scholarly journals Does Varicocelectomy Improve Gonadal Function in Men with Hypogonadism and Infertility? Analysis of a Prospective Study

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Vasan Sathya Srini ◽  
Srinivas Belur Veerachari
Keyword(s):  
Semen Analysis ◽  
Serum Testosterone ◽  
Serum Levels ◽  
Serum Testosterone Level ◽  
Total Testosterone ◽  
Cell Dysfunction ◽  
The Mean ◽  
Group 2 ◽  
A Prospective Study ◽  
Group 1

Varicocele in infertile males is associated with Leydig cell dysfunction and hypogonadism. The effect of varicocelectomy on serum testosterone level is not yet established. We analysed 200 heterosexual infertile men diagnosed to have clinical varicocele they were divided into two groups: group 1 (100 men) had microsurgical varicocelectomy, and group 2 (100 patients) underwent assisted reproduction procedures. All participants had semen analysis, serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), prolactin, and total testosterone (TT), measured both at recruitment time and 6 months later. In group 1, the mean TT level increased significantly after varicocelectomy (1.644±0.029to2.461±0.0198 ng/dL,P<0.0001) and testicular size correlated with the mean change in TT (P=0.001). No similar change was found in group 2. Out of the 100 patients in group 1, 78 had postoperative normalization of TT unlike only 16 men in group 2.

Impact of Varicocele and Varicocele Surgery on Semen Quality, Erectile Function and Serum Hormone Levels

2018 ◽  
Vol 1 (1) ◽  
pp. 129-136
Author(s):  
Badereddin Mohamad Al-Ali ◽  
Emma Persad ◽  
Andreas Lunacek ◽  
Christof Mrstik ◽  
Eugen Plas
Keyword(s):  
Testosterone Level ◽  
Erectile Function ◽  
Semen Quality ◽  
Semen Analysis ◽  
Serum Testosterone ◽  
T Test ◽  
Serum Testosterone Level ◽  
Testosterone Levels ◽  
Group 2 ◽  
Group 1

Introduction: Many studies suggest that varicoceles are associated with hypogonadism and varicocele repair can increase testosterone levels and improve erectile function.Aim: The aim of this retrospective study was to analyze the impact of varicocele and varicocele surgery on testosterone level, semen quality, and erectile function.Methods: Our study included 265 infertile males with a clinical varicocele. This group was divided into three groups: group 1 (193) patients who did not receive surgery, group 2 (72 patients) who were operated on according to the Palomo procedure and group 3 (28 patients), who acted as a control group without a varicocele. All patients completed the International Index of Erectile Function IIEF-5 (German version) and underwent semen analysis. Serum testosterone, follicle stimulating hormone (FSH), and luteinizing hormone (LH) were measured at inclusion into the study and after surgery.Main outcome measures: Changes in semen quality, erectile function, and serum hormones after surgery.Results: The IIEF-5 scores in groups 1 and 2 were 21.01 ± 2.2; and 21.74 ± 1 respectively, and the resulting t-test for equality of variance was significant (p < 0.0001). Total testosterone level in groups 1 and 2 were 3.16 ± 0.37 and 3 ± 0.01, respectively, and the resulting t-test for equality of variance was significant (p < 0.0001). The results of the semen analysis were better in group 2 (after surgery) (28.6%, p < 0.001) in comparison to group 1. Interestingly, pre-operative serum testosterone levels were lower in patients with later improvement of semen analysis (p = 0.05). Body mass index (p = 0.8), pre-operative serum FSH (p = 0.9), LH (p = 0.2), and nicotine consumption (p = 0.6) were similar in both the group that saw improvement and the group with no change in semen quality.Conclusion: Semen quality improved in 28.6% of patients after varicocele surgery. Erectile dysfunction (ED) improved after varicocele surgery. We report that lower pre-operative serum testosterone level might be a possible indicator for successful surgical outcome.

