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21 results on '"Klauser, R."'

1. Patient and graft survival in older kidney transplant recipients: does age matter?

Author

Fabrizii V, Winkelmayer WC, Klauser R, Kletzmayr J, Säemann MD, Steininger R, Kramar R, Hörl WH, and Kovarik J

Subjects
Age Factors, Aged, Female, Follow-Up Studies, Humans, Male, Middle Aged, Retrospective Studies, Survival Rate, Time Factors, Graft Survival, Kidney Transplantation mortality
Abstract

An increasing gap between supply and demand of donor kidneys for transplantation exists. There is concern regarding the allocation of scarce organs to elderly patients, because the benefit obtained by the transplant may be less in elderly compared with younger recipients. It was the objective of this study to determine differences in patient and organ survival between organ recipients >65 yr and 50 to 64 yr of age at transplantation. A retrospective cohort of 627 patients >50 yr who received a kidney transplant between 1993 and 2000 was assembled. Detailed information on patient demographics, comorbidities, and immunological and donor characteristics was ascertained before transplantation. Five-year patient and graft survival were evaluated by Kaplan-Meier survival curves and multivariate Cox proportional-hazard models. Five-year patient mortality was similar between patients aged >65 and 60 to 64 at transplantation (relative risk [RR] = 1.07; 95% confidence interval [CI], 0.66 to 1.74). Patients aged 50 to 59 yr showed a clear trend toward lower 5-yr mortality (RR = 0.66; 95% CI, 0.43 to 1.03). Compared with patients >65 yr, 5-yr graft loss was not different in patients aged 60 to 64 (RR = 1.28; 95% CI, 0.82 to 2.02) or those aged 50 to 59 yr at transplantation (RR = 1.02; 95% CI, 0.68 to 1.53). After thorough control for confounding, 5-yr graft survival was not materially different by age group. Discrimination against older candidates for kidney transplantation on age-related grounds alone is not warranted.

Published
2004
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2. New developments in the management of cytomegalovirus infection and disease after renal transplantation.

Author

Kletzmayr J, Kreuzwieser E, and Klauser R

Subjects
Humans, Cytomegalovirus Infections etiology, Cytomegalovirus Infections therapy, Kidney Transplantation adverse effects
Abstract

The clinical management of cytomegalovirus infection and disease in renal transplant recipients has recently been significantly improved with the availability of data on prophylaxis with oral ganciclovir and valacyclovir. In addition, significant progress in early diagnosis and the quantitation of viral load has been achieved. The influence of novel immunosuppressants on the clinical course of cytomegalovirus infection has been clarified to some extent by recent clinical data. The identification of risk factors for cytomegalovirus disease beyond seroconstellation and immunosuppression is an ongoing process that might lead to a more targeted use of antiviral agents, given the risk of ganciclovir resistance. The understanding of the effects of cytomegalovirus on long-term graft outcome still needs to be deepened in order to design cytomegalovirus-specific interventions to improve graft survival.

Published
2001
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3. Long-term oral ganciclovir prophylaxis for prevention of cytomegalovirus infection and disease in cytomegalovirus high-risk renal transplant recipients.

Author

Kletzmayr J, Kreuzwieser E, Watkins-Riedel T, Berlakovich G, Kovarik J, and Klauser R

Subjects
Administration, Oral, Adult, Cytomegalovirus Infections epidemiology, Cytomegalovirus Infections mortality, Female, Graft Rejection prevention & control, Humans, Immunosuppressive Agents therapeutic use, Male, Middle Aged, Risk Factors, Survival Rate, Time Factors, Antiviral Agents administration & dosage, Cytomegalovirus Infections prevention & control, Ganciclovir administration & dosage, Kidney Transplantation immunology
Abstract

