Safety of pregabalin among hemodialysis patients suffering from uremic pruritus

Objectives: The aim of this study was to assess the safety and probability of adverse events associated with the use of 75 mg pregabalin post hemodialysis (pHD) among patients with UP. Methods: A cross-sectional study done among the hemodialysis patients suffering from uremic pruritus (UP) Aljaber Kidney Center (AJKC), Al-Ahsa, Eastern Province, Saudi Arabia. Assessment for the safety profile of pregabalin was done using Naranjo’s algorithm. A predictive model was developed using binary multiple logistic regression to explore association of patients’ demographics and risk factors with the occurrence of AEs. Throughout statistical significance level was considered significant at 0.05. Key findings: Assessment of safety of pregabalin revealed that somnolence and dizziness were the two frequent adverse events followed by constipation, weight gain and edema. However, it was noticed that female patients aged less than 50 years were found to be at a higher risk in comparison with men. Moreover, those patients having one comorbid complication (i.e. hypertension or diabetes mellitus alone) were at a higher risk of somnolence, weight gain and dry mouth. Conclusion: Naranjo’s quantification for the possibility and probability of adverse events reflect that all the events were probable. Age, gender and comorbid medical conditions are some of the factors that might have clinical association with the occurrence of the AEs.     

Higher Dietary Calcium Intakes Are Associated With Reduced Risks of Fractures,Cardiovascular Events,and Mortality: A Prospective Cohort Study of Older Men and Women

The aim of this population‐based, prospective cohort study was to investigate long‐term associations between dietary calcium intake and fractures, non‐fatal cardiovascular disease (CVD), and death from all causes. Participants were from the Melbourne Collaborative Cohort Study, which was established in 1990 to 1994. A total of 41,514 men and women (～99% aged 40 to 69 years at baseline) were followed up for a mean (SD) of 12 (1.5) years. Primary outcome measures were time to death from all causes (n = 2855), CVD‐related deaths (n = 557), cerebrovascular disease‐related deaths (n = 139), incident non‐fatal CVD (n = 1827), incident stroke events (n = 537), and incident fractures (n = 788). A total of 12,097 participants (aged ≥50 years) were eligible for fracture analysis and 34,468 for non‐fatal CVD and mortality analyses. Mortality was ascertained by record linkage to registries. Fractures and CVD were ascertained from interview ～13 years after baseline. Quartiles of baseline energy‐adjusted calcium intake from food were estimated using a food‐frequency questionnaire. Hazard ratios (HR) and odds ratios (OR) were calculated for quartiles of dietary calcium intake. Highest and lowest quartiles of energy‐adjusted dietary calcium intakes represented unadjusted means (SD) of 1348 (316) mg/d and 473 (91) mg/d, respectively. Overall, there were 788 (10.3%) incident fractures, 1827 (9.0%) incident CVD, and 2855 people (8.6%) died. Comparing the highest with the lowest quartile of calcium intake, for all‐cause mortality, the HR was 0.86 (95% confidence interval [CI] 0.76–0.98, p_trend = 0.01); for non‐fatal CVD and stroke, the OR was 0.84 (95% CI 0.70–0.99, p_trend = 0.04) and 0.69 (95% CI 0.51–0.93, p_trend = 0.02), respectively; and the OR for fracture was 0.70 (95% CI 0.54–0.92, p_trend = 0.004). In summary, for older men and women, calcium intakes of up to 1348 (316) mg/d from food were associated with decreased risks for fracture, non‐fatal CVD, stroke, and all‐cause mortality. © 2015 American Society for Bone and Mineral Research.