The Majority of Myeloma Patients Are Hypogonadal but This Is Not Associated with High Risk Cytogenetics

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5329-5329
Author(s):  
Beau Snoad ◽  
Samantha Hudzik ◽  
Douglas W Sborov ◽  
Nita Williams ◽  
Desiree Jones ◽  
...  
Keyword(s):  
Overall Survival ◽  
High Risk ◽  
Conflicts Of Interest ◽  
Serum Testosterone ◽  
Clinic Visit ◽  
Total Testosterone ◽  
Testosterone Levels ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Introduction: Hypogonadism, i.e. low total testosterone, is present in approximately a quarter of men older than 70 years (Harman SM et al, J. Clin Endo & Met, 2001, PMID 11158037 and Wu FCW et al, J Clin Endo & M et, 2008, PMID 18270261). Myeloma patients are known to suffer from fatigue and decreased functional performance, mood disturbances, and anemia; similar trends have been found in people with hypogonadism. Cytogenetically high risk myeloma characterized by the amplification of 1q21 is associated with increased serum levels of soluble IL-6 receptor (sIL-6r) (Stephens OW, Blood, 2012, PMID 22072558). We hypothesized that total testosterone levels will be associated with overall survival from the time of diagnosis, presence of 1q21 amplification by CD138-selected FISH, anemia, and anti-depressant use. Methods: The Buckeye Myeloma Registry (OSU 10115) opened in 2011 to enroll any patient with a plasma cell dyscrasia. Serum total testosterone was measured at the time of the initial clinic visit to the myeloma group at Ohio State. Less than 325 ng/dL was defined as the hypogonadal range, and testosterone was divided into <100 (group 1), 100-240 (group 2), 240-325 (group 3), and greater than 325 ng/dL (group 4), although normal testosterone decreases with age. Female patient testosterone levels were also analyzed and divided into <10 (group 1), 10-60 ng/dL (group 2), and >60 ng/dL (group 3). A retrospective chart review was initiated to review all myeloma patients with a serum testosterone drawn at the time of their initial clinic visit to OSU. Results: Among 418 male MM patients, median age was 65 y.o. (range 24-95), 86% were Caucasian and 14% African-American, and the distribution of ISS stage was 32% stage 1, 22% stage 2, and 19% stage 3 with 28% missing staging data. Cytogenetic data was missing from 28% of patients. Out of 418 male MM patients, 29 (7%) had serum testosterone <100, 202 (48%) with testosterone 100-240, 79 (19%) with testosterone 241-325, and 108 (26%) > 325 ng/dL. Out of 172 female MM patients, 44 (26%) had an undetectable serum testosterone, 120 (70%) with testosterone 10-60, and 8 (5%) with testosterone > 60. Among male MM patients, log-rank [Mantel-Cox] analysis of overall survival with serum testosterone including all 4 groups demonstrated no significant differences (p=0.917) with only 80 events. Among 275 male MM patients with cytogenetic information available, there was no correlation between presence of 1q21 trisomies or tetrasomies and overall survival (r=0.0714, p=0.238). There was a strong and expected correlation between testosterone and BMI (r=0.14, p=0.00468). Among 161 total female MM patients, log-rank analysis with serum testosterone including all 3 groups also demonstrated no differences (p=0.416) with only 29 events in total. Among 101 females with cytogenetic information, there was also no correlation with 1q21 amplification (r=0.0895, p=0.373). Conclusion: The majority of male MM patients (74%) have secondary hypogonadism and approximately half have total testosterone levels <240 ng/dL. Cox proportional hazards analyses of survival adjusted for significant univariate covariates will be presented at the meeting. Correlations with anemia and medication use (specifically opiates and anti-depressants) will also be presented at the meeting. Disclosures No relevant conflicts of interest to declare.

scholarly journals Changes in Testosterone Levels and Sex Hormone-Binding Globulin Levels in Extremely Obese Men after Bariatric Surgery

2016 ◽  
Vol 2016 ◽  
pp. 1-5 ◽  
Author(s):  
Patchaya Boonchaya-anant ◽  
Nitchakarn Laichuthai ◽  
Preaw Suwannasrisuk ◽  
Natnicha Houngngam ◽  
Suthep Udomsawaengsup ◽  
...  
Keyword(s):  
Bariatric Surgery ◽  
Hypogonadotropic Hypogonadism ◽  
Free Testosterone ◽  
Serum Levels ◽  
Sex Hormone Binding Globulin ◽  
Total Testosterone ◽  
Morbidly Obese ◽  
The Mean ◽  
A Prospective Study ◽  
Estradiol Levels

