scholarly journals Routine follow-up of native valve disease: real life data from a physiologist-led valve clinic

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
K Hyams ◽  
K Balkhausen ◽  
C Townsend
Keyword(s):  
Real Life ◽  
Heart Association ◽  
Native Valve ◽  
Conservative Strategy ◽  
Funding Sources ◽  
Real Life Data ◽  
Number Of Patients ◽  
The Mean ◽  
Funding Acknowledgements

Abstract Funding Acknowledgements Type of funding sources: None. Purpose The 2014 American Heart Association (AHA) guidelines for the management of Valvular Heart Disease (VHD) suggest that patients with mild and moderate native VHD should be followed up with echocardiography at regular intervals. Following audits at our hospital in 2016, dedicated Physiologist Led Valve Clinics (PLVC) were initiated to improve guideline adherence. A conservative strategy for follow-up frequency based on AHA guidelines was chosen (3 years for mild VHD, and 1 year for moderate VHD). This audit aimed to ascertain adherence to this conservative follow-up strategy, and to assess the progression of VHD between echocardiographic assessments to inform a strategy for safe follow-up in our PLVC. Methods Our echocardiography database Cognos was searched for patients with isolated mild and moderate native VHD, seen in our PLVC between 2016-2018 and followed up between 2017-2019. Patients with severe, prosthetic, combined or significant mixed VHD were excluded. Echocardiography reports on McKesson were reviewed and the follow-up interval recorded for each patient. The severity of VHD at the index visit, and then at follow-up, was recorded to determine whether there had been a progression in VHD severity. For patients with progression, it was recorded whether they were symptomatic at follow-up or subsequently underwent valvular intervention. Results 466 index echocardiograms were reviewed; 134 patients were included (mean age 73.4) after removing those with exclusion criteria. The mean follow-up interval in mild VHD ranged between 587.6 ± 188.3 days, and 667.3 ± 174.6 days, well above the recommended 3 years (or 1095 days). The majority of patients with moderate VHD received follow-up well before the upper limit of AHA guidance (2 years, or 730 days). Mean follow-up ranged between 408.3 ± 80.8 days (in moderate aortic stenosis (AS)) and 504.0 ± 29.0 days (in moderate mitral stenosis (MS)). The number of patients followed up with mild VHD was very low. 1 patient in each group progressed to moderate VHD (out of 2, 3 and 5 respectively); none became symptomatic, and none progressed from mild to severe VHD. In moderate VHD, progression rates were highest in AS (34.8%). Patients with progressive disease were more frequently symptomatic (43%) or underwent valve intervention (25%). Fewer with mitral regurgitation (MR) (22%) progressed, 44.5% of whom were symptomatic, 11% undergoing intervention. Patients with moderate aortic regurgitation (AR) saw the lowest progression rates (11.4%), 50% of whom were symptomatic. There was no progression in moderate MS. Conclusions Patients with mild VHD can safely be followed up less conservatively in the PLVC setting, adhering to AHA guidance (3-5 years). Patients with moderate AS should be considered to remain under conservative follow-up (12-18 months). Follow-up for moderate AR, MR and MS can safely be adjusted towards the less conservative end of the AHA guidance (2 years). Abstract Figure.

scholarly journals FRI0117 INCIDENCE RATE OF HERPES ZOSTER IN RHEUMATOID ARTHRITIS PATIENTS UNDER TOFACITINIB: REAL-LIFE DATA FROM TURKEY – HURBIO REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 640.3-640
Author(s):  
E. Bilgin ◽  
F. Ceylan ◽  
E. Duran ◽  
E. C. Bolek ◽  
B. Farisoğullari ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Herpes Zoster ◽  
Rheumatoid Factor ◽  
Incidence Rate ◽  
Real Life ◽  
Janus Kinase ◽  
Life Data ◽  
Real Life Data ◽  
Number Of Patients

