FRI0075 DECREASED RISKS OF HOSPITALIZED INFECTION UNDER TARGETED THERAPIES VS METHOTREXATE IN ELDERLY AND OLDER ELDERLY PATIENTS COMPARED TO YOUNGER PATIENTS WITH RHEUMATOID ARTHRITIS USING JAPANESE HEALTH INSURANCE DATABASE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 614-615
Author(s):  
R. Sakai ◽  
E. Tanaka ◽  
M. Majima ◽  
M. Harigai

Background:Recently, vital prognosis has been improved in patients with rheumatoid arthritis (RA)1. In elderly patients, it is difficult to establish a treatment strategy due to multi-morbidities and treatment-related risks. Since older age is a significant risk factor of serious infections, one of the primary concerns during treatment of RA, rheumatologists should always strike a balance between efficacy and safety of the immunosuppressive treatment. However, infection data under the targeted therapy (TT) in elderly patients is still limited to date.Objectives:To compare the risk of hospitalized infection (HI) under the TT among young, elderly, and older elderly patients with RA using the Japanese health insurance database.Methods:This retrospective longitudinal population-based study was conducted using claims data in Japan provided by Medical Data Vision Co., Ltd. We defined individuals as RA cases if they met all of the following: 1) having at least one ICD10 code (M05x, M06x except for M061, or M08x except for M081 and M082); 2) having at least one prescription of disease-modifying antirheumatic drugs (DMARDs) including methotrexate (MTX) and TT (biological DMARDs and Janus kinase inhibitors) between April 2008 and September 2018; and 3) 16 years old or older. We define the month patients met the above all criteria for the first time in this database as the index month. We excluded patients who were prescribed any DMARDs during the first 12 months from MTX users and those with prescription of any TT during the first 12 months from TT users (i.e., prevalent users). Among the study population, we divided patients into 3 groups according to their age at the index month; young group (16-64), elderly group (65-74), and older elderly group (>=75). The observation started from the index month and ended at 36 months later, the last month of the exposure of DMARDs, the month of loss of follow-up, or September 2019, whichever came first. HI was defined by ICD10 code with one prescription of predefined drugs for each infection during hospitalizations. Some of HIs were defined by ICD10 code alone.Results:In this study, 8269, 6454, 5745 patients with RA were included in the young, elderly, and older elderly groups, respectively. The incidence rate (IR) of HI (/100 patient-years [PY]) [95%CI] was 3.4 [3.1-3.7] in the young group, 5.8 [5.3-6.3] in the elderly group, and 12.0 [11.2-12.8] in the older elderly group. IR rate (IRR) of HI (reference: the young group) was 1.7 [1.5-1.9] in the elderly group and 3.6 [3.2-4.0] in the older elderly group. In the young group, the IRR of HI in TT users vs MTX users was significantly elevated (1.8 [1.5-2.1]), whereas, those of the elderly and the older elderly groups were significantly decreased (IRR 0.8 [0.7-0.9] for elderly; 0.6 [0.5-0.7] for older elderly). Concomitant use of immunosuppressive DMARDs or prednisolone >=10mg/day with TT became less frequent with aging.Conclusion:The elderly and older elderly patients had significantly higher risks of HI compared to the young. The risk of HI under the TT compared to MTX was decreased in the elderly patients, probably due to adjusting for treatment by attending physicians.References:[1]Arthritis Rheum 2014;66:786-93Acknowledgments:This work was supported by JSPS KAKENHI Grant Number 17K08963.Disclosure of Interests:Ryoko Sakai Grant/research support from: Tokyo Women’s Medical University (TWMU) has received unrestricted research grants forDivision of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases from Ayumi Pharmaceutical Co. Ltd., Bristol Meyers Squib, Chugai Pharmaceutical Co. Ltd., Nippon Kayaku Co. Ltd., Taisho Toyama Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corp., and with which TWMU paid the salary of R.S., Eiichi Tanaka Consultant of: ET has received lecture fees or consulting fees from Abbvie, Asahi Kasei pharma co., Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo Co., Eisai Pharmaceutical, Janssen Pharmaceutical K.K., Nippon Kayaku, Pfizer, Takeda Pharmaceutical, Taisho Toyama Pharmaceutical Co., and UCB Pharma., Speakers bureau: ET has received lecture fees or consulting fees from Abbvie, Asahi Kasei pharma co., Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo Co., Eisai Pharmaceutical, Janssen Pharmaceutical K.K., Nippon Kayaku, Pfizer, Takeda Pharmaceutical, Taisho Toyama Pharmaceutical Co., and UCB Pharma., masako majima: None declared, masayoshi harigai Grant/research support from: AbbVie Japan GK, Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Nippon Kayaku Co., Ltd., and Teijin Pharma Ltd. MH has received speaker’s fee from AbbVie Japan GK, Ayumi Pharmaceutical Co., Boehringer Ingelheim Japan, Inc., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., GlaxoSmithKline K.K., Kissei Pharmaceutical Co., Ltd., Oxford Immuotec, Pfizer Japan Inc., and Teijin Pharma Ltd. MH is a consultant for AbbVie, Boehringer-ingelheim, Kissei Pharmaceutical Co., Ltd. and Teijin Pharma.

