The Association between Oxytocin and Lower Limb Osteoarthritis: A Prospective Cohort Study.

Oxytocin (OT), a neuropeptide best known for its role in emotional and social behaviors, has been linked to osteoarthritis (OA). This study aimed to investigate the serum OT level in hip and/or knee OA patients and to study its association with disease progression. Patients from the KHOALA cohort with symptomatic hip and/or knee OA (Kellgren and Lawrence (KL) scores of 2 and 3) and follow-up at 5 years were included in this analysis. The primary endpoint was structural radiological progression, which was defined as an increase of at least one KL point at 5 years. Logistic regression models were used to estimate the associations between OT levels and KL progression while controlling for gender, age, BMI, diabetes and leptin levels. Data from 174 hip OA patients and 332 knee OA patients were analyzed independently. No differences in OT levels were found between the 'progressors' and 'non-progressors' groups among the hip OA patients and knee OA patients, respectively. No statistically significant associations were found between the OT levels at baseline and KL progression at 5 years, the KL score at baseline or the clinical outcomes. Higher structural damage at baseline and severe structural progression of hip and knee osteoarthritis did not appear to be associated with a low serum OT level at baseline.

Staphylococcus aureus endocarditis: Identifying prognostic factors using a method derived from morbidity and mortality conferences.

Objectives: Lethality of Staphylococcus aureus (Sa) infective endocarditis (IE) is high and might be due to yet unidentified prognostic factors. The aim of this study was to search for new potential prognostic factors and assess their prognostic value in SaIE. Materials and methods: We used a two-step exploratory approach. First, using a qualitative approach derived from mortality and morbidity conferences, we conducted a review of the medical records of 30 patients with SaIE (15 deceased and 15 survivors), randomly extracted from an IE cohort database (NCT03295045), to detect new factors of possible prognostic interest. Second, we collected quantitative data for these factors in the entire set of SaIE patients and used multivariate Cox models to estimate their prognostic value. Results: A total of 134 patients with modified Duke definite SaIE were included, 64 of whom died during follow-up. Of the 56 candidate prognostic factors identified at the first step, 3 had a significant prognostic value in multivariate analysis: the prior use of non-steroidal anti-inflammatory drugs [aHR 3.60, 95% CI (1.59-8.15), p = 0.002]; the non-performance of valve surgery when indicated [aHR 1.85, 95% CI (1.01-3.39), p = 0.046]; and the decrease of vegetation size on antibiotic treatment [aHR 0.34, 95% CI (0.12-0.97), p = 0.044]. Conclusion: We identified three potential SaIE prognostic factors. These results, if externally validated, might eventually help improve the management of patients with SaIE.

Improving prenatal care during lockdown: Comparing telehealth and in-person care for low-risk pregnant women in the PROTECT pilot study.

OBJECTIVE: to compare telehealth and in-person care during the COVID-19 lockdown in a population of low-risk pregnant women for prenatal care received and perinatal outcome. METHODS: This single-center study began during the first French lockdown in 2020. Women with at least one telehealth (remote) prenatal care visit were compared with those who received care only in person. Data include results from self-administered surveys and perinatal outcomes. The main outcome was the prenatal care experience, assessed by the 5-point Quality of Prenatal Care Questionnaire (QPCQ) score. Exploratory analyses sought to identify connections between perinatal outcomes and any of their levels of QPCQ score, health/eHealth literacy, stress, and social deprivation scores . RESULTS: The experimental group included 55 women and the control group 52. Maternal and neonatal outcomes were similar in both groups. The mean QPCQ scores did not support any difference between the mothers' experience of prenatal care in each group: 4.15±0.52 in the telehealth and 4.26±0.63 in the in-person groups. Similarly, levels of social deprivation, stress, and health and eHealth literacy did not differ between the groups. CONCLUSION: Regardless of social deprivation or literacy level, both telehealth and in-person monitoring appeared to provide equivalent and good-quality prenatal care experiences during the pandemic, ClinicalTrial.gov registration NCT04368832 (30th April 2020).