Objective.Obesity is a risk factor for hypogonadotropic hypogonadism in men. Weight loss has been shown to improve hypogonadism in obese men. This study evaluated the early changes in sex hormones profile after bariatric surgery.Methods.This is a prospective study including 29 morbidly obese men. Main outcomes were changes in serum levels of total testosterone (TT), free testosterone (cFT), SHBG, estradiol, adiponectin, and leptin at 1 and 6 months after surgery.Results.The mean age of patients was 31 ± 8 years and the mean BMI was 56.8 ± 11.7 kg/m2. Fifteen patients underwent Roux-en-Y gastric bypass and 14 patients underwent sleeve gastrectomy. At baseline, 22 patients (75.9%) had either low TT levels (<10.4 nmol/L) or low cFT levels (<225 pmol/L). Total testosterone and SHBG levels increased significantly at 1 month after surgery (p≤0.001). At 6 months after surgery, TT and cFT increased significantly (p≤0.001) and 22 patients (75.9%) had normalized TT and cFT levels. There were no changes in estradiol levels at either 1 month or 6 months after surgery.Conclusions. Increases in TT and SHBG levels occurred early at 1 month after bariatric surgery while improvements in cFT levels were observed at 6 months after bariatric surgery.

scholarly journals Effects of Aromatase Inhibition in Elderly Men with Low or Borderline-Low Serum Testosterone Levels

2004 ◽  
Vol 89 (3) ◽  
pp. 1174-1180 ◽  
Author(s):  
Benjamin Z. Leder ◽  
Jacqueline L. Rohrer ◽  
Stephen D. Rubin ◽  
Jose Gallo ◽  
Christopher Longcope
Keyword(s):  
Short Form ◽  
Specific Antigen ◽  
Serum Testosterone ◽  
Total Testosterone ◽  
Elderly Men ◽  
Symptom Index ◽  
Testosterone Levels ◽  
Group 2 ◽  
American Urological Association ◽  
Group 1

Abstract As men age, serum testosterone levels decrease, a factor that may contribute to some aspects of age-related physiological deterioration. Although androgen replacement has been shown to have beneficial effects in frankly hypogonadal men, its use in elderly men with borderline hypogonadism is controversial. Furthermore, current testosterone replacement methods have important limitations. We investigated the ability of the orally administered aromatase inhibitor, anastrozole, to increase endogenous testosterone production in 37 elderly men (aged 62–74 yr) with screening serum testosterone levels less than 350 ng/dl. Subjects were randomized in a double-blind fashion to the following 12-wk oral regimens: group 1: anastrozole 1 mg daily (n = 12); group 2: anastrozole 1 mg twice weekly (n = 11); and group 3: placebo daily (n = 14). Hormone levels, quality of life (MOS Short-Form Health Survey), sexual function (International Index of Erectile Function), benign prostate hyperplasia severity (American Urological Association Symptom Index Score), prostate-specific antigen, and measures of safety were compared among groups. Mean ± sd bioavailable testosterone increased from 99 ± 31 to 207 ± 65 ng/dl in group 1 and from 115 ± 37 to 178 ± 55 ng/dl in group 2 (P &lt; 0.001 vs. placebo for both groups and P = 0.054 group 1 vs. group 2). Total testosterone levels increased from 343 ± 61 to 572 ± 139 ng/dl in group 1 and from 397 ± 106 to 520 ± 91 ng/dl in group 2 (P &lt; 0.001 vs. placebo for both groups and P = 0.012 group 1 vs. group 2). Serum estradiol levels decreased from 26 ± 8 to 17 ± 6 pg/ml in group 1 and from 27 ± 8 to 17 ± 5 pg/ml in group 2 (P &lt; 0.001 vs. placebo for both groups and P = NS group 1 vs. group 2). Serum LH levels increased from 5.1 ± 4.8 to 7.9 ± 6.5 U/liter and from 4.1 ± 1.6 to 7.2 ± 2.8 U/liter in groups 1 and 2, respectively (P = 0.007 group 1 vs. placebo, P = 0.003 group 2 vs. placebo, and P = NS group 1 vs. group 2). Scores for hematocrit, MOS Short-Form Health Survey, International Index of Erectile Function, and American Urological Association Symptom Index Score did not change. Serum prostate-specific antigen levels increased in group 2 only (1.7 ± 1.0 to 2.2 ± 1.5 ng/ml, P = 0.031, compared with placebo). These data demonstrate that aromatase inhibition increases serum bioavailable and total testosterone levels to the youthful normal range in older men with mild hypogonadism. Serum estradiol levels decrease modestly but remain within the normal male range. The physiological consequences of these changes remain to be determined.

