Mtor inhibitors associated with higher cardiovascular adverse events—A large population database analysis

2021 ◽  
Author(s):  
Vi N. Nguyen ◽  
Ruben Abagyan ◽  
Shirley M. Tsunoda
Keyword(s):  
Adverse Events ◽  
Large Population ◽  
Mtor Inhibitors ◽  
Database Analysis ◽  
Population Database

scholarly journals POS0675 THE COMPARATIVE 3-YEAR RETENTION RATE OF TARGETED-SYNTHETIC AND BIOLOGIC DRUGS FOR RHEUMATOID ARTHRITIS: REAL-LIFE DATA FROM THE ITALIAN GISEA REGISTRY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 582.1-582
Author(s):  
E. G. Favalli ◽  
F. Iannone ◽  
E. Gremese ◽  
R. Gorla ◽  
R. Foti ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Retention Rate ◽  
Large Population ◽  
Real Life ◽  
Mechanisms Of Action ◽  
Biologic Drugs ◽  
Real Life Setting ◽  
Study Population ◽  
Targeted Drug

Background:Long-term observational data on the real-life use of JAK inhibitors (JAKis) for rheumatoid arthritis (RA) and their comparison with biological drugs are still very limited. Large population-based registries have been increasingly used to investigate the performance of targeted drugs in a real-life setting.Objectives:The aim of this study is to evaluate and compare the 3-year retention rate of JAKis, TNF inhibitors (TNFis) and biologic drugs with other mechanisms of action (OMAs) in the large cohort of RA patients included in the Italian national GISEA registry.Methods:Data of all RA patients treated with targeted synthetic or biologic drugs were prospectively collected in the Italian multicentric GISEA registry. The analysis was limited to patients who started a first- or second-line targeted drug in the period after the first JAKi was marketed in Italy (1st December 2017). The 3-year retention rate was calculated by the Kaplan-Meier method and compared between different drug classes by a log-rank test. A descriptive analysis of reasons for discontinuation was performed.Results:The study population included 1027 RA patients (79.8% females, mean age [±SD] 56.9 [±13.5] years, mean disease duration 9.8 [±9] years, mean baseline SDAI 17.5 [±11.9], ACPA positive 67.4%, RF positive 62.7%) who received JAKis (baricitinib or tofacitinib, n=297), TNFis (n=365), or OMAs (n=365) as first or second targeted drug. Main baseline characteristics of study population were overall well balanced between treatment groups. Retention rate was numerically but not statistically higher (p=0.18) in patients treated with JAKis compared with TNFis or OMAs (80.6, 78.9 and 76.4% at 1 year and 73, 56.8 and 63.8% at 3 years, respectively) (Figure 1). Drug survival was significantly higher in patients receiving concomitant methotrexate (MTX) compared with monotherapy only in TNFis (66.8 vs 47.1%, p=0.04) but not in JAKis (76.1 vs 70.1%, p=0.54) and OMAs (66.1 vs 61.9%, p=0.41) group. Therapy was discontinued in a total of 211 patients because of ineffectiveness (n=107), adverse events (n=88), or compliance/other reasons (n=16). The most frequent reason for treatment withdrawal was ineffectiveness in both JAKis (n=30 out of 56) and TNFis (n=45 out of 74) groups, whereas OMAs were discontinued more frequently because of adverse events (n=41 out of 81).Conclusion:Our data confirmed in a real-life setting a favorable 3-year retention rate of all available targeted mechanisms of action for RA therapy. As expected, concomitant MTX significantly impacted persistence on therapy of TNFis only. Discontinuations of JAKis for adverse events were infrequent overall, confirming the safety profile observed in randomized clinical trials.Figure 1.Three-year retention rate by treatment groupDisclosure of Interests:None declared

scholarly journals Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures

2021 ◽  
Author(s):  
Douglas M. Sidle ◽  
Pablo Stolovitzky ◽  
Ellen M. O'Malley ◽  
Randall A. Ow ◽  
Nathan E. Nachlas ◽  
...  
Keyword(s):  
Adverse Events ◽  
Nasal Obstruction ◽  
Large Population ◽  
Inferior Turbinate ◽  
Nasal Valve ◽  
Serious Adverse Events ◽  
Vas Scores ◽  
Nasal Implant ◽  
Nasal Valve Collapse