Background:Tofacitinib (TOF) is an orally administered Janus Kinase (JAK) inhibitor and is commonly used in rheumatoid arthritis. There is a heterogeneity among numbers reported from different continents about herpes zoster (HZ) incidence rate (1-3). However, data about HZ risk in our country, which stands like a bridge between Asia and Europe, is lacking.Objectives:To assess the real-life incidence of herpes zoster in RA patients under tofacitinib.Methods:We analyzed all patients who had at least 1 control visit under tofacitinib and registered to HURBIO database. We calculated incidence rate by dividing the number of patients with herpes zoster to total follow-up years, then multiplied by 100 (per 100 patient-years).Results:A total of 204 (174 (85.4%) female) patients were recruited. Mean age was 53.2±12.5 years. Mean disease duration was 11.5±8.1 years. Rheumatoid factor and anti-CCP antibodies were positive in 135/198 (68.1 %) and 115/171 (67.2 %) patients, respectively. Median follow-up while receiving TOF was 11.6 (IQR:5.2-26.2) months. Combination with DMARDs was used in 83.3% of patients. 55.5% of patients was biologic-naive. Eleven (5.3%, incidence rate: 3.9 (2.3-8.5; % 95 CI) per 100 patient-years) patients had zona zoster. Ten of these patients was female, median age was 59 (IQR; 52-69) and 4 of them was older than 65 years-old. Rheumatoid factor was positive in 9 patients. Only 1 of these patients had diabetes. Median follow-up of these patients under TOF was 8.1(IQR: 6-25) months. Ten of these patients had concomitant DMARDs (9 hydroxycholoroquine, 4 methotrexate, 2 leflunomide; according to last follow-up visit) and 9 of them received concomitant steroids (med(IQR); 4 (1-8) mg- at equivalant methyl-prednisolon dose). Eight of them was biologic-naive. Tofacitinib was discontinued in 4 of these patients.Conclusion:In this real-life data from Turkey, we found a HZ incidence rate similar to that reported from USA and global data; however, we found a lower incidence rate that reported from Japan (Figure 1).Figure 1.Reported herpes zoster incidence rates across different countries (numbers in paranthesis indicate reference number)References:[1]Winthrop KL, Curtis JR, Lindsey S, Tanaka Y, Yamaoka K, Valdez H, et al. Herpes Zoster and Tofacitinib: Clinical Outcomes and the Risk of Concomitant Therapy. Arthritis & rheumatology (Hoboken, NJ). 2017;69(10):1960-8.[2]Curtis JR, Xie F, Yun H, Bernatsky S, Winthrop KL. Real-world comparative risks of herpes virus infections in tofacitinib and biologic-treated patients with rheumatoid arthritis. Ann Rheum Dis. 2016;75(10):1843-7.[3]Yamanaka H, Tanaka Y, Takeuchi T, Sugiyama N, Yuasa H, Toyoizumi S, et al. Tofacitinib, an oral Janus kinase inhibitor, as monotherapy or with background methotrexate, in Japanese patients with rheumatoid arthritis: an open-label, long-term extension study. Arthritis Res Ther. 2016;18:34.Disclosure of Interests:Emre Bilgin: None declared, Furkan Ceylan: None declared, Emine Duran: None declared, Ertugrul Cagri Bolek: None declared, Bayram Farisoğullari: None declared, Gözde Kübra Yardimci: None declared, Levent Kiliç: None declared, Ali Akdoğan: None declared, Omer Karadag: None declared, Şule Apraş Bilgen: None declared, Sedat Kiraz: None declared, Ali İhsan Ertenli: None declared, Umut Kalyoncu Consultant of: Abbvie, Amgen, Janssen, Lilly, Novartis, UCB

Aflibercept in real-life for the treatment of age-related macular degeneration using a treat and extend protocol: The Armada study

2021 ◽  
pp. 112067212110057
Author(s):  
Pierre Gascon ◽  
Prithvi Ramtohul ◽  
Charles Delaporte ◽  
Sébastien Kerever ◽  
Danièle Denis ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Real Life ◽  
Age Related Macular Degeneration ◽  
Cumulative Number ◽  
Treat And Extend ◽  
Treatment Interval ◽  
Age Related ◽  
Treatment Naïve ◽  
The Mean

