Real-world experience with ospemifene after 3, 6 and 12 months' follow-up: a Spanish cohort of 100 postmenopausal women with VVA

593 Background: Aromatase Inhibitors (AIs) have replaced tamoxifen as first-line therapy for postmenopausal women with metastatic, ER+ breast cancer (BC). However, little information is available on the real-world use of AIs. The objectives of this retrospective claims study were to compare demographic, clinical and treatment characteristics of postmenopausal women with metastatic ER+/HER2- BC treated with AIs and experiencing 0, 1, 2 or ≥ 3 AI failures (AIF). Methods: Women ≥ 55 years old, newly diagnosed with metastatic BC (index) were identified in the 2006-2010 Thomson Reuters MarketScan databases and followed until chemotherapy or 03/31/2011. ER+/HER2- disease was defined as any endocrine therapy (ET: tamoxifen, fulvestrant) or AI (anastrozole, letrozole, or exemestane) use and no trastuzumab or lapatinib use in the 6-month pre-or variable post-index periods. Those with any post-index AI use were retained for study. AIF post-index was defined as a switch to an alternative AI, ET or chemotherapy, or AI discontinuation with no further BC treatment. Patients were stratified by number of post-index AIF: 0, 1, 2 or ≥ 3. Results: Among 4,274 patients identified, 61% had ≥ 1 AIF (1: 80%, 2: 15%, ≥3: 5%). There was no difference in pre-index AI use across AIF cohorts: 0, 1, 2, and ≥3 (54%, 52%, 48%, 56%; p=0.073). AIFs increased with Medicare-eligibility (51%, 56%, 60%, 61%) and bone metastases at index (48%, 53%, 62%, 63%). Among those with ≥1 AIF, median follow-up (FU) increased with each failure but there was no notable pattern to reason for FU end. Median FU of the 0 AIF cohort (408 days) fell between those of the 1 and 2 AIF cohorts, 335 and 517 days. Anastrozole was the most common first line treatment for all cohorts except ≥ 3 AIFs where letrozole was most common. Pre-index and first line fulvestrant use both increased with the number of post-index AIFs: 0.3%, 1.9%, 2.0%, 5.0% and 0.7%, 2.5%, 4.0%, 14.9% respectively. There was no association between number of AIFs and chemotherapy use (36%, 29%, 38%). Conclusions: Over 60% of women with ER+/HER2- metastatic BC treated with AIs failed at least 1 and 20% of those failed ≥ 2. Surprisingly, increased rates of prior fulvestrant treatment appear associated with increasing numbers of AIF.

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P1213 Endothelial-dependent vasodilatation and the incidence of atrial fibrillation in hypertensive postmenopausal women. A long-term follow-up study

European Heart Journal ◽

10.1016/s0195-668x(03)94505-2 ◽

2003 ◽

Vol 24 (5) ◽

pp. 228

Author(s):

R ROSSI

Keyword(s):

Atrial Fibrillation ◽

Postmenopausal Women ◽

Follow Up Study ◽

Long Term Follow Up

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928-P: Dulaglutide Has Higher Adherence and Persistence than Semaglutide and Exenatide QW: 6-Month Follow-Up from U.S. Real-World Data

Diabetes ◽

10.2337/db20-928-p ◽

2020 ◽

Vol 69 (Supplement 1) ◽

pp. 928-P

Author(s):

REEMA MODY ◽

MARIA YU ◽

BAL K. NEPAL ◽

MANIGE KONIG ◽

MICHAEL GRABNER

Keyword(s):

Real World ◽

Real World Data ◽

World Data ◽

Exenatide Qw

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Prior real-world experience influences non-linguistic statistical learning

10.31234/osf.io/yscn8 ◽

2020 ◽

Author(s):

Stephen Charles Van Hedger ◽

Ingrid Johnsrude ◽

Laura Batterink

Keyword(s):

