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      Effectiveness of cinacalcet treatment for secondary hyperparathyroidism on hospitalization: Results from the MBD-5D study

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          Abstract

          Objectives

          To elucidate the effect of cinacalcet use on all-cause and cause-specific hospitalization outcomes using a prospective cohort of maintenance hemodialysis patients.

          Methods

          We used data from a prospective cohort of Japanese hemodialysis patients with secondary hyperparathyroidism and examined baseline characteristics as well as longitudinal changes. All patients were cinacalcet-naïve at study enrollment. Further, we used a marginal structural model to account for time-varying confounders on cinacalcet initiation and hospitalization outcomes, and an Andersen-Gill–type recurrent event model to account for any recurring events of hospitalization in the outcome analysis using the weighted dataset.

          Results

          Among the 3,276 patients, cinacalcet treatment was initiated in 1,384 patients during the entire follow-up. Cinacalcet users were slightly younger, included more patients with chronic glomerulonephritis and fewer patients with diabetes, were more likely to have a history of parathyroidectomy, and were more often used receiving vitamin D receptor activator, phosphate binders, and iron supplements. The overall hospitalization analysis yielded a hazard ratio (HR) of 0.97 (95% confidence interval [CI]: 0.80, 1.18). A trend toward a mild protective association was observed for cardiovascular-related hospitalizations (HR: 0.85; 95% CI: 0.64, 1.14). In the subgroup analysis, a protective association was seen due to cinacalcet use for infection-related hospitalizations in the lowest intact parathyroid hormone group (HR: 0.36; 95% CI: 0.14, 0.95).

          Conclusions

          Cinacalcet initiation in patients on maintenance hemodialysis had no effect on all-cause and cause-specific hospitalizations. Although the overall association was statistically not significant, cinacalcet may have a protective association on cardiovascular-related hospitalization in all patients and infection-related hospitalization in patient with low intact parathyroid hormone.

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          Most cited references19

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          Marginal structural models to estimate the causal effect of zidovudine on the survival of HIV-positive men.

          Standard methods for survival analysis, such as the time-dependent Cox model, may produce biased effect estimates when there exist time-dependent confounders that are themselves affected by previous treatment or exposure. Marginal structural models are a new class of causal models the parameters of which are estimated through inverse-probability-of-treatment weighting; these models allow for appropriate adjustment for confounding. We describe the marginal structural Cox proportional hazards model and use it to estimate the causal effect of zidovudine on the survival of human immunodeficiency virus-positive men participating in the Multicenter AIDS Cohort Study. In this study, CD4 lymphocyte count is both a time-dependent confounder of the causal effect of zidovudine on survival and is affected by past zidovudine treatment. The crude mortality rate ratio (95% confidence interval) for zidovudine was 3.6 (3.0-4.3), which reflects the presence of confounding. After controlling for baseline CD4 count and other baseline covariates using standard methods, the mortality rate ratio decreased to 2.3 (1.9-2.8). Using a marginal structural Cox model to control further for time-dependent confounding due to CD4 count and other time-dependent covariates, the mortality rate ratio was 0.7 (95% conservative confidence interval = 0.6-1.0). We compare marginal structural models with previously proposed causal methods.
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            Modelling recurrent events: a tutorial for analysis in epidemiology.

            In many biomedical studies, the event of interest can occur more than once in a participant. These events are termed recurrent events. However, the majority of analyses focus only on time to the first event, ignoring the subsequent events. Several statistical models have been proposed for analysing multiple events. In this paper we explore and illustrate several modelling techniques for analysis of recurrent time-to-event data, including conditional models for multivariate survival data (AG, PWP-TT and PWP-GT), marginal means/rates models, frailty and multi-state models. We also provide a tutorial for analysing such type of data, with three widely used statistical software programmes. Different approaches and software are illustrated using data from a bladder cancer project and from a study on lower respiratory tract infection in children in Brazil. Finally, we make recommendations for modelling strategy selection for analysis of recurrent event data.
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              Active-comparator design and new-user design in observational studies.

