  
Electronic Cigarette ◽  
Smoking Abstinence ◽  
Daily Consumption ◽  
Treatment Groups ◽  
Global Pandemic ◽  
Real Life Setting

Background: Tobacco use is a global pandemic, affecting an estimated 1.2 billion people and resulting in substantial health burdens and associated costs. Objectives: The aim of this study was to estimate the efficacy of several treatments for smoking cessation in a real-life setting and to evaluate predictors of smoking abstinence. Methods: This research was designed with a sample of 593 cases recorded over the period between 2015 and 2016. Six treatment groups were included: (1) bupropion and motivational interviewing (MI); (2) bupropion, nicotine replacement therapy (NRT), and MI; (3) NRT and MI; (4) varenicline and MI; (5) personal vaporizer electronic cigarette and MI; and (6) electronic cigarette, cigarette like “cigalike,” and MI. Results: Results support the efficacy of all treatment groups when used in a real-life setting. The predictors of smoking abstinence were sex, partner smoking status, previous quit attempts, daily consumption, self-efficacy, and level of nicotine dependence. Conclusions: The use of different therapeutic strategies in clinical practice, including pharmacotherapy and nonstandard electronic nicotine delivery systems, such as an electronic cigarette, ensures a greater chance of cessation success and the possibility of tailoring interventions according to patients’ resources.

scholarly journals Blinded Oral Challenges with Lactose and Placebo Accurately Diagnose Lactose Intolerance: A Real-Life Study

Nutrients ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 1653
Author(s):  
Alba Rocco ◽  
Debora Compare ◽  
Costantino Sgamato ◽  
Alberto Martino ◽  
Luca De Simone ◽  
...  
Keyword(s):  
Abdominal Pain ◽  
Lactose Intolerance ◽  
Real Life ◽  
Hydrogen Breath Test ◽  
Double Blind ◽  
Lactose Malabsorption ◽  
Double Blind Placebo ◽  
Life Study ◽  
Validated Questionnaire ◽  
Real Life Setting

 Lactose intolerance (LI) is characterized by diarrhea, abdominal pain, or bloating occurring after lactose consumption in patients with lactose malabsorption. The National Institute of Health (NIH) proposed a double-blind placebo testing to identify LI individuals correctly. However, until now, no study used this approach in a real-life setting. We aimed to assess double-blind placebo challenge accuracy in diagnosing LI in patients with self-reported symptoms of LI. 148 patients with self-reported LI were consecutively enrolled and blindly underwent hydrogen breath test (HBT) after 25 g lactose or 1 g glucose (placebo) load. One week later, the subjects were challenged with the alternative substrate. Each subject completed a validated questionnaire, including five symptoms (diarrhea, abdominal pain, vomiting, bowel sounds, and bloating) scored on a 10-cm visual analog scale. Home questionnaire (HQ) referred to symptoms associated with the consumption of dairy products at home, while lactose questionnaire (LQ) and placebo questionnaire (PQ) referred to symptoms perceived throughout the 4-h after the administration of the substrates, respectively. After lactose load, HBT was positive in 81 patients (55%), of whom 60 (74%) reported relevant symptoms at LQ (lactose malabsorbers, LM). After placebo challenge, 45 out of 60 with a positive lactose challenge did not complain of symptoms and therefore were diagnosed as lactose intolerant, according to NIH definition. The blinded oral challenges with lactose and placebo accurately diagnose LI and identify patients who will likely benefit from a lactose-free diet. 

Results of the VENUS study: Bevacizumab efficacy and safety in platinum-sensitive recurrent ovarian cancer (OC)—A real-life ambispective study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5540-5540
Author(s):  
Isabelle Laure Ray-Coquard ◽  
Jerome Alexandre ◽  
Francois Goldwasser ◽  
Jean-Philippe Spano ◽  
Dominique Berton-Rigaud ◽  
...  
Keyword(s):  
De Novo ◽  
Real Life ◽  
Progression Free Survival ◽  
Recurrent Ovarian Cancer ◽  
Free Survival ◽  
Life Study ◽  
Platinum Sensitive ◽  
Real Life Setting ◽  
Grade 3