Purpose: To report the visual and anatomic outcomes in treatment-naïve neovascular age-related macular degeneration (nAMD) patients treated with aflibercept under a standardized Treat and Extend (T&E) protocol for up to 3 years of follow-up in “real-life” practice. Methods: This retrospective, observational, multicenter study included patients with treatment-naïve nAMD and at least 12 months of follow-up. T&E regimen adjustment was initiated after loading phase. At each visit best-corrected visual acuity (BCVA) and optical coherence tomography parameters were performed. Results: One hundred and thirty-six eyes of 115patients had at least 1 year of follow-up with 114 and 82 eyes completing at least 2 and 3 years of follow-up, respectively (mean follow-up duration: 2.7 ± 1.3 years). Mean age was 78.6 ± 8.6 years old and 52% were women. Mean BCVA increased from 60.6 ± 18.7 letters at diagnosis to 66.9 ± 16.2 letters at 1 year (+6.3 letters, p = 0.003) and remained stable throughout the follow-up period (63.1 ± 20.3 letters (+2.5, p = 0.1) and 64.0 ± 20.1 letters (+3.4, p = 0.27) at 2 and 3 years, respectively). The mean central retinal thickness decreased significantly from 358.2 ± 87.9 µm at baseline to 302 ± 71.7 µm at 12 months and maintained stable after 36 months of follow-up (297.1 ± 76 µm, p < 0.0001). Mean number of injections was 6.6 ± 2.2, 4.8 ± 1.9, and 5.6 ± 1.7 at 1, 2, and 3 years, respectively. Mean cumulative number of 16.4 ± 5.6 injections after 3 years. Mean treatment interval was 6.8 ± 2.5 weeks at 1 year. Eight-week and 12-week treatment interval were achieved in 59.5% and 19.1%, 65.8%, and 36.8% and 69.5% and 41.5% at 1, 2, and 3 years, respectively. Conclusions: Our study demonstrated that intravitreal injections of aflibercept initiated under a standardized T&E for patients with treatment-naïve nAMD allow for significant visual improvement at 12 months, which was maintained over a 3-year follow-up period.

Management of optic disc pit-associated maculopathy: A case series from a tertiary referral center

2021 ◽  
pp. 112067212110237
Author(s):  
Ilkay Kilic Muftuoglu ◽  
Ecem Onder Tokuc ◽  
V Levent Karabas
Keyword(s):  
Optic Disc ◽  
Case Series ◽  
Internal Limiting Membrane ◽  
Maximum Height ◽  
Optic Disc Pit ◽  
Tertiary Referral Center ◽  
Number Of Patients ◽  
The Mean ◽  
Foveal Center

Purpose: To report outcomes of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) stuffing technique in patients with optic disc pit associated maculopathy (ODP-M). Methods: Data including best-corrected visual acuity (BCVA), central macular thickness (CMT), foveal center point thickness (FCP), and maximum height of fluid (max_fluid) (intraretinal or subretinal) were collected from the medical records of the patients. Results: Six eyes of six patients with a mean age of 28.0 ± 17.68 years (range: 9–53 year) underwent PPV + ILM plug surgery. The mean follow-up duration was 25.62 ± 26.11 months (range: 11.80–78.00 month) duration. The mean BCVA increased from 1.25 ± 1.04 logMAR (20/355, Snellen equivalent) to 0.86 ± 1.09 logMAR (20/144, Snellen equivalent) at last follow-up ( p = 0.043). Compared to baseline, CMT, FCP, and max_fluid significantly decreased at all visits after the surgery ( p < 0.05 for all visits). At last follow-up, 66.6% of the eyes (four eyes) showed complete resolution of fluid at a mean of 5.25 ± 4.99 months (range: 1–12 months) after the surgery. Conclusion: PPV with ILM plug seemed to be an effective surgical technique in ODP-M. Studies with longer follow-up and higher number of patients are needed to confirm our results.

scholarly journals A longitudinal analysis of the progression from normal blood pressure to stage 2 hypertension: A 12-year Korean cohort

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eun Sun Yu ◽  
Kwan Hong ◽  
Byung Chul Chun
Keyword(s):  
Blood Pressure ◽  
Health Insurance ◽  
American Heart Association ◽  
American Heart ◽  
Heart Association ◽  
Normal Blood ◽  
Normal Blood Pressure ◽  
The Mean ◽  
Stage 1

