scholarly journals Factors associated with parathyroid hormone control in haemodialysis patients with secondary hyperparathyroidism treated with cinacalcet in real-world clinical practice: Mimosa study

2019 ◽  
Vol 12 (6) ◽  
pp. 871-879 ◽  
Author(s):  
Jacques Rottembourg ◽  
Pablo Ureña-Torres ◽  
Daniel Toledano ◽  
Victor Gueutin ◽  
Abdelaziz Hamani ◽  
...  
Keyword(s):  
Parathyroid Hormone ◽  
Secondary Hyperparathyroidism ◽  
Real Life ◽  
Normal Range ◽  
Life Study ◽  
Dialysis Vintage ◽  
Cinacalcet Hydrochloride ◽  
Kdigo Guidelines ◽  
Hormone Control

Abstract Background Secondary hyperparathyroidism (SHPT) is frequent in haemodialysis (HD) patients. Oral cinacalcet-hydrochloride (HCl) decreases parathyroid hormone (PTH); however, real-life PTH data, according to Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, are still lacking. Our goal is to assess the percentage of cinacalcet-HCl-treated HD patients with controlled SHPT (PTH <9× upper limit of the normal range) after 12 months (M12) of treatment. Methods This is a retrospective observational study in HD patients with SHPT treated by cinacalcet-HCl between 2005 and 2015 and dialysed in seven French HD centres using the same database (Hemodial™). Results The study included 1268 patients with a mean (standard deviation) follow-up of 21 ± 12 months. Their mean dialysis vintage was 4.3 ± 5.6 years. PTH values were available and exploitable at M12 in 50% of them (645 patients). Among these patients, 58.9% had controlled (mean PTH of 304 ± 158 pg/mL) and 41.1% uncontrolled SHPT (mean PTH of 1084 ± 543) at M12. At the baseline, patients with controlled SHPT were older (66 ± 15 versus 61 ± 17 years), and had lower PTH (831 ± 346 versus 1057 ± 480 pg/mL) and calcaemia (2.18 ± 0.2 versus 2.22 ± 0.19 mmol/L) than uncontrolled patients. In multivariate analysis, these three factors still remained significantly associated with controlled SHPT. Conclusion In this real-life study, 41.1% of HD patients with SHPT treated with cinacalcet-HCl remained with a PTH above the KDIGO recommended target after 12 months of treatment. Apart from the possibility of non-compliance, the severity of SHPT appears to be a major factor determining the response to cinacalcet-HCl treatment, reinforcing the importance of treating SHPT at earlier stages.

P1425EFFICACY AND SAFETY OF INTRAVENOUS PARICALCITOL TREATMENT IN CHINESE HEMODIALYSIS PATIENTS WITH SECONDARY HYPERPARATHYROIDISM: A REAL-WORLD DATABASE ANALYSIS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Niansong Wang ◽  
Gengru Jiang
Keyword(s):  
Parathyroid Hormone ◽  
Observational Study ◽  
Secondary Hyperparathyroidism ◽  
Median Time ◽  
Real World ◽  
Hemodialysis Patients ◽  
Target Range ◽  
Total Serum ◽  
Weekly Dose

