Dietary habits in Australian, New Zealand and Malaysian patients with end stage kidney failure: A pre-specified cross-sectional study of the FAVOURED trial participants.

BACKGROUND: Dietary management plays an important role in patients with kidney failure. Current dietary habits of Australians and New Zealanders (ANZ) and Malaysians with chronic kidney disease (CKD Stage 4-5) have not been adequately investigated. We report the dietary habits of people with advanced CKD and their adherence to country-specific dietary guidelines. METHODS: Participants with CKD Stage 4-5, enrolled in the Omega-3 Fatty Acids (Fish oils) and Aspirin in Vascular access Outcomes in Renal Disease (FAVOURED) trial, completed a lifestyle questionnaire at baseline on their dietary intake. RESULTS: Of 567 participants, 538 (ANZ, n = 386; Malaysian, n = 152; mean ± SD age 54.8 ± 14.3 years, 64% male) completed the questionnaire. Dietary fruit and vegetable intakes were higher in ANZ participants; 49% (n = 189) consumed ≥2 serves day-1 of fruit and 61% (n = 235) ate ≥2 serves day-1 of vegetables compared to 24% (n = 36) and 34% (n = 52) of Malaysians, respectively (p < 0.0001). Only 4% (n = 15) of ANZ participants met Australian Dietary recommendations of two fruit and five vegetable serves day-1 . Fish consumption was higher in Malaysians with 83% (n = 126) consuming ≥2 serves week-1 compared to 21% (n = 81) of ANZ participants (p < 0.001). Red meat intake was higher in ANZ participants; however, chicken consumption was similar; 48% (n = 185) consumed >2 chicken serves week-1 and 65% (n = 251) ate >2 serves week-1 of red meat compared to 43% (n = 65) and 15% (n = 23) of Malaysians, respectively. CONCLUSIONS: Significant regional variation in dietary intake for fruit, vegetables and animal protein is described that likely reflects cultural and economic differences. Barriers to meeting recommended dietary intakes require further investigation.

Prevalence of chronic kidney disease and its associated factors in Malaysia; findings from a nationwide population-based cross-sectional study.

BACKGROUND: The prevalence of chronic kidney disease (CKD) in Malaysia was 9.07% in 2011. We aim to determine the current CKD prevalence in Malaysia and its associated risk factors. METHODS: A population-based study was conducted on a total of 890 respondents who were representative of the adult population in Malaysia, i.e., aged ≥18 years old. Respondents were randomly selected using a stratified cluster method. The estimated glomerular filtration rate (eGFR) was estimated from calibrated serum creatinine using the CKD-EPI equation. CKD was defined as eGFR < 60 ml/min/1.73m2 or the presence of persistent albuminuria if eGFR ≥60 ml/min/1.73m2. RESULTS: Our study shows that the prevalence of CKD in Malaysia was 15.48% (95% CI: 12.30, 19.31) in 2018, an increase compared to the year 2011 when the prevalence of CKD was 9.07%. An estimated 3.85% had stage 1 CKD, 4.82% had stage 2 CKD, and 6.48% had stage 3 CKD, while 0.33% had stage 4-5 CKD. Hypertension (aOR 3.72), diabetes mellitus (aOR 3.32), increasing BMI (aOR 1.06), and increasing age (aOR 1.06) were significantly associated with CKD. CONCLUSION: Our study has shown that CKD has become one of the leading public health issues in Malaysia. Thus, there is an urgent need to screen for CKD and prevent its progression, associated morbidity, and mortality at the national level.

Health related quality of life of dialysis patients in Malaysia: Haemodialysis versus continuous ambulatory peritoneal dialysis.