Background: Although specific therapy is available with ganciclovir, cytomegalovirus (CMV) disease remains a major problem after renal transplantation especially in CMV seronegative recipients of organs of seropositive donors (D+R-)., Methods: In an open-labeled prospective controlled trial we evaluated the effect of long-term oral ganciclovir prophylaxis (3 g/day for 3 months posttransplantation) in a cohort of 31 CMV-high risk (D+R-) renal transplant recipients (GC) compared with a cohort of 28 high-risk patients with targeted CMV prophylaxis (CO) receiving i.v. ganciclovir during antirejection therapy. Primary end-points were CMV infection, diagnosed by pp65 antigenemia assay or serologic method, and CMV disease. Additionally severity of CMV disease quantified by a scoring system was evaluated., Results: CMV prophylaxis significantly reduced the incidence of CMV infection (CO: 75%, GC: 45%; P<.05) and CMV disease (CO: 60%, GC: 29%; P<.05) without relevant side effects and without any clinical suspicion of ganciclovir resistance. Severity of CMV disease as quantified by a scoring system was reduced from 8.3+/-6.7 points in controls to 3.3+/-2.6 points in ganciclovir-treated patients (P<.05). Mortality did not differ significantly between the two groups (CO: n=3, GC: n=1; NS). However, there was one lethal CMV disease and a second death possibly attributable to CMV disease in the control group, whereas in ganciclovir-treated patients there was no CMV-associated fatal outcome., Conclusion: Long-term oral ganciclovir prophylaxis is effective and safe in CMV high-risk renal transplant recipients.

Published
2000
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4. Pharmacokinetic cyclosporine A profiles under long-term Neoral treatment in renal transplant recipients: does fat intake still matter?

Author

Klauser RM, Irschik H, Kletzmayr J, Sturm I, Brunner W, Woloszczuk W, and Kovarik J

Subjects
Administration, Oral, Body Weight, Cholesterol blood, Creatinine blood, Cyclosporine administration & dosage, Cyclosporine therapeutic use, Female, Hematocrit, Humans, Kidney Transplantation immunology, Male, Metabolic Clearance Rate, Cyclosporine pharmacokinetics, Diet, Fat-Restricted, Dietary Fats, Kidney Transplantation physiology
Published
1997
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5. Impact of high-dose oral acyclovir prophylaxis on cytomegalovirus (CMV) disease in CMV high-risk renal transplant recipients.

Author

Kletzmayr J, Kotzmann H, Popow-Kraupp T, Kovarik J, and Klauser R

Subjects
Acyclovir therapeutic use, Administration, Oral, Adult, Aged, Cytomegalovirus Infections drug therapy, Dose-Response Relationship, Drug, Female, Ganciclovir therapeutic use, Graft Rejection, Humans, Male, Middle Aged, Risk Factors, Acyclovir administration & dosage, Cytomegalovirus Infections prevention & control, Kidney Transplantation
Abstract

Recent studies showed contradictory results concerning the efficacy of oral acyclovir in the prevention or amelioration of cytomegalovirus (CMV) disease after renal transplantation (TX). This study evaluated the incidence and severity of CMV disease within the first year after TX in high-risk renal transplant recipients (CMV-seropositive donor, seronegative recipient) treated prophylactically with oral acyclovir (800 to 3200 mg/day) over a period of 12 wk (ACY, N = 22), compared with high-risk patients randomly assigned as controls (CO, N = 10). Follow-up for CMV infection included serological determination of CMV-specific immunoglobulin G and immunoglobulin M antibodies, antigen detection in peripheral blood leukocytes (PP 65), shell vial culture (blood), and virus isolation/early antigen detection (urine). Severity of CMV disease was quantified by a scoring system for CMV-related symptoms. Nine patients (40.1%) in the acyclovir group and four patients (40%) in the control group developed CMV disease. Neither severity (ACY, 11.4 versus CO; 12.5 points score), nor duration of disease (ACY, 21 days; CO, 22 days), nor transplant function at the end of the observation period differed significantly. The onst of CMV disease was not delayed significantly in acyclovir-treated patients compared with controls (ACY, 47 +/- 34 days versus CO, 27 +/- 14 days after TX, not significant). Our results show no beneficial effect of oral acyclovir prophylaxis in CMV high-risk renal transplant recipients.

Published
1996
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6. Neoral--a new microemulsion formula of cyclosporine A: interpatient pharmacokinetic variability in renal transplant recipients.

