scholarly journals Real-Life Active Surveillance of a Naphazoline/ Hypromellose Fixed Combination’s Safety Profile in Peruvian Population

2021 ◽  
Vol Volume 10 ◽  
pp. 127-133
Author(s):  
Homero Contreras-Salinas ◽  
Mariana Barajas-Hernández ◽  
Leopoldo Martín Baiza-Durán ◽  
Vanessa Orozco-Ceja ◽  
Lourdes Yolotzin Rodríguez-Herrera
Keyword(s):  
Active Surveillance ◽  
Safety Profile ◽  
Real Life

Effectiveness, Durability, and Safety of Dolutegravir and Lamivudine Versus Dolutegravir, Lamivudine, and Abacavir in a Real-Life Cohort of HIV-Infected Adults

2021 ◽  
pp. 106002802110341
Author(s):  
Inés Mendoza ◽  
Alicia Lázaro ◽  
Miguel Torralba
Keyword(s):  
Viral Load ◽  
Safety Profile ◽  
Real Life ◽  
Hazard Ratio ◽  
Treatment Discontinuation ◽  
Treatment Naïve ◽  
Tn 4 ◽  
Risk Of Treatment ◽  
Hiv 1 ◽  
All Treatment

Background: Dolutegravir (DTG) plus lamivudine (2-DR) is suggested as an initial and switch option in HIV-1 treatment. Objective: To analyze the effectiveness, durability, and safety of 2-DR compared with DTG plus abacavir/lamivudine (3-DR). Methods: This was an observational, ambispective study that included all treatment-naïve (TN) and treatment-experienced (TE) patients who started 2-DR or 3-DR between July 1, 2018, and November 30, 2020. The primary end point was noninferiority, at 24 and 48 weeks, of 2-DR versus 3-DR regarding the percentage of patients with viral load (VL)≥50 and 200 copies/mL in TN (4% margin) and VL<50 and 200 copies/mL in TE (margin 12%). Durability of response, and safety were also measured. Results: 242 patients were included (53 TN and 189 TE). Two TN patients on 2-DR had VL≥50 copies/mL and 1 had VL≥200 copies/mL at week 24. In TE patients on 2-DR, 90.2% achieved VL<200 copies/mL at week 24 (difference: 3.8%; 95% CI = −6.3% to 14%) and 91.8% at week 48 (difference: 0.06%; 95% CI = −9% to 10%), meeting noninferiority criteria. Among the 53 TN patients, only 1 VF was observed in 2-DR. In TN patients, the risk of treatment discontinuation was similar between groups (hazard ratio [HR] = 0.37; P = 0.15); similar rates were also found in TE patients (HR = 0.94; P = 0.85). TE patients on 2-DR showed a better safety profile compared with 3-DR patients ( P<0.001). Conclusion and Relevance: Our results did not show noninferiority in terms of virological effectiveness. Nevertheless, all effectiveness measures support the use of 2-DR in a real-life cohort of TN and TE. Additionally, durability and safety of 2-DR were confirmed to be similar to that of 3-DR.

scholarly journals Ticagrelor safety profile in real-life setting of acute coronary syndrome patients

2017 ◽  
Vol 80 (3) ◽  
pp. 183-184 ◽  
Author(s):  
Niccolò Lombardi ◽  
Giada Crescioli ◽  
Ersilia Lucenteforte ◽  
Alessandro Mugelli ◽  
Alfredo Vannacci
Keyword(s):  
Acute Coronary Syndrome ◽  
Safety Profile ◽  
Real Life ◽  
Coronary Syndrome ◽  
Real Life Setting

Activity of aflibercept (Afli) in combination with FOLFIRI (F) for patients with metastatic colorectal cancer (mCRC) in a real-life setting in Spain: Final results of the retrospective study Named Patient Program.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 689-689
Author(s):  
Javier Sastre ◽  
Jaime Feliu ◽  
Purificación Martinez ◽  
Cristina Buges ◽  
Jose Carlos Mendez ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Safety Profile ◽  
Prognostic Model ◽  
Objective Response ◽  
Real Life ◽  
Progression Free Survival ◽  
Vascular Events ◽  
The Real ◽  
Real Life Setting ◽  
Metastatic Sites