Abstract Background The study aimed to estimate the incidence of and period of progression to stage 2 hypertension from normal blood pressure. Methods We selected a total of 21,172 normotensive individuals between 2003 and 2004 from the National Health Insurance Service-Health Screening and followed them up until 2015. The criteria for blood pressure were based on the American College of Cardiology/American Heart Association 2017 guideline (normal BP: SBP < 120 and DBP < 80 mmHg, elevated BP: SBP 120–129 and DBP < 80 mmHg, stage 1 hypertension: SBP 130–139 or DBP 80–89 mmHg, stage 2 hypertension: SBP ≥140 or DBP ≥ 90 mmHg). We classified the participants into four courses (Course A: normal BP → elevated BP → stage 1 hypertension→ stage 2 hypertension, Course B: normal BP → elevated BP → stage 2 hypertension, Course C: normal BP → stage 1 hypertension → stage 2 hypertension, Course D: normal BP → stage 2 hypertension) according to their progression from normal blood pressure to stage 2 hypertension. Results During the median 12.23 years of follow-up period, 52.8% (n= 11,168) and 23.6% (n=5004) of the participants had stage 1 and stage 2 hypertension, respectively. In particular, over 60 years old had a 2.8-fold higher incidence of stage 2 hypertension than 40–49 years old. After the follow-up period, 77.5% (n=3879) of participants with stage 2 hypertension were found to be course C (n= 2378) and D (n=1501). After the follow-up period, 77.5% (n=3879) of participants with stage 2 hypertension were found to be course C (n= 2378) and D (n=1501). The mean years of progression from normal blood pressure to stage 2 hypertension were 8.7±2.6 years (course A), 6.1±2.9 years (course B), 7.5±2.8 years (course C) and 3.2±2.0 years, respectively. Conclusions This study found that the incidence of hypertension is associated with the progression at each stage. We suggest that the strategies necessary to prevent progression to stage 2 hypertension need to be set differently for each target course.

The underrepresentation of female participants in studies assessing the impact of high-dose exercise on cardiovascular outcomes: a scoping review

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
S Pallikadavath ◽  
R Patel ◽  
CL Kemp ◽  
M Hafejee ◽  
N Peckham ◽  
...  
Keyword(s):  
Scoping Review ◽  
High Volume ◽  
Cardiovascular Outcomes ◽  
High Dose ◽  
Funding Sources ◽  
Review Protocol ◽  
The Mean ◽  
The Impact ◽  
Over Time ◽  
Funding Acknowledgements

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Cardiovascular adaptations as a result of exercise conducted at high-intensity and high-volume are often termed the ‘Athlete’s heart’. Studies have shown that these cardiovascular adaptations vary between sexes. It is important that both sexes are well represented in this literature. However, many studies assessing the impact of high-dose exercise on cardiovascular outcomes under-recruit female participants. Purpose This scoping review aimed to evaluate the representation of females in studies assessing the impact of high-dose exercise on cardiovascular outcomes and demonstrate how this has changed over time. Methods The scoping review protocol as outlined by Arksey and O’Malley was used. OVID and EMBASE databases were searched and studies independently reviewed by two reviewers. Studies must have investigated the effects of high-dose exercise on cardiovascular outcomes. To assess how the recruitment of females has changed over time, two methods were used. One, the median study date was used to categorise studies into two groups. Two, studies were divided into deciles to form ten equal groups over the study period. Mean percentage of female recruitment and percentage of studies that failed to include females were calculated. Results Overall, 250 studies were included. Over half the studies (50.8%, n = 127) did not include female participants. Only 3.2% (n = 8) did not include male participants. Overall, mean percentage recruitment was 18.2%. The mean percentage of recruitment was 14.5% before 2011 and 21.8% after 2011. The most recent decile of studies demonstrated the highest mean percentage of female recruitment (29.3%) and lowest number of studies that did not include female participants (26.9%). Conclusion Female participants are significantly underrepresented in studies assessing cardiovascular outcomes caused by high-dose exercise. The most recent studies show that female recruitment may be improving, however, this still falls significantly short for equal representation. Risk factors, progression and management of cardiovascular diseases vary between sexes, hence, translating findings from male dominated data is not appropriate. Future investigators should aim to establish barriers and strategies to optimise fair recruitment. Mean percentage females recruited per study (%) Percentage studies that do not include women (%) Overall (n = 250) 18.2 50.8 (n = 127) Studies before 2011 (n = 121) 14.5 59.5 (n = 72) Studies after 2011 (n = 129) 21.8 42.6 (n = 55) Table 1: Female recruitment characteristics. The year 2011 (median study year) was chosen as this divides all included studies into two equal groups.