BACKGROUND: Health related quality of life (HRQOL) is an important predictor of clinical outcomes for End Stage Renal Disease (ESRD) patients and to establish quality adjusted life years (QALYs) for economic evaluation studies. This study aims to measure the health utilities and to identify socio-demographic and clinical factors associated with HRQOL for haemodialysis (HD) and continuous ambulatory peritoneal dialysis (CAPD) in Malaysia. METHODS: A total of 141 patients (77 HD and 64 CAPD) from 1 federal and four state hospitals participated in this cross-sectional study. Patients were randomly selected from the National Renal Registry (NRR) using a stratified random sampling. The EQ-5D-3 L questionnaire was used to measure HRQOL. Variables investigated include dialysis modalities, sociodemographic characteristics, co-morbidities and biochemical markers. Utilities are measured on an ordinal scale of 0-1, where 1 indicates full health and 0 indicates death. RESULTS: The mean utility scores were 0.854 ± 0.181 and 0.905 ± 0.124 (p > 0.05) and the mean Visual Analogue Scale (VAS) scores were 76.2 ± 12.90 and 77.1 ± 10.26 (p > 0.05) for HD and CAPD patients respectively. There was a significant difference in problems reported between HD (35.1%) and CAPD (15.6%) on usual activities dimension (p = 0.009). The proportion of patients having problems in the pain/discomfort domain in both modalities was high (34.0%). Haemoglobin (< 10 g/dL) (p = 0.003), number of co-morbidities ≥3 (p = 0.004) and wheelchair-bound status (p < 0.001) were significant predictors of poor HRQOL. CONCLUSIONS: The present cross-sectional study shows that CAPD patients have a higher utility index score than HD patients but this was not statistically significant. The utilities index score may be used to calculate QALYs.

Addressing the burden of dialysis around the world: A summary of the roundtable discussion on dialysis economics at the First International Congress of Chinese Nephrologists 2015.

To address the issue of heavy dialysis burden due to the rising prevalence of end-stage renal disease around the world, a roundtable discussion on the sustainability of managing dialysis burden around the world was held in Hong Kong during the First International Congress of Chinese Nephrologists in December 2015. The roundtable discussion was attended by experts from Hong Kong, China, Canada, England, Malaysia, Singapore, Taiwan and United States. Potential solutions to cope with the heavy burden on dialysis include the prevention and retardation of the progression of CKD; wider use of home-based dialysis therapy, particularly PD; promotion of kidney transplantation; and the use of renal palliative care service.

A population-based study measuring the prevalence of chronic kidney disease among adults in West Malaysia.

In this population-based study, we determine the prevalence of chronic kidney disease in West Malaysia in order to have accurate information for health-care planning. A sample of 876 individuals, representative of 15,147 respondents from the National Health and Morbidity Survey 2011, of the noninstitutionalized adult population (over 18 years old) in West Malaysia was studied. We measured the estimated glomerular filtration rate (eGFR) (CKD-EPI equation); albuminuria and stages of chronic kidney disease were derived from calibrated serum creatinine, age, gender and early morning urine albumin creatinine ratio. The prevalence of chronic kidney disease in this group was 9.07%. An estimated 4.16% had stage 1 chronic kidney disease (eGFR >90 ml/min per 1.73 m(2) and persistent albuminuria), 2.05% had stage 2 (eGFR 60-89 ml/min per 1.73 m(2) and persistent albuminuria), 2.26% had stage 3 (eGFR 30-59 ml/min per 1.73 m(2)), 0.24% had stage 4 (eGFR 15-29 ml/min per 1.73 m(2)), and 0.36% had stage 5 chronic kidney disease (eGFR <15 ml/min per 1.73 m(2)). Only 4% of respondents with chronic kidney disease were aware of their diagnosis. Risk factors included increased age, diabetes, and hypertension. Thus, chronic kidney disease in West Malaysia is common and, therefore, warrants early detection and treatment in order to potentially improve outcome.

Stroke incidence in the South West District of the Penang Island, Malaysia: PEARLs: Penang Acute Stroke Research Longitudinal Study.

OBJECTIVES: This community based incidence study aims to report the stroke incidence in the south-west region of the Penang Island. METHODS: All strokes occurring in the population of residents in the southwest region of the Penang Island, Malaysia during a period of 12 months, from April 2010 to March 2011 were screened and assessed. Standard definitions for stroke were used. All stroke cases were ascertained using multiple overlapping sources. Incidence rate was based on first ever in a lifetime stroke cases. All recurrent strokes were excluded from the incidence count. RESULTS: The overall stroke incidence rate in the study region during the study period was 67 per 100,000 after age adjustment to 2010 Malaysian population. CONCLUSION: This study provides the first stroke incidence data in Malaysia and is vital for effective health system planning.

Prevalence and risk factors for proteinuria: the National Kidney Foundation of Malaysia Lifecheck Health Screening programme.

