Background and objectives The calcimimetic cinacalcet reduced the risk 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.Results Older patients had higher baseline prevalence of diabetes mellitus and CV comorbidity. Annualized rates 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. ConclusionsIn 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.
In adults treated with hemodialysis, poorer dental health was associated with early death, whereas preventive dental health practices were associated with longer survival.
Latin America is a conglomerate of adjacent countries having in common a Latin extraction and language (Spanish or Portuguese) and exhibiting extreme variations in socioeconomic status. The Latin American Society of Nephrology and Hypertension Dialysis and Renal Transplantation Registry was created in 1991. Annual data are sent by local societies in 3 forms: patient, center, and country. The prevalence of renal replacement therapy (RRT) (all modalities) increased from 119 patients per million population (pmp) in 1991 to 349 pmp in 2001; the acceptance rate was 91.7 pmp in 2001. Dialysis prevalence was 277 pmp; hemodialysis was the predominant modality, except in Mexico (86% on peritoneal dialysis). The highest dialysis prevalence and acceptance rates were reported by Puerto Rico, Uruguay, and Chile. Among incident patients, diabetic nephropathy (33%) and nephroangioesclerosis (32%) were the primary causes; 38% were older than 65 years old. Renal transplants increased from 3.7 pmp in 1987 to 13.7 pmp in 2001. In 2003, 6357 transplants were performed (55% living donor); the cumulative number performed since 1987 reached 55,947. Prevalence and incidence are low because not all patients with end-stage renal disease have access to RRT because of restricted availability, difficulties in referral, and inequities in coverage. The annual increase in the number of patients on RRT (8%-10%) is higher, proportionally, than the annual growth of the Latin American population in general (1.5%). Efforts must be focused on prevention and treatment of chronic kidney disease, especially in diabetic and older patients, and in implementing better organ donation programs to improve the pool of cadaveric donors.
IntroductionAdults with end-stage kidney disease (ESKD) treated with haemodialysis experience mortality of between 15% and 20% each year. Effective interventions that improve health outcomes for long-term dialysis patients remain unproven. Novel and testable determinants of health in dialysis are needed. Nutrition and dietary patterns are potential factors influencing health in other health settings that warrant exploration in multinational studies in men and women treated with dialysis. We report the protocol of the “DIETary intake, death and hospitalisation in adults with end-stage kidney disease treated with HaemoDialysis (DIET-HD) study,” a multinational prospective cohort study. DIET-HD will describe associations of nutrition and dietary patterns with major health outcomes for adults treated with dialysis in several countries.Methods and analysisDIET-HD will recruit approximately 10 000 adults who have ESKD treated by clinics administered by a single dialysis provider in Argentina, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Spain, Sweden and Turkey. Recruitment will take place between March 2014 and June 2015. The study has currently recruited 8000 participants who have completed baseline data. Nutritional intake and dietary patterns will be measured using the Global Allergy and Asthma European Network (GA2LEN) food frequency questionnaire. The primary dietary exposures will be n-3 and n-6 polyunsaturated fatty acid consumption. The primary outcome will be cardiovascular mortality and secondary outcomes will be all-cause mortality, infection-related mortality and hospitalisation.Ethics and disseminationThe study is approved by the relevant Ethics Committees in participating countries. All participants will provide written informed consent and be free to withdraw their data at any time. The findings of the study will be disseminated through peer-reviewed journals, conference presentations and to participants via regular newsletters. We expect that the DIET-HD study will inform large pragmatic trials of nutrition or dietary interventions in the setting of advanced kidney disease.
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