Author

Klauser R, Irschik H, Kletzmayr J, Sturm I, Brunner W, Woloszczuk W, and Kovarik J

Subjects
Adolescent, Adult, Computer Simulation, Cyclosporine blood, Emulsions, Female, Humans, Immunosuppressive Agents blood, Male, Middle Aged, Models, Biological, Cyclosporine administration & dosage, Cyclosporine pharmacokinetics, Immunosuppressive Agents administration & dosage, Immunosuppressive Agents pharmacokinetics, Kidney Transplantation physiology
Published
1995

7. Recombinant human erythropoietin in renal transplant recipients with renal anemia.

Author

Traindl O, Barnas U, Franz M, Falger S, Klauser R, Kovarik J, and Graf H

Subjects
Adult, Anemia blood, Anemia etiology, Blood Pressure, Creatinine blood, Female, Graft Rejection, Hemoglobins analysis, Humans, Kidney Failure, Chronic physiopathology, Kidney Failure, Chronic surgery, Male, Recombinant Proteins, Anemia therapy, Erythropoietin therapeutic use, Kidney Failure, Chronic complications, Kidney Transplantation
Abstract

Thirty-seven kidney graft recipients with chronically declining transplant function accompanied by renal anemia were treated with recombinant human erythropoietin for 3 months. In all these patients anemia improved and mean hemoglobin levels increased from 7.67 +/- 1.26 g/dl to 9.83 +/- 1.94 g/dl (p < 0.01). Mean creatinine increased from 4.23 +/- 1.82 to 4.62 +/- 2.42 (p < 0.05) but the progression of transplant failure was not influenced when compared with pretreatment values obtained at least 6 months before study entry. Mean blood pressure levels were not altered but 12 patients required additional antihypertensive medication.

Published
1994

8. Renal cell carcinoma in an allograft kidney transplant.

Author

Heinz-Peer G, Helbich T, Nöttling B, Klauser R, Mühlbacher F, and Hübsch P

Subjects
Carcinoma, Renal Cell chemically induced, Carcinoma, Renal Cell etiology, Humans, Immunosuppressive Agents adverse effects, Kidney Neoplasms chemically induced, Kidney Neoplasms etiology, Male, Middle Aged, Risk Factors, Carcinoma, Renal Cell epidemiology, Kidney Neoplasms epidemiology, Kidney Transplantation adverse effects
Published
1994
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9. Secondary hyperparathyroidism and acute tubular necrosis following renal transplantation.

Author

Traindl O, Längle F, Reading S, Franz M, Watschinger B, Klauser R, Woloszczuk W, and Kovarik J

Subjects
Adult, Calcium metabolism, Creatinine blood, Female, Humans, Hyperparathyroidism, Secondary blood, Kidney Transplantation physiology, Kidney Tubular Necrosis, Acute blood, Male, Middle Aged, Parathyroid Hormone blood, Hyperparathyroidism, Secondary etiology, Kidney Transplantation adverse effects, Kidney Tubular Necrosis, Acute etiology
Abstract

In the present study we investigated the relationship between secondary hyperparathyroidism in renal graft recipients and post-transplantation acute tubular necrosis (ATN). Patients were divided into two groups according to graft function: group A consisted of 28 patients who had an uneventful postoperative period and did not require haemodialysis. Group B comprised 26 patients with primary non-function of the graft due to biopsy-proven ATN who required continued haemodialysis for the first postoperative week or longer (mean 14.2 +/- 8.7 days). Both groups had comparable donor characteristics, HLA-matching and ischaemia times. All patients were given cyclosporin and low-dose prednisolone for immunosuppression. Pretransplant levels of intact PTH were significantly greater in group B than in group A (203.5 +/- 193.1 pg/ml versus 81.7 +/- 45.2 pg/ml, P < 0.01). Group B patients had more transplant biopsies (50 versus 7) and a longer hospitalization time (33.4 +/- 10.9 days versus 21.9 +/- 11.9 days, P < 0.01), although serum creatinine on the day of discharge was higher in group B (1.77 +/- 0.51 mg/dl versus 1.5 +/- 0.45 mg/dl, P < 0.05). We conclude that patients with secondary hyperparathyroidism as assessed by measuring circulating levels of intact PTH have an increased incidence of ATN.

Published
1993

10. Is determination of PP 65 useful for early diagnosis of cytomegalovirus infection in renal transplantation?

Author

Klauser R, Kotzmann H, Wamser P, Braza P, Popov-Kraupp T, Franz M, Traindl O, Watschinger B, Pohanka E, and Mühlbacher F

Subjects
Adult, Cytomegalovirus Infections immunology, Female, Humans, Immune Tolerance immunology, Immunosuppressive Agents administration & dosage, Leukocytes immunology, Male, Middle Aged, Opportunistic Infections immunology, Postoperative Complications immunology, Cytomegalovirus Infections diagnosis, Kidney Transplantation, Opportunistic Infections diagnosis, Phosphoproteins blood, Postoperative Complications diagnosis, Viral Matrix Proteins blood, Viremia diagnosis
Published
1992

