Peginterferon beta-1a every 2 weeks demonstrated better clinical outcomes than glatiramer acetate once-daily in patients with RRMS: Propensity score matching of phase 3 data from ADVANCE and CONFIRM

2019 ◽  
Vol 175 ◽  
pp. S96
Author(s):  
Thomas Scott ◽  
Oksana Mokliatchouk ◽  
Carmen Castrillo-Viguera ◽  
Adrian Harrington ◽  
Maria L. Naylor
2021 ◽  
Vol 14 ◽  
pp. 175628642097591
Author(s):  
Thomas F. Scott ◽  
Ray Su ◽  
Kuangnan Xiong ◽  
Arman Altincatal ◽  
Carmen Castrillo-Viguera ◽  
...  

Background: Peginterferon beta-1a and glatiramer acetate (GA) are approved first-line therapies for the treatment of relapsing forms of multiple sclerosis, but their therapeutic efficacy has not been compared directly. Methods: Clinical outcomes at 2 years, including no evidence of disease activity (NEDA), for patients receiving peginterferon beta-1a 125 mcg every 2 weeks (Q2W) or GA 20 mg/ml once daily (QD) were compared by propensity score matching analysis using individual patient data from ADVANCE and CONFIRM phase III clinical trials. In addition, clinical outcomes at 1–3 years for patients receiving peginterferon beta-1a Q2W or GA 40 mg/ml three times a week (TIW) were evaluated using a matching-adjusted comparison analysis of individual patient data from ADVANCE and the ADVANCE extension study, ATTAIN, and aggregate patient data from the phase III GALA and the GALA extension studies. Results: Propensity-score-matched peginterferon beta-1a patients ( n = 336) had a significantly lower annualized relapse rate [ARR (0.204 versus 0.282); rate ratio = 0.724; p = 0.045], a significantly lower probability of 12-week confirmed disability worsening (10.0% versus 14.6%; hazard ratio = 0.625; p = 0.048), and a significantly higher rate of NEDA (20.3% versus 11.5%; p = 0.047) compared with GA 20 mg/ml QD patients after 2 years of treatment. Matching-adjusted peginterferon beta-1a patients (effective n = 276) demonstrated a similar ARR at 1 year (0.278 versus 0.318; p = 0.375) and significantly lower ARR at 2 years (0.0901 versus 0.203; p = 0.032) and 3 years (0.109 versus 0.209; p = 0.047) compared with GA 40 mg/ml TIW patients ( n = 834). Conclusion: Results from separate matching comparisons of phase III clinical trials and extension studies suggest that peginterferon beta-1a 125 mcg Q2W may provide better clinical outcomes than GA (20 mg/ml QD or 40 mg/ml TIW).


2020 ◽  
Vol 8 (1) ◽  
pp. e001179
Author(s):  
Yan Wei ◽  
Yingyao Chen ◽  
Yingnan Zhao ◽  
Russell Rothman ◽  
Jian Ming ◽  
...  

IntroductionPatients with diabetes in China have low health literacy, which likely leads to poor clinical outcomes. This study aimed to assess the effectiveness of health literacy and exercise interventions on clinical measurements in Chinese adults with type 2 diabetes mellitus (T2DM).Research design and methodsA cluster randomized controlled trial was conducted from February 2015 through April 2017 in Shanghai, China. 799 patients with T2DM aged 18 years or older recruited from eight Community Healthcare Centers were randomized into one control arm and three intervention arms receiving 1-year health literacy intervention, exercise intervention or both as the comprehensive intervention. Propensity score matching was employed to minimize potential imbalance in randomization. The intervention-attributable effects on main clinical outcomes were estimated using a difference-in-difference regression approach.ResultsAfter propensity score matching, 634 patients were included in the analysis. The three intervention groups had decreased hemoglobin A1c (A1c) level after 12 months of intervention. The largest adjusted decrease was observed in the health literacy group (−0.95%, 95% CI: −1.30 to −0.59), followed by the exercise group (−0.81%, 95% CI: −1.17 to −0.45). However, A1c was observed to increase in the health literacy and the comprehensive groups from 12 to 24 months. No obvious changes were observed for other measurements including high-density and low-density lipoprotein cholesterols, and systolic and diastolic blood pressures.ConclusionsHealth literacy and exercise-focused interventions improve glycemic control in Chinese patients with diabetes after 12 months of intervention, and the health literacy intervention shows the greatest effect. Our results suggest that the interventions may have the potential to improve diabetes self-management and reduce diabetes burden in China.Trial registration numberISRCTN76130594.