AIM: Treatment of chronic kidney disease (CKD) poses a huge burden to the healthcare system. To address the problem, the National Kidney Foundation of Malaysia embarked on a programme to screen for proteinuria and educate the public on CKD. METHODS: The public was invited for health screening and the data collected over a 21 month period was analyzed. RESULTS: In total, 40400 adults from all the states in Malaysia were screened. The screening population had a mean age of 41 years, 30.1% had hypertension and 10.6% had diabetes. Proteinuria was detected in 1.4% and haematuria in 8.9% of the participants. Factors associated with the highest risk for proteinuria were the presence of diabetes (adjusted odds ratio (OR) 2.63 (95% confidence interval (CI) 2.16-3.21)), hypertension (OR 2.49 (95% CI 2.03-3.07)) and cardiac disease (OR 2.05 (95% CI 1.50-2.81)). Other risk factors identified were lower educational level, family history of kidney disease, hypercholesterolaemia, obesity and lack of regular exercise. Chinese had the lowest risk for proteinuria among the races (OR 0.71 (95% CI 0.57-0.87) compared with Malays). The combination of high blood glucose and high blood pressure (BP) substantially increased the risk for proteinuria (OR 38.1 for glucose ≥ 10 mmol/L and systolic BP ≥ 180 mm Hg and OR 47.9 for glucose ≥ 10 mmol/L and diastolic BP ≥ 110 mm Hg). CONCLUSION: The prevalence of proteinuria in Malaysia is similar to other countries. The major risk factors for proteinuria were diabetes, hypertension and cardiac disease. The presence of both high blood pressure and high blood glucose exert a synergistic effect in substantially increasing the risk for proteinuria.

Randomized controlled trial to compare the efficacy and safety of oral paricalcitol with oral calcitriol in dialysis patients with secondary hyperparathyroidism.

AIM: The objective of the study was to compare the efficacy and safety of oral paricalcitol with oral calcitriol for treating secondary hyperparathyroidism. METHODS: We conducted the first multicenter open-labelled parallel group randomized controlled trial in 66 patients on dialysis. Patients were randomized to paricalcitol or calcitriol at a 3:1 dose ratio and adjusted to maintain intact parathyroid hormone (iPTH) level between 150-300 pg/mL, serum calcium ≤2.74 mmol/L and calcium-phosphate product ≤5.63 mmol(2) /L(2). The primary end point was the proportion of patients who achieved >30% reduction in iPTH. RESULTS: At 24 weeks, 22 (61.1%) patients in the paricalcitol and 22 (73.3%) in the calcitriol group had achieved the primary end-point (P-value = 0.29). The cumulative proportion of patients who achieved the end-point at 6 weeks, 12 weeks and 24 weeks were 50%, 80.6% and 86.1%, respectively, in paricalcitol and 53.3%, 86.7% and 86.7%, respectively, in the calcitriol group (P-value = 0.67). Median time to the end-point was 6 weeks in both groups. There were no significant differences in iPTH level at any time during the study. The median reduction in iPTH at 24 weeks was 48.4% in the paricalcitol group and 41.9% in the calcitriol group (P-value = 0.6). The median maximal iPTH reduction was 77.1% (paricalcitol) and 83.7% (calcitriol), P-value = 0.3. Serum calcium and incidence of hypercalcaemia did not differ between groups. 16.7% of patients in both groups had at least one episode of hypercalcaemia (serum calcium >2.74 mmol/L). Other adverse events were similar between groups. CONCLUSION: Our study suggests that oral paricalcitol has similar efficacy and safety to oral calcitriol.

A comparison of arteriovenous fistula failure between Malaysian and Australian and New Zealand participants enrolled in the FAVOURED trial.

AIM: To describe and compare de novo arteriovenous fistula (AVF) failure rates between Australia and New Zealand (ANZ), and Malaysia. BACKGROUND: AVFs are preferred for haemodialysis access but are limited by high rates of early failure. METHODS: A post hoc analysis of 353 participants from ANZ and Malaysia included in the FAVOURED randomised-controlled trial undergoing de novo AVF surgery was performed. Composite AVF failure (thrombosis, abandonment, cannulation failure) and its individual components were compared between ANZ (n = 209) and Malaysian (n = 144) participants using logistic regression adjusted for patient- and potentially modifiable clinical factors. RESULTS: Participants' mean age was 55 ± 14.3 years and 64% were male. Compared with ANZ participants, Malaysian participants were younger with lower body mass index, higher prevalence of diabetes mellitus and lower prevalence of cardiovascular disease. AVF failure was less frequent in the Malaysian cohort (38% vs 54%; adjusted odds ratio (OR) 0.53, 95% confidence interval (CI) 0.31-0.93). This difference was driven by lower odds of cannulation failure (29% vs 47%, OR 0.45, 95% CI 0.25-0.80), while the odds of AVF thrombosis (17% vs 20%, OR 1.24, 95% CI 0.62-2.48) and abandonment (25% vs 23%, OR 1.17, 95% CI 0.62-2.16) were similar. CONCLUSIONS: The risk of AVF failure was significantly lower in Malaysia compared to ANZ and driven by a lower risk of cannulation failure. Differences in practice patterns, including patient selection, surgical techniques, anaesthesia or cannulation techniques may account for regional outcome differences and warrant further investigation.

