Prevalence of arterial stiffness and associated factors in Thai hemodialysis patients: A multicenter cross-sectional study.

BACKGROUND: Hemodialysis (HD) patients have higher risks of cardiovascular morbidity and mortality compared to the general population. Cardio-femoral pulse wave velocity (cfPWV) is associated with cardiovascular morbidity and mortality in HD patients. This study aimed to evaluate the prevalence and associated factors of arterial stiffness in Thai HD patients. MATERIALS AND METHODS: This cross-sectional multicenter study was conducted at 4 HD centers in Bangkok, Thailand. cfPWV and peripheral blood pressure were assessed using SphygmoCor XCEL Model EM4C (AtCor medical Inc., Sydney, Australia). Significant arterial stiffness was defined by cfPWV > 10 m/s. Univariate and multivariable regression models were used to identify factors associated with arterial stiffness. RESULTS: 144 HD patients were assessed for arterial stiffness by cfPWV measurement. The mean age of the patients was 57.8 ± 12.8 years, with 50% male and a mean dialysis vintage of 7.6 years. The mean cfPWV was 11.7 ± 3.0 m/s. The prevalence of increased arterial stiffness was 73.6%. Multivariable analysis showed that older age, hypertension, lower HD adequacy, and higher fasting plasma glucose were independently associated with arterial stiffness. CONCLUSION: There was a high prevalence of arterial stiffness among HD patients. Some modifiable factors found to be independently associated, including dialysis adequacy and glycemic control, should be further investigated to identify approaches to retard vascular stiffness.

Effect of Menaquinone-7 Supplementation on Arterial Stiffness in Chronic Hemodialysis Patients: A Multicenter Randomized Controlled Trial.

BACKGROUND: There is a very high prevalence of subclinical vitamin K deficiency in patients requiring hemodialysis (HD), and this problem is associated with vascular calcification and arterial stiffness. Vitamin K2 (MK-7) supplementation can improve vitamin K status in HD patients. However, the benefits of vitamin K supplementation on arterial stiffness have still not been established. The present study was conducted to evaluate the efficacy of menaquinone-7 (MK-7) supplementation on arterial stiffness in chronic HD patients. METHODS: This open-label multicenter randomized clinical trial was conducted in 96 HD patients who had arterial stiffness, defined by high carotid femoral pulse wave velocity (cfPWV ≥ 10 m/s). The patients were randomly assigned to receive oral MK-7 (375 mcg once daily) for 24 weeks (n = 50) or standard care (control group; n = 46). The change in cfPWV was the primary outcome. RESULTS: Baseline parameters were comparable between the two groups. There was no significant difference in the change in cPWV at 24 weeks between the MK-7 group and standard care [-6.0% (-20.2, 2.3) vs. -6.8% (-19.0, 7.3), p = 0.24]. However, we found that MK-7 significantly decreased cPWV in patients with diabetes [-10.0% (-15.9, -0.8) vs. 3.8% (-5.8, 11.6), p = 0.008]. In addition, the MK-7 group had a lower rate of arterial stiffness progression, compared to controls (30.2% vs. 39.5%, p = 0.37), especially in diabetes patients (21.4% vs. 72.7%, p = 0.01). No serious adverse events were observed during the 24 weeks. CONCLUSION: Vitamin K supplements provided a beneficial impact in lowering the rate of arterial stiffness progression in chronic hemodialysis patients with diabetes. Possible benefits on cardiovascular outcomes require further investigation.

Effect of Maintenance Intravenous Iron Treatment on Erythropoietin Dose in Chronic Hemodialysis Patients: A Multicenter Randomized Controlled Trial.

BACKGROUND: There is no consensus on intravenous (IV) iron supplement dose, schedule, and serum ferritin target in functional iron deficiency anemia to maintain optimum target levels of iron stores by several guidelines. OBJECTIVE: To examine the effect of IV iron supplementation to different targets of serum ferritin on erythropoietin dose and inflammatory markers in chronic hemodialysis (HD) patients with functional iron deficiency anemia. DESIGN: A multicenter, randomized, open-label study. SETTING: In a developing country, Thailand. PATIENTS: Chronic HD patients with functional iron deficiency anemia. MEASUREMENTS: Erythropoietin resistance index, high-sensitivity C-reactive protein, and fibroblast growth factor 23. METHODS: Two hundred adult chronic HD patients with transferrin saturation less than 30% and serum ferritin of 200 to 400 ng/mL were randomized 1:1 to maintain serum ferritin 200 to 400 ng/mL (low-serum ferritin group, N = 100) or 600 to 700 ng/mL (high-serum ferritin group, N = 100). During a 6-week titration period, participants randomized to the high-serum ferritin group initially received 600 mg IV iron (100 mg every week), while the participants in the low-serum ferritin group did not receive IV iron. During the 6-month follow-up period, the dose of IV iron was adjusted by protocol. RESULTS: The mean dose of IV iron was 108.3 ± 28.2 mg/month in the low-serum ferritin group and 192.3 ± 36.2 mg/month in the high-serum ferritin group. The mean serum ferritin was 367.0 ± 224.9 ng/mL in the low ferritin group and 619.6 ± 265.2 ng/mL in the high ferritin group. The erythropoietin resistance index was significantly decreased in the high-serum ferritin group compared to the low-serum ferritin group after receiving IV iron in the 6-week titration period (mean difference: -113.43 ± 189.14 vs 41.08 ± 207.38 unit/week/g/dL; P < .001) and 3-month follow-up period (mean differences: -88.88 ± 234.43 vs -10.48 ± 217.75 unit/week/g/dL; P = .02). LIMITATIONS: Short follow-up period. CONCLUSION: Maintaining a serum ferritin level of 600 to 700 ng/mL by IV iron administration of approximately 200 mg per month as a maintenance protocol can decrease erythropoietin dose requirements in chronic HD patients with functional iron deficiency anemia. TRIALS REGISTRATION: The study was registered with the Thai Clinical Trials Registry TCTR20180903003.