11. Low-dose lovastatin in hyperlipidemic kidney graft recipients with cyclosporine A.

Author

Traindl O, Reading S, Franz M, Falger S, Klauser R, Gisinger J, Widhalm K, and Kovarik J

Subjects
Adult, Cholesterol blood, Cholesterol, HDL blood, Cholesterol, LDL blood, Cyclosporine adverse effects, Female, Humans, Hyperlipidemias blood, Lipoprotein(a) blood, Lovastatin adverse effects, Male, Middle Aged, Postoperative Complications blood, Triglycerides blood, Cyclosporine administration & dosage, Hyperlipidemias therapy, Kidney Transplantation physiology, Lovastatin administration & dosage, Postoperative Complications therapy
Published
1992

12. Incidence of urinary tract infections and vesicorenal reflux: a comparison between conventional and antirefluxive technique of ureter implantation.

Author

Franz M, Klaar U, Hofbauer H, Höbarth K, Steininger R, Klauser R, Mühlbacher F, Kovarik J, and Pohanka E

Subjects
Adult, Anastomosis, Surgical methods, Female, Follow-Up Studies, Humans, Male, Middle Aged, Postoperative Complications diagnostic imaging, Ureter diagnostic imaging, Urinary Tract Infections diagnostic imaging, Urography, Vesico-Ureteral Reflux diagnostic imaging, Kidney Transplantation methods, Postoperative Complications surgery, Ureter surgery, Urinary Tract Infections surgery, Vesico-Ureteral Reflux surgery
Published
1992

13. Cyclosporine A toxicity is associated with reduced endothelin immunoreactivity in renal endothelium.

Author

Watschinger B, Ulrich W, Vychytil A, Traindl O, Seidl S, Kainz H, Klauser R, Wamser P, and Kovarik J

Subjects
Biopsy, Cyclosporine administration & dosage, Endothelium, Vascular pathology, Humans, Immunoenzyme Techniques, Kidney Function Tests, Kidney Transplantation immunology, Kidney Tubular Necrosis, Acute pathology, Kidney Tubules, Proximal drug effects, Kidney Tubules, Proximal pathology, Vasoconstriction drug effects, Vasoconstriction physiology, Cyclosporine adverse effects, Endothelins physiology, Endothelium, Vascular drug effects, Kidney blood supply, Kidney Transplantation pathology, Kidney Tubular Necrosis, Acute chemically induced
Published
1992

14. Single-dose response kinetics of oral cyclosporine A: a critical reexamination.

Author

Klauser R, Irschik H, Wolfram J, Woloszczuk W, and Kovarik J

Subjects
Administration, Oral, Adult, Cyclosporine administration & dosage, Dose-Response Relationship, Drug, Female, Humans, Male, Metabolic Clearance Rate physiology, Middle Aged, Cyclosporine pharmacokinetics, Kidney Transplantation immunology, Renal Dialysis, Uremia blood
Published
1992

15. Cytokine release and dynamics of leukocyte populations after CD3/TCR monoclonal antibody treatment.

Author

Zlabinger GJ, Stuhlmeier KM, Eher R, Schmaldienst S, Klauser R, Vychytil A, Watschinger B, Traindl O, Kovarik J, and Pohanka E

Subjects
Antibodies, Monoclonal adverse effects, CD3 Complex adverse effects, Humans, Lymphocyte Activation immunology, T-Lymphocytes immunology, Antibodies, Monoclonal therapeutic use, CD3 Complex therapeutic use, Cytokines biosynthesis, Graft Rejection drug therapy, Kidney Transplantation immunology, Leukocytes immunology
Abstract

Cytokine release and clinical side effects resulting from the use of OKT3 and BMA 031 monoclonal antibodies in the treatment of kidney graft recipients were evaluated and compared. The rise observed in serum levels of interferon gamma. TNF alpha, and IL-8 was similar after administration of either monoclonal antibody. Furthermore, both OKT3 and BMA 031 resulted in rapid disappearance not only of virtually all T cells, but also of substantial percentages of all major leukocyte populations from the circulation; this effect is probably due to cytokine release activating endothelial cells and thereby causing extravasation even of leukocytes not specifically recognized by the administered antibodies. Evidence has thus been obtained that BMA 031 is as potent as OKT3 in inducing unequivocal signs of T cell activation in vivo. However, while OKT3 therapy was accompanied by adverse side effects in our study as in previous ones, we saw no such reactions in any of the patients receiving BMA 031. This contrast might be due to different mechanisms of leukocyte activation possibly inducing other mediators in the case of OKT3, which then, in combination with the cytokines, could generate treatment-associated morbidity.