Simple and fast LC-MS/MS method for quantification of terazosin in human plasma and application to bioequivalence study.

A simple, fast and sensitive LC-MS/MS method was developed to quantify terazosin in human plasma. The mobile phase consisted of acetonitrile-0.1% (v/v) formic acid (70:30, v/v). Prazosin was used as internal standard (IS). As deproteinization agent, acetonitrile produced a clean sample. A higher response intensity with more symmetrical peak was obtained using Agilent Poroshell 120 EC-C18 - Fast LC column (100 × 2.1mmID, 2.7 µm) compared with Kinetex XB-C18 (100 × 2.1 mm, 2.6 µm) column. The response of terazosin and IS were approximately two times in citrate phosphate dextrose (CPD) plasma compared with dipotassium ethylenediaminetetraacetic acid (K2EDTA) plasma. Plasma calibration curve was linear from 1.0 to 100.0 ng/mL, with coefficient of determination r2 ≥ 0.99. The within-run and between-run precision values (CV, %) were <5.2% and <7.8%, while accuracy values were 102.8-112.7% and 103.4-112.2%. The extended run accuracy was 98.6-102.8% and precision (CV, %) 4.3-10.4%. The recovery of analyte was >98% and IS >94%. Terazosin in plasma kept at benchtop was stable for 24 h, in autosampler tray for 48 h, in instrumentation room for 48 h, for 7 freeze-thaw cycles and in freezer for 140 days. Terazosin and IS stock standard solutions were stable for 140 days at room temperature and in the chiller. The high throughput method was successfully utilized to measure 935 samples in a bioequivalence study of terazosin.

Consensus Recommendations by the Asian Pacific Society of Cardiology: Optimising Cardiovascular Outcomes in Patients with Type 2 Diabetes.

The Asian Pacific Society of Cardiology convened a consensus statement panel for optimising cardiovascular (CV) outcomes in type 2 diabetes, and reviewed the current literature. Relevant articles were appraised using the Grading of Recommendations, Assessment, Development and Evaluation system, and consensus statements were developed in two meetings and were confirmed through online voting. The consensus statements indicated that lifestyle interventions must be emphasised for patients with prediabetes, and optimal glucose control should be encouraged when possible. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are recommended for patients with chronic kidney disease with adequate renal function, and for patients with heart failure with reduced ejection fraction. In addition to SGLT2i, glucagon-like peptide-1 receptor agonists are recommended for patients at high risk of CV events. A blood pressure target below 140/90 mmHg is generally recommended for patients with type 2 diabetes. Antiplatelet therapy is recommended for secondary prevention in patients with atherosclerotic CV disease.

Clinical effectiveness of a Malaysian-manufactured CAPD product: A randomised trial.

BACKGROUND: We compared the clinical effectiveness of a new peritoneal dialysis (PD) product with polyvinyl chloride-containing tubing (Stay Safe Link®, SSL) with the plastic-free alternative (Stay Safe®, STS) in patients on continuous ambulatory peritoneal dialysis (CAPD). METHOD: A multicentre, parallel, randomised, controlled, open-label, non-inferiority trial was conducted. Adult patients receiving CAPD were randomised in a 1:1 ratio to SSL or STS. The primary outcome was the rate of peritonitis after 1 year of follow-up. RESULTS: A total of 472 subjects were randomised (SSL, n = 233; STS, n = 239). One subject in each group was excluded from the analysis as they withdrew consent before the first dialysis dose. Four hundred and seventy subjects (SSL, n = 232; STS, n = 238) were included in the modified intention-to-treat analysis. Non-inferiority between two groups was established as no significant difference was found in peritonitis rate (incident rate ratio: 0.91, 95% CI: 0.65-1.28). No significant difference was detected in weekly Kt/V (p = 0.58) and creatinine clearance (p = 0.55). However, the average ultrafiltration volume was significantly lower in SSL, with a mean difference of 93 ml (p < 0.01). SSL also demonstrated a 2.57-times higher risk of device defect than STS (95% CI: 1.77-3.75). CONCLUSION: SSL was non-inferior in peritonitis rate compared to plastic-free STS over 1 year in patients requiring CAPD. There was no difference in the delivered dialysis dose, but there was a higher rate of device defects with SSL.