Abstract Background and Aims The aim of this retrospective, real-world data based observational study was to evaluate the efficacy, safety profile of paricalcitol in Chinese hemodialysis (HD) patients with secondary hyperparathyroidism (SHPT) under routine clinical practice. Method From the Zemplar Engagement Program (ZEP) database, a total of 668 Chinese hemodialysis patients from 104 dialysis centers between January 2015 and May 2019 were included in the analysis set. Intact parathyroid hormone (iPTH), total serum calcium (Ca), phosphate (P), dosage of intravenous (IV) paricalcitol (Zemplar®) were analyzed and discussed via retrospective analysis of the database during the treatment. The comparison between baseline and end of treatment was made to reveal the fluctuation trend of each biomarker and reflected us with clues of IV paricalcitol’s algorithm in real-world practice. Results Patients were divided into five groups according to the duration of follow-up, which includes Month 0.5-3 (Day 14–90), Month 3-6 (Day 91–180), Month 6-12 (Day 181–360), Month 12-24 (Day 361–720) and Month 24-48 (Day 721–1440). Median iPTH levels decreased from 1183.05 pg/ml at baseline to 676.03 pg/ml at last visit by 30.88% (p < 0.0001). 56.14% of patients had a ≥30% decrease and 29.34% of patients had a ≥50% decrease in iPTH. The proportion of patients achieving the Chinese CKD-MBD Guideline target range (<600 pg/ml) increased from 9.88% at treatment initiation to 40.12% at last observation. Serum Ca levels remained within the normal range throughout the study with only a slight but statistically significant increase in the group of Month 12-24 (P=0.0479). Serum phosphate remained stable in all follow-up groups (P>0.05). Subgroup analyses of 221 patients with hyperphosphatemia at baseline >1.78 mmol/l showed a rapid phosphate reduction from 2.00±0.20 mmol/l to 1.76±0.34mmol/l by 11.64% (P< 0.0001), within the first few weeks, along with the reduction of iPTH. Of all patients, 62.72% experienced a 30% decrease in iPTH within a median time of 16.86 weeks (95% CI, 15.57-17.86), 38.17% experienced a 50% decrease in iPTH within a median time of 21.29 weeks (95% CI, 19.86-23.14). The average weekly dose of paricalcitol was 19.69±8.99ug/week. Total dose of paricalcitol used and baseline iPTH were negatively correlated with the decrease in iPTH. Conclusion This is the first national retrospective real-world observational study since IV paricalcitol is available in China since 2014. It proves that up to 20ug weekly IV paricalcitol treatment is safe and effective in China HD patients with higher iPTH level. Physicians and patients could expect significantly iPTH decrease within 16-21 weeks when IV paricalcitol is initiated. This study also encores the pre-published results of paricalcitol trials and high-quality cohorts, from the real-world perspective. In summary, IV paricalcitol is well tolerated and serves as an effective approach to treat SHPT in Chinese HD patients. Figure.1 Mean iPTH values from baseline to last measurement (pg/ml) Figure.2 iPTH changes compared with baseline stratified by baseline iPTH values (%) Figure.3 Proportion of patients with a >=30% or 50% decrease in parathyroid hormone (%) Figure.4 Changes of iPTH and P from baseline to last measurement in the subgroup of hyperphosphatemia (Mean ± SD); (Hyperphosphatemia, defined as P>1.78 mmol/l)

scholarly journals Betahistine in the Treatment of Peripheral Vestibular Vertigo: Results of a Real-Life Study in Primary Care

2019 ◽  
Vol 99 (6) ◽  
pp. 356-360
Author(s):  
Guillermo Sanchez-Vanegas ◽  
Carlos Castro-Moreno ◽  
Diana Buitrago
Keyword(s):  
Primary Care ◽  
Incidence Rate ◽  
Cumulative Incidence ◽  
Primary Care Physicians ◽  
Real Life ◽  
Global Improvement ◽  
Life Study ◽  
Observational Prospective Cohort Study ◽  
Vestibular Vertigo

The present research was carried out with the objective to establish the clinical effect and safety of betahistine (48 mg daily), for the management of peripheral vestibular vertigo, in patients treated by primary care physicians in Colombia. An observational prospective cohort study was conducted including patients older than 15 years with clinical diagnosis of peripheral vestibular vertigo who were candidates to be treated with betahistine (48 mg daily). A sample size of 150 individuals was calculated, and weekly follow-ups were planned for 12 weeks. Rotatory movement sensation, loss of balance, and global improvement scale from 0 to 100 points were evaluated. Complete improvement was defined when the patient reached a level of 100 points. We calculated average weekly improvement, cumulative incidence of complete improvement, incidence rate of complete improvement, and the probability of complete improvement as a function of time. After the first week, the average improvement was 56.6 points (95% confidence interval [CI]: 50.4-62.7). At the end of week 12, it was 89.3 points (95% CI: 86.5-92.2). Sixty-one percent of the patients had achieved complete improvement at the end of the second week. After the sixth week, the percentage of cumulative improvement was 72%, and after 12 weeks of follow-up, the cumulative incidence of complete improvement was 73% (95% CI: 65%-80%). Based on the follow-up times, a complete improvement incidence rate of 16 cases per 100 people/week was calculated (95% CI: 13-19). We concluded that Betahistine (48 mg daily) has a positive effect, controlling the symptoms associated with benign paroxysmal vertigo, with an adequate safety profile.