Published
1992
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16. High incidence of significant bacteriuria in kidney graft recipients with triple therapy.

Author

Franz M, Traindl O, Pohanka E, Höbarth K, Simak R, Klauser R, Watschinger B, and Kovarik J

Subjects
Australia, Bacteriuria epidemiology, Female, Humans, Immunosuppression Therapy adverse effects, Immunosuppression Therapy methods, Incidence, Male, Middle Aged, Retrospective Studies, Sex Characteristics, Urinary Tract Infections epidemiology, Azathioprine therapeutic use, Bacteriuria etiology, Cyclosporine therapeutic use, Kidney Transplantation immunology, Postoperative Complications epidemiology, Prednisolone therapeutic use, Urinary Tract Infections etiology
Published
1992

17. Hepatitis C antibody in renal transplant patients.

Author

Klauser R, Franz M, Traindl O, Pidlich J, Hay U, Watschinger B, Pohanka E, and Kovarik J

Subjects
Blood Transfusion, Female, Hepatitis C transmission, Hepatitis C Antibodies, Humans, Kidney Diseases surgery, Kidney Diseases therapy, Kidney Transplantation immunology, Male, Middle Aged, Renal Dialysis, Risk Factors, Hepacivirus immunology, Hepatitis Antibodies analysis, Kidney Transplantation physiology
Published
1992

18. Induction of an acute phase response after OKT3 therapy.

Author

Pohanka E, Kovarik J, Klauser R, Woloszcsuk W, and Zlabinger GJ

Subjects
Acute-Phase Proteins metabolism, Cytokines blood, Humans, Interferon-gamma blood, Reference Values, Time Factors, Tumor Necrosis Factor-alpha metabolism, Graft Rejection, Kidney Transplantation immunology, Muromonab-CD3 therapeutic use
Published
1992

19. Influence of immunosuppressive therapy on infectious complications in renal transplant recipients.

Author

Klauser R, Zlabinger GJ, Traindl O, Franz M, Watschinger B, Pohanka E, Kudlacek S, and Kovarik J

Subjects
Adult, Antilymphocyte Serum adverse effects, Antilymphocyte Serum therapeutic use, Azathioprine adverse effects, Azathioprine therapeutic use, Bacteremia epidemiology, Cyclosporine adverse effects, Cyclosporine therapeutic use, Female, Humans, Immunosuppressive Agents therapeutic use, Incidence, Male, Middle Aged, Muromonab-CD3 adverse effects, Muromonab-CD3 therapeutic use, Prednisolone adverse effects, Prednisolone therapeutic use, Retrospective Studies, Virus Diseases epidemiology, Bacteremia etiology, Graft Rejection, Immunosuppressive Agents adverse effects, Kidney Transplantation immunology, Virus Diseases etiology
Published
1992

20. Treatment of hyperlipidemic kidney graft recipients with lovastatin: effect on LDL-cholesterol and lipoprotein (a).

Author

Traindl O, Reading S, Franz M, Watschinger B, Klauser R, Pidlich H, Widhalm K, Pohanka E, and Kovarik J

Subjects
Adult, Cholesterol, HDL metabolism, Cholesterol, LDL metabolism, Female, Humans, Lipoprotein(a) metabolism, Male, Middle Aged, Time Factors, Hyperlipidemias drug therapy, Kidney Transplantation, Lovastatin therapeutic use
Abstract