Do Glucocorticoid Injections Increase the Risk of Knee Osteoarthritis Progression Over 5 Years?

OBJECTIVE: Recent findings have demonstrated that intraarticular (IA) glucocorticoid injections can be deleterious for knees with osteoarthritis (OA). This study was undertaken to assess, in a real-life setting, the risk of knee OA progression in patients who received IA glucocorticoid injections over a 5-year follow-up period. METHODS: We used marginal structural modeling with inverse probability of treatment weighting to determine the causal association between IA glucocorticoid injections and the 5-year risk of disease progression in patients with symptomatic knee OA from the Knee and Hip Osteoarthritis Long-term Assessment cohort. OA progression was defined as an incident total knee replacement (TKR) and/or radiographic worsening (Kellgren/Lawrence [K/L] grade or joint space narrowing [JSN]). We also examined these outcomes in knees that received IA hyaluronan (IAHA) injections. RESULTS: Among the 564 patients with knee OA included in the study sample, 51 (9.0%) and 99 (17.5%) received IA glucocorticoid or IAHA injections, respectively, and 414 (63.1%) did not receive any injection during follow-up. Compared to untreated knees, those treated with IA glucocorticoid injections had a similar risk of incident TKR (hazard ratio [HR] 0.92 [95% confidence interval (95% CI) 0.20, 4.14]; P = 0.91) or K/L grade worsening (HR 1.33 [95% CI 0.64, 2.79]; P = 0.44). IAHA injections had no effect on the risk of TKR (HR 0.81 [95% CI 0.14, 4.63]; P = 0.81) or K/L grade worsening (HR 1.36 [95% CI 0.85, 2.17]; P = 0.20). Similar results were obtained for JSN, and when TKR and radiographic outcomes were combined. CONCLUSION: In this study, IA glucocorticoid injections for symptomatic knee OA did not significantly increase the 5-year risk of incident TKR or radiographic worsening. These findings should be interpreted cautiously and replicated in other cohorts.

Characteristics of patients with knee and/or hip osteoarthritis undergoing spa treatment: the prospective KHOALA cohort study.

Knee and hip osteoarthritis (KHOA) are a source of functional impairment. With aging, the management of osteoarthritis (OA) is a major issue in the search for improved quality of life. Spa treatment provides short- and mid-term symptom relief without serious side effects. This study aimed to identify characteristics of patients with KHOA associated with use of spa treatment. The prospective KHOALA cohort included 878 adults aged 40 to 75 years with symptomatic KHOA. We separately analyzed knee and hip OA data and compared patients who never had spa treatment with those who had at least one or multiple treatments during 5 years of follow-up in terms of socio-demographic characteristics, clinical data, quality of life (OAKHQOL, SF-36), physical activity (MAQ), functional impairment (WOMAC), and health care consumption (pharmacological and non-pharmacological treatments). Factors associated with at least one or multiple spa treatments were evaluated with regression logistic models. In all, 607 (69.1%) patients had knee OA (KOA), 222 (25.3%) hip OA (HOA) and 49 (5.6%) both, 91 (13.9%) with KOA, and 33 (12.2%) with HOA had at least one spa treatment. In the KOA cohort, the probability of at least one, two, or three spa treatments was increased with older age (odds ratio = 1.6 [95% confidence interval 1.2-2.2], 1.8 [1.2-2.8], 2.4 [1.4-4.2], respectively), greater use of physiotherapy (OR = 3.9 [2.1-7.1], 2.7 [1.3-5.6], 2.5 [1.1-5.9]), having a prosthesis (OR = 2.1 [1.2-3.8], 2.2 [1.1-4.3], 2.5 [1.1-5.5]), and low MAQ score (OR = 0.7 [0.6-0.9], 0.7 [0.5-1.0], 0.7 [0.5-1.0]). In the HOA cohort, female sex was associated with at least one (OR = 3.0 [1.1-8.0]) or two (OR = 5.1 [1.2-22.5]) spa treatments. In this cohort of KHOA, repeated spa treatment over 5 years was strongly associated with older age, greater use of physiotherapy and presence of a prothesis with KOA and female sex with HOA. This study may help to better understand spa treatment determinants in OA.

