The purpose of this study was to review and summarise the literature on appropriateness criteria for treatment of osteoporotic vertebral compression fractures (OVCF), with appropriateness defined as a treatment where the expected benefits outweigh the expected harms, confirmed by available evidence and expert opinion. A comprehensive search of peer-reviewed publications (PubMed, EMBASE) and grey literature was performed. To be included for analysis, documents had to be a review article (e.g. clinical guideline or meta-analysis), focus on OVCF and make a statement on treatment appropriateness. Eleven publications fulfilled the eligibility criteria. Among the five publications that made recommendations about non-surgical management (NSM), there is agreement that conservative methods are appropriate in OVCF patients who have low level of pain, and that the majority of patients should be treated with conservative methods before other treatments are initiated. All publications made recommendations about vertebral augmentation procedures (VAP), i.e. vertebroplasty (VP) and/or balloon kyphoplasty (BKP). VAP are mostly considered appropriate in patients with high level of pain who do not respond to NSM. However, results cannot be generalised due to heterogeneity of treatment recommendations and patient selection. Although there is a consensus that NSM should be considered as the first-line treatment, there is more heterogeneity in treatment recommendations for VAP. This could most likely be explained by an insufficient clinical evidence base for VAP and heterogeneity of OVCF patients, leading to greater reliance on expert opinion affecting the quality of evidence in the primary sources.
of prostate cancer patients with bone metastases (patients who were specifically coded as "Castration-resistant prostate cancer" (ICD-10, C61) and "8848040" (Japan MEDIS-DC)), who had been treated with ADT and a CRPC-targeted treatment (according to approved indication). Results: 276 patients were identified, with a mean age of 71.0 y.o (S.D. 8.7). Visceral metastasis was present in 43.8% of the patients, with the most common site being the lungs (34.4%). The mean treatment period for mCRPC was 34 months. 87.4% had undergone medical Androgen Deprivation Therapy (ADT), with 5.8% undergoing surgical ADT. Radiation therapy was given to 29.3% of patients, and 40% had been treated with opioids. 89.5% of the patients had undergone bone scanning. There were an average number of 67 outpatient visits and 2.8 inpatient admissions per patient during the treatment period. A mean of 9.9 laboratory and imaging examinations in the year prior to CRPC diagnosis was observed, increasing to a mean 28.6 one year post-diagnosis. The most common diagnostic and imaging combination done prior to mCRPC diagnosis was bone scintigraphy, CT, PSA, and blood biochemistry test. Mean per patient monthly costs increased 6-fold from prior to CRPC to post-CRPC diagnosis. ConClusions: Metastatic castration-resistant prostate cancer brings about increased resource use for patients in Japan, with a three-fold increase in diagnostic and monitoring tests, increased hospital visits, and increased monthly per patient costs as a result of diagnosis.
Objectives: To evaluate the effect of active vitamin D therapy on hypercalcaemia in patients with non-dialysis chronic kidney disease (ND-CKD) and secondary hyperparathyroidism (SHPT). Methods: A systematic literature search of the PubMed database from inception until 19 June 2018 was performed for randomized controlled trials (RCTs) of single-agent, oral active (1a-hydroxylated) vitamin D therapies versus placebo in adult patients with ND-CKD and SHPT. Only studies with $30 participants per arm and $6 weeks in duration were eligible for inclusion. The primary outcome of interest was the number of subjects with hypercalcaemia deemed as related, or potentially related, to the study drug by the study investigator. A meta-analysis was performed using Comprehensive Meta-Analysis software version 3.0 (Biostat, Inc.). The combined odds ratio (OR) and the corresponding 95% confidence intervals (95% CIs) were calculated for the eligible studies. Results: A total of 6 placebo-controlled RCTs (5 studies evaluated paricalcitol, 1 evaluated alfacalcidol) involving 799 patients were eligible for inclusion. Study duration ranged from 16 weeks to 2 years. Weekly doses of paricalcitol administered were 7 mg (3 studies) and 14 mg (2 studies), while the weekly dose in the alfacalcidol study was 1.7527.0 mg. Across the studies, rates of hypercalcaemia ranged from 1.1243.3% versus 023.4% in the active vitamin D and placebo groups, respectively. Overall, active vitamin D therapy was associated with a 6.6-fold greater probability of hypercalcaemia versus placebo (OR: 6.63, 95% CIs: 2.37, 18.55, P,0.001). Conclusions: Compared with placebo, treatment with active vitamin D therapy significantly increased the risk of hypercalcaemia among ND-CKD patients with SHPT. These findings highlight the need for new therapies for the treatment of SHPT in this patient population that avoid undesired elevations in serum calcium. Limitations of the current analysis included the small number of studies included and heterogeneity in the study designs.
related outcomes. RESULTS: In total, n¼1,889 ND CKD patients received oral iron, n¼156 low dose intravenous, and n¼49 high dose intravenous iron with over 90% being treated with Ferric Carboxymaltose. After matching, 44 patients remained in each treatment cohort. Significant differences were observed concerning all-cause hospitalizations (oral iron vs. high dose intravenous iron (90.9% vs. 72.7%, p¼0.035)) and ID/A-related hospitalizations (oral iron vs. low dose intravenous iron (56.8% vs. 27.3%, p¼0.007) and oral iron vs. high dose intravenous iron (56.8% vs. 29.6%, p¼0.007)). The cost comparison revealed significantly higher average ID/A-related hospitalization costs for the oral iron cohort and lowest costs for the high intravenous iron cohort. The oral iron cohort had the highest observable mortality. CONCLUSIONS: The results showed that the use of high dose intravenous iron treatment was associated with the lowest all-cause hospitalization and the highest cost savings, compared to oral and low dose intravenous iron.
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