scholarly journals A Prospective Study to Evaluate the efficacy of Isopropyl Alcohol Irrigations to Prevent Cerumen Impaction

2012 ◽  
Vol 91 (3) ◽  
pp. E25-E28 ◽  
Author(s):  
Herbert Silverstein ◽  
Benjamin J. Wycherly ◽  
Yadiel Alameda ◽  
Mark J. Van Ess
Keyword(s):  
Prospective Study ◽  
Crossover Study ◽  
Isopropyl Alcohol ◽  
Initial Evaluation ◽  
Safety And Efficacy ◽  
Significant Difference ◽  
The Mean ◽  
Group 2 ◽  
A Prospective Study ◽  
Group 1

We conducted a prospective crossover study to assess the safety and efficacy of 70 % isopropyl alcohol delivered from a squeezable bottle with a specially designed tip as a weekly irrigant to reduce cerumen accumulation. Twenty patients were divided into 2 groups of 10 (20 ears in each group). The patients in group 1 instilled 70% isopropyl alcohol once a week for 2 months; this was followed by 2 months of no ear cleaning. The patients in group 2 performed the opposite routine. At each visit (0, 2, and 4 mo), cerumen accumulation was graded on a scale of 0 to 4, indicating 0, 25, 50, 75, and 100% occlusion, respectively. After the accumulation was graded, a cerumenectomy was performed. At the initial evaluation, the mean occlusion scores were 3.1 for group 1 and 3.3 for group 2—not a statistically significant difference. After the first 2 months of the study, there was a significant difference in occlusion scores between groups 1 and 2 (0.75 and 1.55, respectively; p (p = 0.38). At study's end, there were also significant differences within each group between occlusion scores obtained during the treatment and nontreatment periods (group 1: p 0.02; group 2: p.

scholarly journals Digital Tool to Help Stop Newborn Phototherapy: A Prospective Study

2020 ◽  
Vol 15 (8) ◽  
pp. 3-9
Author(s):  
Dennis Costakos ◽  
Mengyi Zha ◽  
Lynn Dahlen
Keyword(s):  
Nurse Practitioners ◽  
User Satisfaction ◽  
Medical Center ◽  
End User ◽  
Digital Tool ◽  
The Mean ◽  
Family Nurse Practitioners ◽  
Group 2 ◽  
A Prospective Study ◽  
Group 1

The present study evaluated end-user experience for effectiveness, efficiency, and satisfaction of a mobile application (app) to estimate the risk of rebound hyperbilirubinemia within 72 hours after initial phototherapy ends for infants at 35 weeks’ gestation or longer and age younger than 14 days. This prospective parallel study was performed at one medical center. The 26 participants are neonatology and pediatric and family physicians, neonatal and family nurse practitioners, and family practice residents, who were asked to estimate the risk of rebound hyperbilirubinemia when phototherapy is stopped for a fictional newborn. Participants in Group 1 (no app) were compared with Group 2 (with app). Satisfaction measured from 1 (0%) to 7 (100%). Group 1 had fewer correct answers than Group 2 (38.5% vs. 84.6%; P = .04). The mean satisfaction score for Group 1 was 2, lower than the score for Group 2, 6.6 (P < .001). This provider-developed app is effective and receives high end-user satisfaction.

scholarly journals The Impact of COVID-19 Pandemic during 2020–2021 on the Vitamin D Serum Levels in the Paediatric Population in Warsaw, Poland

Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1990
Author(s):  
Agnieszka Rustecka ◽  
Justyna Maret ◽  
Ada Drab ◽  
Michalina Leszczyńska ◽  
Agata Tomaszewska ◽  
...  
Keyword(s):  
Vitamin D ◽  
Seasonal Variability ◽  
Serum Levels ◽  
Paediatric Population ◽  
Sunlight Exposure ◽  
Vitamin D Levels ◽  
The Mean ◽  
Group 2 ◽  
The Impact ◽  
Group 1