Statistical Learning ◽

Real World ◽

Language Experience ◽

Pitch Range ◽

Test Items ◽

Instrument Measuring ◽

Statistical Regularities ◽

Context Free ◽

Specific Learning

Listeners are adept at extracting regularities from the environment, a process known as statistical learning (SL). SL has been generally assumed to be a form of “context-free” learning that occurs independently of prior knowledge, and SL experiments typically involve exposing participants to presumed novel regularities, such as repeating nonsense words. However, recent work has called this assumption into question, demonstrating that learners’ previous language experience can considerably influence SL performance. In the present experiment, we tested whether previous knowledge also shapes SL in a non-linguistic domain, using a paradigm that involves extracting regularities over tone sequences. Participants learned novel tone sequences, which consisted of pitch intervals not typically found in Western music. For one group of participants, the tone sequences used artificial, computerized instrument sounds. For the other group, the same tone sequences used familiar instrument sounds (piano or violin). Knowledge of the statistical regularities was assessed using both trained sounds (measuring specific learning) and sounds that differed in pitch range and/or instrument (measuring transfer learning). In a follow-up experiment, two additional testing sessions were administered to gauge retention of learning (one day and approximately one-week post-training). Compared to artificial instruments, training on sequences played by familiar instruments resulted in reduced correlations among test items, reflecting more idiosyncratic performance. Across all three testing sessions, learning of novel regularities presented with familiar instruments was worse compared to unfamiliar instruments, suggesting that prior exposure to music produced by familiar instruments interfered with new sequence learning. Overall, these results demonstrate that real-world experience influences SL in a non-linguistic domain, supporting the view that SL involves the continuous updating of existing representations, rather than the establishment of entirely novel ones.

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Effectiveness of Dulaglutide in the Real World and in Special Populations of Type 2 Diabetic Patients

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/clinem/dgaa204 ◽

2020 ◽

Vol 105 (7) ◽

pp. e2617-e2625 ◽

Cited By ~ 1

Author(s):

Mario Luca Morieri ◽

Vera Frison ◽

Mauro Rigato ◽

Michele D’Ambrosio ◽

Federica Tadiotto ◽

...

Keyword(s):

Body Weight ◽

Real World ◽

Disease Duration ◽

Diabetic Patients ◽

Type 2 Diabetic Patients ◽

Body Weight Reduction ◽

Background Population ◽

Glucagon Like Peptide 1

Abstract Context In randomized controlled trials (RCTs) on type 2 diabetes (T2D) patients, the glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-RA) dulaglutide reduced HbA1c and body weight, but generalizability of such findings to real-world T2D patients is challenging. Objective We evaluated effectiveness of dulaglutide in routine clinical practice, especially in subgroups of patient that are underrepresented in RCTs. Design Retrospective multicenter study. Setting Diabetes outpatient clinics. Patients and intervention All consecutive patients who initiated dulaglutide between 2015 and 2018. Main outcome measures Changes in HbA1c and body weight were assessed up to 30 months after baseline. Effectiveness was analyzed in patient subgroups according to: prior use of GLP-1RA, persistence on treatment and dose, age, sex, disease duration, renal function, obesity, cardiovascular disease, or concomitant use of insulin or sulphonylurea. Results From a background population of 83,116 patients, 2084 initiated dulaglutide (15.3% switching from another GLP-1RA), 1307 of whom had at least 1 follow-up visit. Overall, dulaglutide reduced HbA1c by 1.0% and body weight by 2.9 kg at the end of observation. These effects were more pronounced in GLP-1RA-naïve patients and in those with shorter disease duration. Improvement in HbA1c was highly significant and consistent across all subgroups, including those aged ≥ 75 years, nonobese, or with chronic kidney disease. Body weight declined in all subgroups and significantly more with the 1.5-mg versus 0.75-mg dose. Conclusions In real-world T2D patients, effectiveness of dulaglutide on HbA1c and body weight reduction was highly consistent and significant even in subgroups of patients poorly represented in RCTs.

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Real-World Outcomes of Ivacaftor Treatment in People with Cystic Fibrosis: A Systematic Review

Journal of Clinical Medicine ◽

10.3390/jcm10071527 ◽

2021 ◽

Vol 10 (7) ◽

pp. 1527

Author(s):

Jamie Duckers ◽

Beth Lesher ◽

Teja Thorat ◽

Eleanor Lucas ◽

Lisa J. McGarry ◽

...

Keyword(s):