2021 ◽  
Vol 19 ◽  
pp. 205873922110457
Author(s):  
Yoshinobu Nakao ◽  
Yu Funakubo Asanuma ◽  
Takuma Tsuzuki Wada ◽  
Mayumi Matsuda ◽  
Hiroaki Yazawa ◽  
...  

Objective: We evaluated the efficacy, safety, and drug survival rate of tocilizumab in the elderly patients with rheumatoid arthritis (RA). Methods: This study was conducted in 108 RA patients who started tocilizumab between 2008 and 2018. The patients were divided into a young group (<65 years) and an elderly group (≥65 years). The efficacy, safety, and drug survival rate of tocilizumab were compared between the two groups. Results: At baseline, there were no significant differences between the elderly ( n = 45) and the young group ( n = 63) in RA duration, percentage of biologic-naïve, and RA disease activity. Health Assessment Questionnaire-Disability Index (HAQ-DI) was higher, renal function was worse, and frequency of using methotrexate was lower in the elderly group. Tocilizumab demonstrated similar efficacy in the elderly and the young group with Clinical Disease Activity Index and HAQ-DI. Compared with baseline, the frequency of steroid use was lower at one year after initiation of tocilizumab in both groups. There was no significant difference between the groups in the drug survival rate of tocilizumab for three years. Discontinuation rates of TCZ due to toxic adverse events were similar between the two groups. Conclusions: The efficacy, steroid-sparing effect, and safety of tocilizumab therapy, as well as the drug survival rate for three years, were not inferior in elderly RA compared to young RA patients.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1885.2-1886
Author(s):  
R. Sakai ◽  
E. Tanaka ◽  
M. Harigai