5540 Background: The VENUS study reports on the efficacy/safety of bevacizumab (Bev) in patients (pts) treated in the real-life setting. Methods: In this multicentric observational ambispective VENUS study, all Pts were naive of any antiVEGF and received Bev +/- chemotherapy. Pts were followed until progression or death, for a maximum of 3 years since Bev initiation. De novo side effects were defined as symptoms for which patients were naïve at baseline. Results: 148 OC pts were included (27 centres), 10 excluded and 8 were lost of follow-up. 52 were retrospective. Median age 64 years (55-70). 84.1% were advanced. Median duration of Bev was 8.6 months, min 1 max 36 months. Initial Bev dose was 15 mg/kg Q3W for 65.3%, 10.0 for 22.5%, 7.5 for 10.2% and 5.0 for 2%. 2 pts presented with thrombotic micro-angiopathy (1.4%). Before Bev, hypertension (HTN) was present in 28.9%; proteinuria in 11.3%. Incidence of de novo HTN was 25%. 43 pts (31.2%) experienced de novo Grade 1-2 Pu, for a total of 56 events, no grade 3-4 was observed. A total of 12 Grade 4 events occurred: 9 neutropenia and 3 thrombopenia. Mean overall survival (OS) and progression free survival (PFS) were 30.0 and 13.3 months, respectively. Conclusions: 1) 1/3 of pts were treated at low doses in this real-life study; 2) safety of Bev in real-life was manageable and as expected, 3) OS and PFS were consistent with those reported in the OCEANS study: PFS 12.4 and OS 33.6 months but lower than in the GOG-0213 study: PFS 13.8 and OS 42.6 months. De novo events recorded during follow-up. [Table: see text]

scholarly journals Inhaled Dry Powder Antibiotics in Patients with Non-Cystic Fibrosis Bronchiectasis: Efficacy and Safety in a Real-Life Study

2020 ◽  
Vol 9 (7) ◽  
pp. 2317
Author(s):  
Miguel Ángel Martínez-García ◽  
Grace Oscullo ◽  
Esther Barreiro ◽  
Selene Cuenca ◽  
Angela Cervera ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Real Life ◽  
Common Adverse Effect ◽  
Common Side Effect ◽  
Chronic Obstructive ◽  
Efficacy And Safety ◽  
Dry Powder ◽  
Multi Centre Study ◽  
Life Study ◽  
Inhaled Antibiotics

Background: Nebulised antibiotics are habitually used in patients with bronchiectasis, but the use of dry powder inhaled antibiotics (DPIA) in these patients is extremely limited. This study seeks to analyse the efficacy and safety of DPIA in bronchiectasis patients. Material and methods: Multi-centre study of historic cohorts. All the hospital centres in Spain were contacted in order to collect data on patients with a diagnosis of bronchiectasis who had taken at least one dose of DPIA. Its efficacy was analysed in clinical, functional and microbiological terms by comparing the year before and the year after the prescription of DPIA. Adverse effects and variables associated with these effects, or any need to withdraw the drug, were also analysed. Results: 164 patients from 33 Spanish centres were included; 86% and 14% of these were treated with dry powder colistin and tobramycin, respectively. Chronic bronchial infection by Pseudomonas aeruginosa was present in 86% of these patients, and DPIA significantly reduced the number of exacerbations, the quantity and purulence of sputum and the isolation of pathogenic microorganisms. The most common adverse effect was cough (40%), particularly in cases of Chronic Obstructive Pulmonary Disease (COPD) and a previous cough and in those patients who had difficulties in handling the device. These factors were associated with a higher level of withdrawal of the treatment. There were no serious adverse effects. Conclusions: Our study suggests that DPIA are clinically efficacious and safe for treating bronchiectasis patients. Cough was shown to be the most common side-effect and reason for withdrawal of the treatment.

scholarly journals Real-life effect of a microcrystalline tyrosine adjuvanted mite immunotherapy in patients with allergic rhinitis

Immunotherapy ◽  
2020 ◽  
Vol 12 (1) ◽  
pp. 53-62 ◽  
Author(s):  
Albert Roger ◽  
Alfons Malet ◽  
Victoria Moreno ◽  
Antonio Parra ◽  
Diego Gutiérrez ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Treatment Initiation ◽  
Real Life ◽  
Subcutaneous Immunotherapy ◽  
Serious Adverse Events ◽  
End Points ◽  
Life Study ◽  
Real Life Setting ◽  
Medication Score ◽  
Real Life Study

Aim: Evaluate the effectiveness and safety of immunotherapy with Acarovac Plus® in a 1-year prospective multicentered real-life study. Methods: A total of 118 adults with allergic rhinitis sensitized to Dermatophagoides received subcutaneous immunotherapy with Acarovac Plus. Treatment outcomes were evaluated at baseline, 6 months and 1 year after treatment initiation. Primary end point was the evolution of the combined symptom and medication score. Secondary end points included other effectiveness outcomes and measurement of product tolerability. Results: Acarovac Plus induced significant improvements in primary and secondary end points after 6 months compared with baseline. These differences persisted after 1 year of treatment (p < 0.001; baseline vs 1 year): combined symptom and medication score (1.60 vs 0.79). No serious adverse events were recorded. Conclusion: Acarovac Plus for 1 year was effective and well tolerated in a real-life setting.