Outcomes of a Cardiac Rehabilitation (CRH) Program after phase II: what about our patients almost 4 years later?

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
J Borrego Rodriguez ◽  
C Palacios Echevarren ◽  
S Prieto Gonzalez ◽  
JC Echarte Morales ◽  
R Bergel Garcia ◽  
...  
Keyword(s):  
Phase Ii ◽  
Hospital Readmissions ◽  
Clinical Results ◽  
Level Of Evidence ◽  
Coronary Syndrome ◽  
Funding Sources ◽  
The Mean ◽  
Acute Cardiovascular Event ◽  
Mean Time

Abstract Funding Acknowledgements Type of funding sources: None. INTRODUCTION CRH in patients with ischemic heart disease is recommended by the different clinical practice guidelines with an IA level of evidence, with an important role in reducing cardiovascular mortality and hospital readmissions during follow-up. OBJECTIVE The goal of this study is to show the 4-year clinical results of a population of patients who participated in an CRH program after an Acute Coronary Syndrome (ACS). METHODS Between May/2014 and September/2017, 221 patients who had recently presented an ACS completed the 12 weeks of phase II of the CRH program at our center. In May/2020 we collected epidemiological, clinical and echocardiographic information at the time of the acute cardiovascular event; and we evaluate the current vital status of the patients and the incidence of readmissions for: angina, HF, new ACS, or arrhythmic events. RESULTS Of the 221 patients, 182 were men (82%). The mean age of our population was 58.3 ± 7.8 years. 58% (129 patients) suffered from ST-elevation ACS. The mean time of hospital stay was 6.20 ± 2.9 days. An echocardiogram was performed at discharge, which showed an average LVEF of 56 ± 6%. Eight patients (4%) developed early Ventricular Fibrilation (VF) during the acute phase of ACS. Among the classic CVRF, smoking (79%) was the most prevalent, followed by dyslipidemia (53%) and hypertension (47%). The mean time from hospital discharge to the start of phase II RHC was 42 ± 16 days. The overall incidence of events was 9%: 10 patients suffered reinfarction during follow-up, and 7 were readmitted for unstable angina, all of whom underwent PCI; no patient was admitted for HF; and none of the 8 patients with early VF had a new tachyarrhythmia, registering a single admission for VT during follow-up. None of the patients had sustained ventricular tachyarrhythmias during exercise-training. At the mean 4.5-year follow-up, 218 patients were still alive (98%). CONCLUSION The incidence of CV events in the follow-up of our cohort was low, which can be explained by the fact that it is a young population, with an LVEF at low limits of normality at discharge, which is one of the most important predictors in the prognosis after an ischemic event. As an improvement, we must shorten the time until the start of phase II of the program. CRH shows once again its clinical benefit after an ACS, in consonance with the existing evidence. Abstract Figure. Outcomes of a CRH program.

scholarly journals Renal functional improvement after pediatric pyeloplasty in kidneys with split renal function less than 20%: a single institute experience

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Elsayed Salih ◽  
Ibrahim Abdelmaksoud ◽  
Mohamed Elfeky ◽  
Gamal Selmy ◽  
Hussein Galal ◽  
...  
Keyword(s):  
Renal Function ◽  
Statistical Significance ◽  
Functional Improvement ◽  
Renal Unit ◽  
Poor Renal Function ◽  
Split Renal Function ◽  
Renal Function Deterioration ◽  
Number Of Patients ◽  
The Mean

Abstract Background Pediatric pyeloplasty in ureteropelvic junction obstruction (UPJO) is indicated in renal impaired drainage or renal function deterioration. The improvement of renal function after pediatric pyeloplasty is still controversial in poorly functioning kidneys. Past studies on poorly functioning kidneys had a variable SRF specification, and these studies often had a limited number of patients so that they did not achieve statistical significance. The study aims to detect the renal functional improvement after pediatric Anderson-Hynes pyeloplasty (AHP) with split renal function (SRF) less than 20% (poor renal function). Results A retrospective study included 46 pediatric patients with unilateral UPJO who underwent open AHP with SRF < 20% on a renal isotope scan from August 2012 to October 2018. Success was defined based on either improvement in symptoms, improvement in drainage on postoperative renography, and/or improvement or stability in SRF on the renal scan done 6 months postoperatively and yearly thereafter. Deterioration of SRF by more than 5% was deemed to be deterioration. An increase in SRF of more than 5% was deemed to be an improvement. A total of 46 patients with a mean age of 32 months with poor renal function on isotope renogram (SRF < 20%) were included. All patients had an obstructive pattern on the preoperative radionuclide scans. The median preoperative SRF was 9.26%. The mean (range) follow-up was 30 months. The success rate was 91.3%. Three patients underwent redo pyeloplasty, whereas a secondary nephrectomy was necessary for one. The remaining (42) patients showed stability or improvement of SRF with no further symptoms. Renal scintigraphy at 6 and 12 months after surgery revealed significantly increased SRF compared to preoperative one. Conclusion Poorly functioning renal unit with SRF < 20% can show functional improvement and recoverability after pediatric pyeloplasty.