Background:Antineutrophil cytoplasmic antibody-associated vasculitis (AAV) requires a long-term maintenance therapy (MT), often accompanied by hospitalization due to relapse and/or comorbidities such as infection1. However, data about direct medical costs of hospitalization during MT in patients with AAV is limited to date despite of an increasing concern about the economic burden of patients with AAV2-3.Objectives:To describe frequency of hospitalization and its direct medical costs during MT after the remission-induction therapy (RT) in patients with AAV using Japanese health insurance database.Methods:This retrospective longitudinal population-based study was conducted using claims data in Japan provided by Medical Data Vision Co., Ltd. We defined individuals as AAV cases receiving RT if they met all of the following: 1) having at least one ICD10 code (M300, M301, M313, or M318); 2) having at least one prescription of oral corticosteroids with prednisolone-equivalent dosage ≥30 mg/day, methylprednisolone pulse therapy, immunosuppressive drugs (cyclophosphamide [IVCY], methotrexate, or mycophenolate mofetil), or rituximab (RTX) during hospitalization between April 2008 and April 2017; and 3) having at least 7 days of hospitalization. The observation started from the next day of discharge from the first hospitalization for RT and ended at 24 months later, the month of loss of follow-up, or April 2017. We described the frequency of hospitalization and calculated direct medical costs (per month) during the observation. We analyzed medical costs from a societal perspective. We classified reasons of hospitalization into 3 categories; intensification of treatments for AAV, AAV MT including IVCY or RTX treatments, and comorbidities (infection, cardiovascular disease [CVD], malignancy, and others) using ICD10 codes plus treatments or interventions during the hospitalization.Results:In this study, 1,703 patients with AAV were included. The median [IQR] age was 72 [63, 79] years and 55.7% were female. The total number of hospitalization was 1,897 in 863 patients (50.7%). Among the hospitalizations, 296 hospitalization in 235 patients were categorized as intensification of treatments for AAV, 627 hospitalization in 297 patients were AAV MT, and 974 hospitalization in 572 patients were categorized as comorbidities. In the last category, infections were most frequent (220), followed by malignancy (54) and CVD (15). The mean direct medical costs per month was 20,945 EUR (1 EUR=125 JPY) in patients with hospitalization and 599 EUR in those without. Patients with hospitalization due to intensification of treatments for AAV had the highest direct medical costs (3,000 EUR), followed by those with hospitalization due to comorbidities (2,001 EUR), and those with hospitalization due to AAV MT (1,649 EUR).Conclusion:More than half of the patients had hospitalization during MT, and hospitalization due to comorbidities were most frequent. The mean direct medical costs in patients with at least one hospitalization was approximately 3.5 times as high as that in those without hospitalization.References:[1]Presse Med. 2015; 44:e251-e257[2]J. Rheumatol. 2015; 42:2383-91[3]Clin Exp Rheumatol.2019:137-43Acknowledgments:This work was supported by AMED under Grant Number JP17ek0109121.Disclosure of Interests:Ryoko Sakai Grant/research support from: Tokyo Women’s Medical University (TWMU) has received unrestricted research grants forDivision of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases from Ayumi Pharmaceutical Co. Ltd., Bristol Meyers Squib, Chugai Pharmaceutical Co. Ltd., Nippon Kayaku Co. Ltd., Taisho Toyama Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corp., and with which TWMU paid the salary of R.S., Eiichi Tanaka Consultant of: ET has received lecture fees or consulting fees from Abbvie, Asahi Kasei pharma co., Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo Co., Eisai Pharmaceutical, Janssen Pharmaceutical K.K., Nippon Kayaku, Pfizer, Takeda Pharmaceutical, Taisho Toyama Pharmaceutical Co., and UCB Pharma., Speakers bureau: ET has received lecture fees or consulting fees from Abbvie, Asahi Kasei pharma co., Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo Co., Eisai Pharmaceutical, Janssen Pharmaceutical K.K., Nippon Kayaku, Pfizer, Takeda Pharmaceutical, Taisho Toyama Pharmaceutical Co., and UCB Pharma., masayoshi harigai Grant/research support from: AbbVie Japan GK, Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Nippon Kayaku Co., Ltd., and Teijin Pharma Ltd. MH has received speaker’s fee from AbbVie Japan GK, Ayumi Pharmaceutical Co., Boehringer Ingelheim Japan, Inc., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., GlaxoSmithKline K.K., Kissei Pharmaceutical Co., Ltd., Oxford Immuotec, Pfizer Japan Inc., and Teijin Pharma Ltd. MH is a consultant for AbbVie, Boehringer-ingelheim, Kissei Pharmaceutical Co., Ltd. and Teijin Pharma.


2021 ◽  
Author(s):  
Jin Hee Ahn ◽  
Jae-Geum Shim ◽  
Sung Hyun Lee ◽  
Kyoung-Ho Ryu ◽  
Mi Yeon Lee ◽  
...  