An increased incidence of hyperlipidemia places kidney graft recipients at increased risk for cardiovascular disease and may contribute to a decline in graft function. A study was undertaken to evaluate the safety and efficacy of lovastatin in these patients. Twelve kidney graft recipients with stable graft function and a cholesterol (chol) level over 250 mg/dl (6.46 mmol/l) were included. The lipid-lowering treatment consisted of 20 mg lovastatin daily, and all patients received immunosuppression with ciclosporin (CS) and prednisolone. Total chol decreased by 27% (300 +/- 56 to 219 +/- 28 mg/dl; 7.76 +/- 1.45 to 5.66 +/- 0.72 mmol/l; p < 0.01), LDL-chol by 35% (220 +/- 38 to 143 +/- 17 mg/dl; 5.69 +/- 0.98 to 3.70 +/- 0.44 mmol/l; p < 0.01) and triglycerides by 33% (207 +/- 127 to 138 +/- 56 mg/dl; 2.36 +/- 1.44 to 1.57 +/- 0.64 mmol/l; p < 0.05). HDL-chol increased by 10% (57 +/- 11 to 63 +/- 13 mg/dl; 1.47 +/- 0.28 to 1.63 +/- 0.34 mmol/l; NS). The ratio of total chol/HDL-chol, a generally accepted risk predictor of atherosclerosis, fell from 5.4 +/- 1.3 to 3.3 +/- 1.2, p < 0.01. Lipoprotein (a) [lp(a)], an independent risk predictor for atherosclerosis, was also evaluated at baseline and after 6 months of lovastatin treatment and showed a decrease of 39% (32.9 +/- 27.6 to 19.9 +/- 22.9 mg/dl; 0.85 +/- 0.71 to 0.51 +/- 0.59 mmol/l; p < 0.05). No adverse side effects were seen at this dosage, and hepatic and renal parameters remained unchanged.(ABSTRACT TRUNCATED AT 250 WORDS)

Published
1992
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21. The effects of cinacalcet in older and younger patients on hemodialysis: The evaluation of cinacalcet HCL therapy to lower cardiovascular events (EVOLVE) trial

