The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese male patients with osteoporosis.

We conducted a post-marketing observational study to investigate the safety and effectiveness of eldecalcitol for the treatment of osteoporosis in a Japanese clinical setting. The observation period was 12 months for women and 36 months for men. The final results for the female patients have already been published. In this article, the final results for the male patients are reported. A total of 470 male osteoporosis patients were enrolled. The safety analysis set included 431 patients (mean age, 76.8 years; mean ± SD follow-up period, 631.0 ± 450.3 days), and 175 patients continued treatment throughout the 3-year observational period. Adverse drug reactions (ADRs) were reported in 28 patients (6.49%); the most common ADRs were hypercalcemia (1.16%) and renal impairment (1.16%). Serious ADRs were reported in 5 patients (1.16%). Mean serum calcium was within the normal range throughout the observation period. The cumulative incidence of new vertebral and nonvertebral fractures at 36 months, estimated by Kaplan-Meier analysis, was 10.23 and 4.06%, respectively. At the last observation, mean lumbar spine bone mineral density was 3.49% higher (P < 0.0001) than at baseline, and levels of the bone turnover markers BAP and TRACP-5b were reduced (-14.64%; P = 0.0009, and - 29.51%; P < 0.0001, respectively). In conclusion, the safety and effectiveness of eldecalcitol for the treatment of Japanese male osteoporosis patients was confirmed in clinical practice. Careful monitoring of serum calcium and estimated glomerular filtration rate, both before and during treatment, is necessary to minimize the risk of hypercalcemia and renal impairment while maximizing the effectiveness of eldecalcitol.

Psychosocial predictors of psychiatric disorders after living donor liver transplantation.

Objective. Adult recipients of living donor liver transplantation (LDLT) often have psychiatric disorders before and after surgery. The aim of this study was to investigate pretransplant psychosocial factors that can be used to predict psychiatric disorders after LDLT. Methods. The subjects were 67 recipients of adult-to-adult LDLT at Kyoto University Hospital, Japan, from November 2001 through July 2003. All subjects were interviewed and examined by means of the Beck Depression Inventory, State-Trait Anxiety Inventory, World Health Organization Quality-of-Life Assessment-26, and Psychosocial Assessment of Candidates for Transplantation (PACT) just before LDLT. The subjects were followed up for 90 days for the presence of psychiatric disorders. Results. Mood disorders in the past, inability to maintain a healthy lifestyle, family support instability, and suicidal ideation just before LDLT might be predictors of major depressive disorder after LDLT. Delirium just before LDLT might be a predictor of delirium after LDLT, while no psychosocial factors associated with posttransplant delirium could be found. Conclusion. Information about life history rather than any psychological examination is important for predicting the occurrence of posttransplant depression. PACT is useful for obtaining information about the life history of LDLT recipients.

Relevant factors to psychological status of donors before living-related liver transplantation.

BACKGROUND: While previous surveys have demonstrated the psychological impact on living-related liver transplantation (LRLT) donors, such as anxiety, depression, ambivalence and anger, the details regarding the relevant factors that affect donors' psychological status have not been well described. METHODS: To evaluate environmental factors, 66 donors were interviewed to obtain information regarding donors' decision-making motivation, process, conflicts, and internal pressure about donation just before surgery. To determine the donors' psychological status, they completed the State-Trait Anxiety Inventory, Beck Depression Inventory, and World Health Organization Quality of Life 26 standardized psychological tests for anxiety, depression, and quality of life (QOL). Respective recipients completed the same tests separately, in order to determine psychological synchronization with the donors. With regard to motivation, donors were divided into two groups, and further divided into three groups based on processes. Donors were also sorted in groups of those "with conflict" and "with pressure." Their psychological test results were compared within groups, as well as with those from recipients. RESULTS: Donors from the nonvolunteer or postponement groups were significantly more anxious and depressed than other donors. Donors from the "with conflict" or "with pressure" groups were significantly more anxious, more depressed, and had worse QOL. There was a significant positive correlation between donors' and recipients' test results for anxiety and QOL, especially when donors belonged to the volunteer group. CONCLUSIONS: Our results suggest that donors' decision-making process and recipients' psychological status, especially donors' state anxiety should be considered when assessing donors' psychological status before LRLT.