FYDATA STUDY: PERAMPANEL STUDY IN A REAL-LIFE SETTING

2015 ◽  
Vol 86 (11) ◽  
pp. e4.146-e4
Author(s):  
V Villanueva ◽  
M Garces ◽  
FJ López Gonzalez ◽  
X Rodriguez-Osorio ◽  
JJ Rodriguez Uranga ◽  
...  
Keyword(s):  
Interim Analysis ◽  
Real Life ◽  
Psychiatric Condition ◽  
Inclusion Criteria ◽  
Onset Seizure ◽  
Partial Onset Seizure ◽  
Real Life Setting ◽  
Clinical Records ◽  
Written Informed Consent ◽  
Study Inclusion

FYDATA is a multi-centre, retrospective, 1-year, observational study (inclusion criteria: written informed consent to review clinical charts; patients ≥12 years old; partial-onset seizure [POS] diagnosis; perampanel treatment according to clinical practice as add-on therapy; patients with ≥1 POS in year prior to starting perampanel). The source of data was patient clinical records collected by physicians. An interim analysis was performed at 3 months in 111 patients (mean age: 37.8 years; mean epilepsy duration: 24 years). Mean seizure number/month at onset was 19.3. At baseline, patients had tried a mean of 8.3 antiepileptic drugs (AEDs) and half were taking ≥3 concomitant AEDs. 31% of patients had a comorbid psychiatric condition. At 3 months, with a mean perampanel dose of 5.4 mg, 9% of patients were seizure-free and 44% were responders (≥50% reduction in seizure number). Adverse events were reported by 41.4% of patients; most frequent were irritability (13.5%), somnolence (10.8%) and dizziness (9.9%). Irritability and aggressiveness were more frequent if patients had a comorbid psychiatric condition – personality disorder/hyperactivity. Preliminary results at 3 months in refractory POS patients receiving adjunctive perampanel in a real-life setting showed a promising response. Study sponsors: Eisai Inc. Writing support: Choice Healthcare Solutions; funding, Eisai Ltd.

scholarly journals P289 A French nationwide prospective study on patients with Crohn’s disease and ulcerative colitis treated with Infliximab-biosimilar CT-P13 in a real-life setting: two-year follow-up of the ReFLECT study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S320-S321
Author(s):  
Y Bouhnik ◽  
S Nancey ◽  
M Assing ◽  
N Mammar ◽  
D Laharie
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Disease Activity ◽  
Safety Data ◽  
Real Life ◽  
Life Study ◽  
Mayo Score ◽  
Real Life Setting

Abstract Background ReFLECT study was carried out to investigate real-life use of CT-P13, the first monoclonal antibody biosimilar to infliximab (IFX) originator. Methods This multicentre, prospective, observational study was conducted in France to assess characteristics of patients (pts) receiving CT-P13, its effectiveness and safety in a real-life setting. Eligible were both pts who had been switched from IFX originator (IFXS) and IFX-naïve pts started on CT-P13 (IFXN). These interim descriptive statistical analyses are about pts with Crohn’s disease (CD) and ulcerative colitis (UC). Results Among the 1370 adult pts included between October 2016 and April 2019, data were analysed for 508 CD pts (48.6% males; mean age ± SD: 37.7±13.7; median [Q1;Q3] disease duration: 6.2 [1.9;13.7] years; 323 IFXN/145 IFXS) and 213 UC pts (54%; 42.9±17.2; 5.4 [1.6;12.8]; 154 IFXN/46 IFXS). Previous biologics other than IFX were taken by 32.9% of CD and 39.0% of UC pts; 31% (CDS) and 23% (UCS) of pts were switched from IFX originator to CT-P13. At the time of the first administration of CT-P13, disease had been more active in IFXN vs IFXS pts: 52.9% vs 13.3% in CD with a median [Q1;Q3] Harvey Bradshaw Index (HBI) of 4 [1;8] vs 1 [0;2] and, 82.9% vs 33.3% in UC with a median Mayo Score of 7 [3;10] vs 2 [0;4]. In IFXS pts, disease activity remained stable after 2 years of treatment with median differences of HBI and Mayo score since first administration of 1 [0;2] and 0 [-4;1]. In IFXN pts, median differences of HBI and Mayo score since first administration were -2 [-7;1] and -7 [-8;-5]; CT-P13 brought disease activity down to levels below or comparable to those seen in IFXS pts. Reasons for CT-P13 withdrawing and safety data are reported in Tables 1 and 2. Conclusion Year 2 follow-up data indicate that CT-P13 effectively induced improvement in disease activity in IFXN pts with CD or UC and maintained stable activity in IFXS pts. This real-life study did not highlight any new safety concerns.

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