Hand hygiene promotion delivered by change agents-Two attitudes, similar outcome.

OBJECTIVE: To assess the effect of peer-identified change agents (PICAs) compared to management-selected change agents (MSCAs) on hand hygiene behavior in acute care. DESIGN: Randomized-controlled study. SETTING: Two internal medicine wards of a public, university-affiliated, tertiary-care hospital in Malaysia. METHODS: We randomly allocated 2 wards to hand hygiene promotion delivered either by PICAs (study arm 1) or by MSCAs (study arm 2). The primary outcome was hand hygiene compliance using direct observation by validated auditors. Secondary outcomes were hand hygiene knowledge and observations from ward tours. RESULTS: Mean hand hygiene compliance in study arm 1 and study arm 2 improved from 48% (95% confidence interval [CI], 44%-53%) and 50% (95% CI, 44%-55%) in the preintervention period to 66% (63%-69%) and 65% (60%-69%) in the intervention period, respectively. We detected no statistically significant difference in hand hygiene improvement between the 2 study arms. Knowledge scores on hand hygiene in study arm 1 and study arm 2 improved from 60% and 63% to 98% and 93%, respectively. Staff in study arm 1 improved hand hygiene because they did not want to disappoint the efforts taken by the PICAs. Staff in study arm 2 felt pressured by the MSCAs to comply with hand hygiene to obtain good overall performance appraisals. CONCLUSION: Although the attitude of PICAs and MSCAs in terms of leadership, mode of action and perception of their task by staff were very different, or even opposed, both PICAs and MSCAs effectively changed behavior of staff toward improved hand hygiene to comparable levels.

Predictors of Arteriovenous Fistula Failure: A Post Hoc Analysis of the FAVOURED Study.

Background: An autologous arteriovenous fistula (AVF) is the preferred hemodialysis vascular access, but successful creation is hampered by high rates of AVF failure. This study aimed to evaluate patient and surgical factors associated with AVF failure to improve vascular access selection and outcomes. Methods: This is a post hoc analysis of all participants of FAVOURED, a multicenter, double-blind, multinational, randomized, placebo-controlled trial evaluating the effect of fish oil and/or aspirin in preventing AVF failure in patients receiving hemodialysis. The primary outcome of AVF failure was a composite of fistula thrombosis and/or abandonment and/or cannulation failure at 12 months post-AVF creation, and secondary outcomes included individual outcome components. Patient data (demographics, comorbidities, medications, and laboratory data) and surgical factors (surgical expertise, anesthetic, intraoperative heparin use) were examined using multivariable logistic regression analyses to evaluate associations with AVF failure. Results: Of 536 participants, 253 patients (47%) experienced AVF failure during the study period. The mean age was 55±14.4 years, 64% were male, 45% were diabetic, and 4% had peripheral vascular disease. Factors associated with AVF failure included female sex (odds ratio [OR], 1.79; 95% confidence interval [CI], 1.20 to 2.68), lower diastolic BP (OR for higher DBP, 0.85; 95% CI, 0.74 to 0.99), presence of central venous catheter (OR, 1.49; 95% CI, 1.02 to 2.20; P=0.04), and aspirin requirement (OR, 1.60; 95% CI, 1.00 to 2.56). Conclusions: Female sex, requirement for aspirin therapy, requiring hemodialysis via a central venous catheter, and lower diastolic BP were factors associated with higher odds of AVF failure. These associations have potential implications for vascular access planning and warrant further studies.

Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis.

INTRODUCTION: Peritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making. METHODS AND ANALYSIS: The study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume. ETHICS AND DISSEMINATION: The study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT03177031; Pre-results.

Hand hygiene - social network analysis of peer-identified and management-selected change agents.