Pain in women with knee and/or hip osteoarthritis is related to systemic inflammation and to adipose tissue dysfunction: Cross-sectional results of the KHOALA cohort.

BACKGROUND: Considering the role of metabolic diseases in osteoarthritis (OA), we investigated whether biomarkers of adipose tissue dysfunction could be associated with OA-related pain. DESIGN: We cross-sectionally analyzed patients with knee and/or hip OA at inclusion in the KHOALA cohort. We used visual analogic scale (VAS) for pain, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) pain subscores. At inclusion, we measured ultra-sensitive CRP (usCRP), leptin and adiponectin for calculation of leptin:adiponectin ratio (LAR), a marker of adipose tissue dysfunction associated with central adiposity, high-molecular-weight adiponectin, visfatin and apolipoproteins. Univariate and multivariable analyses using stepwise linear regression models were performed to search for correlation between pain assessments and these biomarkers, with systematic adjustment on age. RESULTS: In 596 women with hip and/or knee OA, multivariable analyses indicated that higher pain intensity was associated with higher LAR (VAS pain: ß=0.49; p = 0.0001, OAKHQOL pain: ß=-0.46; p = 0.0002, WOMAC pain: ß=0.30; p = 0.001) in the whole group as well as in hip or knee OA patients considered separately. Pain intensity correlated also with usCRP level (VAS pain: ß= 0.27; p = 0.02, OAKHQOL pain: ß =-0.30; p = 0.01) and Kellgren-Lawrence score. In 267 men, no correlation between biomarkers and pain was found. CONCLUSION: Serum LAR and usCRP level are associated with pain level, independently of radiographic structural severity in women with hip and/or knee OA, emphasizing the role of adipose tissue dysfunction and of meta-inflammation in pain experience in the female population.

The burden of osteoarthritis: self-reported severity in the KHOALA population-based cohort.

OBJECTIVES: Lay descriptions of mild, moderate and severe disease states have been utilized in Global Burden of Disease studies in the calculation of years lived with disability, and may be a useful brief starting point for clinical care. The primary aims of this study were to estimate the proportion of an OA cohort within each severity level, and to assess the validity of lay descriptions of OA. METHODS: During 2014 to 2016, participants in the KHOALA population-based cohort completed questionnaires including pain, function, and quality of life, in addition to indicating which of the lay descriptions devised for presenting to populations in GBD2010 they felt best described their current condition. RESULTS: 569 participants comprising 152 with hip OA, 384 knee OA and 33 with both hip+knee OA participated. 10% of hip OA and 17% of knee OA participants classified themselves as having severe OA, a considerably higher proportion than the 2% reported for high-income countries in GBD2010.The lay descriptions showed significant convergent and divergent validity: pain, function and stiffness scores increased as the rating of severity increased, with a significant trend for EQ5D and EUROQOL VAS to decline, also indicating worse health state, as level of severity increased. CONCLUSION: Lay descriptions of levels of severity are understandable by participants and show convergent validity with standardized measure of physical and functional outcomes. The proportion of people with OA who align themselves with the severe category is considerably larger than that used in GBD estimates to estimate the impact of OA.

Chondrocalcinosis of the Knee and the Risk of Osteoarthritis Progression: Data From the Knee and Hip Osteoarthritis Long-term Assessment Cohort.

