Long-term treatment of endometriosis with dienogest: Real-world results from the VIPOS study

2021 ◽  
pp. 228402652199368
Author(s):  
Sabine Moehner ◽  
Kerstin Becker ◽  
Jens A Lange ◽  
Sophia von Stockum ◽  
Marco Serrani ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Health Care Professionals ◽  
Study Entry ◽  
Safety Signal ◽  
Real World Data ◽  
Serious Adverse Events ◽  
Long Term Treatment

Introduction: The Visanne Post-approval Observational Study (VIPOS) was designed to assess the safety of dienogest 2 mg (DNG, Visanne) compared to other hormonal endometriosis treatments. Methods: Large, prospective, non-interventional, active surveillance study in six European countries (Germany, Poland, Russia, Hungary, Switzerland, and Ukraine). Women with a new hormonal therapy for endometriosis were enrolled by gynecologists and specialized centers between 2010 and 2016 and observed for up to 7 years. Self-administered questionnaires during study entry and follow-up collected information on baseline characteristics, health status and endometriosis treatment. Self-reported clinical outcomes of interest were validated by health care professionals. Results: Among the >27,000 enrolled participants, 3262 women started DNG use either at study entry or during follow-up. A total of 798 study participants used DNG during follow-up continuously for 15 months or longer (DNG long-term users). When comparing the occurrence of serious adverse events (SAE) in users treated with DNG, no safety signal emerged for long-term users; the SAE incidence rate per 10,000 women-years was 367.7 (95% CI: 274.1–481.9) in DNG long-term users and 416.4 (349.1–492.5) in short-term users (treated with DNG for less than 15 months). Conclusions: Previous data on DNG long-term safety were derived from studies with relatively low numbers of patients and limited follow-up time. VIPOS provided valuable real-world data on the long-term use of DNG 2 mg in around 800 women treated in Europe and observed no safety signal regarding serious adverse events.

Three-year real-world outcomes of intravitreal anti-VEGF therapies in patients affected by myopic choroidal neovascularization

2020 ◽  
pp. 112067212096345
Author(s):  
Paolo Corazza ◽  
Jamil Kabbani ◽  
Taha Soomro ◽  
Mostafa Mohamed Ragheb Alam ◽  
Francesco Maria D’Alterio ◽  
...  
Keyword(s):  
Adverse Events ◽  
Choroidal Neovascularization ◽  
Real World ◽  
Adverse Event Rate ◽  
Real World Data ◽  
Serious Adverse Events ◽  
Myopic Choroidal Neovascularization ◽  
Anti Vegf ◽  
Significant Difference

Purpose: To describe real world data in patients affected by myopic choroidal neovascularization (CNV) treated with anti-vascular endothelial growth factors (VEGFs) and to compare our results with previous studies and clinical trials. Methods: This retrospective monocentric cohort study analyzed 96 eyes of 96 myopic-CNV patients treated with an anti-VEGF pro-re-nata regimen over a 3-year-long follow up period. Aflibercept and Ranibizumab were considered as first-line agents whereas Bevacizumab was reserved on a compassionate basis in patients outside the criteria for treatment. All patients underwent a best-corrected visual acuity (BCVA) recording at each follow up visit. Results: Our data showed that all three molecules produced significant improvements in BCVA at year 1, with no significant differences between the three drugs. Moreover, during the second year of treatment, Ranibizumab and Bevacizumab showed a significant improvement in the visual function. However, at year 3 of treatment, the data available indicated the BCVA improvement was not significant with Ranibizumab and Bevacizumab. In addition, no significant difference in the average number of injections between the three groups was detected over the follow up period. No serious adverse events were recorded, but five minor adverse events documented. Conclusion: Our study correlates with previous studies showing significant BCVA gains with the use of these molecules. Similarly, all three molecules seem to provide a similar duration of effects as previous studies have shown, with a low ocular adverse event rate.

scholarly journals Long Term Real-World Outcomes of Trifluridine/Tipiracil in Metastatic Colorectal Cancer—A Single UK Centre Experience

2021 ◽  
Vol 28 (3) ◽  
pp. 2260-2269
Author(s):  
Daniel Tong ◽  
Lei Wang ◽  
Jeewaka Mendis ◽  
Sharadah Essapen
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Systemic Treatment ◽  
Progression Free Survival ◽  
Median Number ◽  
Current Data ◽  
Real World Data