              Over the past decade, an increasing number of observational studies have examined the effectiveness or safety of treatments for rheumatoid arthritis. Unlike randomized controlled trials (RCTs), however, observational studies of drug effects have methodological limitations such as confounding by indication. Active-comparator designs and new-user designs can help mitigate such biases in observational studies and improve the validity of their findings by making them more closely approximate RCTs. In an active-comparator study, the drug of interest is compared with another agent commonly used for the same indication, rather than with no treatment (a 'non-user' group). This principle helps to ensure that treatment groups have similar treatment indications, attenuating both measured and unmeasured differences in patient characteristics. The new-user study includes a cohort of patients from the time of treatment initiation, enabling assessment of patients' pretreatment characteristics and capture of all events occurring during follow-up. These two principles should be considered when designing or reviewing observational studies of drug effects.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Project administrationRole: Writing – original draft
                Role: Formal analysisRole: MethodologyRole: Writing – original draft
                Role: ConceptualizationRole: MethodologyRole: ResourcesRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: Writing – original draft
                Role: ConceptualizationRole: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: Writing – review & editing
                Role: SupervisionRole: Writing – review & editing
                Role: SupervisionRole: Writing – review & editing
                Role: SupervisionRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                29 May 2019
                2019
                : 14
                : 5
                : e0216399
                Affiliations
                [1 ] Medical Affairs Department, Kyowa Hakko Kirin, Chiyoda-ku, Tokyo, Japan
                [2 ] Departments of Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America
                [3 ] Human Health Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan
                [4 ] The Keihanshin Consortium for Fostering the Next Generation of Global Leaders in Research (K-CONNEX), Kyoto, Japan
                [5 ] Institute for Health Outcomes and Process Evaluation Research (iHope International), Kyoto, Japan
                [6 ] Center for Innovative Research for Communities and Clinical Excellence (CiRC(2)LE), Fukushima Medical University, Fukushima, Japan
                [7 ] Department of Innovative Research and Education for Clinicians and Trainees (DiRECT), Fukushima Medical University Hospital, Fukushima, Japan
                [8 ] Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Tokyo, Japan
                [9 ] Department of Healthcare Epidemiology, School of Public Health, Kyoto University Faculty of Medicine, Kyoto, Japan
                [10 ] Showa University, Shinagawa-ku, Tokyo, Japan
                Tokushima University Graduate School, JAPAN
                Author notes

                Competing Interests: SA, TN, and MW are employees of Kyowa Hakko Kirin (KHK). KY and YO have no conflicts of interest to declare. S. Fukuma and NK have acted as scientific advisors for KHK. S. Fukuhara has acted as a scientific advisor for and has received grants from KHK. MF has received consulting fees from KHK and Ono Pharmaceutical; lecture fees from KHK, Bayer, Torii Pharmaceutical, and Ono Pharmaceutical; and grants from KHK and Bayer. TA has received consulting fees from KHK, Astellas Pharma, Bayer, Fuso Pharmaceutical, Japan Tobacco, Ono Pharmaceutical, and NIPRO; and lecture fees from KHK, Chugai Pharmaceutical, Bayer, Kissei Pharmaceutical, Torii Pharmaceutical, and Ono Pharmaceutical. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

                Author information
                http://orcid.org/0000-0002-7717-8945
                Article
                PONE-D-18-31765
                10.1371/journal.pone.0216399
                6541241
                31141505
                f4938641-8fc6-4c9d-84a5-154455b4bd8f
                © 2019 Asada et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 4 November 2018
                : 20 April 2019
                Page count
                Figures: 4, Tables: 2, Pages: 15
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/501100004095, Kyowa Hakko Kirin;
                The MBD-5D study was funded by Kyowa Hakko Kirin.
                Categories
                Research Article
                Medicine and Health Sciences
                Nephrology
                Medical Dialysis
                Medicine and Health Sciences
                Endocrinology
                Endocrine Disorders
                Diabetes Mellitus
                Medicine and Health Sciences
                Metabolic Disorders
                Diabetes Mellitus
                Physical Sciences
                Chemistry
                Chemical Compounds
                Phosphates
                Biology and Life Sciences
                Biochemistry
                Hormones
                Parathyroid Hormone
                Medicine and Health Sciences
                Cardiovascular Medicine
                Cardiovascular Diseases
                Medicine and Health Sciences
                Nephrology
                Chronic Kidney Disease
                Biology and Life Sciences
                Biochemistry
                Metabolism
                Bone and Mineral Metabolism
                Biology and Life Sciences
                Physiology
                Physiological Processes
                Calcification
                Medicine and Health Sciences
                Physiology
                Physiological Processes
                Calcification
                Custom metadata
                All relevant data are within the manuscript and its Supporting Information files.

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                Uncategorized

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