Abstract 015: Importance of Balanced Follow-up Time and Other Study Design Considerations When Evaluating Adherence Using Two Novel Oral Anticoagulants

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Craig Coleman ◽  
Zhong Yuan ◽  
Jeffrey Schein ◽  
Concetta Crivera ◽  
Veronica Ashton ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Real World ◽  
Oral Anticoagulant Therapy ◽  
Oral Anticoagulants ◽  
Real World Data ◽  
Adherence Measure ◽  
Adherence Measurement ◽  
Minimum Number ◽  
The Impact

Background: Medication adherence rates decline over time, especially after the first dispensing. Comparing adherence rates for medications that have been on the market for differing period of time may distort real differences in medication adherence. Other analysis factors such as minimum number of dispensing criteria and Pharmacy Quality Alliance (PQA) adherence measures can also affect adherence measurement. Objectives: To use one real world example (rivaroxaban vs apixaban) in non-valvular atrial fibrillation (NVAF) patients to quantify the impact of adjusting for imbalances in follow-up periods, minimum number of dispensing, and use of the PQA adherence measure. Methods: Using IMS Health Real-World Data Adjudicated Claims and Truven MarketScan claims databases, we included adult patients with ≥1 rivaroxaban or apixaban dispensing (index date), ≥1 year of pre-index eligibility, ≥1 AF diagnosis pre-index, newly initiated on oral anticoagulant therapy, and no valvular involvement. Adherence was evaluated using proportion of days covered (PDC) ≥0.8 for cohorts with (1) unbalanced follow-up (2) balanced follow-up (by matching on month and year of follow-up since fill-date) (3) ≥2 rivaroxaban or apixaban dispensings and a balanced follow-up, and using (4) the PQA adherence measure. Results: Rivaroxaban users had significantly longer mean (SD) follow-up than apixaban (408 [300] versus 254 [196] days, respectively). While apixaban users appeared to be more adherent in unadjusted analyses, this finding was reversed after 1) adjusting for unbalanced follow-up 2) excluding single-time users; and 3) applying the PQA-endorsed adherence measure (Figure). Similar results were found using the Truven databases. Conclusion: Comparisons of the adherence rates among medications need to account for the period of time each have been on the market, number of dispensing and PQA measures. Retrospective analyses of adherence that do not adjust for such differences could produce spurious findings.

scholarly journals Management and outcomes of real-world use of non-vitamin-K oral anticoagulants (NOACs) in patients with atrial fibrillation: experience of a dedicated NOAC clinic

2019 ◽  
Vol 27 (12) ◽  
pp. 605-612 ◽  
Author(s):  
A. J. W. M. de Veer ◽  
N. Bennaghmouch ◽  
M. C. E. F. Wijffels ◽  
J. M. ten Berg
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Drug Reactions ◽  
Vitamin K ◽  
Real World ◽  
Oral Anticoagulants ◽  
Daily Practice ◽  
Drug Reactions ◽  
Real World Data ◽  
First Choice

Abstract Background Current guidelines recommend non-vitamin‑K oral anticoagulants (NOACs) as the first-choice therapy for stroke prevention in patients with atrial fibrillation (AF). The use of drugs in a clinical trial setting differs from that in real-world populations. Real-world data are important to accrue more heterogeneous patient populations with respect to co-morbidities and co-medication use. The aim of this study was to evaluate the use of NOACs in daily practice in a large tertiary hospital in the Netherlands. Methods A single-centre prospective study was conducted among all patients with AF using a NOAC in the St. Antonius Hospital between 2013 and June 2017. The outcomes were the rates of any bleeding, stroke/transient ischaemic attack, mortality, discontinuation rate and adverse drug reactions. Results In total, 799 patients were enrolled with a mean follow-up of 1.7 years. Mean age was 69.8 (SD ± 11) and 61.2% were male. Mean CHA2DS2-VASc score was 2.8 (SD ± 1.6) and mean HAS-BLED score was 1.4 (SD ± 0.9). Bleeding occurred in 6.0, major bleeding in 1.8, stroke in 1.2 patients per 100 patient-years, and 87 patients (10.9%) died during the follow-up period. Adverse drug reactions were reported by 59 patients (7.4%). Finally, 249 patients (31.2%) reported a temporary interruption and 132 (16.5%) permanent discontinuation of NOAC treatment, of whom 33 (25%) patients switched to a vitamin‑K antagonist. Conclusions We observed low rates of bleeding and adverse drug reactions. However, rates of mortality and discontinuation were relatively high. These results could possibly be explained by the real-world nature of the data including higher-risk patients.

