In an unadjusted intention-to-treat analysis, cinacalcet did not significantly reduce the risk of death or major cardiovascular events in patients with moderate-to-severe secondary hyperparathyroidism who were undergoing dialysis. (Funded by Amgen; EVOLVE ClinicalTrials.gov number, NCT00345839.).
Background: Patients with chronic kidney disease (CKD) often have uncontrolled hypertension despite polypharmacy. Pharmacogenomic drug-gene interactions (DGIs) may impact the metabolism or efficacy of antihypertensive agents. We hypothesized that providing a panel of 11 pharmacogenomic predictors of antihypertensive response would improve hypertension control. Methods: A prospective cohort with CKD and hypertension was followed to assess the effect of pharmacogenomic testing on blood pressure control. The analysis population included 382 hypertensive subjects genotyped for cross-sectional assessment of drug-gene interactions and 335 subjects followed for 1 year to assess systolic (SBP) and diastolic blood pressure (DBP). Results: Most participants (58.2%) with uncontrolled hypertension had a DGI reducing the efficacy of one or more antihypertensive agents. Subjects with a DGI had 1.88-fold (95% CI 1.2-2.8) higher odds of uncontrolled hypertension as compared to those without a DGI, adjusted for race and CKD grade. CYP2C9 reduced metabolism genotypes were associated with losartan response and uncontrolled hypertension (Odds Ratio 5.2, CI 1.9 -14.7). CYP2D6 intermediate or poor metabolizers had less frequent uncontrolled hypertension compared to normal metabolizers taking metoprolol or carvedilol (OR 0.55, CI 0.3-0.95). In 335 subjects completing 1 year follow-up, SBP (-4.0 mmHg, CI 1.6- 6.5) and DBP (-3.3 mmHg, CI 2.0-4.6) were improved. The magnitude of reductions in SBP (-14.8 mmHg, CI 10.3-19.3) and DBP (-8.4 mmHg, CI 5.9-10.9) were greatest in the 90 individuals with uncontrolled hypertension and an actionable genotype. Conclusions: There is a potential role for the addition of pharmacogenomic testing to optimize antihypertensive regimens in patients with CKD.
Importance: End Stage Renal Disease (ESRD) patients have significant symptom burden. Reduced provider awareness of symptoms contributes to underutilization of symptom management resources.Objective: Assess symptom burden in patients with ESRD on dialysis. We hypothesized that improved nephrologist awareness of symptoms leads to symptom improvement.Design, Setting and Participants: In this prospective, multicentre interventional study, 53 geriatric ESRD inpatients underwent symptom assessment using the modified Edmonton Symptom Assessment System (ESAS) at admission and 1-week post-discharge. Enrollers were sequentially randomized into 2 groups. The nephrologist of each individual was provided baseline symptom assessment in group 1 but was unaware in group 2.Main Outcomes and Measures: Severity ratings were compared between in-hospital and post discharge scores and between groups.Results: 52 patients completed the study; 1 died. Baseline characteristics were compared. For 70% of the total cohort, physicians reported not being surprised if their patient died within a year. There was no difference in baseline scores between groups. Total ESAS scores improved more in group 1 (12.9) than group 2 (9.2) (p=0.04). Among individual symptoms, there was greater improvement in pain control (p=0.02), and nominal improvement in itching (p=0.03) in Group 1 as compared to Group 2. There were three palliative care consults. Conclusions:Our findings reinforce the high symptom burden prevalent in geriatric ESRD patients. The improvement in total scores, and individual symptoms of pain and itching in group 1 indicates better symptom control when physician awareness is increased. Residual symptoms post hospitalization and low utilization of palliative care resources is suggestive of a missed opportunity by nephrologists to address the high symptom burden at the inpatient encounter which is selective for sicker patients and/or inadequacy of dialysis to control these symptoms.
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