Background: The main source of vitamin D is skin synthesis, which depends on sunlight exposure. During the pandemic, COVID-19 children were obliged to home confinement, which potentially limiting sunlight exposure. The aim of this study was to evaluate whether home confinement led to decreased vitamin D serum levels in children in Warsaw, Poland. Methods: The study included 1472 children who were divided into two groups, based on the date of 25(OH)D level blood sampling: before and during the pandemic. Children under 1 year of age (infants) were analysed separately. Results: A statistically significant decrease in the average level of vitamin D was observed between groups of children over 1 year of age (35 ng/mL ± 18 vs. 31 ng/mL ± 14). In infants from both groups, the mean vitamin D levels were within the normal range (Group 1 inf 54 ng/mL ± 21 vs. Group 2 inf 47 ng/mL ± 15). The characteristic seasonal variability was observed before the pandemic, with maximal vitamin D levels in summer (40 ng/mL ± 17) and minimal levels in winter (30 ng/mL ± 14). During the pandemic, no seasonal variability was observed (summer 30 ng/mL ± 11 vs. winter 30 ng/mL ± 19). Conclusions: The COVID-19 pandemic restrictions led to a significant decrease in vitamin D serum levels in children.

RISKS OF ANEMIA DEVELOPMENT IN DONORS ACCORDING TO INHERITED PREDISPOSITION AND REGULARITY OF BLOOD DONATION

2020 ◽  
pp. 72-83
Author(s):  
I.M. Vorotnikov ◽  
V.A. Razin ◽  
I.M. Lamzin ◽  
M.N. Sokolova ◽  
M.E. Khapman ◽  
...  
Keyword(s):  
Blood Donors ◽  
Blood Donation ◽  
Hla Antigens ◽  
Hla Typing ◽  
Main Role ◽  
Inherited Predisposition ◽  
Group 2 ◽  
Student’S T ◽  
A Prospective Study ◽  
Group 1

Anemia is one of the most common complications of blood donation. Thus, the objective of the paper was to assess the risks of anemia development in donors according to the regularity of donation and inherited predisposition. Materials and Methods. The authors carried out a prospective study, which included 241 blood donors, using random sampling and case-control techniques. Depending on blood donation frequency, the donors were divided into 2 groups: Group 1 consisted of 122 people (51.5 %) frequently donating blood; Group 2 included 119 people (48. 5 %) rarely donating blood. We studied the initial indicators of a general blood test and the same indicators a year after the first blood donation. Additionally, we performed HLA typing of donors. Statistica v. 8.0 software package (Stat Soft Inc., USA) was used for statistical analysis. To compare two independent samples, we used a nonparametric Mann-Whitney U-test and a parametric Student’s t-test (depending on the type of distribution). To assess anemia risks, the odds ratio was calculated. Results. One year after the first blood donation, anemia was diagnosed in 13 people (10.6 %) in Group 1 and in 7 people (5.9 %) in Group 2 (p=0.179). A11 and B7 HLA antigens did not increase anemia risks in group 1 (OS=1.257 (95 % CI 0.318–4.973) and OS=0.240 (95 % CI 0.051–1.134, respectively). HLA-antigens A11 and B7 did not increase anemia risks in Group 1 (OR=1.257 (95 % CI 0.318-4.973) and OR=0.240 (95 % CI 0.051–1.134), respectively). In group 2, antigen-A11 was also an insignificant factor (OS=2.902 (95 % CI 0.606-13.889)) for anemia development. Whereas, antigen-B7 increased anemia risks by 14 times (OS=14.364 (95 % CI 1.644-124.011)). Conclusion. In rare blood donors, it is the genetic factor that plays the main role in anemia development. High prevalence rates of anemia in frequent blood donors are probably determined by other factors. Keywords: anemia, blood donors, HLA typing. Механизмы развития анемий и факторы, их индуцирующие, остаются до конца не изученными. Целью исследования стало изучение риска развития анемии у доноров крови в зависимости от частоты донации и наличия наследственной предрасположенности к развитию анемии. Материалы и методы. Проведено проспективное исследование, выполненное методами случайной выборки и «случай-контроль», в которое вошел 241 донор крови. В зависимости от частоты сдачи доноры были поделены на 2 группы: группу 1 составили 122 чел. (51,5 %), часто сдающие кровь; группу 2 – 119 чел. (48,5 %), редко сдающих кровь. Изучались исходные показатели общего анализа крови и через год от начала донации. Дополнительно проводилось HLA-типирование доноров. Статистический анализ осуществлялся с применением программы Statistica v. 8.0 (Stat Soft Inc., США). Для сравнения двух независимых выборок использовался непараметрический U-критерий Манна–Уитни и параметрический t-критерий Стьюдента (в зависимости от типа распределения). Для оценки риска возникновения анемии рассчитывалось отношение шансов. Результаты. Через год с момента первой сдачи крови в группе 1 выявлено 13 чел. (10,6 %) с анемией, в группе 2 – 7 чел. (5,9 %) (р=0,179). Наличие HLA-антигенов А11 и B7 не повышало риск развития анемии в группе 1 (ОШ=1,257 (95 % ДИ 0,318–4,973) и ОШ=0,240 (95 % ДИ 0,051–1,134 соответственно). В группе 2 наличие гена А11 также являлось незначимым фактором (ОШ=2,902 (95 % ДИ 0,606–13,889), присутствие гена В7 в 14 раз повышало риск развития анемии (ОШ=14,364 (95 % ДИ 1,664–124,011). Выводы. Высокий риск развития анемии у редко сдающих кровь доноров обусловливается генетическими факторами. Высокая распространённость анемии у часто сдающих кровь доноров, вероятно, определяется другими факторами. Ключевые слова: анемия, доноры крови, HLA-типирование.