OBJECTIVE: To assess the impact of knee chondrocalcinosis (CC) on the 5-year risk of joint replacement and disease progression in patients with knee osteoarthritis (OA). METHODS: Patients with symptomatic knee OA without previous total joint (knee or hip) replacement (TJR) were recruited from the Knee and Hip Osteoarthritis Long-term Assessment cohort. Cox proportional hazards regression and generalized estimating equation models were used to compare the time from inclusion or OA diagnosis to total knee replacement (TKR) or TJR between patients with and those without knee CC at inclusion. In patients without incident TKR, logistic regression was performed to examine the association between CC and radiographic progression (Kellgren/Lawrence [K/L] grade) or worsening of Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscores for OA pain or function between years 0 and 5. Hazard ratios (HRs) and 95% confidence intervals (95% CIs) were estimated. Analyses were adjusted for age, sex, body mass index, WOMAC subscores, and K/L grade. RESULTS: Among the 656 patients included, 93 (14.2%) had knee CC, and 91 (13.9%) underwent TKR during the follow-up. Risk of TKR was not affected by the presence of knee CC (HR 1.26 [95% CI 0.74-2.17]). Similar results were obtained for the risk of incident TJR. For patients without incident TKR, knee CC did not affect the risk of worsening of K/L grade (odds ratio [OR] 0.9 [95% CI 0.4-1.7]), WOMAC pain subscore (OR 1.1 [95% CI 0.7-1.4]), or WOMAC function subscore (OR 0.9 [95% CI 0.4-2.0]). CONCLUSION: In patients with symptomatic knee OA, the presence of knee CC did not affect the risk of arthroplasty or disease progression at 5 years.

Perceived Health and Quality of Life in Patients With CKD, Including Those With Kidney Failure: Findings From National Surveys in France.

RATIONALE & OBJECTIVE: Health-related quality of life (HRQoL) is a major outcome measure increasingly used in patients with chronic kidney disease (CKD). We evaluated the association between different stages of CKD and the physical and mental health domains of HRQoL. STUDY DESIGN: Cross-sectional study. SETTING & PARTICIPANTS: 2,693 outpatients with moderate (stage 3, estimated glomerular filtration rate [eGFR], 30-60mL/min/1.73m2) or advanced (stages 4-5, estimated glomerular filtration rate<30mL/min/1.73m2, not on kidney replacement therapy [KRT]) CKD under the care of a nephrologist at 1 of 40 nationally representative facilities, 1,658 patients with a functioning kidney transplant, 1,251 patients on maintenance dialysis randomly selected from the national Renal Epidemiology and Information Network registry, and 20,574 participants in the French Decennial Health Survey, representative of the general population. PREDICTOR: Severity of kidney disease (moderate CKD, advanced CKD, maintenance dialysis as KRT, and functioning kidney transplant as KRT), compared with a sample of the general population. OUTCOMES: HRQoL scores assessed using the Medical Outcomes Study 36-Item Short Form Health Survey or the Kidney Disease Quality of Life 36 scale. ANALYTICAL APPROACH: Age- and sex-standardized (to the general population) prevalence of poor or fair health status was estimated for each study kidney disease group. Analysis of variance was used to estimate adjusted differences in mean physical and mental health scores between the kidney disease subgroups and the general population. RESULTS: Mean age was 67.2±12.6 (SD) years for patients with non-KRT-requiring CKD, 69.3±17.7 years for dialysis patients, and 55.3±14.2 years for those with functioning kidney transplants; 60% were men. Age- and sex-standardized health status was perceived as fair or poor in 27% of those with moderate CKD,>40% of those with advanced CKD or receiving dialysis, 12% with a functioning transplant, and 3% of the general population sample. HRQoL physical scores (adjusted for age, sex, education, obesity, and diabetes) were significantly lower in patients in all CKD subgroups than in the general population. For patients receiving dialysis, the magnitude of the difference in physical score versus the general population exceeded 4.5 points, the minimal clinically important difference for this score in this study; for both kidney transplant recipients and patients with advanced CKD, the magnitude of the difference was close to this threshold. For mental score, only dialysis patients had a score that differed from that of the general population by more than the minimal clinically important difference. LIMITATIONS: Cross-sectional study design for each subpopulation. CONCLUSIONS: This study highlights the degree to which perceived physical health is lower in the setting of CKD than in the general population, even in the absence of kidney failure, and calls for greater attention to CKD-related quality of life.