scholarly journals The photoplethysmography dictionary: practical guidance on signal interpretation and clinical scenarios from TeleCheck-AF

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
R M J Van Der Velden ◽  
D V M Verhaert ◽  
A N L Hermans ◽  
M Gawalko ◽  
D Duncker ◽  
...  
Keyword(s):  
Heart Rate ◽  
Clinical Scenario ◽  
On Demand ◽  
Practical Guide ◽  
Funding Sources ◽  
Internal Review ◽  
Clinical Scenarios ◽  
Number Of Patients

Abstract Introduction During the coronavirus disease 2019 (COVID-19) pandemic, numerous centres in Europe used on-demand photoplethysmography (PPG) technology to remotely assess heart rate and rhythm in conjunction with teleconsultations within the TeleCheck-AF project. Purpose To develop an educational structured stepwise practical guide on how to interpret PPG signals and to study typical clinical scenarios how on-demand PPG was used in the TeleCheck-AF project. Methods During an online conference, the structured stepwise practical guide on how to interpret PPG signals was discussed and further refined during an internal review process. We provide the number of respective PPG recordings and number of patients managed within a clinical scenario during the TeleCheck-AF project. Results To interpret PPG recordings, we introduce a structured stepwise practical guide and provide representative PPG recordings. In the TeleCheck-AF project, 2522 subjects collected 90.616 recordings. The majority of these recordings was classified by the PPG algorithm as sinus rhythm (57.6%), followed by atrial fibrillation (AF) (23.6%). In 9.7% of recordings the quality was too low to interpret. Other observed rhythms were tachycardia (1.4%), extra systoles (4.7%), bigeminy episodes (1.8%), trigeminy episodes (0.6%) and atrial flutter (0.2%). The most frequent clinical scenario where PPG technology was used in the TeleCheck-AF project was follow-up after AF ablation (1110 patients) followed by heart rate and rhythm assessment around (tele)consultation (966 patients), sometimes including remote PPG-guided adaption of rate or rhythm control. 275 patients were followed around cardioversion, either (semi-)acute or elective. Other possible scenarios are assessment of palpitations, assessment of symptom-rhythm correlation and monitoring during up-titration of heart failure medication. Conclusion We introduce a newly developed structured stepwise practical guide on PPG signal interpretation developed based on presented experiences from TeleCheck-AF. The present clinical scenarios for the use of on-demand PPG technology derived from the TeleCheck-AF project will help to implement PPG technology in the management of arrhythmia patients. FUNDunding Acknowledgement Type of funding sources: None. TeleCheck-AF clinical scenarios Classification of PPG recordings

scholarly journals Evaluation of efficacy and comparative frequency of adverse events in patients with ulcerative colitis receiving the original infliximab and its biosimilar. One year of observation

2019 ◽  
Vol 91 (8) ◽  
pp. 41-46
Author(s):  
O V Knyazev ◽  
T V Shkurko ◽  
A V Kagramanova ◽  
A A Lishchinskaya ◽  
M Yu Zvyaglova ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Real Life ◽  
Fecal Calprotectin ◽  
Biologic Drugs ◽  
Real Life Data ◽  
Bowel Diseases ◽  
Significant Clinical Improvement ◽  
One Year