Author(s):  
Paolo Berretta ◽  
Mariano Cefarelli ◽  
Luca Montecchiani ◽  
Jacopo Alfonsi ◽  
Walter Vessella ◽  
...  

Abstract OBJECTIVES The impact of minimally invasive extracorporeal circulation (MiECC) systems on the clinical outcomes of patients undergoing minimally invasive aortic valve replacement (MI-AVR) has still to be defined. This study compared in-hospital and 1 year outcomes of MI-AVR interventions using MiECC systems versus conventional extracorporeal circulation (c-ECC). METHODS Data from 288 consecutive patients undergoing primary isolated MI-AVR using MiECC (n = 102) or c-ECC (n = 186) were prospectively collected. Treatment selection bias was addressed by the use of propensity score matching (MiECC vs c-ECC). After propensity score matching, 2 groups of 93 patients each were created. RESULTS Compared with c-ECC, MiECC was associated with a higher rate of autologous priming (82.4% vs 0%; P < 0.001) and a greater nadir haemoglobin (9.3 vs 8.7 g/dl; P = 0.021) level and haematocrit (27.9% vs 26.4%; P = 0.023). Patients who had MiECC were more likely to receive ultra-fast-track management (60.8% vs 26.9%; P < 0.001) and less likely to receive blood transfusions (32.7% vs 44%; P = 0.04). The in-hospital mortality rate was 1.1% in the MiECC group and 0% in the c-ECC group (P = 0.5). Those in the MiECC group had reduced rates of bleeding requiring revision (0% vs 5.3%; P = 0.031) and postoperative atrial fibrillation (AF) (30.1% vs 44.1%; P = 0.034). The 1-year survival rate was 96.8% and 97.5% for MiECC and c-ECC patients, respectively (P = 0.4). CONCLUSIONS MiECC systems were a safe and effective tool in patients who had MI-AVR. Compared with c-ECC, MiECC promotes ultra-fast-track management and provides better clinical outcomes as regards bleeding, blood transfusions and postoperative AF. Thus, by reducing surgical injury and promoting faster recovery, MiECC may further validate MI-AVR interventions.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Seguchi ◽  
K Sakakura ◽  
K Yamamoto ◽  
Y Taniguchi ◽  
H Wada ◽  
...  

Abstract Background Acute myocardial infarction (AMI) in the very elderly is associated with high morbidity and mortality. Because the majority of study population in clinical researches focusing on the very elderly with AMI were octogenarians, clinical evidences regarding AMI in nonagenarians are sparse. The aim of the present study was to compare in-hospital clinical outcomes of AMI between octogenarians and nonagenarians. Methods We included consecutive 415 very elderly (≥80 years) patients with AMI, and divided into the nonagenarian group (n=38) and the octogenarian group (n=377). Clinical characteristics and in-hospital outcomes were compared between the 2 groups. Furthermore, we used propensity-score matching to find the matched octogenarian group (n=38). Results Percutaneous coronary interventions (PCI) to the culprit of AMI were similarly performed between the nonagenarian (86.8%) and octogenarian (87.0%) groups The incidence of in-hospital death in the nonagenarian group (13.2%) was similar to that in the octogenarian group (14.6%) (P=0.811). The length of hospital stay was significantly shorter in the nonagenarian group (7.4±4.2 days) than that in the octogenarian group (15.4±19.4 days) (P<0.001). After using the propensity-score matching, the incidence of in-hospital death was less in the nonagenarian group (13.2%) than in the matched octogenarian group (21.1%) without reaching statistical significance (P=0.361). The length of hospitalization was significantly shorter in the nonagenarian group (7.4±4.2 days) than in the matched octogenarian group (17.8±37.0 days) (P=0.01). Clinical outcomes Nonagenarian group (n=38) Octogenarian group (n=377) P value In-hospital death, n (%) 5 (13.2) 55 (14.6) 0.811 Length of hospital stay (days) 7.4±4.2 15.4±19.4 <0.001 Length of CCU stay (days) 3.3±2.5 4.7±5.1 0.109 LVEF (%) 48.2±9.2 50.8±13.7 0.152 Peak CPK (U/L) 1424.8±1580.8 1640.1±2394.4 0.912 CCU indicates Coronary care unit; LVEF, Left ventricular ejection fraction; CPK, Creatine kinase. Flow-chart Conclusions The in-hospital mortality of nonagenarians with AMI was comparable to that of octogenarians with AMI. In-hospital outcomes in nonagenarians with AMI may be acceptable as long as acute medical management including PCI to the culprit of AMI is performed. Acknowledgement/Funding None


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