AbstractThe aim of the study is to report outcomes after treatment of nasal valve collapse with a bioabsorbable nasal implant. It involves two prospective, multicenter, post-market studies evaluating long-term effectiveness of the LATERA implant for severe to extreme nasal obstruction. Participants underwent implant alone or with concomitant inferior turbinate reduction (ITR) and/or septoplasty. Outcome measures included the change from baseline Nasal Obstruction Symptom Evaluation (NOSE) scores, NOSE responder rates, visual analog scale (VAS) scores, and adverse events. A total cohort of 277 participants (109 implants only, 67 implants + ITR, 101 implants + septoplasty + ITR) enrolled at 19 U.S. centers was available for analysis with 177 participants (69 implants only, 39 implants + ITR, 69 implants + septoplasty + ITR) available at 2 years. The mean changes from baseline in NOSE scores and VAS scores were statistically significant (p < 0.001) at all follow-up periods. The baseline NOSE score of 77.8 ± 13.6 was improved to 24.2 ± 23.6 at 24 months. Greater than 90% of participants were NOSE responders across all follow-up periods, 6.1% withdrew for lack of treatment effect. The baseline VAS score of 66.7 ± 18.8 was improved to 21.1 ± 23.9 at 24 months. There were no serious adverse events related to the device or implant procedure. Implant retrieval rate was 4.0% (22/543 implants). Nonserious adverse events were mild to moderate in severity, typically occurred within 6 months of implant, and resolved or were stable. Significant reductions in NOSE and VAS scores and high responder rates from our large population of patients with nasal obstruction who had nasal valve implants confirm sustained effectiveness at 24 months after treatment. The studies are registered on www.clinicaltrials.gov (NCT02952313 and NCT02964312).

scholarly journals S67 Mortality in copd patients following community acquired pneumonia: a population database analysis of linked healthcare records

Thorax ◽  
2016 ◽  
Vol 71 (Suppl 3) ◽  
pp. A40.1-A40
Author(s):  
N Williams ◽  
NA Coombs ◽  
M Johnson ◽  
L Josephs ◽  
LA Rigge ◽  
...  
Keyword(s):  
Community Acquired Pneumonia ◽  
Database Analysis ◽  
Population Database ◽  
Copd Patients

scholarly journals Effects of Age and Serum 25-OH-Vitamin D on Serum Parathyroid Hormone Levels

2012 ◽  
Vol 97 (11) ◽  
pp. 3989-3995 ◽  
Author(s):  
A. Valcour ◽  
F. Blocki ◽  
D. M. Hawkins ◽  
Sudhaker D. Rao
Keyword(s):  
Vitamin D ◽  
Calcium Absorption ◽  
Small Sample Size ◽  
International Workshop ◽  
Large Population ◽  
Small Sample ◽  
Reference Laboratory ◽  
Population Database ◽  
Age Related ◽  
Serum Pth

Context: Several studies define optimal serum 25-hydroxyvitamin D (25-OHD) levels based on serum PTH level reaching an asymptote. However, results differ widely, ranging from 25-OHD levels of 12–44 ng/ml: many studies are constrained by small sample size. Objective: The objective of the study was to determine the relationship between serum PTH and 25-OHD levels and age in a very large reference laboratory database. Design: This was a detailed cross-sectional analysis of 312,962 paired serum PTH and 25-OHD levels measured from July 2010 to June 2011. Results: Median PTH levels and the proportion of patients (PTH &gt; 65 pg/ml), from 63 successive 25-OHD frequency classes of 5000 patients, provide smooth, exceptionally well-fitted curves (R2 = 0.994 and R2 = 0.995, respectively) without discernible inflection points or asymptotes but with striking age dependencies. Serum 25-OHD was below the recent Institute of Medicine sufficiency guidance of 20 ng/ml in 27% (85,000) of the subjects. More importantly, 40 and 51% of subjects (serum 25-OHD &lt;20 and 10 ng/ml, respectively) had biochemical hyperparathyroidism (PTH &gt; 65 pg/ml). Conclusions: This analysis, despite inevitable inherent limitations, introduces several clinical implications. First, median 25-OHD-dependent PTH levels revealed no threshold above which increasing 25-OHD fails to further suppress PTH. Second, the large number of subjects with 25-OHD deficiency and hyperparathyroidism reinforces the Third International Workshop on Asymptomatic Primary Hyper parathyroidism's recommendations to test for, and replete, vitamin D depletion before considering parathyroidectomy. Third, strong age dependency of the PTH-25-OHD relationship likely reflects the composite effects of age-related decline in calcium absorption and renal function. Finally, this unselected large population database study could guide clinical management of patients based on an age-dependent, PTH-25-OHD continuum.