An Ergonomic Assessment Of Four Different Donor Nephrectomy Approaches For The Surgeons And Their Assistants.

INTRODUCTION: Open surgery is increasingly being replaced by laparoscopic approaches that are more demanding for the surgical team. The physical and mental workload of these approaches have not been quantified. MATERIALS AND METHODS: A multicenter prospective study was performed evaluating the physical and mental stresses of 4 surgical approaches (open surgery [OS], standard laparoscopy [SL], hand-assisted laparoscopy [HAL], and robot-assisted laparoscopy [RAL]) for donor nephrectomy for the surgeon and their assistant. The Borg Scale was used to evaluate exertion in different body parts every 30 mins during surgery and the NASA-TLX score was used to evaluate overall workload. RESULTS: 264 nephrectomies were performed over a 33-month period and 258 questionnaires evaluating these surgeries were obtained. Surgeons experienced less left shoulder and arm exertion and left forearm and hand exertion, but greater lower back exertion, as measured by the Borg scale, with RAL. Leg exertion was significantly greater with OS. Assistant surgeons experienced increased exertion in the back, right shoulder and arm, and right forearm and hand with RAL. NASA Task load index (TLX) surgeon scores showed mental demand was similar for all 4 surgical approaches. Physical demand was lower and overall performance was higher with RAL. DISCUSSION: Four different nephrectomy surgical approaches were evaluated in a multicenter setting. Surgeon and assistant scores of physical exertions were generally in the "easy" range but confirmed that robotic surgery is an ergonomic progress compared to other techniques, except for the axial skeleton. Further, it degrades the working conditions for the assistant.

Performance of 18F-sodium fluoride positron emission tomography with computed tomography to assess inflammatory and structural sacroiliitis on magnetic resonance imaging and computed tomography, respectively, in axial spondyloarthritis.

PURPOSE: To assess increased sacroiliac joint (SIJ) uptake on 18F-NaF PET/CT and to compare with MRI for inflammation and with CT scan for structural damages in a population of 23 patients with spondyloarthritis (SpA). METHODS: Twenty-three patients with active SpA according to the Assessment of SpondyloArthritis international Society (ASAS) and/or modified NY criteria were included. All patients had a pelvic radiograph, MRI, and CT scan of the SIJ and 18F-NaF PET/CT examinations within a month, analyzed by three blinded readers. MRIs were assessed according to the ASAS criteria and SPARCC method. On CT scans, erosion and ankylosis were quantified using the same methodology. On the 18F-NaF PET, abnormal uptake was assessed using a qualitative method inspired by the ASAS criteria and two quantitative approaches (the PET-activity score according to the SPARCC method and Maximum Standardized Uptake Value (SUVmax)). RESULTS: Structural sacroiliitis was observed on 7 radiographs and 10 CT scans; 10 MRIs showed inflammatory sacroiliitis, and 20 patients had a positive PET. The inter-reader reliability was good for the PET activity score and good to excellent for the SUVmax. A positive PET was not correlated with a positive MRI or with a structural sacroiliitis on CT scan. The PET-activity score and SUVmax were correlated with the SPARCC inflammation score but not with erosion or ankylosis scores on CT scan. CONCLUSION: Abnormal uptake by the SIJ on 18F-NaF PET is more frequent than inflammatory and structural sacroiliitis in a population of SpA patients. The PET activity score and SUVmax had good correlations with inflammatory sacroiliitis but not with structural lesions on CT scan.