Evaluation of PSA progression after initiation of enzalutamide or abiraterone: Real-world data on metastatic castration-resistant prostate cancer (mCRPC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5024-5024
Author(s):  
Fernando López-Campos ◽  
David Lorente ◽  
Casilda Llacer Perez ◽  
Miguel Ramirez-Backhaus ◽  
Paula Peleteiro ◽  
...  
Keyword(s):  
Real World ◽  
Cox Regression ◽  
Castration Resistant Prostate Cancer ◽  
Real World Data ◽  
Castration Resistant ◽  
Real World Setting ◽  
Psa Progression ◽  
Definition Of ◽  
The Impact

5024 Background: PSA value is widely used for the monitoring of treatment outcome in mCRPC in the clinical real-world setting. Early PSA changes are not considered in the definition of PSAProg due to the potential for spurious “flare” reactions. We aimed to evaluate the significance of an early PSA increase in mCRPC patients (pts) treated with enzalutamide or abiraterone (Enz/Abi). Methods: We retrospectively evaluated Enz/Abi-treated mCRPC pts from 11 hospitals between 2011-2020. Early PSAProg was defined as a 25% increase in PSA from baseline at 4 (PSAProg4) or 8 (PSAProg8) weeks after treatment initiation. PSA progression at 12 weeks (PSAProg12) was confirmed by a second reading. Uni- and multivariable (MV) Cox regression models were conducted to explore the association of PSAProg and overall survival (OS) in chemotherapy naïve patients treated with Abi or Enz. Interaction tests were conducted to explore differences in the impact of PSA progression on OS in Abi or Enz-treated pts. Results: We analyzed 511 chemotherapy-naïve mCRPC pts treated with Abi (N=391; 76.5%) or Enz (N=120; 23.5%). Median follow-up: 30.2 months. OS was longer in Enz-treated pts (38.1 vs 29m; HR 1.4; p=0.027). 59 (15.1%), 70 (17.9%) and 48 (12.3%) of Abi-treated and 9 (7.5%), 11 (9.2%) and 10 (8.3%) of Enz-treated pts experienced PSAProg4, PSAProg8 and PSAProg12, respectively, although differences were not statistically significant. PSAProg was associated with worse OS at all 3 timepoints only in Abi-treated pts. In Enz-treated pts, PSAProg4 had a large impact on OS, not observed in PSAProg8 or PSAProg12. We observed no significant interaction between agent (Enz/Abi) and PSA progression (Table). Conclusions: PSA progression at 4 weeks after Enz/Abi is significantly associated with shorter OS and may help identify pts not benefitting from Abi/Enz before clinical or radiographic progression. PSA pattern progression and its association with OS might differ depending on the drug used (Enz/Abi). Prospective validation studies are needed.[Table: see text]

scholarly journals Sofosbuvir-based therapies achieved satisfactory virological response in Chinese with genotypes 3 and 6 infection: a real-world experience from a centre

2020 ◽  
Author(s):  
Qiao Tang ◽  
Li Wei ◽  
Xiaoqing Liu ◽  
Peng Hu
Keyword(s):  
Sustained Virological Response ◽  
Real World ◽  
Virological Response ◽  
Genotype 3 ◽  
Svr12 Rate ◽  
Real World Data ◽  
Cirrhotic Patients ◽  
The Impact ◽  
High Sustained Virological Response

Abstract BackgroundAs previously shown by others, sofosbuvir-based regimens yield high sustained virological response rates in patients with HCV infection except for genotype 3b complicating with cirrhosis. The real-world study aims to explore efficacy and safety of sofosbuvir-based regimens in genotypes 3 and 6 infected patients, especially the impact of ribavirin co-administration on sustained virological response in cirrhotic patients with genotype 3b infection. MethodsA retrospective cohort study included 173 patients initiated on sofosbuvir-based regimens. Main endpoint of treatment was sustained virological response at post-treatment week 12 (SVR12).Results92 patients with sufficient follow-up were included. Overall, SVR12 rate was 96.7% (89/92), including 62 patients treated with addition of ribavirin to sofosbuvir-based regimens, given superior SVR12 rate (98.4%) than ribavirin free regimens (93.3%). SVR12 rates were 96.3% and 96.7% in patients infected with genotype3 (54) and genotype 6 (38) Among patients with genotype 3b infection, SVR12 was achieved in 97.1%, and 100% when complicating with cirrhosis. SVR12 rate was achieved in 96.6% among patients with cirrhosis (28/29), 100% with ribavirin co-administration regimens and 87.5% without ribavirin. Totally, three patients failed to achieve SVR12, including 2 non-cirrhotic patients with genotype 3b and 6a infection treated with sofosbuvir+ribavirin and sofosbuvir/velpatasvir regimen, one cirrhotic patient with genotype 3k infection treated with SOF/VEL regimen. No sever adverse events occurred.ConclusionsReal-world data show that sofosbuvir-based regimens are highly effective and safe for patients with HCV genotypes 3 and 6 infection. Addition of ribavirin to sofosbuvir-based regimens may improve efficacy, especially in patients with genotype 3 infection and cirrhosis.Trial registrationNot applicable.