Abstract Background: Most gastric ultrasound studies have been conducted in young middle-aged patients. Although age is known to influence gastric ultrasound, comparisons of gastric ultrasound in elderly patients with young patients have not been well elucidated. This study aimed to 1) compare gastric ultrasound assessments between young and elderly patients, 2) determine whether the CSA cutoff values for elderly and young patients should be different, and 3) suggest CSA cutoff values for elderly patients.Methods: This retrospective case-control study evaluated the data of 120 patients who underwent elective surgery under general anesthesia between July 2019 and August 2020. Demographic and gastric ultrasound assessment data were retrieved. Patients were divided into the elderly group (n = 58, age: ≥65 years) and young group (n = 62, age: <65 years). The antral cross-sectional area (CSA) in the supine and right lateral decubitus positions (RLDP), semiquantitative three-point Perlas grade (grades 0, 1, and 2), and gastric volume were determined. CSAs according to different Perlas grades were compared between the two groups. The CSA cutoff values for predicting a high risk of pulmonary aspiration in both the groups were determined. Results: Among patients with Perlas grade 0 (empty stomach), the CSA supine and CSA RLDP were greater in the elderly group than in the young group (CSA supine: 5.12 ± 1.99 cm2 vs. 3.92 ± 0.19 cm2, P = 0.002, and CSA RLDP: 6.24 ± 0.43 cm2 vs. 4.58 ± 0.21 cm2, P = 0.002). The specificity, positive predictive value, and accuracy of the CSA decreased when the CSA cutoff value for the young group (CSA RLDP: 6.92 cm2) was applied to the elderly group. The CSA cutoff values for the elderly group were: CSA supine, 6.92 cm2 and CSA RLDP, 10.65 cm2.Conclusions: The CSA of the empty stomach was greater in elderly patients than in young patients. The CSA cutoff values for predicting pulmonary aspiration risk in elderly and young patients should be differentiated. We suggest that the following CSA cutoff values should be used for predicting pulmonary aspiration risk in elderly patients: CSA supine, 6.92 cm2 and CSA RLDP, 10.65 cm2.


2021 ◽  
Author(s):  
Naoya Inagaki ◽  
Takaaki Tanaka ◽  
Jun Udaka ◽  
Shoshi Akiyama ◽  
Tatsuki Matsuoka ◽  
...  

Abstract Background The fixation strength of bone screws depends on bone mineral density (BMD), so it is important to evaluate bone strength at fracture sites. Few studies have investigated BMD in the pelvis. The aims of this study were to measure the regional Hounsfield unit (HU) values in the cancellous bone of the acetabulum and pelvic ring and to compare these values between young and elderly patients. Methods This study enrolled young patients with high-energy trauma (aged 20–44 years; young group) and elderly patients with low-energy trauma (aged 65–89 years; elderly group). Patients without pelvic computed tomography (CT) scans, those with pelvic bone implants, and those who died were excluded. The HU values on the contralateral (non-fractured) side of the pelvis were measured on CT scans. The CT data were divided into 7 areas: the pubic bone, the anterior and posterior walls and roof of the acetabulum, the ischial tuberosity, the body of the ilium, and the third lumbar vertebra. The HU values in each area were compared between the young and elderly groups. Results Sixty-one young patients and 154 elderly patients were included in the study. The highest HU value was in the roof of the acetabulum regardless of age and sex. HU values were significantly higher in the ischial tuberosity and body of the ilium and lower in the pubic bone and anterior wall. The HU values in all pelvic areas were significantly lower in the elderly group than in the young group, especially in the anterior area. Conclusions HU values in the 6 pelvic areas were not uniform and were strongly related to load distribution. The HU distribution and age-related differences could explain the characteristic causes and patterns of acetabular fractures in the elderly and may help in surgical treatment.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 992.1-992
Author(s):  
S. Muraoka ◽  
Z. Yamada ◽  
W. Hirose ◽  
H. Kono ◽  
S. Yasuda ◽  
...  