Performance of 18F-sodium fluoride positron emission tomography with computed tomography to assess inflammatory and structural sacroiliitis on magnetic resonance imaging in axial spondyloarthritis.

OBJECTIVES: To assess increased sacroiliac joint (SIJ) uptake on 18F-NaF PET/CT according to a qualitative and quantitative approach and to compare with MRI SIJ assessments for structural and inflammatory sacroiliitis in a population of 23 patients with spondyloarthritis (SpA) (IDRCB: 2012-A00568-35; ClinicalTrials.gov: NCT 02869100). METHODS: This single-center prospective study included 23 patients with active SpA according to the ASAS and/or modified NY criteria. All patients had a pelvic AP-view radiograph, MRI of the SIJ and 18F-NaF PET/CT examinations within a month, which were analysed by three blinded readers. For MRI data, the SIJs were assessed according to the ASAS criteria and SPARCC method for scoring structural lesions (erosion, sclerosis, fat metaplasia, backfill and ankylosis) and inflammation. On the 18F-NaF PET, the SIJs were scored according to a slice-by-slice approach. Abnormal uptake was assessed using a qualitative method inspired by the ASAS criteria and two quantitative approaches (the PET-activity score according to the SPARCC method and the maximum standardised uptake value (SUVmax) for each SIJ). RESULTS: Structural sacroiliitis was observed on 7 radiographs and 15 MRIs. 10 MRIs showed inflammatory sacroiliitis (mean SPARCC 18.7). Twenty patients had a positive PET with a mean PET-activity score of 18.2 (±8.7). The mean SUVmax for a positive PET was 1.78 vs. 1.45 for a negative one. The inter-reader reliability was good for the PET activity score (ICC= 0.56 [IC-95: 0.32; 0.76]) and good to excellent for the SUVmax (ICC=0.70-0.90 [IC-95: 0.41; 0.96]). According to a binary approach, a positive PET was not correlated with a positive MRI for structural sacroiliitis. The PET-activity score (r=0.61, p=0.001) and SUVmax (r=0.56, p=0.004) were correlated with the SPARCC inflammation score but not with structural sacroiliitis or for SPARCC structural lesions. CONCLUSIONS: Abnormal uptake by the SIJ on 18F-NaF PET is more frequent (87.0%) than inflammatory (43.5%) and structural sacroiliitis (65.2%) on MRI in a population of SpA patients. The PET activity score and SUVmax had good correlations with inflammatory sacroiliitis but not with structural lesions on MRI.

Nephrectomy Complication Is a Risk Factor of Clinically Meaningful Decrease in Health Utility among Living Kidney Donors.

OBJECTIVES: To assess the clinically relevant change in health state utility (HSU) in living kidney donors and whether this change value is constant across measures and clinical conditions and is useful for health economics studies. We aimed to 1) measure the change in the HSU score for living kidney donors from before donation to 3 months after donation and 2) estimate the minimal important decrease (MIDe) in the HSU score for living kidney donors and its associated clinical factors. METHODS: Data from a prospective multicenter observational study measuring quality of life of kidney donors by the three-level EuroQol five-dimensional questionnaire (EQ-5D-3L) and the six-dimensional health state short form (SF-6D) before donation and at 3 months after donation provided HSU scores. Two methods were used to derive the MIDe: the anchor-based method and the distribution-based (standard error of measurement) method. Logistic regression was used to identify clinical factors associated with the MIDe after donation. RESULTS: In total, 228 and 216 donors completed the EQ-5D-3L and the SF-6D, respectively. Mean HSU scores were 0.932 and 0.823 before donation and 0.895 and 0.764 at 3 months after donation. HSU scores were significantly decreased at 3 months, and 18.5% of donors rated their global health as "somewhat worse." By the EQ-5D-3L and the SF-6D, the MIDe was estimated at -0.113 and -0.116 with the anchor-based method and -0.075 and -0.077 with the distribution-based method. Risk of decreased HSU score was significantly associated with clinical complications but only marginally with surgical technique. CONCLUSIONS: A short-term clinically relevant decrease in HSU was significantly associated with clinical complications in kidney donors. Preventing perioperative complications is of prime importance in kidney donation.