In the UK, Trifluridine-tipiracil (Lonsurf) is used to treat metastatic colorectal cancer in the third-line setting, after prior exposure to fluoropyrimidine-based regimes. Current data on the real-world use of Lonsurf lack long-term follow-up data. A retrospective evaluation of patients receiving Lonsurf at our Cancer Centre in 2016–2017 was performed, all with a minimum of two-year follow-up. Fifty-six patients were included in the review. The median number of cycles of Lonsurf administered was 3. Median follow-up was 6.0 months, with all patients deceased at the time of analysis. Median progression-free survival (PFS) was 3.2 months, and overall survival (OS) was 5.8 months. The median interval from Lonsurf discontinuation to death was two months, but seven patients received further systemic treatment and median OS gained was 12 months. Lonsurf offered a slightly better PFS but inferior OS to that of the RECOURSE trial, with PFS similar to real-world data previously presented. Interestingly, 12.5% had a PFS > 9 months, and this cohort had primarily left-sided and RAS wild-type disease. A subset received further systemic treatment on Lonsurf discontinuation with good additional OS benefit. Lonsurf may alter the course of disease for a subset of patients, and further treatment on progression can be considered in carefully selected patients.

scholarly journals Efficacy of treatment with Ombitasvir, Paritaprevir / r + Dasabuvir over 8 versus 12 weeks in chronic HCV hepatitis genotype 1B

2021 ◽  
Vol 24 (1) ◽  
pp. 44-50
Author(s):  
Mircea Manuc ◽  
◽  
Carmen Monica Preda ◽  
Laura Iliescu ◽  
Doina Istratescu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Drop Out ◽  
Real World Data ◽  
Serious Adverse Events ◽  
Intention To Treat ◽  
Genotype 1B ◽  
Male Patients ◽  
Severe Adverse Events ◽  
Chronic Hcv

Background and aims. For the 8-week OPrD regimen, real world data are insufficient. This study aims to compare the efficacy of the two types of regimens (12-week versus 8-week) in a real world cohort of patients with genotype 1b. Material and methods. We analysed a multicentric retrospective cohort enrolling 1436 patients who started HCV therapy in 2018-2019. Liver fibrosis was staged in all subjects by Fibromax. Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12). Results. Out of the 1436 analysed patients, 112 received 8 weeks therapy and 1324 received 12 weeks. In this cohort the proportion of male patients was 25.2%, the median age 61 years, 28.2% were interferon pre-treated, and the rate of co-morbidities was 47%. 42% of the subjects had F2 fibrosis, 29% F1 fibrosis, 16% F3 and 12% F4. The SVR rate was comparable in both groups of patients (97% in those treated with OPrD 12 weeks vs 96.4% in those that received OPrD 8 weeks) (by intention-to-treat). In the 12 weeks arm, the drop-out rate was 0.8% and the rate of severe adverse events was 1%, while in the arm of 8 weeks therapy there were no severe adverse events reported and no drop-out (p = 0.25). The only predictive factor for non-response in both treatment arms was the male sex. Conclusions. OPrD 8 weeks proved to be highly efficient in our patients with a 96.4% SVR. No serious adverse events and no drop out were reported.

scholarly journals Real world experience with coronary sinus reducer implantation for the treatment of refractory angina: a single-centre experience

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
J P Dias Ferreira Reis ◽  
R Ramos ◽  
P Rio ◽  
A Fiarresga ◽  
D Cacela ◽  
...  
Keyword(s):  
Coronary Sinus ◽  
Real World ◽  
Therapeutic Option ◽  
Objective Evaluation ◽  
Short Version ◽  
Refractory Angina ◽  
Single Centre ◽  
Real World Data ◽  
Serious Adverse Events

