658 research outputs found

    Alendronate or alfacalcidol in glucocorticoid-induced osteoporosis

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    BACKGROUND: Treatment with glucocorticoids is associated with bone loss starting soon after therapy is initiated and an increased risk of fracture. METHODS: We performed a randomized, double-placebo, double-blind clinical trial of 18 months' duration among patients with a rheumatic disease who were starting glucocorticoids at a daily dose that was equivalent to at least 7.5 mg of prednisone. A total of 201 patients were assigned to receive either alendronate (10 mg) and a placebo capsule of alfacalcidol daily or alfacalcidol (1 mu g) and a placebo tablet of alendronate daily. The primary outcome was the change in bone mineral density of the lumbar spine in 18 months; the secondary outcome was the incidence of morphometric vertebral deformities. RESULTS: A total of 100 patients received alendronate, and 101 received alfacalcidol; 163 patients completed the study. The bone mineral density of the lumbar spine increased by 2.1 percent in the alendronate group (95 percent confidence interval, 1.1 to 3.1 percent) and decreased by 1.9 percent in the alfacalcidol group (95 percent confidence interval, -3.1 to -0.7 percent). At 18 months, the mean difference of change in bone mineral density between the two groups was 4.0 percent (95 percent confidence interval, 2.4 to 5.5 percent). Three patients in the alendronate group had a new vertebral deformity, as compared with eight patients in the alfacalcidol group (of whom three had symptomatic vertebral fractures) (hazard ratio, 0.4; 95 percent confidence interval, 0.1 to 1.4). CONCLUSIONS: During this 18-month trial in patients with rheumatic diseases, alendronate was more effective in the prevention of glucocorticoid-induced bone loss than was alfacalcidol

    Efficacy and safety of long-acting recombinant fusion protein linking factor IX with albumin in haemophilia B patients undergoing surgery.

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    IntroductionRecombinant factor IX fusion protein (rIX‐FP) has been developed to improve the pharmacokinetic (PK) profile of factor IX (FIX), allowing maintenance of desired FIX activity between injections at extended intervals, ultimately optimizing haemophilia B treatment.AimTo determine the efficacy and safety of rIX‐FP in the perioperative setting.MethodsSubjects were adult and paediatric patients with severe to moderately severe haemophilia B (FIX ≀ 2%) participating in three Phase III clinical trials and undergoing a surgical procedure. PK profiles were established prior to surgery for each patient. Haemostatic efficacy was assessed by the investigator for up to 72 h after surgery. Safety measurements during the study included adverse events and inhibitors to FIX. FIX activity was monitored during and after surgery to determine if repeat dosing was required.ResultsTwenty‐one, both major and minor, surgeries were performed in 19 patients. Haemostatic efficacy was rated as excellent (n = 17) or good (n = 4) in all surgeries. A single preoperative dose maintained intraoperative haemostasis in 20 of 21 surgeries. Nine major orthopaedic surgeries were conducted in eight patients with a mean of 7 (range: 6–12) rIX‐FP injections during surgery and the 14‐day postoperative period. Median rIX‐FP consumption for orthopaedic surgeries was 87 IU kg−1 preoperatively and 375 IU kg−1 overall. No subject developed inhibitors to FIX or antibodies to rIX‐FP.ConclusionRecombinant factor IX fusion protein was well tolerated and effectively maintained haemostasis during and after surgery. Stable FIX activity was achieved with a prolonged dosing interval and reduced consumption compared to conventional or currently available long‐acting recombinant FIX

    Goals of Care Documentation: Insights from A Pilot Implementation Study

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    ContextThe Life Sustaining Treatment Decision Initiative is a national effort by the Veterans Health Administration to ensure goals of care documentation occurs among all patients at high risk of life-threatening events. ObjectivesExamine likelihood to receive goals of care documentation and explore associations between documentation and perceived patient care experience at the individual and site level. MethodsRetrospective, quality improvement analysis of initiative pilot data from four geographically diverse Veterans Affairs (VA) sites (Fall 2014-Winter 2016) before national roll-out. Goals of care documentation according to gender, marital status, urban/rural status, race/ethnicity, age, serious health condition, and Care Assessment Needs scores. Association between goals of care documentation and perceived patient care experience analyzed based on Bereaved Family Survey outcomes of overall care, communication, and support. ResultsVeterans were more likely to have goals of care documentation if widowed, urban residents, and of white race. Patients older than 65-years and those with a higher Care Assessment Needs score were twice as likely as a frail patient to have goals of care documented. One pilot site demonstrated a positive association between documentation and perceived support. Pilot site was a statistically significant predictor of the occurrence of goals of care documentation and Bereaved Family Survey scores. ConclusionOlder and seriously ill patients were most likely to have goals of care documented. Association between a documented goals of care conversation and perceived patient care experience were largely unsupported. Site-level largely contributed to understanding the likelihood of documentation and care experience

    Prevention of glucocorticoid induced osteoporosis with alendronate or alfacalcidol:Relations of change in bone mineral density, bone markers, and calcium homeostasis

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    Objective. To explore the relation of changes in measures of bone turnover and changes in bone mineral density (BMD) of the lumbar spine and total hip over 18 months in a double-blinded, randomized trial, comparing the effect of alfacalcidol (101 patients) versus alendronate (100 patients) on BMD in patients who recently started treatment with glucocorticoids for various rheumatic diseases. Methods. Associations between changes in serum procollagen type I C-propeptide (P1CP), fasting urine N-terminal telopeptide of type I collagen (NTx), serum calcium, parathyroid hormone (PTH), osteocalcin, and change from baseline in BMD over 18 months were explored with regression and correlation analyses. Results. In both treatment groups, there was a statistically significant decrease in NTx. In the alfacalcidol group there was also a significant increase in P1CP and osteocalcin, in contrast to the alendronate group, but BMD in the alfacalcidol decreased versus an increase in the alendronate group (p <0.001). In neither treatment group were changes in biochemical measures correlated with the change in BMD, with the exception of a negative correlation in the alendronate group between changes in total hip BMD and NTx. Use of alendronate resulted in an increased PTH in 27 patients, but the increase in BMD of these patients was not statistically significantly different compared to patients taking alendronate with normal PTH levels. Conclusion. Changes in BMD were not associated with changes in bone measures, with the exception of NTx in the alendronate group. For the patient taking glucocorticoids in clinical practice, the value of serial assessment of bone markers is low; changes in markers are no substitute for changes in BMD
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