Background:The widespread use of biologic agents has greatly improved the prognosis of rheumatoid arthritis (RA). On the other hand, elderly patients with RA are relatively increasing. Although achieving low disease activity is a goal for those elderly patients as well as young patients, the efficacy of tumor necrosis factor inhibitors were reported to be equally or slightly less effective in elderly patients than in young patients. There is a lack of evidence for the efficacy of abatacept (ABT) in elderly patients.Objectives:In this study, we aimed to clarify the efficacy of ABT in elderly and young patients with RA compared to csDMARDs.Methods:This is a multicenter, open-label, prospective, observational study. All patients with RA enrolled this study are refractory to csDMARDs and have not received any biologics. Either ABT or csDMARDs was administered at the discretion of physicians to elderly (65 years and older) and young (20-64 years) patients (ABT-elderly, ABT-young, control (CTL)-elderly, and CTL-young groups). Comparison was made between 4 groups of patients. The primary study endpoint was a good response by EULAR response criteria at week 24 after administration. The research procedure has been approved by the ethics committee of Toho University School of Medicine (Approval number: A17112).Results:A total of 219 patients, 127 in the ABT group and 92 in the CTL group, were enrolled in this study. The majority of patients were women (82.7%) with a mean age (±SD) of 64.9±13.6 years (74.5±5.9 years in the elderly group and 52.4±10.1 years in the young group). The ABT group had higher disease activity, higher HAQ, and higher steroid use rates and dosage than the CTL group. These were also observed in the elderly group. In the young group, although the ABT group had higher disease activity and higher HAQ than the CTL group, no difference was observed in steroid use rates and dosage. The ABT group more frequently achieved a good response by EULAR response criteria compared to the CTL group at week 24 (58.8% and 27.2%, respectively, p<0.0001). The ABT group also showed higher efficacy than the CTL group in the elderly and young groups with a good response. Regarding the improvement in DAS28-ESR and DAS28-CRP, the ABT group was also superior to the CTL group. There was no difference on efficacy between elderly and young patients from the ABT groups.Based on propensity score matching for disease activity at baseline, 61 matched pairs of patients treated with ABT or csDMARDs were statistically extracted. Although there was no significant difference in the rate of patients with a good response by EULAR response criteria between the ABT and the CTL groups, the ABT group showed significantly better response than the CTL group in the elderly. Furthermore, the ABT group was superior to the CTL group in improvement in both DAS28-ESR and DAS28-CRP, and similar results were obtained in the elderly. However, there was no significant difference between the ABT group and the CTL group in the young. In addition, elderly patients had significant improvement in DAS28-ESR compared with young patients in the ABT group.Conclusion:Treatment with ABT showed higher efficacy compared with CTL, particularly in elderly patients with RA.References:[1]Harigai M, et al. Mod Rheumatol. 2019;29:747.[2]Sugihara T, Harigai M. Drugs Aging. 2016;33:97.Disclosure of Interests:Sei Muraoka Consultant of: Asahikasei Pharma Corp., Speakers bureau: Ono Pharmaceutical Co., Ltd., Eisai Co., Ltd., Asahikasei Pharma Corp., and Astellas Pharma Inc., Zento Yamada: None declared, Wataru Hirose: None declared, Hajime Kono: None declared, Shinsuke Yasuda Speakers bureau: Bristol Myers Squibb, Chugai Pharmaceutical Co., Tanabe Mitsubishi Parma Co., and GlaxoSmith Kline, Toshihiro Nanki Grant/research support from: Chugai Pharmaceutical Co., Eisai Co., Ltd., Teijin Pharma Ltd., Eli Lilly Japan K.K., Bristol-Myers K.K., Ono Pharmaceutical Co., Ltd., Novartis Pharma K.K., Asahikasei Pharma Corp., Mitsubishi-Tanabe Pharma Co., Astellas Pharma Inc., Ayumi Pharmaceutical Co., Pfizer Japan Inc., Daiichi Sankyo Co., Ltd., Shionogi & Co., Ltd., Sanofi K.K., Nippon Kayaku Co., Ltd., Yutoku Pharmaceutical Ind. Co., Ltd., UCB Japan Co. Ltd., Nihon Pharmaceutical Co., Ltd., and Bayer Yakuhin, Ltd., Consultant of: UCB Japan Co., Ltd., Eisai Co., Ltd., and Chugai Pharmaceutical Co., Speakers bureau: Mitsubishi-Tanabe Pharma Co., Chugai Pharmaceutical Co., Eisai Co., Ltd., Astellas Pharma Inc., Janssen Pharmaceutical K.K., Ayumi Pharmaceutical Co., Pfizer Japan Inc., Asahikasei Pharma Corp., Sanofi K.K., Novartis Pharma K.K., Eli Lilly Japan K.K., Nippon Kayaku Co., Ltd., Teijin Pharma Ltd., Takeda Pharmaceutical Co., Nippon Boehringer Ingelheim Co., Ltd., and AbbVie GK.