Abstract Background Coronary sinus Reducer device (CSF) implantation is a novel therapeutic option to relieve symptoms in patients with refractory angina (RA). There is limited real-world data describing its use outside of clinical trials. Aim To assess the safety and efficacy of this procedure in a real-world setting. Methods This is a report of a single centre prospective registry of consecutive patients with RA (CCS II-IV) deemed unsuitable for revascularization. Between May 2017 and August 2019, 17 patients were referred to CSF implantation. Baseline and follow-up evaluation consisted of clinical assessment, including completion of the short version of the Seattle Angina Questionnaire (SAQ-7) and CCS class evaluation and objective evaluation by transthoracic echocardiography and cardiopulmonary exercise test (CPET). Results A total of 13 patients (70,6±6,5 years, 76,9% male) underwent CSF implantation with a procedural success of 84.6%. No cases of periprocedural serious adverse events were reported. At 12-month follow-up, any reduction in CCS Class was achieved in 72.7% of cases, with 27.2% reducing 2 CCS classes. Baseline CCS score was reduced from 2.8±0.4 to 1.7±0.8 (p=0.009). Quality of life (QoL) was significantly improved as assessed by the improvement seen in all items of SAQ-7 (p<0.017 for all). CPET duration was significantly increased (p=0.034), but no change was noted in the remainder CPET variables. During follow-up, 3 patients suffered myocardial infarction, resulting in 1 death. Conclusion CSF implantation in patients with RA was safe and led to a significant reduction of the angina burden and improvement of QoL at 12-month follow-up. FUNDunding Acknowledgement Type of funding sources: None.

scholarly journals Reducing the Toxicity of Long-Term Glucocorticoid Treatment in Large Vessel Vasculitis

2020 ◽  
Vol 22 (12) ◽  
Author(s):  
Andriko Palmowski ◽  
Frank Buttgereit
Keyword(s):  
Adverse Events ◽  
Takayasu Arteritis ◽  
Term Treatment ◽  
Large Vessel Vasculitis ◽  
Large Vessel ◽  
Serious Adverse Events ◽  
Glucocorticoid Treatment ◽  
Long Term Treatment ◽  
Higher Doses

Abstract Purpose While glucocorticoids (GCs) are effective in large vessel vasculitis (LVV), they may cause serious adverse events (AEs), especially if taken for longer durations and at higher doses. Unfortunately, patients suffering from LVV often need long-term treatment with GCs; therefore, toxicity needs to be expected and countered. Recent Findings GCs remain the mainstay of therapy for both giant cell arteritis and Takayasu arteritis. In order to minimize their toxicity, the following strategies should be considered: GC tapering, administration of conventional synthetic (e.g., methotrexate) or biologic (e.g., tocilizumab) GC-sparing agents, as well as monitoring, prophylaxis, and treatment of GC-related AEs. Several drugs are currently under investigation to expand the armamentarium for the treatment of LVV. Summary GC treatment in LVV is effective but associated with toxicity. Strategies to minimize this toxicity should be applied when treating patients suffering from LVV.

scholarly journals P335 Long-term follow-up of switching from original infliximab to infliximab biosimilar: real-world data

2019 ◽  
Vol 13 (Supplement_1) ◽  
pp. S268-S269
Author(s):  
M Guerra Veloz ◽  
M Belvis Jimenez ◽  
T Valdes Delgado ◽  
L Castro Laria ◽  
B Maldonado Pérez ◽  
...  
Keyword(s):  
Real World ◽  
Real World Data ◽  
World Data ◽  
Long Term Follow Up

Safety and efficacy analysis of long-term follow up real-world data with ibrutinib monotherapy in 58 patients with CLL treated in a single-center in Greece

2019 ◽  
Vol 60 (12) ◽  
pp. 2939-2945 ◽  
Author(s):  
Maria Dimou ◽  
Theodoros Iliakis ◽  
Vasileios Pardalis ◽  
Catherin Bitsani ◽  
Theodoros P. Vassilakopoulos ◽  
...  
Keyword(s):  
Real World ◽  
Single Center ◽  
Real World Data ◽  
Safety And Efficacy ◽  
World Data ◽  
Efficacy Analysis ◽  
Long Term Follow Up

scholarly journals P451 Short-and long-term effectiveness of ustekinumab in patients with Crohn’s disease: real-world data from a German IBD cohort

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S405-S405
Author(s):  
A Kubesch ◽  
L Rueter ◽  
K Farrag ◽  
T Krause ◽  
K Stienecker ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Treatment Options ◽  
Real World Data ◽  
Free Response ◽  
Faecal Calprotectin ◽  
Short And Long Term