A RADIOIMMUNOASSAY FOR PARATHYROID HORMONE IN MAN

1970 ◽  
Vol 63 (4) ◽  
pp. 655-666 ◽  
Author(s):  
R. M. Lequin ◽  
W. H. L. Hackeng ◽  
W. Schopman
Keyword(s):  
Parathyroid Hormone ◽  
Primary Hyperparathyroidism ◽  
Guinea Pig ◽  
Secondary Hyperparathyroidism ◽  
Calcium Metabolism ◽  
Normal Adult ◽  
Normal Range ◽  
The Mean

ABSTRACT With a guinea-pig antiserum against bovine PTH, human PTH could be measured in plasma. PTH-levels were expressed in terms of equivalents b/PTH per ml. In normal, adult subjects the mean plasma PTH concentration was 140 pg b-PTH eq./ml with a range of non-detectable (< 70) to 200 pg b-PTH eq./ml. Patients with primary hyperparathyroidism showed overlap with the normal range; in secondary hyperparathyroidism the levels were usually far higher. The PTH levels in patients with a variety of disorders involving calcium metabolism were studied.

scholarly journals Functional Progression in Patients with Interstitial Lung Disease Resulted Positive to Antisynthetase Antibodies: A Multicenter, Retrospective Analysis

2020 ◽  
Vol 9 (9) ◽  
pp. 3033
Author(s):  
Giulia Dei ◽  
Paola Rebora ◽  
Martina Catalano ◽  
Marco Sebastiani ◽  
Paola Faverio ◽  
...  
Keyword(s):  
Interstitial Lung Disease ◽  
Lung Function ◽  
Lung Disease ◽  
Demographic Data ◽  
Real Life ◽  
Lung Function Decline ◽  
Main Determinant ◽  
Life Study ◽  
Antisynthetase Antibodies

Antisynthetase syndrome (ASSD) is a rare autoimmune disease characterized by serologic positivity for antisynthetase antibodies. Anti-Jo1 is the most frequent, followed by anti PL-7, anti PL-12, anti EJ, and anti OJ antibodies. The lung is the most frequently affected organ, usually manifesting with an interstitial lung disease (ILD), which is considered the main determinant of prognosis. Some evidences suggest that non-anti-Jo-1 antibodies may be associated with more severe lung involvement and possibly with poorer outcomes, while other authors do not highlight differences between anti-Jo1 and other antisynthetase antibodies. In a multicenter, retrospective, “real life” study, we compared lung function tests (LFTs) progression in patients with ILD associated with anti-Jo1 and non-anti-Jo1 anti-synthetase antibodies to assess differences in lung function decline between these two groups. Therefore, we analyzed a population of 57 patients (56% anti-Jo1 positive), referred to the outpatient Clinic of four referral Centers in Italy (Modena, Monza, Siena, and Trieste) from 2008 to 2019, with a median follow-up of 36 months. At diagnosis, patients showed a mild ventilatory impairment and experienced an improvement of respiratory function during treatment. We did not observe statistically significant differences in LFTs at baseline or during follow-up between the two groups. Moreover, there were no differences in demographic data, respiratory symptoms onset (acute vs. chronic), extrapulmonary involvement, treatment (steroid and/or another immunosuppressant), or oxygen supplementation. Our study highlights the absence of differences in pulmonary functional progression between patients positive to anti-Jo-1 vs. non anti-Jo-1 antibodies, suggesting that the type of autoantibody detected in the framework of ASSD does not affect lung function decline.

Improved Control of Secondary Hyperparathyroidism in Hemodialysis Patients Switching from Oral Cinacalcet to Intravenous Etelcalcetide, Especially in Nonadherent Patients

2019 ◽  
Vol 48 (2) ◽  
pp. 106-114 ◽  
Author(s):  
Marc Xipell ◽  
Enrique Montagud-Marrahi ◽  
María Victoria Rubio ◽  
Raquel Ojeda ◽  
Marta Arias-Guillén ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Secondary Hyperparathyroidism ◽  
Prospective Observational Study ◽  
Conversion Factor ◽  
Statistical Significance ◽  
Hemodialysis Patients ◽  
Normal Range ◽  
Improve Treatment ◽  
Dose Conversion Factor