2012 ◽  
Vol 2012 ◽  
pp. 1-4 ◽  
Author(s):  
Yasuchika Aoki ◽  
Shiro Sugiura ◽  
Koichi Nakagawa ◽  
Arata Nakajima ◽  
Hiroshi Takahashi ◽  
...  

Because we have a clinical impression that elderly patients have low back pain while in motion and standing, but less pain when sitting, we investigate characteristics of nonspecific low back pain (NSLBP), using a new detailed visual analog scale (VAS) scoring system. One hundred eighty-nine patients with NSLBP were divided into an elderly group (≥65 years old, n=56) and a young group (<65 years old, n=133). Low back pain was evaluated by a traditional VAS scoring system, the Oswestry Disability Index (ODI), and a new detailed VAS scoring system in which pain is independently evaluated in three different postural situations (in motion, standing, and sitting). No significant differences were observed in traditional VAS and ODI scores between the two groups. The results of the detailed VAS showed no significant differences between the two groups while in motion and standing. However, the elderly group showed significantly lower VAS score while sitting compared to the young group. In this study of the first use of a new detailed VAS scoring system, differences in characteristics of NSLBP between elderly and young patients were successfully detected. This minor modification of the traditional VAS may be useful for characterizing and evaluating low back pain.


1993 ◽  
Vol 60 (1) ◽  
pp. 19-22
Author(s):  
P. Bassi ◽  
M. Gholam Alipour ◽  
G.L. Drago Ferrante ◽  
N. Piazza ◽  
N. Panza ◽  
...  

Radical cystectomy is the most common treatment for deeply invasive bladder cancer; due to reported operative risks, concerns have been expressed regarding the suitability of this operation in elderly patients. We reviewed the morbility and mortality rates in 50 patients aged 70 years and over (elderly group), undergoing radical cystectomy and urinary diversion, to verify if this procedure could be considered as initial treatment in older-age patients. The findings were compared with those observed in 50 patients aged 40 to 69 years (control group). In the elderly group there was no operative mortality; however 2 patients (4%) died post-operatively due to pulmonary embolism and multi-organ-failure syndrome respectively. Four patients (8%) were re-operated due to intestinal obstruction (2 pts), pelvic hematoma (1 pt) and wound dehiscence (1 pt). Wound separation was the more frequent complication (15%); 6% of patients experienced extended intestinal atonia. The length of hospital stay was 17.1 days. In the control group, surgical complications were comparable to those observed in the elderly group: furthermore medical complications were more frequent. In conclusion, these data suggest that radical cystectomy and urinary diversion can be safely performed in the elderly. Radical surgery is an effective treatment modality for elderly individuals who are in reasonably good general health. A higher incidence of medical complications must be expected in elderly patients.


2021 ◽  
Vol 8 ◽  
Author(s):  
Zhongyuan Ren ◽  
Binni Cai ◽  
Songyun Wang ◽  
Peng Jia ◽  
Yang Chen ◽  
...  