Background: Hand hygiene compliance can be improved by strategies fostering collaborative efforts among healthcare workers (HCWs) through change agents. However, there is limited information about how change agents shape the social networks of work teams, and how this relates to organisational culture. The objectives of this study were to describe the influence of peer-identified change agents (PICAs) and management-selected change agents (MSCAs) on hand hygiene, perception of their leadership style by peers, and the role of the organisational culture in the process of hand hygiene promotion. Methods: This study, stratified in pre-, during, and post-intervention periods, was conducted between February 2017 and March 2018 in two wards at a tertiary care hospital in Malaysia. Hand hygiene promotion was facilitated either by PICAs (study arm 1) or MSCAs (study arm 2), and the two wards were randomly allocated to one of the two interventions. Outcomes were: 1) perceived leadership styles of PICAs and MSCAs by staff, vocalised during question and answer sessions; 2) the social network connectedness and communication patterns between HCWs and change agents by applying social network analysis; and 3) hand hygiene leadership attributes obtained from HCWs in the post-intervention period by questionnaires. Results: Hand hygiene compliance in study arm 1 and study arm 2 improved by from 48% (95% CI: 44-53%) to 66% (63-69%), and from 50% (44-55%) to 65% (60-69%), respectively. There was no significant difference between the two arms. Healthcare workers perceived that PICAs lead by example, while MSCAs applied an authoritarian top-down leadership style. The organisational culture of both wards was hierarchical, with little social interaction, but strong team cohesion. Position and networks of both PICAs and MSCAs were similar and generally weaker compared to the leaders who were nominated by HCWs in the post-intervention period. Healthcare workers on both wards perceived authoritative leadership to be the most desirable attribute for hand hygiene improvement. Conclusion: Despite experiencing successful hand hygiene improvement from PICAs, HCWs expressed a preference for the existing top-down leadership structure. This highlights the limits of applying leadership models that are not supported by the local organisational culture.

Fish oil and aspirin effects on arteriovenous fistula function: Secondary outcomes of the randomised omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) trial.

BACKGROUND: Arteriovenous fistulas (AVF) for haemodialysis often experience early thrombosis and maturation failure requiring intervention and/or central venous catheter (CVC) placement. This secondary and exploratory analysis of the FAVOURED study determined whether omega-3 fatty acids (fish oils) or aspirin affected AVF usability, intervention rates and CVC requirements. METHODS: In 567 adult participants planned for AVF creation, all were randomised to fish oil (4g/d) or placebo, and 406 to aspirin (100mg/d) or placebo, starting one day pre-surgery and continued for three months. Outcomes evaluated within 12 months included AVF intervention rates, CVC exposure, late dialysis suitability failure, and times to primary patency loss, abandonment and successful cannulation. RESULTS: Final analyses included 536 participants randomised to fish oil or placebo (mean age 55 years, 64% male, 45% diabetic) and 388 randomised to aspirin or placebo. Compared with placebo, fish oil reduced intervention rates (0.82 vs 1.14/1000 patient-days, incidence rate ratio [IRR] 0.72, 95% confidence interval [CI] 0.54-0.97), particularly interventions for acute thrombosis (0.09 vs 0.17/1000 patient-days, IRR 0.53, 95% CI 0.34-0.84). Aspirin significantly reduced rescue intervention rates (IRR 0.45, 95% CI 0.27-0.78). Neither agent significantly affected CVC exposure, late dialysis suitability failure or time to primary patency loss, AVF abandonment or successful cannulation. CONCLUSION: Although fish oil and low-dose aspirin given for 3 months reduced intervention rates in newly created AVF, they had no significant effects on CVC exposure, AVF usability and time to primary patency loss or access abandonment. Reduction in access interventions benefits patients, reduces costs and warrants further study.

Survivability of hospitalized chronic kidney disease (CKD) patients with moderate to severe estimated glomerular filtration rate (eGFR) after experiencing adverse drug reactions (ADRs) in a public healthcare center: a retrospective 3 year study.