Background: Etelcalcetide is a novel second-generation calcimimetic that, because of its intravenous administration, could improve treatment adherence in secondary hyperparathyroidism (SHPT). The aim of this study was to evaluate the effectiveness of etelcalcetide compared with that of cinacalcet in controlling SHPT in patients under hemodialysis. Methods: A prospective observational study was performed in 29 patients with SHPT under hemodialysis who switched from cinacalcet to etelcalcetide with a follow-up of 6 months. A survey was conducted of adherence to the oral calcimimetic. The primary end-point of the study was to assess whether etelcalcetide was more effective than cinacalcet in controlling SHPT. Results: After the switch of treatment, none of the patients developed clinical intolerance or new adverse effects. Etelcalcetide was more effective than cinacalcet in controlling intact parathyroid hormone (iPTH), with an overall decrease in iPTH levels that was significant from the second month. Average calcium levels remained within the normal range, with a higher percentage of hypocalcemia with etelcalcetide (6.9 vs. 13.8%), which was asymptomatic in all cases. Patients who were nonadherent to cinacalcet (38%) showed a significant reduction in calcium and iPTH during follow-up with etelcalcetide. The adherent group (62%) also showed a trend to lower iPTH levels reaching statistical significance after 5 months of follow-up. The dose conversion factor for the switch from cinacalcet to etelcalcetide was etelcalcetide/session = 0.111*mg cinacalcet/day + 0.96, R2 = 0.57. Conclusions: Etelcalcetide was more effective than cinacalcet in this patient population, especially in the nonadherent subgroup, leading to better SHPT control without adverse effects.

scholarly journals DOP26 Real-life dosing patterns and concomitant drug use among ustekinumab-treated patients with Crohn’s disease

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S066-S066
Author(s):  
C G af Björkesten ◽  
T Ilus ◽  
T Hallinen ◽  
E Soini ◽  
A Eberl ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Maintenance Treatment ◽  
Real Life ◽  
Dosage Interval ◽  
Biologic Agent ◽  
Life Study ◽  
Insufficient Response

Abstract Background Real-life long-term evidence on ustekinumab treatment in patients with Crohn’s disease (CD) is limited. We performed a retrospective non-interventional nation-wide chart review study of dosing and long-term clinical outcomes in Finnish CD patients treated with ustekinumab (FINUSTE2, EUPAS30920). Methods FINUSTE2 was carried out in 17 Finnish centres. Eligible patients were adults with CD, receiving an intravenous (IV) first dose of ustekinumab during 2017 or 2018. Data on disease activity, dosage, and concomitant medications were collected at baseline, 16 weeks, and 1 year from treatment initiation. All measurements on ustekinumab trough concentrations (TC) were recorded. Results The study included 155 patients (48% female) with a mean age of 44 and disease duration of 14 years. The disease was stricturing or penetrating in 69% of patients, 59% had prior CD-related surgeries, and 96% had a treatment history of at least one biologic agent. After one IV dose and one to two subcutaneous (SC) doses at 8 to 16 weeks, 140 patients (93%) continued to maintenance treatment with SC ustekinumab, of which nearly three-quarters with a dosage interval of 8 weeks (Figure 1). Of 93 patients with a follow-up of at least 1 year, 77 were still on ustekinumab. During follow-up, 55 patients (39%) had their ustekinumab dose adjusted, mostly (n = 44, 31.4%) as a shortening of the dosage interval. Forty-nine patients had in total 65 ustekinumab TC measurements performed, with a mean of 2.2 µg/ml at 16 weeks (n = 23) and 2.7 µg/ml at 1 year (n = 25). In 67% of cases, the reason for measuring TC was lack of or insufficient response. No anti-drug antibodies appeared at any time point. The proportion of patients on ustekinumab monotherapy increased significantly, from 34% (n = 52) at baseline to 54% (n = 79/146; p &lt; 0.001) at 16 weeks and 64% (n = 49/77; p &lt; 0.01) at 1 year. Correspondingly, corticosteroid use decreased significantly, and a trend towards reduced use of immunomodulators was observed (Figure 2). Conclusion In this nationwide real-life study, treatment with ustekinumab in patients with longstanding and complicated CD was persistent and allowed for significant corticosteroid tapering. A vast majority started the maintenance treatment with an 8-week dosage interval and nearly one-third of all patients required a dose increase, suggesting a highly refractory disease phenotype. The lack of detected antidrug antibodies during follow-up indicates low immunogenicity for ustekinumab.