Safety and efficacy of direct acting oral anticoagulants and vitamin K antagonists in nonvalvular atrial fibrillation – a network meta-analysis of real-world data

VASA ◽  
2019 ◽  
Vol 48 (2) ◽  
pp. 134-147 ◽  
Author(s):  
Mirko Hirschl ◽  
Michael Kundi
Keyword(s):  
Real World ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Nonvalvular Atrial Fibrillation ◽  
Real World Data ◽  
Hazard Ratios ◽  
Direct Acting ◽  
Event Rates

Abstract. Background: In randomized controlled trials (RCTs) direct acting oral anticoagulants (DOACs) showed a superior risk-benefit profile in comparison to vitamin K antagonists (VKAs) for patients with nonvalvular atrial fibrillation. Patients enrolled in such studies do not necessarily reflect the whole target population treated in real-world practice. Materials and methods: By a systematic literature search, 88 studies including 3,351,628 patients providing over 2.9 million patient-years of follow-up were identified. Hazard ratios and event-rates for the main efficacy and safety outcomes were extracted and the results for DOACs and VKAs combined by network meta-analysis. In addition, meta-regression was performed to identify factors responsible for heterogeneity across studies. Results: For stroke and systemic embolism as well as for major bleeding and intracranial bleeding real-world studies gave virtually the same result as RCTs with higher efficacy and lower major bleeding risk (for dabigatran and apixaban) and lower risk of intracranial bleeding (all DOACs) compared to VKAs. Results for gastrointestinal bleeding were consistently better for DOACs and hazard ratios of myocardial infarction were significantly lower in real-world for dabigatran and apixaban compared to RCTs. By a ranking analysis we found that apixaban is the safest anticoagulant drug, while rivaroxaban closely followed by dabigatran are the most efficacious. Risk of bias and heterogeneity was assessed and had little impact on the overall results. Analysis of effect modification could guide the clinical decision as no single DOAC was superior/inferior to the others under all conditions. Conclusions: DOACs were at least as efficacious as VKAs. In terms of safety endpoints, DOACs performed better under real-world conditions than in RCTs. The current real-world data showed that differences in efficacy and safety, despite generally low event rates, exist between DOACs. Knowledge about these differences in performance can contribute to a more personalized medicine.

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

Diabetes ◽  
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

scholarly journals 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?

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.

scholarly journals NCDB Analysis of Melanoma 2004–2015: Epidemiology and Outcomes by Subtype, Sociodemographic Factors Impacting Clinical Presentation, and Real-World Survival Benefit of Immunotherapy Approval

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1455
Author(s):  
Sunny R. K. Singh ◽  
Sindhu J. Malapati ◽  
Rohit Kumar ◽  
Christopher Willner ◽  
Ding Wang
Keyword(s):  
Metastatic Melanoma ◽  
Metastatic Disease ◽  
Real World ◽  
Care Delivery ◽  
Sociodemographic Factors ◽  
P Value ◽  
Real World Data ◽  
Factors Associated ◽  
Improvement In Survival ◽  
The Impact

Background: The incidence of invasive melanoma is rising, and approval for the first immune checkpoint inhibitor (ICI) to treat metastatic melanoma occurred in 2011. We aim to describe the epidemiology and outcomes in recent years, sociodemographic factors associated with the presence of metastasis at diagnosis, and the real‐world impact of ICI approval on survival based on melanoma subtype and race. Methods: This is a retrospective analysis of the National Cancer Database (NCDB) from the years 2004–2015. The primary outcome was the overall survival of metastatic melanoma by subtype. Secondary outcomes included sociodemographic factors associated with the presence of metastasis at diagnosis and the impact of treatment facility type and ICI approval on the survival of metastatic melanoma. Results: Of the 419,773 invasive melanoma cases, 93.80% were cutaneous, and 4.92% were metastatic at presentation. The odds of presenting with metastatic disease were higher in African Americans (AA) compared to Caucasians (OR 2.37; 95% CI 2.11–2.66, p < 0.001). Treatment of metastatic melanoma at an academic/research facility was associated with lower mortality versus community cancer programs (OR 0.75, 95 % CI 0.69–0.81, p-value<0.001). Improvement in survival of metastatic melanoma was noted for Caucasians after the introduction of ICI (adjusted HR 0.80, 95% CI 0.78–0.83, p < 0.001); however, this was not statistically significant for AA (adjusted HR 0.80, 95% CI 0.62–1.02, p‐value = 0.073) or ocular cases (HR 1.03, 95% CI 0.81–1.31, p‐value 0.797). Conclusion: Real‐world data suggest a 20% improvement in survival of metastatic melanoma since the introduction of ICI. The disproportionately high odds of metastatic disease at presentation in AA patients with melanoma suggest the need for a better understanding of the disease and improvement in care delivery.

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