689 Background: InVELOUR trial the addition of aflibercept to FOLFIRI regimen, demonstrated a statistically significant overall survival improvement in mCRC patients (pts) who progressed on or after a prior oxaliplatin based regimen with or without biologic agents. Our goal is to assess in the real-life setting the activity and safety profile of Afli+F in mCRC. Methods: Retrospective data collection (baseline characteristics, progression free survival [PFS], objective response rate [ORR], salvage surgeries, and safety profile) of pts who received Afli+F as a 2nd line treatment on a compassionate use program in Spain. GERCOR prognostic model has been applied to evaluate PFS. These are the final results of the analysis (Cut-off date June 2015). Results: The retrospective study population comprised 71 pts (34 hospitals); 60.6% men and 39.4% women, median age 64 years (19.7% > 70) and 98.6% had ECOG scores = 0-1. 63.4% (n = 45) had ≥ 2 metastatic sites (liver [81.7%], lung [38.0%]) and 67.7% (46/68) patients were K-RAS mutated. 60.6% (n = 43) had received prior bevacizumab (BVZ) treatment, 16.9% (n = 12) had received prior cetuximab and 5.6% (n = 4) panitumumab. Patients received a median of 6 cycles (range: 1-30) of Afli+F. Median PFS with Afli+F was 5.3 months (CI 95%: 3.7-8.6); which was not significantly modified by the presence of K-RAS mutation (HR: 1.1663; 95%CI: 0.6676-2.0373; p = 0.5867), by prior BVZ treatment (HR: 1.2424; 95%CI: 0.7238-2.1327; p = 0.4283) or by anti-EGFRs treatment (HR: 0.5681; 95%CI: 0.3117-1.0356; p = 0.0604). ORR was 19.7% (CI 95%: 11.2-30.9) and 8.5% (n = 6) of salvage surgeries. The most frequent adverse events grade ≥ 3 related with treatment were asthenia (n = 8), neutropenia (n = 7) and diarrhea (n = 6). The characteristic anti-angiogenic events were hypertension (n = 8), proteinuria (n = 1), vascular events (n = 1), and one intestinal perforation resulting in death. GERCOR prognostic model: Median PFS = 8.30 months [1.28-18.71] low risk, 5.29 [4.08-9.93] intermediate risk and 2.56 [1.94-4.57] high risk. Conclusions: In spite of the differences in sample size, in the real-life setting, Afli+F achieve a PFS comparable to VELOUR, regardless of K-RAS status or prior BVZ and anti-EGFR’s treatment, with an appropriate safety profile. Funding: Sanofi.

Active Surveillance for Prostate Cancer in a Real-life Cohort: Comparing Outcomes for PRIAS-eligible and PRIAS-ineligible Patients

2018 ◽  
Vol 1 (3) ◽  
pp. 231-237 ◽  
Author(s):  
Timo F.W. Soeterik ◽  
Harm H.E van Melick ◽  
Lea M. Dijksman ◽  
Douwe H. Biesma ◽  
J. Alfred Witjes ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Real Life

scholarly journals Can active surveillance really reduce the harms of overdiagnosing prostate cancer? A reflection of real life clinical practice in the PRIAS study

2018 ◽  
Vol 17 (2) ◽  
pp. e92-e95 ◽  
Author(s):  
F.J. Drost ◽  
C. Bangma ◽  
Y. Kakehi ◽  
T. Pickles ◽  
A. Rannikko ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Practice ◽  
Active Surveillance ◽  
Real Life

scholarly journals Ophthalmic Solution Safety Profile: Active Surveillance of a Sodium Hyaluronate/Chondroitin Sulfate Combination in Peruvian Population