Author

P. Ryckelynck, Y. Woredekal, T. Gehr, Marian Klinger, J. Passauer, K. Liss, E. Del Valle, B. Linares, Ferdinando Avella, Stolear Jc, S. Tolkan, O. Hermida, V. Wizemann, Ricardo Correa-Rotter, J. Santos, Gert Mayer, Michael Anger, B. Pellegrino, B. Wikström, A. Ståhl, H. Al-Bander, Pedro Alejandro Gordan, Philip A. Kalra, E. Galindo-Ramos, Carmine Zoccali, G. Dolson, M. Eigner, Sanjay Dalal, G. Touchard, J Peeters, G. Da Roza, Shannon Murphy, R. Errico, M. Lonergan, A. Andrusev, H. Boulechfar, P. Zaoui, Michael Suranyi, de Francisco Martín de Francisco, S. Jacobson, B. Gupta, C. Stafford, J. Picollo de Oliveira, Ilka Regina Souza de Oliveira, F. Dumler, J. Martinez Saye, E. de Almeida Romão, Emmanuel A. Burdmann, C. Vermeij, N. Kumar, E. Shahmir, J. Stratton, R. Schmidt, Mario Cozzolino, Lars Christian Rump, Rainer Oberbauer, J. Kumar, M. Saklayen, Brian Hutchison, C. Denu-Ciocca, L. Weiss, E. Friedman, L. Renders, K. Gurevich, L. Brandi, W. Shapiro, Kym M. Bannister, K. Berta, Muhammad M. Yaqoob, C. Lok, A. Pedrosa, Rosa M.A. Moysés, K. Bhandari, J. Arrieta, T. Crouch, Brigitte Maes, G. Wong, Myriam González, Matthew R. P. Davies, R. Gonzalez, Geoffrey A. Block, T. Nammour, T. Youell, J. Ramirez, S. Tobe, N. Ramirez, T. Bochicchio-Ricardelli, J. Cangiano-Rivera, D. Streja, J. Endsley, K. Ang, R. Patak, J. Cheng, T. Rogers, Alberto Albertazzi, H. Holzer, G. Choukroun, Jose A.L. Arruda, Philippe Rieu, P. Simon, Stephen Z. Fadem, Jared G. Sugihara, H. Alfred, Bruce F. Culleton, G. Frascà, Giovanni Pertosa, W. Van Kuijk, H. Beresan, Samuel S. Blumenthal, Piergiorgio Messa, H. Baer, Michael C. Braun, B. Rutkowski, W. Riegel, M. Komandenko, V. Ermolenko, Martin Wilkie, N. Muirhead, Peter G. Kerr, D. Rattensberger, J. Sabto, Anjay Rastogi, L. Lef, M. El Shahawy, D. Tharpe, A. Smirnov, J. Pons, F. García, F. Zantvoort, A. Lionet, J. Topf, Marcia R. Silver, Reinhard Kramar, E. Moriero, A. Rekhi, S. Roe, P. Batista, E. Kolmakova, F. Rahim, M. Ostrowski, Janice P. Lea, Patrizia Ondei, C. Martinez, J. Donck, Nicole Lopez, F. Schena, Allen R. Nissenson, Alex P.S. Disney, R. Valtuille, C. Najun Zarazaga, M. Fraenkel, Pieter Evenepoel, R. Cottiero, S. Di Giulio, V. Gura, S. Karunakaran, P. Nader, F. Saldanha Thome, Walter Douthat, A. Fekete, L. Arbeit, W. Sulowicz, I. Marin, Charles R.V. Tomson, Andrzej Wiecek, Luis A. Juncos, G. Mingardi, P. Light, Max Dratwa, H. Reichel, R. Raja, U. Ranjit, G. Sterner, E. Coll Piera, P. Pai, Robert J. Walker, R. Bregman, E. Hübel, M. Timofeev, T. Szabo, A. Elli, N. Padmanabhan, N. Garrote, M. Mysliwiec, David C. Wheeler, J. Cruz-Valdez, R. Klauser, Maree-Ross Smith, Antonio Carlos Carvalho, A. Losito, M. Durlik, G. Petraglia, Gianni Cappelli, Y. Lien, M. Chaffin, N. García, R. Halligan, Glenn M. Chertow, M. Bastos, P. Smak Gregoor, S. Ong, M. Belledonne, Fredric O. Finkelstein, J. Martínez García, R. Pecoits Filho, M. Klingberg, B. Carvalho, S. Noble, T. Plumb, A. Chew Wong, Michael Roppolo, U. Neyer, S. Ahmad, J. Mackie, R. Minasian, M. Verrelli, A. Abukurah, M. Laski, P. Brunet, Madeleine V. Pahl, Daniel Zehnder, E. Alas, Muralidhar Acharya, G. Rudolf, G. Zakar, M. Reddy, R. Specter, G. Grandaliano, I. Kulcsar, A. Amatya, Eugenie Pedagogos, O. Ayodeji, G. Jensen, S. Diamond, Xavier Warling, P. Teredesai, M. Mathew, M. Haque, M. Solis, E. Andrés Ribes, M.A. van den Dorpel, Akhtar Ashfaq, Christian Rabbat, David G. Warnock, M. Sebastian Diaz, C. Mousson, R. Darwish, M. Sperto Baptista, N. Salgado, E. Alvarez Sandoval, M. Vasilevsky, P. Chidester, D. Polack, Simon J. Davies, G. Brosnahan, A. Agarwal, Chaim Charytan, T. Hannedouche, M. Gross, I. Arias, G. James, Jürgen Floege, Tom Dejagere, Patrick S. Parfrey, S. Cournoyer, T. Cavalieri, Gérard M. London, K. Gandhi, A. Kshirsagar, O. Khrustalev, J. Zacharias, Michel Dhaene, Jennifer Tuazon, W. Weise, J. Guzman-Rivera, HS Brink, Alastair J. Hutchison, P. D. Cunha, Robyn G Langham, S. Soman, J. Goldman, S. Kazup Erdelyine, A. Widerhorn, M. Henriquez, N. Hunt, W. Hoerl, O. Arkossy, J. Szegedi, R. Dhingra, M. Fernandez Lucas, Jesus Navarro, A. Kark, Andrey Gurevich, Cynthia J. Brown, Rajnish Mehrotra, L. Kleinman, S. Ferenczi, Loreto Gesualdo, V. Schwenger, M. Ramirez, N. Mittman, Ana María Cusumano, K. Marczewski, Moustafa Moustafa, Sônia M. H. A. Araújo, E. Ladanyi, M. Auricchio, Maurice Laville, P. Urena Torres, C. Gallart, A. Israelit, V. Altobelli, E. Hagen, S. Nosrati, John P. Middleton, Kant Ks, F. Al-Saghir, S. Steinberg, S. Neiva Coelho, Botond Csiky, Philip G Zager, M. Sekkarie, Vanda Jorgetti, Domingos O. d'Avila, Carol A. Pollock, L. Lai, B. von Albertini, Beckie Michael, U. Kunzendorf, N. Frischmuth, A. Durrbach, L. Vasconcellos, Raymond Vanholder, M. Dickenmann, B. Schiller-Moran, Steven D. Soroka, J. Rubin, O. Balkarova, S. Morse, M. Teixeira Araújo, D. Perlin, M. Khan, C. Hura, Dagmar-C. Fischer, D. Machado, Seamas C. Donnelly, D. Sapir, V. Lorica, L. Deboni, M. Jose, M. Galicia, K. Bidas, David Spiegel, David Goldsmith, Peter F Mount, A. Strokov, L. Yu, J. Pitone, Biagio Ricciardi, Alastair Gillies, M. Moyses Neto, Piergiorgio Bolasco, V. Anashkin, John R. Sedor, M. Lee, E.M. Jones, M. Culpepper, G. London, D. Joly, N. Khadikova, Charles A. Herzog, P. Meier, M. Farina, Dana V. Rizk, William M. McClellan, M. Cook, Bastian Dehmel, Patrizia Ferrari, F. Almeida, V. Pogue, R. McCrary, F. Macario, J. Golden, E. Wijeyesinghe, Tilman B. Drüeke, E. Osanloo, M. Muszytowski, F. Arif, Giuseppe Villa, M. Torres Zamora, Steven Zeig, N. Thompson, A. Jamal, C. Sholer, P. Stroumza, D. Reddan, Arun Gupta, J. Montenegro, T. DelGiorno, D. Eadington, G. Shostka, Michel Jadoul, A. Weigert, Sergio Stefoni, P. Dreyer, Carmel M. Hawley, J. Cardeal da Costa, M. Switalski, G. Talaulikar, A. Felsenfeld, J. MacLaurin, T. Herman, N. Pritchard, M. Michaud, K.-U. Eckardt, R. Romero, G. Volgina, Fred E. Husserl, J. Soler Amigó, David S. Goldfarb, A. Matalon, M. 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Subjects
Parathyroidectomy, Adult, Male, medicine.medical_specialty, Cinacalcet, Epidemiology, medicine.medical_treatment, Calcimimetic Agents, Critical Care and Intensive Care Medicine, Lower risk, Severity of Illness Index, CKD, cardiovascular disease, hemodialysis, hyperparathyroidism, mineral metabolism, Age Factors, Aged, Aged, 80 and over, Cardiovascular Diseases, Cinacalcet Hydrochloride, Female, Humans, Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Kidney Transplantation, Middle Aged, Renal Dialysis, Nephrology, Transplantation, Internal medicine, medicine, Intensive care medicine, Hyperparathyroidism, business.industry, Original Articles, medicine.disease, Secondary hyperparathyroidism, Hemodialysis, business, medicine.drug
Abstract