Trajectories of CKD-MBD biochemical parameters over a 2-year period following diagnosis of secondary hyperparathyroidism: a pharmacoepidemiological study.

OBJECTIVES: To define groups of patients according to the changes of biochemical parameters, that is, serum calcium, phosphate and parathyroid hormone (PTH), over a 2-year follow-up period using group-based multi-trajectory modeling (GBMM) among a cohort of dialysis patients with newly diagnosed secondary hyperparathyroidism (SHPT) (ie, PTH≥500 ng/L for the first time) and to compare their patient characteristics and treatments. DESIGN: Pharmacoepidemiological study. SETTING: In the 12 dialysis units located in the French region of Lorraine. PARTICIPANTS: A total of 269 dialysis patients with newly diagnosed SHPT were prospectively included from December 2009 to May 2012 and followed-up for 2 years. RESULTS: We identified four distinct trajectory groups: 'rapid PTH drop' experiencing a rapid and sharp decrease (over weeks) in PTH level associated with decreasing phosphate level within normal range (n=34; 12.7%), 'gradual PTH decrease' experiencing a gradual and continuous decrease (over months) in PTH level and maintaining phosphate at a middle level throughout the study (n=98; 36.4%), 'slow PTH decrease with high phosphate' experiencing a slow decrease in PTH level associated with a relatively high phosphate level (n=105; 39.0%) and 'uncontrolled SHPT' with high levels of PTH and phosphate throughout the study (n=32; 11.9%). Patients in the 'uncontrolled SHPT' group were significantly (p<0.00001) younger than patients in other groups. Kidney Disease Improving Global Outcomes (KDIGO) targets for PTH, phosphate and calcium were reached simultaneously for 14.9% of patients at baseline and 16.7% at the end of the study. Patients were given cinacalcet more frequently at months 3 and 6 in the 'rapid PTH drop' and at month 24 in the 'uncontrolled SHPT' groups. CONCLUSIONS: Over 2 years following a new SHPT diagnosis, a younger age and a higher rate of alkaline phosphatase were associated to a continuous uncontrolled SHPT. Patients with the lowest PTH at the end of the follow-up tended to receive more often cinacalcet. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov number, NCT02888639, post results.

Minimal impact of calcimimetics on the management of hyperparathyroidism in chronic dialysis.

BACKGROUND: The calcimimetic drug cinacalcet has changed the prescription patterns in patients with secondary hyperparathyroidism, despite the lack of randomized studies that compare cinacalcet with conventional treatment, including parathyroidectomy. The aim of this study was to evaluate current management of patients on chronic dialysis with incidental and parathyroid hormone (PTH) levels ≥ 500 ng/L. METHODS: Prospective pharmacoepidemiologic study of chronic dialysis patients with PTH level ≥ 500 ng/L. RESULTS: We studied 269 patients. Among the 186 patients who had 2-year follow-up, 125 (67%) were managed using cinacalcet. At 2 years, when comparing the cinacalet with the noncinacalet groups, we found that mean PTH values were 400 ± 318 versus 388 ± 251 ng/L (P = ns) and the percentage of patients following 2009 PTH Kidney Disease Improving Global Outcomes (KDIGO) guidelines were 79 versus 85% (P = ns). Eight patients (4%) underwent parathyroidectomy. On multivariate analysis, the use of cinacalcet was not a predictor for PTH within KDIGO guidelines at 2-year follow-up. CONCLUSION: Cinacalcet was used in the majority (67%) of patients on chronic dialysis with secondary hyperparathyroidism, but the use of cinacalcet did not affect mean PTH values nor the proportion of patients following KDIGO guidelines compared with patients not using calcimimetics.