2021 ◽  
Vol Volume 13 ◽  
pp. 117-123
Author(s):  
Homero Contreras-Salinas ◽  
Mariana Barajas-Hernández ◽  
Leopoldo Martín Baiza-Durán ◽  
Vanessa Orozco-Ceja ◽  
Lourdes Yolotzin Rodríguez-Herrera
Keyword(s):  
Chondroitin Sulfate ◽  
Active Surveillance ◽  
Safety Profile ◽  
Sodium Hyaluronate ◽  
Ophthalmic Solution

scholarly journals P481 Effectiveness and safety profile of biological therapy in inflammatory bowel disease: real life data from an active pharmacovigilance project

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S470-S471
Author(s):  
A Viola ◽  
M A Barbieri ◽  
V Pisana ◽  
P M Cutroneo ◽  
W Fries ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Safety Profile ◽  
Index Date ◽  
Descriptive Analysis ◽  
Real Life ◽  
Biologic Agent ◽  
Skin Reactions ◽  
Inflammatory Bowel

Abstract Background Biological therapies are now the mainstay for the treatment of Inflammatory bowel disease (IBD). Post-marketing activities become crucial for monitoring the long-term safety. Aim of this project was to evaluate the effectiveness and the safety profile of biologics for the treatment of IBD patients during a prospective pharmacovigilance study. Methods From January 2017 to December 2020, all patients with Crohn’s Disease (CD) and Ulcerative Colitis (UC) treated with at least one biologic agent at the start of the study or commenced a biologic during the study period were enrolled. Demographic, clinical, and disease-related data were collected. A descriptive analysis of patients’ characteristics at the index date was performed. Moreover, an analysis of all adverse events (AEs) and all primary/secondary failures expressed as number of AEs or failures/10 treatment years was carried out taking into account the total years of treatment for each biologic including all patients treated with a biologic at least once during the follow-up period. Results A total of 654 patients were enrolled, 58.4% with CD and 41.6% with UC. Mean age (±SD) was 44 ± 17 years and 59.0% were males. At the index date, the following treatments were used: 40.8% adalimumab (ADA), 33.3% infliximab (IFX), 21.3% vedolizumab (VED), 2.4% ustekinumab (UST), and 2.1% golimumab (GOL). Patients naïve for biologic therapy were 79.1%. The total years of treatment were 887 yrs for ADA, 663 yrs for IFX, 309 yrs for VED, 89 yrs for UST, and 51 yrs for GOL. Data for AEs and failures were the following: IFX – 1.1 AEs and 0.8 failures, ADA – 0.8 and 0.9, VED – 1.1 and 1.8, GOL – 1.2 and 3.4, and UST - 1.4 and 0.9, respectively (Tab.1). During follow-up, 196 AEs were reported. Infections mainly occurred in patients treated with GOL and ADA (8.7% and 7.6%, respectively), skin reactions in patients treated with ADA (7.6%), while infusion related reactions with IFX (12.6%). A higher frequency of malignancies was observed in patients on treatment with VED (3.4%). Conclusion There were no major differences for AEs between the different treatments, but a higher frequency of failures with GOL and VED, both rarely used as first line therapies. Nevertheless, the acquisition of data from clinical practice should be endorsed to better define the safety and efficacy profile of new biologic agents in IBD.

Real-life efficacy and safety profile of TACE in patients with intermediate HCC in a large German cohort

2020 ◽  
Author(s):  
P Maximilian ◽  
U Schöler ◽  
J Kraczyk ◽  
C Casar ◽  
T Fründt ◽  
...  
Keyword(s):  
Safety Profile ◽  
Real Life ◽  
Efficacy And Safety

scholarly journals Nintedanib Treatment for Idiopathic Pulmonary Fibrosis Patients Who Have Been Switched from Pirfenidone Therapy: A Retrospective Case Series Study

2020 ◽  
Vol 9 (2) ◽  
pp. 422 ◽  
Author(s):  
Andrea Vianello ◽  
Francesco Salton ◽  
Beatrice Molena ◽  
Cristian Turato ◽  
Maria Laura Graziani ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Disease Progression ◽  
Safety Profile ◽  
Real Life ◽  
Case Series ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Case Series Study