Results of the VENUS study: Bevacizumab efficacy and safety in platinum-sensitive recurrent ovarian cancer (OC)—A real-life ambispective study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5540-5540
Author(s):  
Isabelle Laure Ray-Coquard ◽  
Jerome Alexandre ◽  
Francois Goldwasser ◽  
Jean-Philippe Spano ◽  
Dominique Berton-Rigaud ◽  
...  
Keyword(s):  
De Novo ◽  
Real Life ◽  
Progression Free Survival ◽  
Recurrent Ovarian Cancer ◽  
Free Survival ◽  
Life Study ◽  
Platinum Sensitive ◽  
Real Life Setting ◽  
Grade 3

5540 Background: The VENUS study reports on the efficacy/safety of bevacizumab (Bev) in patients (pts) treated in the real-life setting. Methods: In this multicentric observational ambispective VENUS study, all Pts were naive of any antiVEGF and received Bev +/- chemotherapy. Pts were followed until progression or death, for a maximum of 3 years since Bev initiation. De novo side effects were defined as symptoms for which patients were naïve at baseline. Results: 148 OC pts were included (27 centres), 10 excluded and 8 were lost of follow-up. 52 were retrospective. Median age 64 years (55-70). 84.1% were advanced. Median duration of Bev was 8.6 months, min 1 max 36 months. Initial Bev dose was 15 mg/kg Q3W for 65.3%, 10.0 for 22.5%, 7.5 for 10.2% and 5.0 for 2%. 2 pts presented with thrombotic micro-angiopathy (1.4%). Before Bev, hypertension (HTN) was present in 28.9%; proteinuria in 11.3%. Incidence of de novo HTN was 25%. 43 pts (31.2%) experienced de novo Grade 1-2 Pu, for a total of 56 events, no grade 3-4 was observed. A total of 12 Grade 4 events occurred: 9 neutropenia and 3 thrombopenia. Mean overall survival (OS) and progression free survival (PFS) were 30.0 and 13.3 months, respectively. Conclusions: 1) 1/3 of pts were treated at low doses in this real-life study; 2) safety of Bev in real-life was manageable and as expected, 3) OS and PFS were consistent with those reported in the OCEANS study: PFS 12.4 and OS 33.6 months but lower than in the GOG-0213 study: PFS 13.8 and OS 42.6 months. De novo events recorded during follow-up. [Table: see text]

Long-term follow-up of diabetic macular edema treated with dexamethasone implant: a real-life study

2020 ◽  
Vol 57 (12) ◽  
pp. 1413-1421 ◽  
Author(s):  
Thibaud Mathis ◽  
Théo Lereuil ◽  
Amro Abukashabah ◽  
Nicolas Voirin ◽  
Aditya Sudhalkar ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Real Life ◽  
Dexamethasone Implant ◽  
Life Study ◽  
Long Term Follow Up ◽  
Real Life Study

scholarly journals Relapse in rheumatoid arthritis patients undergoing dose reduction and withdrawal of biologics: are predictable factors more relevant than predictive parameters? An observational prospective real-life study

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e031467
Author(s):  
Olivier Vittecoq ◽  
Sandra Desouches ◽  
Marie Kozyreff ◽  
Julia Nicolau ◽  
Sophie Pouplin ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Dose Reduction ◽  
Activity Index ◽  
Real Life ◽  
Disease Activity Index ◽  
Female Gender ◽  
Life Study ◽  
Predictive Parameters ◽  
Real Life Study

ObjectiveTo determine predictive/predictable factors of relapse in rheumatoid arthritis (RA) patients undergoing biologic Disease-Modifying Anti-Rheumatic Drugs (bDMARDs) dose reduction/discontinuation.Patients and methodsRA patients receiving the same bDMARD for more than 1 year, in Simplified Disease Activity Index (SDAI) remission, were selected in an observational monocentric real-life study. The 18-month follow-up included spacing (6 months) and withdrawal (12 months) periods of bDMARD. Clinical, biological and ultrasonographic (US) parameters were collected regularly. Relapse was defined by SDAI>11.ResultsFifty-three RA patients (mean age: 58 years; 72% women; median duration: 11 years) were enrolled. Forty-two received anti-cytokinic bDMARD targeting tumour necrosis factor (n=39) or interleukin-6R (n=3) and 11 were treated by abatacept. The number of relapses during the spacing and discontinuation periods were 19 and 20, respectively. After 18 months of follow-up, among the 53 patients, 12 maintained bDMARD-free remission, 39 had relapsed and 2 were lost of follow-up. Median time to relapse was 11.8 months. In multivariate analysis, baseline factors predictive of relapse were corticosteroid intake, female gender, longer disease duration and no methotrexate intake with bDMARD. Concerning the survival analysis, also taking into account the factors of predictability, the main risk factor of relapse after discontinuation was an increase of SDAI >0 during the spacing period (p=0.03). US findings were not contributive.ConclusionIn the context of RA in remission under bDMARDs, variation of SDAI during the dose-reduction phase is more relevant than baseline parameters to predict success of drug withdrawal.

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