Creation of physiologic rhythm by closed loop stimulation in heart failure patients with severe chronotropic incompetence: worldwide first results of a pilot study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Proff ◽  
B Merkely ◽  
R Papp ◽  
C Lenz ◽  
P.J Nordbeck ◽  
...  
Keyword(s):  
Heart Rate ◽  
Closed Loop ◽  
Funding Source ◽  
Chronotropic Incompetence ◽  
First Results ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Abstract Background The prevalence of chronotropic incompetence (CI) in heart failure (HF) population is high and negatively impacts prognosis. In HF patients with an implanted cardiac resynchronisation therapy (CRT) device and severe CI, the effect of rate adaptive pacing on patient outcomes is unclear. Closed loop stimulation (CLS) based on cardiac impedance measurement may be an optimal method of heart rate adaptation according to metabolic need in HF patients with severe CI. Purpose This is the first study evaluating the effect of CLS on the established prognostic parameters assessed by the cardio-pulmonary exercise (CPX) testing and on quality of life (QoL) of the patients. Methods A randomised, controlled, double-blind and crossover pilot study has been performed in CRT patients with severe CI defined as the inability to achieve 70% of the age-predicted maximum heart rate (APMHR). After baseline assessment, patients were randomised to either DDD-CLS pacing (group 1) or DDD pacing at 40 bpm (group 2) for a 1-month period, followed by crossover for another month. At baseline and at 1- and 2-month follow-ups, a CPX was performed and QoL was assessed using the EQ-5D-5L questionnaire. The main endpoints were the effect of CLS on ventilatory efficiency (VE) slope (evaluated by an independent CPX expert), the responder rate defined as an improvement (decrease) of the VE slope by at least 5%, percentage of maximal predicted heart rate reserve (HRR) achieved, and QoL. Results Of the 36 patients enrolled in the study, 20 fulfilled the criterion for severe CI and entered the study follow-up (mean age 68.9±7.4 years, 70% men, LVEF=41.8±9.3%, 40%/60% NYHA class II/III). Full baseline and follow-up datasets were obtained in 17 patients. The mean VE slope and HRR at baseline were 34.4±4.4 and 49.6±23.8%, respectively, in group 1 (n=7) and 34.5±12.2 and 54.2±16.1% in group 2 (n=10). After completing the 2-month CPX, the mean difference between DDD-CLS and DDD-40 modes was −2.4±8.3 (group 1) and −1.2±3.5 (group 2) for VE slope, and 17.1±15.5% (group 1) and 8.7±18.8% (group 2) for HRR. Altogether, VE slope improved by −1.8±2.95 (p=0.31) in DDD-CLS versus DDD-40, and HRR improved by 12.9±8.8% (p=0.01). The VE slope decreased by ≥5% in 47% of patients (“responders to CLS”). The mean difference in the QoL between DDD-CLS and DDD-40 was 0.16±0.25 in group 1 and −0.01±0.05 in group 2, resulting in an overall increase by 0.08±0.08 in the DDD-CLS mode (p=0.13). Conclusion First results of the evaluation of the effectiveness of CLS in CRT patients with severe CI revealed that CLS generated an overall positive effect on well-established surrogate parameters for prognosis. About one half of the patients showed CLS response in terms of improved VE slope. In addition, CLS improved quality of life. Further clinical research is needed to identify predictors that can increase the responder rate and to confirm improvement in clinical outcomes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Biotronik SE & Co. KG