Real - life data on the effectiveness and safety of biosimilar and biologic drugs licensed for treatment of inflammatory bowel diseases (IBD) is lacking. Aim. To investigate efficacy of original Infliximab (IFX) and its biosimilar in treating patients with ulcerative colitis (UC) and determine the frequency of adverse events during 1 year follow - up period. Materials and methods. Our cohort consisted of 98 ulcerative colitis patients, treated with original IFX and its biosimilar since December 2017 till December 2018 years. Original Infliximab was prescribed in 56 UC patients (57.1%) during 5 years and longer; 16 patients (16.3%) were switched to IFX biosimilar; 13 UC bio - naïve patients (13.3%) received original IFX, 29 (29.6%) patients - biosimilar IFX. In 14 patients (14.3%) original infliximab was rotated with biosimilar. We picked out 42 patients to assess efficacy of original IFX and biosimilar. Results and discussion. Twelve patients, received original IFX and 28 patients, treated with its biosimilar, showed significant clinical improvement by decreasing Mayo index from 9.7±0.4 and 10.2±0.2 points to 1.9±0.09 and 2.1±0.1 points, accordingly. Also we noticed positive change in laboratory markers - CRP decrease from 89.6±8.7 mg/l and 77.5±8.0 mg/l to 6.5±0.8 mg/l and 6.9±0.8 mg/l (p>0.05), albumin increase from 30.1±4.7 g/l and 29.6±3.6 g/l to 34.1±6.3 g/l and 32.8±5.9 g/l (p>0.05), increase of serum iron levels from 6.4±0.5 mcg/l and 7.1±0.65 mcg/l to 14.6±4.4 mcg/l and 15.9±5.1 mcg/l (p>0.05), hemoglobin increase from 104.7±9.8 g/l and 102.2±8.8 g/l till 124±11.3 g/l and 121±10.9 g/l (p>0.05), and fecal calprotectin decrease from 1680±134 mcg/g and 1720±126 mcg/g till 245.5±33.4 mcg/g and 230.5±29.8 mcg/g (p>0.05). During 1 year follow - up 12 UC patients, treated with original IFX and its biosimilar, developed adverse events. The majority of adverse events (n=8) were registered in patients, rotating administration of original IFX and its biosimilar. Conclusion. IFX biosimilar is effective as well as original IFX. Frequency of adverse events, occurred in patients, treated with original IFX, was comparable with adverse events frequency in patients, received biosimilar IFX. Frequency of adverse events was significantly higher in UC patients, rotating original IFX and its biosimilar.

scholarly journals Electrocardiographic characteristics of patients with coronavirus disease 2019 (COVID-2019) related pneumonia at first presentation

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
U Nguyen ◽  
M Strik ◽  
S Abu-Arib ◽  
A Bruekers ◽  
T Nguyen ◽  
...  
Keyword(s):  
Clinical Presentation ◽  
Negative Group ◽  
Male Mortality ◽  
Funding Sources ◽  
Atrial Enlargement ◽  
Study Population ◽  
Polymerase Chain ◽  
Repolarization Abnormalities ◽  
Funding Acknowledgements

Abstract Funding Acknowledgements Type of funding sources: None. Purpose To evaluate electrocardiographic (ECG) characteristics at first presentation in patients with possible coronavirus disease (COVID-19) pneumonia. Methods and results 356 patients presenting at the emergency room with possible COVID-19 pneumonia based on clinical presentation and computed tomography findings were included and subdivided into a COVID-19 positive group ([COVID-19-positive], n = 231, 65%) and a COVID-19 negative group ([COVID-19-negative], n = 125, 35%) based on polymerase chain reaction tests. The study population was predominantly middle aged-elderly (67 ± 14 year; n = 235, 66% male). Mortality rate was 24% after 1-month follow-up. There were no significant (NS) differences in sex, age, and mortality between the COVID-19-positive and COVID-19-negative group.  Atrial fibrillation (AF) was common (9%), though its prevalence was NS (regression analyses adjusted for age and sex) different in the COVID-19-positive vs. the COVID-19-negative group. ECG characteristics reflecting atrial enlargement and repolarization abnormalities were frequently present (&lt;38% and 14% respectively). No significant differences were found between the COVID-19-positive vs. the COVID-19-negative group for the majority of morphological ECG characteristics (Figure 1 for more detailed data).  Conclusion AF and ECG characteristics reflecting atrial enlargement and repolarization abnormalities are commonly present in COVID-19 patients. The prevalence of these ECG characteristics however do NS differ from their COVID-19-negative counterparts. Abstract Figure.

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