Pharmacodynamics of cinacalcet over 48 hours in patients with controlled secondary hyperparathyroidism: useful data in clinical practice.

CONTEXT: Cinacalcet induces immediate changes in serum PTH levels, but the pharmacodynamic effect throughout the daily dosing interval in controlled patients is unknown. Also, in patients with reduced PTH, it is unknown what happens in the first 24 hours after withdrawal. OBJECTIVE: Our aim was to describe the effect over 48 hours of cinacalcet in hemodialysis patients with controlled secondary hyperparathyroidism. DESIGN: This was a phase 4, open-label, single-arm, single-dose, single-center clinical trial. SETTING: The study was conducted at a public hospital (Hospital Perpetuo Socorro, Alicante, Spain). PATIENTS: We included 10 patients on cinacalcet for 6 months or longer with intact PTH (iPTH) levels 100-400 pg/mL [8 men, mean age of 66 years (range 39-82 years)], chronically treated with 30 mg (n = 6), 60 mg (n = 3), or 90 mg (n = 1) of cinacalcet. INTERVENTION: A single dose (30-90 mg) was administered at baseline. MAIN OUTCOME MEASURES: iPTH (Duo Kit Scantibodies and Elecsys Roche), PTH 1-84, ionized calcium, phosphorus (P), and calcitonin were determined at baseline and at 1, 3, 6, 12, 24, and 48 hours. RESULTS: There was a significant reduction in iPTH between 1 and 6 hours, and values returned to baseline at 24 hours [maximum mean (95% confidence interval) percent change from baseline: -50%(-34; -66) at 3 hours]. A transient increase in calcitonin and a decrease in P were also observed, with no changes in calcium. At 48 hours, there was a significant increase in iPTH [+51% (26; 76)] and P. Changes in PTH were similar with the 3 determination methods. CONCLUSIONS: In hemodialysis patients with secondary hyperparathyroidism controlled by cinacalcet, a transient (1-6 hours) reduction in PTH and P and an increase in calcitonin are observed after each daily dose, with return to baseline at 24 hours. After calcimimetics discontinuation, PTH was significantly increased at 48 hours. The assay used to measure PTH does not influence relative changes induced by cinacalcet.

Evaluation of spiritual well-being in haemodialysis patients.

INTRODUCTION: Spirituality can be defined as a personal search for meaning and purpose in life that may or may not encompass religion. In this article we report on the development and testing of an instrument for measuring spiritual well-being within a sample of haemodialysis patients. MATERIAL AND METHOD: The main instrument, a 21-item Meaning in Life Scale (MiLS), comprises four scales: Life Perspective, Purpose and Goals, Confusion and Lessened Meaning, Harmony and Peace, and Benefits of Spirituality. A total score for spiritual well-being is also produced. We also used the following variables: clinical (time on haemodialysis, modified Charlson comorbidity index), sociodemographic (age, gender), and self-assessments of health, quality of life (general and recent), personal happiness, religiosity, and belief in the afterlife. A cross-sectional study was carried out on 94 haemodialysis patients. RESULTS: This study demonstrates that the MiLS-Sp is a psychometrically sound measure of spiritual well-being for dialysis patients (reliability, validity) as they manage the complex demands of a chronic illness. Spiritual well-being was significantly associated with various quality of life variables, health status, personal happiness, or religiosity in patients on dialysis. There was no relationship between spirituality scores and comorbidity, HD duration, gender, or age. Spiritual well-being is relatively low in dialysis patients. CONCLUSION: Spirituality may play an important role on psychological well-being, quality of life, and self-rated health for patients on haemodialysis. Spiritual well-being in these patients is relatively low. Results suggest that assessing and addressing spiritual well-being in dialysis patients may be helpful in clinical practice.