Background andobjectivesThecalcimimeticcinacalcet reduced therisk of death or cardiovascular (CV) events in older, but not younger, patients with moderate to severe secondary hyperparathyroidism (HPT) who were receiving hemodialysis. To determine whether the lower risk in younger patients might be due to lower baseline CV risk and more frequent use of cointerventions that reduce parathyroid hormone (kidney transplantation, parathyroidectomy, and commercial cinacalcet use), this study examined the effects of cinacalcet in older ($65 years, n=1005) and younger (,65 years, n=2878) patients. Design, setting, participants, & measurements Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) was a global, multicenter, randomized placebo-controlled trial in 3883 prevalent patients on hemodialysis, whose outcomes included death, major CV events, and development of severe unremitting HPT. The age subgroup analysis was prespecified. ResultsOlderpatients hadhigher baselineprevalenceof diabetesmellitusandCV comorbidity. Annualizedrates of kidney transplantation and parathyroidectomy were .3-fold higher in younger relative to older patients and were more frequent in patients randomized to placebo. In older patients, the adjusted relative hazard (95% confidence interval) for the primary composite (CV) end point (cinacalcet versus placebo) was 0.70 (0.60 to 0.81); in younger patients, the relative hazard was 0.97 (0.86 to 1.09). Corresponding adjusted relative hazards for mortality were 0.68 (0.51 to 0.81) and 0.99 (0.86 to 1.13). Reduction in the risk of severe unremitting HPT was similar in both groups. Conclusions In the EVOLVE trial, cinacalcet decreased the risk of death and of major CV events in older, but not younger, patients with moderate to severe HPT who were receiving hemodialysis. Effect modification by age may be partly explained by differences in underlying CV risk and differential application of cointerventions that reduce parathyroid hormone. Clin J Am Soc Nephrol 10: ccc–ccc, 2015. doi: 10.2215/CJN.07730814

Published
2015

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