Platelet Indices and Risk of Death and Cardiovascular Events: Results from a Large Population-Based Cohort Study

2019 ◽  
Vol 119 (11) ◽  
pp. 1773-1784 ◽  
Author(s):  
Giuseppe Patti ◽  
Giuseppe Di Martino ◽  
Fabrizio Ricci ◽  
Giulia Renda ◽  
Sabina Gallina ◽  
...  
Keyword(s):  
Platelet Count ◽  
Ischemic Stroke ◽  
Adverse Events ◽  
Large Population ◽  
Previous History ◽  
Population Based ◽  
Platelet Indices ◽  
Risk Of Death ◽  
Previous Stroke ◽  
History Of

AbstractStudies evaluating the relationship between platelet indices and cardiovascular (CV) outcomes yielded conflicting results. We assessed the incidence of adverse events according to baseline quintiles of platelet indices in the prospective cohort of the Malmö Diet and Cancer Study. A total of 30,314 individuals (age 57 ± 8 years) were followed for a median of 16 years (468,490 person-years). Outcome measures included all-cause death, CV death, myocardial infarction (MI), and ischemic stroke. The fifth quintile of platelet count (> 274.6 × 109/L) was associated with higher incidence of all-cause death (hazard ratio [HR] 1.20, 95% confidence interval [CI] 1.09–1.32, p < 0.001), CV death (HR 1.19, 95% CI 1.00–1.42; p = 0.044), MI (HR 1.32, 95% CI 1.12–1.54; p = 0.001), and ischemic stroke (HR 1.27, 95% CI 1.08–1.50, p = 0.004) compared with the first quintile (≤ 185 × 109/L), and also associated with a lower survival, regardless of previous history of MI (p for interaction = 0.58) or stroke (p for interaction = 0.42). In the highest quintile, history of stroke had a higher risk of CV death (HR 3.18, 95% CI 1.54–6.54) compared with no previous stroke (HR 1.12, 95% CI 0.96–1.31). The risk of MI and stroke was greatest in the fifth quintile, regardless of previous MI or previous stroke, respectively. The risk of all adverse events was similar across different quintiles of mean platelet volume. In conclusion, elevated platelet count is associated with higher mortality and risk of CV events, regardless of previous MI and stroke. Platelet count may thus be a useful marker for further stratification of CV risk, and especially of death.

Prognostic Significance of HPV Status in Laryngeal Squamous Cell Carcinoma: A Large-Population Database Study

2020 ◽  
pp. 019459982097617
Author(s):  
Bharat A. Panuganti ◽  
Andrey Finegersh ◽  
Mitchell Flagg ◽  
Xin Tu ◽  
Ryan Orosco ◽  
...  
Keyword(s):  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Laryngeal Squamous Cell Carcinoma ◽  
Large Population ◽  
Larynx Cancer ◽  
National Cancer Database ◽  
Population Database ◽  
Hpv Status

Objective To explore the survival implications of human papillomavirus (HPV) positivity and subtype in larynx cancer through a national cancer database. To investigate staging discrepancies in larynx cancer associated with HPV status. Study Design Retrospective observational cohort study. Setting National Cancer Database. Methods Data were extracted concerning adults with known HPV status who were treated between 2010 and 2016 for laryngeal squamous cell carcinoma. Patients without known HPV subtype were excluded. Cox multivariable regression models were fit to evaluate the survival impact of HPV status, characterized as a binary variable (HPV+ vs HPV–) and by subtype. Two- and 5-year survival rates were calculated via the Kaplan-Meier method and compared by stage between the HPV+ and HPV– cohorts per the log-rank test. Results Patients with HPV+ larynx cancer were younger (60.5 vs 64.3 years, P < .001), more likely to have private insurance (37.2% vs 31.2%, P < .001), more commonly White (84.6% vs 82.4%, P = .013), and more likely to present with nodal disease (42.6% vs 33.0%, P < .001). HPV positivity and HPV subtype 16 were associated with improved overall survival. One-stage discrepancies in 5-year survival were observed between the HPV+ and HPV– cohorts: stage II HPV+ (69.45%) vs stage I HPV– (65.77%); stage IV HPV+ (47.67%) vs stage III HPV– (46.80%). Conclusions HPV positivity and infection with HPV subtype 16 are correlated with improved overall survival in patients with laryngeal squamous cell carcinoma, manifesting with a 1-stage incremental survival advantage. Future prospective studies are indicated to corroborate the findings from this large-population database retrospective study.

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