Systematic Review ◽

Cystic Fibrosis ◽

Real World ◽

Safety Profile ◽

Clinical Trial Data ◽

Patient Characteristics ◽

Healthcare Resource Utilization ◽

Patient Reported ◽

Clinical Benefits

Cystic fibrosis (CF) is a rare, progressive, multi-organ genetic disease. Ivacaftor, a small-molecule CF transmembrane conductance regulator modulator, was the first medication to treat the underlying cause of CF. Since its approval, real-world clinical experience on the use of ivacaftor has been documented in large registries and smaller studies. Here, we systematically review data from real-world observational studies of ivacaftor treatment in people with CF (pwCF). Searches of MEDLINE and Embase identified 368 publications reporting real-world studies that enrolled six or more pwCF treated with ivacaftor published between January 2012 and September 2019. Overall, 75 publications providing data from 57 unique studies met inclusion criteria and were reviewed. Studies reporting within-group change for pwCF treated with ivacaftor consistently showed improvements in lung function, nutritional parameters, and patient-reported respiratory and sino-nasal symptoms. Benefits were evident as early as 1 month following ivacaftor initiation and were sustained over long-term follow-up. Decreases in pulmonary exacerbations, Pseudomonas aeruginosa prevalence, and healthcare resource utilization also were reported for up to 66 months following ivacaftor initiation. In studies comparing ivacaftor treatment to modulator untreated comparator groups, clinical benefits similarly were reported as were decreases in mortality, organ-transplantation, and CF-related complications. The safety profile of ivacaftor observed in these real-world studies was consistent with the well-established safety profile based on clinical trial data. Our systematic review of real-world studies shows ivacaftor treatment in pwCF results in highly consistent and sustained clinical benefit in both pulmonary and non-pulmonary outcomes across various geographies, study designs, patient characteristics, and follow-up durations, confirming and expanding upon evidence from clinical trials.

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Real-World Experience with Bezlotoxumab for Prevention of Recurrence of Clostridioides difficile Infection

Journal of Clinical Medicine ◽

10.3390/jcm10010002 ◽

2020 ◽

Vol 10 (1) ◽

pp. 2

Author(s):

Rosa Escudero-Sánchez ◽

María Ruíz-Ruizgómez ◽

Jorge Fernández-Fradejas ◽

Sergio García Fernández ◽

María Olmedo Samperio ◽

...

Keyword(s):

Clinical Trials ◽

Real World ◽

Recurrence Rates ◽

Factors Associated ◽

Clostridioides Difficile ◽

Multicentre Cohort Study ◽

Clostridioides Difficile Infection ◽

Prevention Of Recurrence ◽

Multicentre Cohort

Bezlotoxumab is marketed for the prevention of recurrent Clostridioides difficile infection (rCDI). Its high cost could be determining its prescription to a different population than that represented in clinical trials. The objective of the study was to verify the effectiveness and safety of bezlotoxumab in preventing rCDI and to investigate factors related to bezlotoxumab failure in the real world. A retrospective, multicentre cohort study of patients treated with bezlotoxumab in Spain was conducted. We compared the characteristics of cohort patients with those of patients treated with bezlotoxumab in the pivotal MODIFY trials. We assessed recurrence rates 12 weeks after completion of treatment against C. difficile, and we analysed the factors associated with bezlotoxumab failure. Ninety-one patients were included in the study. The cohort presented with more risk factors for rCDI than the patients included in the MODIFY trials. Thirteen (14.2%) developed rCDI at 12 weeks of follow-up, and rCDI rates were numerically higher in patients with two or more previous episodes (25%) than in those who had fewer than two previous episodes of C. difficile infection (CDI) (10.4%); p = 0.09. There were no adverse effects attributable to bezlotoxumab. Despite being used in a more compromised population than that represented in clinical trials, we confirm the effectiveness of bezlotoxumab for the prevention of rCDI.

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Moderate Consumption of Beer (with and without Ethanol) and Menopausal Symptoms: Results from a Parallel Clinical Trial in Postmenopausal Women

Nutrients ◽

10.3390/nu13072278 ◽

2021 ◽

Vol 13 (7) ◽

pp. 2278

Author(s):

Marta Trius-Soler ◽

María Marhuenda-Muñoz ◽

Emily P. Laveriano-Santos ◽

Miriam Martínez-Huélamo ◽

Gemma Sasot ◽

...

Keyword(s):

Postmenopausal Women ◽

Study Groups ◽

Menopausal Symptoms ◽

Control Group ◽

P Value ◽

Intervention Trial ◽

Hormone Profile ◽

Perimenopausal Symptoms ◽

Main Food Source

The menopausal transition can be a challenging period for women’s health and a trigger of uncomfortable symptoms. Beer is the main food source of isoxanthohumol, a precursor of 8-prenylnaringenin, the strongest phytoestrogen identified to date. As phytoestrogens are reported to reduce perimenopausal symptoms, we evaluated if a daily moderate consumption of beer with (AB) and without alcohol (NAB) could improve menopausal symptoms and modify cardiovascular risk factors. A total of 37 postmenopausal women were enrolled in a parallel controlled intervention trial and assigned to three study groups: 16 were administered AB (330 mL/day), 7 NAB (660 mL/day), and 14 were in the control group. After a 6-month follow-up of the 34 participants who finished the trial, both interventions (AB and NAB) significantly reduced the severity of the menopause-related symptoms (p-value AB vs. Control: 0.009; p-value NAB vs. Control: 0.033). Moreover, AB had a beneficial net effect on psychological menopausal discomforts compared to the control group. As the sex hormone profile did not differ significantly between the study groups, the effects of both types of beers (AB and NAB) are attributed to the non-alcoholic fraction of beer. Furthermore, moderate NAB consumption improved the lipid profile and decreased blood pressure in postmenopausal women.