Abstract Background The IL-12/23 inhibitor ustekinumab (UST) opened up new treatment options for patients with Crohn’s disease (CD). Due to the recent approval, Real-World German data on long-term efficacy and safety are lacking. This study aimed to assess the clinical course of CD patients under UST therapy and to identify potential predictive markers. Methods Patients with CD receiving UST treatment in three hospitals and two outpatient centres were included and retrospectively analysed. Rates for short- and long-term remission and response were analysed with the help of clinical (Harvey–Bradshaw Index [HBI]) and biochemical (C-reactive protein [CRP], faecal calprotectin [fCal]) parameters for disease activity. Results Data from 180 patients were evaluated. One hundred six patients had a follow-up of at least 8 weeks and were included. 96.2% of the patients were pre-exposed to anti- TNFα agents and 34.4% to both anti-TNFα and anti-integrin. The median follow-up was 49.1 weeks (95% CI 42.03–56.25). At week 8, 51 patients (54.8%) showed response to UST, and 24 (24.7%) were in remission. At week 48, 39 (41.9%) responded to UST, and 20 patients (21.5%) were in remission. Steroid-free response and remission at week eight were achieved by 30.1%, and 19.3% of patients. At week 48, 26.9% showed steroid-free response to UST, and 15.1% of the initial patient population was in steroid-free remission. Clinical response at week 16 was independently associated with remission at week 48. Conclusion Our study confirms short- and long-term UST effectiveness and tolerability in a cohort of multi-treatment exposed patients.

Imatinib Long Term Effects (ILTE) Study: An Independent, International Study in CML Patients.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1099-1099
Author(s):  
Carlo Gambacorti-Passerini ◽  
Dong-Wook Kim ◽  
François-Xavier Mahon ◽  
Giuseppe Saglio ◽  
Fabrizio Pane ◽  
...  
Keyword(s):  
Adverse Events ◽  
International Study ◽  
Imatinib Treatment ◽  
Long Term Effects ◽  
First Line ◽  
Eligibility Criteria ◽  
Serious Adverse Events ◽  
Second Cancers

Abstract Imatinib is an effective first line therapy for chronic myeloid leukemia (CML) and has substantially changed its biological and clinical behavior. Durable complete cytogenetic responses (CCyR) were reported in the majority of patients, with a rather benign side effect profile, despite the ‘off target’ inhibition of several other kinases, including Kit, PDGFR and Lck. Since available information is largely based on industry-sponsored trials and long-term field studies are lacking, the ILTE study was conceived as an industryindependent, academic, multicenter trial supported by the Italian Drug Safety Agency (AIFA). ILTE is an international study on a retrospective cohort and includes 31 centers in Europe, North/South America, Africa and Asia; therefore it is uniquely positioned to present a global picture of imatinib long-term effects. Consecutive patients with Ph+ CML who started imatinib between 01 September 1999 and 31 December 2004 were eligible if they were in Complete Cytogenetic Response (CCyR) after two years of imatinib treatment. Study endpoints were survival, serious adverse events (SAE, including second cancers), toxicities not qualifying as SAE (NSAE) but judged by the referring physician as substantially impacting quality of life, loss of CCyR, and development of PCR negativity. A total of 957 patients were enrolled, 92% of which met eligibility criteria. The median age of eligible patients was 50 (range 15–92) years; 59% of patients were males and the median follow-up was 3.1 years (excluding the first 2 years of treatment). As of Dec. 31 2007, 2564 person years were available for analysis. Eleven deaths were observed (only 3 of them caused by relapsed CML), with a standardized rate of 0.4/100 person years and an observed/expected ratio of 0.48 (95% CI = 0.24–0.85). One-hundred SAE were recorded (rate 3.9/100 person years, most frequent type “heart failure”), with 21% being considered related to imatinib. Second cancers were documented in 28 patients (rate 1.1/100 person years), with an observed/expected ratio of 1.27 (95% CI = 0.84–1.84). Among the 576 NSAE recorded (0.65/patient) the most frequent types were “edema, cramps, skin fragility, diarrhea”; 71% of them were related to imatinib. A total of 12 patients (1.4 %) discontinued imatinib because of toxicities during the period of observation. Thirty-four patients lost CCyR, corresponding to a rate of 1.4/100 person years (1.0 in patients with imatinib as first-line treatment, 1.5 in patients who were treated with imatinib >6 months after diagnosis), with stable or increasing rates over time. Finally, 214 patients (24.5%) developed durable (> 1 year) PCR negativity. In conclusion, the first report from ILTE shows that CML patients on imatinib die unfrequently of CML related causes, do not appear to have substantially higher second cancer rates than the general population, have mortality rates lower than expected in an age/sex matched population and do not show new types of imatinib-related adverse events. They also experience a low but steady rate of loss of CCyR and develop PCR negativity in approximately ¼ of cases. Follow-up and further analysis are ongoing. (Presented on behalf of the ILTE Investigators group)

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