Background: The efficacy and effectiveness of nintedanib as a first-line therapy in idiopathic pulmonary fibrosis (IPF) patients have been demonstrated by clinical trials and real-life studies. Our aim was to examine the safety profile and effectiveness of nintedanib when it is utilized as a second-line treatment in subjects who have discontinued pirfenidone. Methods: The medical charts of 12 patients who were switched from pirfenidone to nintedanib were examined retrospectively. The drug’s safety was defined by the number of adverse events (AEs) that were reported; disease progression was evaluated based on the patient’s vital status and changes in forced vital capacity (FVC) at 12-month follow-up. Results: The numbers of patients experiencing AEs and of the AEs per patient in our study group didn’t significantly differ with respect to a group of 56 individuals who were taking nintedanib as a first-line therapy during the study period (5/12 vs. 22/56; p = 0.9999, and 0.00 (0.00–1.00) vs. 0.00 (0.00–3.00); p = 0.517, respectively). Two out of the 3 patients who had been switched to nintedanib due to a rapid disease progression showed stabilized FVC values. Conclusions: Nintedanib was found to have an acceptable safety profile in the majority of the IPF patients switched from pirfenidone. Prospective studies are warranted to determine if the drug can effectively delay disease progression in these patients.

Clinical profile and patterns of progression (PD) of patients (pts) with advanced nonsquamous non-small cell lung cancer (nsNSCLC) treated with first-line bevacizumab (B): AVVA study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18015-e18015
Author(s):  
Javier De Castro ◽  
Manuel Domine ◽  
Jose Maria Garcia-Bueno ◽  
Salvador Saura ◽  
Ramon Garcia-Gomez ◽  
...  
Keyword(s):  
Pulmonary Disease ◽  
Safety Profile ◽  
Real Life ◽  
Stage Iv ◽  
Clinical Profile ◽  
Tumor Diameter ◽  
Concomitant Disease ◽  
Thoracic Disease ◽  
Best Response ◽  
Tumor Load

e18015 Background: B in combination with platinum doublets prolongs survival and delays PD in chemo-naïve pts with advanced nsNSCLC and its safety profile has been widely described in clinical trials. In this study we aim to evaluate the behavior, clinical profile and patterns of PD of real-life nsNSCLC pts treated with B in 44 Spanish institutions. Methods: AVVA is a multicenter, epidemiological study to define the clinical profile (gender, age, PS, histology, stage, comorbidities, tumor load, Tx, response and tolerability) and describe the patterns of PD. Pts diagnosed with advanced nsNSCLC and evidence of PD after treatment (Tx) with standard chemotherapy (CT) plus B up to 6 cycles followed by maintenance B were included. Results: Data of 158 pts are presented. Clinical profile was: median age 58 years (range 34-79); male 65%; stage IV 91%; adenocarcinoma 77%; ECOG PS 0/1/≥2 (%): 35/56/9; never/current/former smokers (%): 23/40/37. 64% of pts presented relevant concomitant disease at baseline (27% cardiovascular disease, 24% pulmonary disease). Tx received: B plus carboplatin-doublet/cisplatin-doublet/other (%) 70/25/5. Median no. of cycles for CT/B: 6/9. Patterns of PD: 44% presented high tumor load (tumor diameter ≥55mm and ≥5 lesions); 97% of pts presented intra-thoracic disease, 53% presented extra-thoracic disease and 13% only pulmonary disease. High tumor load was associated with extra-thoracic disease (p<0.05). ORR was 53% (95% CI: 45-61) and disease control rate was 85%. Best response was achieved after a median of 4 cycles (range 1-16). ECOG 0/1 at PD (%): 15/50. Median PFS was 7.7 months (95% CI: 7.3-8.1). No differences were found in ORR or PFS according to tumor load and intra/extra-thoracic disease. Grade 3/4 toxicities were: venous thrombosis (3.2%/0), proteinuria (0.6%/0), hemoptysis (0.6%/0), pulmonary embolism (0/0.6%) and mucositis (0.6%/0). Conclusions: B was effective in this real-life patients’ population, irrespective of tumor load and location of the disease. These results confirm the well-established safety profile and the efficacy of B as frontline Tx in nsNSCLC.

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