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Is the use of two versus one long-acting bronchodilator by patients with COPD associated with a higher risk of acute coronary syndrome in real-world clinical practice?

BMJ Open Respiratory Research ◽

10.1136/bmjresp-2020-000840 ◽

2021 ◽

Vol 8 (1) ◽

pp. e000840

Author(s):

Lianne Parkin ◽

Sheila Williams ◽

David Barson ◽

Katrina Sharples ◽

Simon Horsburgh ◽

...

Keyword(s):

Acute Coronary Syndrome ◽

Clinical Practice ◽

Real World ◽

Chronic Obstructive ◽

Treatment Intensification ◽

Cardiovascular Comorbidity ◽

Coronary Syndrome ◽

Long Acting ◽

The Impact

BackgroundCardiovascular comorbidity is common among patients with chronic obstructive pulmonary disease (COPD) and there is concern that long-acting bronchodilators (long-acting muscarinic antagonists (LAMAs) and long-acting beta2 agonists (LABAs)) may further increase the risk of acute coronary events. Information about the impact of treatment intensification on acute coronary syndrome (ACS) risk in real-world settings is limited. We undertook a nationwide nested case–control study to estimate the risk of ACS in users of both a LAMA and a LABA relative to users of a LAMA.MethodsWe used routinely collected national health and pharmaceutical dispensing data to establish a cohort of patients aged >45 years who initiated long-acting bronchodilator therapy for COPD between 1 February 2006 and 30 December 2013. Fatal and non-fatal ACS events during follow-up were identified using hospital discharge and mortality records. For each case we used risk set sampling to randomly select up to 10 controls, matched by date of birth, sex, date of cohort entry (first LAMA and/or LABA dispensing), and COPD severity.ResultsFrom the cohort (n=83 417), we identified 5399 ACS cases during 281 292 person-years of follow-up. Compared with current use of LAMA therapy, current use of LAMA and LABA dual therapy was associated with a higher risk of ACS (OR 1.28 (95% CI 1.13 to 1.44)). The OR in an analysis restricted to fatal cases was 1.46 (95% CI 1.12 to 1.91).ConclusionIn real-world clinical practice, use of two versus one long-acting bronchodilator by people with COPD is associated with a higher risk of ACS.

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Translating Virtual Reality Cue Exposure Therapy for Binge Eating into a Real-World Setting: An Uncontrolled Pilot Study

Journal of Clinical Medicine ◽

10.3390/jcm10071511 ◽

2021 ◽

Vol 10 (7) ◽

pp. 1511

Author(s):

Katherine Nameth ◽

Theresa Brown ◽

Kim Bullock ◽

Sarah Adler ◽

Giuseppe Riva ◽

...

Keyword(s):

Virtual Reality ◽

Eating Disorder ◽

Binge Eating ◽

Real World ◽

Exposure Therapy ◽

Post Treatment ◽

Cue Exposure ◽

Treatment Gains ◽

Intent To Treat

Binge-eating disorder (BED) and bulimia nervosa (BN) have adverse psychological and medical consequences. Innovative interventions, like the integration of virtual reality (VR) with cue-exposure therapy (VR-CET), enhance outcomes for refractory patients compared to cognitive behavior therapy (CBT). Little is known about the feasibility and acceptability of translating VR-CET into real-world settings. To investigate this question, adults previously treated for BED or BN with at least one objective or subjective binge episode/week were recruited from an outpatient university eating disorder clinic to receive up to eight weekly one-hour VR-CET sessions. Eleven of 16 (68.8%) eligible patients were enrolled; nine (82%) completed treatment; and 82% (9/11) provided follow-up data 7.1 (SD = 2.12) months post-treatment. Overall, participant and therapist acceptability of VR-CET was high. Intent-to-treat objective binge episodes (OBEs) decreased significantly from 3.3 to 0.9/week (p < 0.001). Post-treatment OBE 7-day abstinence rate for completers was 56%, with 22% abstinent for 28 days at follow-up. Among participants purging at baseline, episodes decreased from a mean of one to zero/week, with 100% abstinence maintained at follow-up. The adoption of VR-CET into real-world clinic settings appears feasible and acceptable, with a preliminary signal of effectiveness. Findings, including some loss of treatment gains during follow-up may inform future treatment development.

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