BACKGROUND: Accurate identification and routine preventive practices are crucial steps in lessening the incidence of medications and patients related adverse drug reactions (ADRs). METHODS: Three years retrospective study was conducted among chronic kidney disease (CKD) patients at multi-wards in a tertiary healthcare center. Data collected included demographic characteristics, physical examination results, comorbid conditions, laboratory tests and medications taken. Only medication prescribed during the hospital stay were considered in this study. RESULTS: From this study only one ADR incident was definitely preventable and majority of other ADRs (88.3%) were possibly preventable. Type of renal replacement therapy (p = 0.023) and stages of renal function (p = 0.002) were significantly associated with survivability of the hospitalized CKD patients after ADRs. Highest percentage of mortality based on categories were 50-59 years (20.0%), male (16.3%), Indian ethnicity (23.7%), obese (15.0%), smoking (17.1%), consumes alcohol (17.4%), conservative management of renal disease (19.5%) and renal function of < 15 mL/min/1.73m2. Overall survivability using Kaplan-Meier analysis reported a significant difference of 18-day survival rate between patients undergoing hemodialysis and patients conservatively managing their renal disease. The 18 days survival rate of patients undergoing hemodialysis, peritoneal dialysis and conservative management were 94.9%, 91.7% and 75.1% respectively. Eighteen days survival rate of patients with renal functions of 30-59 mL/min/1.73m2, 15-29 mL/min/1.73m2 and < 15 mL/min/1.73m2 were 87.4%, 69.8% and 88.6% respectively. Similarly, Cox regression analysis revealed that renal replacement therapy was the only factor significantly contributed to ADRs related mortality. CKD patients whom conservatively managed renal disease or/and with renal function of < 15 mL/min/1.73m2 had 5.61 and 5.33 higher mortality risk respectively. CONCLUSION: Majority of the reported ADRs were possibly preventable. Renal replacement therapy and/or renal function were significant risk factors for mortality due to ADRs among hospitalized CKD patients stages 3 to 5. Clinician engagement, intensive resources and regular updates aided with online monitoring technology are needed for enhancing care and prevention of ADRs among CKD patients.

Efficacy of Oral Mixed Tocotrienols in Diabetic Peripheral Neuropathy: A Randomized Clinical Trial.

Importance: Management of painful diabetic peripheral neuropathy remains challenging. Most therapies provide symptomatic relief with varying degrees of efficacy. Tocotrienols have modulatory effects on the neuropathy pathway and may reduce neuropathic symptoms with their antioxidative and anti-inflammatory activities. Objective: To evaluate the efficacy of oral mixed tocotrienols for patients with diabetic peripheral neuropathy. Design, Setting, and Participants: The Vitamin E in Neuroprotection Study (VENUS) was a parallel, double-blind, placebo-controlled trial that recruited participants from January 30, 2011, to December 7, 2014, with 12 months of follow-up. This trial screened 14 289 patients with diabetes from 6 health clinics and ambulatory care units from 5 public hospitals in Malaysia. A total of 391 patients who reported neuropathic symptoms were further assessed with Total Symptom Score (TSS) and Neuropathy Impairment Score (NIS). Patients 20 years or older with a TSS of 3 or higher and an NIS of 2 or higher were recruited. Interventions: Patients were randomized to receive 200 mg of mixed tocotrienols twice daily or matching placebo for 12 months. Patients with hyperhomocysteinemia (homocysteine level ≥2.03 mg/L) received oral folic acid, 5 mg once daily, and methylcobalamin, 500 µg thrice daily, in both groups. Main Outcomes and Measures: The primary outcome was patient-reported neuropathy TSS (lancinating pain, burning pain, paresthesia, and asleep numbness) changes at 12 months. The secondary outcomes were NIS and sensory nerve conduction test result. Results: Of 391 eligible patients, 300 were recruited (130 [43.3%] male; mean [SD] age, 57.6 [8.9] years; mean [SD] duration of diabetes, 11.4 [7.8] years) and 229 (76.3%) completed the trial. The TSS changes between the tocotrienols and placebo groups at 12 months (-0.30; 95% CI, -1.16 to 0.56; P = .49) were similar. No significant differences in NIS (0.60; 95% CI, -1.37 to 2.65; P = .53) and sensory nerve conduction test assessments were found between both groups. In post hoc subgroup analyses, tocotrienols reduced lancinating pain among patients with hemoglobin A1C levels greater than 8% (P = .03) and normohomocysteinemia (homocysteine level <2.03 mg/L; P = .008) at 1 year. Serious adverse events in both groups were similar, except more infections were observed in the tocotrienols group (6.7% vs 0.7%, P = .04). Results reported were of modified intention-to-treat analyses. Conclusions and Relevance: Supplementation of oral mixed tocotrienols, 400 mg/d for 1 year, did not improve overall neuropathic symptoms. The preliminary observations on lancinating pain among subsets of patients require further exploration. Trial Registration: National Medical Research Registry Identifier: NMRR-10-948-7327 and clinicaltrials.gov Identifier: NCT01973400.