Background: Left bundle branch pacing (LBBP) has been shown to be a safe and effective means to achieve physiological pacing. However, elderly patients have increased risks from invasive procedures and the risk of LBBP in elderly patients is not known. We aimed to investigate the safety and efficacy of LBBP in elderly patients &gt;80 years of age.Methods: From December 2017 to June 2019, 346 consecutive patients with symptomatic bradycardia, 184 patients under 80 years of age and 162 over 80 years, were included and underwent LBBP. The safety and prognosis of LBBP were comparatively evaluated by measured pacing parameters, periprocedural complications, and follow-up clinical events.Results: Compared with the younger, the elderly group had worse baseline cardiac and renal function. LBBP was achieved successfully in both groups with comparable fluoroscopic time and paced QRS duration (110.0 [102.0, 118.0] ms for the young vs. 110.0 [100.0, 120.0] ms for the elderly, P = 0.874). Through a follow-up of 20.0 ± 6.1 months, pacing parameters were stable while higher threshold and impedance were observed in the elderly group. In the evaluation of safety, overall procedure-related complication rates were comparable (4.4 vs. 3.8%, young vs. elderly). For prognosis, similar rates of major adverse cardiocerebrovascular events (7.1 vs. 11.9%, young vs. elderly) were observed.Conclusions: Compared to younger patients, LBBP could achieve physiological pacing in patients over 80 with comparable midterm safety and prognosis. Long-term safety and benefits of LBBP, however, necessitate further evaluation.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 638-639
Author(s):  
R. Alten ◽  
W. Rigby ◽  
A. Pechonkina ◽  
Z. Yin ◽  
K. Hasegawa ◽  
...  

Background:In the FINCH 3 study, filgotinib (FIL)—a potent, selective, oral small molecule Janus kinase 1 inhibitor1—in combination with methotrexate (MTX), demonstrated significant improvements in the signs and symptoms of rheumatoid arthritis (RA) vs MTX alone in patients (pts) who were MTX-naïve.2For pts with RA, rapid control of pain and fatigue along with maintenance of physical function and health-related quality of life (HRQoL) are important outcomes of their care.3Thus, patient-reported outcomes (PROs) can provide physicians with evidence to guide treatment decisions beyond the guideline-recommended treatment targets of reducing immune inflammation to prevent joint damage, physical disability, and mortality.4Objectives:To evaluate the rate and magnitude of change in PROs assessing functional status, pain, HRQoL, and fatigue from FINCH 3.Methods:In the FINCH 3 study (NCT02886728), pts with active RA who were MTX-naïve received FIL 200 mg daily + MTX, FIL 100 mg + MTX, FIL 200 mg (+ placebo [PBO]), or MTX (+ PBO) for up to 52 weeks. PROs were recorded prospectively and included HAQ-DI (functional status) and VAS pain scale (day 1, week [W]2, W4, W8, W12, W16, W20, W24, W30, W36, W44, W52), SF-36 (HRQoL), and FACIT-Fatigue (day 1, W4, W12, W24, W36, W52). The least squares mean of the change from baseline (CFB) at each time point up to W52 and p values (each FIL arm vs MTX) were analysed using a mixed-effects model for repeated measures. For HAQ-DI, the proportion of pts who achieved the minimum clinically important difference (MCID; reduction ≥0.22) between each FIL arm and MTX was analysed using logistic regression analysis. P values for the comparisons of PROs were not adjusted for multiplicity, except for HAQ-DI CFB at W24 for FIL 200 mg + MTX and FIL 100 mg + MTX vs MTX.Results:Of the 1249 pts randomised and treated (FIL 200 mg + MTX, n = 416; FIL 100 mg + MTX, n = 207; FIL 200 mg, n = 210; MTX, n = 416), 1025 (82.1%) completed the study. Compared with MTX alone, a nominally significantly greater CFB in functional status and pain from W2 to W24 was observed in all FIL arms; the benefit was sustained from W30 to W52 (Fig 1). By W2, a nominally significantly greater proportion of pts achieved the HAQ-DI MCID or greater (≥0.22) in all FIL arms (FIL 200 mg + MTX: 61.9%, p <0.001; FIL 100 mg + MTX: 58.5%, p <0.001; FIL 200 mg: 53.9%, p = 0.004) compared with MTX (42.2%). By W8, ≥72% of pts in all FIL arms vs 63% of pts in the MTX arm achieved the HAQ-DI MCID; a numerically greater proportion of pts in FIL arms vs MTX achieved HAQ-DI MCID through W52. SF-36 physical component summary and FACIT-Fatigue scores were nominally significantly improved with FIL treatment vs MTX alone at various time points (Fig 2A, B). Improvements in SF-36 mental component summary scores were nominally significant for pts in all FIL arms vs MTX alone as early as W4, and the CFB reached at W12 for FIL arms was generally sustained up to W52 (Fig 2A).Conclusion:For pts with moderate to severe RA who were MTX-naïve, FIL—with or without concomitant MTX—led to more rapid and sustained improvements in functional status, pain, fatigue, and HRQoL, compared with MTX alone.References:[1]Van Rompaey, et al.J Immunol. 2013;131:3568–77.[2]Westhovens, et al.Arthritis Rheumatol. 2019;71 (suppl 10):1606–8.[3]Fautrel B, et al.Rheumatol Int.2018;38:935–47.[4]Smolen JS, et al.Ann Rheum Dis.2017;76:960–77.Disclosure of Interests:Rieke Alten Grant/research support from: Pfizer, Galapagos, Galapagos NV, Gilead, Gilead Sciences, Inc., Novartis, Consultant of: Pfizer, Speakers bureau: Pfizer, William Rigby Consultant of: Gilead Sciences, Inc., Alena Pechonkina Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Zhaoyu Yin Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Ken Hasegawa Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Thijs Hendrikx Shareholder of: Galapagos (share/warrant holder), Employee of: Galapagos, Tatsuya Atsumi Grant/research support from: Eli Lily Japan K.K., Alexion Pharmaceuticals, Inc., Bristol-Myers Squibb Co., AbbVie Inc., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Astellas Pharma Inc., Consultant of: Gilead Sciences, Inc., Eli Lilly Japan K.K., UCB Japan Co. Ltd., AbbVie Inc., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Speakers bureau: Eli Lilly Japan K.K., UCB Japan Co. Ltd., Bristol-Myers Squibb Co., AbbVie Inc., Eisai Co. Ltd., Otsuka Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Takeda Pharmaceutical Co., Ltd., Astellas Pharma Inc., Rene Westhovens Grant/research support from: Celltrion Inc, Galapagos, Gilead, Consultant of: Celltrion Inc, Galapagos, Gilead, Speakers bureau: Celltrion Inc, Galapagos, Gilead


Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Dania Mohty ◽  
Philippe Pibarot ◽  
Jean-Pierre Despres ◽  
Amelie Cartier ◽  
Benoit Arsenault ◽  
...  

Background: Fetuin A is a circulating calcium-regulatory glycoprotein that inhibits ectopic and vascular calcification. Aortic stenosis (AS) is a disease process involving an active calcification of the aortic valve (AV). Its prevalence increases markedly with aging. We examined the association between plasma level of Fetuin A and disease progression in AS Methods and Results: 114 patients operated for AS, were divided into 2 groups according to their age: the young and middle-age group included the first (25–65 y-o) and second (66–74 y-o) tertiles and the elderly group included the last tertile (range 75–88 y-o). Plasma Fetuin-A level was determined by Elisa method and calcium content of the AV by a chelator quantitative method respectively. The annualized progression rate of the disease was calculated for the subset of patients in whom at least 2 transthoracic echocardiography separated by at least 6 months were available pre-operatively. In the elderly group, the preoperative progression rate of the maximum transvalvular gradient was 2-fold faster in patients with decreased plasma Fetuin-A level <0.36 ng/ml (median value) when compared to those with higher level of Fetuin-A (10±4 vs. 5±3 mmHg, p=0.01). Moreover, there was a significant correlation between calcium content of the AV explanted at the time of surgery and Fetuin-A plasma level (R=0.37, p<0.01). After adjusting for age, gender, bicuspid AV, creatinine, Fetuin-A remained significantly associated with AV calcification (R 2 =0.26, p=0.02). There was no correlation between Fetuin-A level and AV calcium content or AS progression in the younger patients group (R=0.06, p=0.62 and R=0.05, p=0.76, respectively) Conclusion: In the elderly patients, decreased level of Fetuin-A may contribute to enhanced valvular calcification and accelerated stenosis progression


Sign in / Sign up

Export Citation Format

Share Document