scholarly journals SAT0140 SAFETY OF TOFACITINIB THERAPY IN HBSAG CARRIERS WITH RHEUMATOID ARTHRITIS: A PROSPECTIVE STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1008.2-1008
Author(s):  
L. Fang ◽  
Z. Lin ◽  
Z. Liao ◽  
O. Jin ◽  
Y. Pan ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Viral Load ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Hbv Infection ◽  
Hbsag Carriers ◽  
B Virus ◽  
Group 2 ◽  
A Prospective Study ◽  
Group 1

Background:Targeted synthetic DMARDs (ts-DMARDs) are becoming more available and affordable in developing countries, where the prevalence of hepatitis B virus (HBV) infection is still an important public health issue. The safety of ts-DMARDs therapy in terms of the reactivation of hepatitis B virus (HBV) infection need more concern. Rare data from a prospective study focus on the use of ts-DMARDs in patients with concurrent rheumatoid arthritis (RA) and HBV infection were available by now.Objectives:To evaluate the influence of tofacitinib on reactivation of HBV infection in HBsAg carriers with RA.Methods:In this 52 weeks observation, HBsAg carriers with active RA (DAS28>5.1) despite failed combined treatment with MTX and other non-biological DMARDs were enrolled. Patients must have normal liver function prior to study. All patients received therapy with tofacitinib (5mg twice daily) and concomitant MTX (10-12.5mg/w). Entecavir was prescribed preventively for patients who had a baseline HBV load >2000 copy/ml (group 1), and Lamivudin for patients with HBV load ≤ 2000 copy/ml (group 2). Liver enzymes (AST/ALT) and HBV viral load were monitored every 4 weeks. Increased viral load and abnormal liver function were managed according to expert opinion.Results:Thirteen patients (10 female) were recruited. Nine patients had a baseline viral load >2000 copy/ml (group 1, with preventive Entecavir), and the other 4 patients had a viral load ≤ 2000 copy/ml (group 2, with preventive Lamivudin). Two patients from group 1 discontinued tofacitinib at week 12 due to ineffectiveness, and both continued taking Entecavir for another 3 months after the discontinuation of tofacitinib.No reactivation of hepatitis B was observed in patients from group 1. One patients (female, 54 years old) from group 2 underwent a mild increase of both ALT and AST (67 and 56 IU/L, respectively) at week 16. An elevated viral load (4.9e6 copies/ml, baseline 1.4e3) and a HBV YMDD mutant was also found. The tofacitinib treatment continued. After prescription of Adefovir (combined with the pre-existing Lamivudin), both liver enzyme and viral load decreased to normal range in 8 weeks and remained normal throughout the study.Conclusion:An aggressive Tofacitinib + MTX therapy may be a safe option for HBsAg carriers with cs-DMARDs refractory RA. More active and effective prophylaxis strategy may be recommended to reduce the risk of HBV reactivation during the treatment.References:[1]Chen YM, Huang WN, Wu YD, et al. Reactivation of hepatitis B virus infection in patients with rheumatoid arthritis receiving tofacitinib: a real-world study. Ann Rheum Dis 2018; 77:780-2.Disclosure of Interests: :None declared

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