CONTEXTE: Il n'existe aucun consensus sur la dose et la posologie du supplément de fer administré par voie intraveineuse (IV) dans le traitement de l'anémie ferriprive fonctionnelle, ni sur la cible de ferritine sérique permettant de maintenir les réserves ferriques optimales définies par les différentes recommandations. OBJECTIF: Examiner l'effet d'un supplément de fer IV, à différentes cibles de ferritine sérique, sur la dose d'érythropoïétine et les marqueurs inflammatoires de patients sous hémodialyse chronique atteints d'une anémie ferriprive fonctionnelle. TYPE D'ÉTUDE: Essai multicentrique ouvert à répartition aléatoire. CADRE: L'étude s'est tenue en Thaïlande, un pays en développement. SUJETS: Des patients sous hémodialyse chronique atteints d'anémie ferriprive fonctionnelle. MESURES: L'indice de résistance à l'érythropoïétine, la protéine C réactive très sensible et le facteur de croissance des fibroblastes 23. MÉTHODOLOGIE: Deux cents adultes sous HD chronique présentant une saturation en transferrine inférieure à 30 % et un taux de ferritine sérique entre 200 et 400 ng/mL ont été répartis en deux groupes (ratio 1:1). On visait le maintien d'un taux de ferritine sérique entre 200 et 400 ng/mL dans le premier groupe (faible taux de ferritine sérique; n=100) et entre 600 et 700 ng/mL dans le deuxième groupe (taux élevé de ferritine sérique; n=100). Au cours d'une période d'ajustement de six semaines, les sujets du groupe à taux élevé de ferritine sérique ont initialement reçu une dose de 600 mg de fer par IV (100 mg par semaine) alors que les sujets de l'autre groupe n'en ont pas reçu. La dose de fer IV a été ajustée selon le protocole au cours des six mois de suivi. RÉSULTATS: La dose moyenne de fer administrée par IV était de 108,3 ±28,2 mg/mois pour les sujets du groupe à faible taux de ferritine sérique et de 192,3 ±36,2 mg/mois pour les sujets du groupe à taux élevé de ferritine sérique. En ce qui concerne les taux de ferritine sérique, ceux-ci s'établissaient respectivement à 367,0 ±224,9 ng/mL et à 619,6 ±265,2 ng/mL. Les sujets du groupe à taux élevé de ferritine sérique présentaient un indice de résistance à l'érythropoïétine significativement réduit par rapport à ceux du groupe à faible taux après avoir reçu un supplément de fer IV durant la période d'ajustement de six semaines (différence moyenne: -113,43 ±189,14 contre 41,08 ±207,38 unités/semaine/g/dL; p<0,001) et après trois mois de suivi (différence moyenne: -88,88 ±234,43 contre -10,48 ±217,75 unités/semaine/g/dL; p=0,02). LIMITES: Courte période de suivi. CONCLUSION: Le maintien d'un taux de ferritine sérique entre 600 et 700 ng/mL par l'administration IV d'une supplémentation en fer, à raison d'environ 200 mg par mois (protocole de maintien), peut contribuer à réduire la posologie d'érythropoïétine chez les patients hémodialysés et atteints d'anémie ferriprive fonctionnelle. ENREGISTREMENT DE L'ESSAI: L'essai a été enregistré selon le registre des essais cliniques thaïlandais TCTR20180903003.

Prevalence trend of renal replacement therapy in Thailand: impact of health economics policy.

OBJECTIVE: The national health insurance fund in Thailand initiated by the national health security act in November, 2002. In October 2007, the national health insurance fund launched the first renal replacement therapy (RRT) reimbursement plan by the "Peritoneal Dialysis-First" (PD First) policy. The rationale of the PD First Policy resulted from the perspective that PD for end stage renal disease (ESRD) treatment offers the most economic and efficient outcome. The present study was conducted to determine whether the increase of RRT penetration by national health policy could impact the national RRT prevalence. MATERIAL AND METHOD: The Thailand Renal Replacement Therapy (TRT) database in 2007, 2008, and 2009 were retrieved and analyzed. RESULTS: By TRT registry data, the total yearly prevalence of RRT increased by an average of 14.8% after the implementation of national health insurance and the "PD First" policy from 2007 to 2009. The total yearly prevalence of hemodialaysis (HD) modestly increased (14.7%) while the total yearly prevalence of PD remarkably expanded by 107.3%. The yearly incidence of all RRT modalities increased by an average of 34.8% in 2007 to 2009. The yearly incidence of HD modestly increased (8.1%) while the total yearly incidence of PD remarkably elevated by 157.8%. Civil Servants Medical Benefit Compensation (CSMBS) was the major funding source of RRT cases (34.5%) while national health insurance funding was the second major funding source (26.0%). From 2007-2009, the CSMBS funding was the majority of HD while national health insurance funding was the majority of PD. The sharing of PD by national health insurance increased from 33.9% in 2007, 58.6% in 2208, and 77.2% in 2009. CONCLUSION: The coverage ofESRD patients by national health insurance fund by the "PD First" policy impacted the RRT prevalence and incidence both the total prevalence and total incidence due to the universal penetration to RRT treatment of Thai population. Also, the policy altered the RRT modality predisposition. PD modality willfinally be the majority ofThaiRRT modalities if the policy can be managed successfully.