A systematic review of sodium-glucose cotransporter 2 inhibitors and renal profiles among Japanese patients with type 2 diabetes mellitus.

BACKGROUND: We conducted a systematic review and meta-analysis to summarize the available literature and comprehensively appraise the renal profiles of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in Japanese patients with type 2 diabetes mellitus (T2DM). METHODS: The electronic databases MEDLINE, Ichushi-web, and ClinicalTrials.gov were searched for studies without language restrictions from their inception until 20 July 2023 and CENTRAL until 21 September 2021. Studies were included if they were double-masked randomized controlled trials (RCTs) (1) including Japanese patients with T2DM aged > 18 years who received SGLT2i or a placebo, (2) reporting at least one renal outcome of serum creatinine or the estimated glomerular filtration rate (eGFR), and (3) with a follow-up of > 12 weeks. Cross-over and open label trials were excluded. The risk of bias based on the Cochrane risk-of-bias tool for randomized trials (RoB 2) was appraised. We computed the weighed mean difference with 95%CI for each renal outcome and used a random-effects model (inverse variance method). RESULTS: We ultimately retrieved 13 RCTs including 2687 individuals in our review. The durations of RCTs ranged between 12 and 104 weeks. Only one trial had a longer duration of more than one year. Ten out of 13 RCTs reported serum creatinine, while nine included eGFR. Serum creatinine and eGFR were slightly worse with SGLT2i than with a placebo [mean difference 0.01 (95%CI 0.00 to 0.02) mg/dL, p = 0.002, mean difference - 1.30 (95%CI -2.23 to -0.37) mL/min/1.73 m2, p = 0.006, respectively]. Merged results revealed insignificant heterogeneity (I2 < 30%). CONCLUSION: These results suggest that SGLT2i slightly worsens serum creatinine and eGFR in Japanese patients with T2DM. However, since the durations of most RCTs were short, the effects of eGFR in particular may be transient. Further evidence is needed from rigorous studies that focus on renal outcomes with a longer duration to confirm the present results.

Comparing the Dosing Period in Package Inserts of Antimicrobial Agents Between Japan and the United States.

Introduction: The duration of antimicrobial therapy is a critical evaluation index of antimicrobial stewardship (AS). The inclusion of the dosing period on package inserts provides a strong reason for clinical intervention by pharmacists in cases where physicians prescribe inappropriate dosing periods. This study investigated differences in the description of dosing periods in antimicrobial package inserts between Japan and the U.S. Methods: We conducted a survey comparing differences in the dosing period of oral and injectable antimicrobials approved and marketed in Japan and the U.S. as of May 1, 2021. The Fisher exact test was used to compare the presence or absence of a description of the dosing period on the package insert between these two countries. Results: We evaluated 69 antimicrobial agents, of which 34 were oral; and 35 were injectable agents. In Japan, 20 (29.0%) of the antimicrobials had package inserts stating the dosing periods, compared with 58 (84.1%) in the U.S. (p < 0.001). Conclusions: It was found that the information on the duration of administration was missing from the package insert in Japan compared to the U.S. Lack of information on the duration of administration may lead to long-term administration by the treating physician and also make it difficult for the pharmacist to inquire about the administration. It is expected that the inclusion of scientifically-based dosing periods in all package inserts will promote AS among physicians and pharmacists who are not specialists in infectious disease therapy.

Evaluation of a New Home Patient Services Practicum for Community Pharmacy Students in Japan.

This study aimed to evaluate the usefulness of the practicum as well as assess the knowledge, skills, and various specific realizations that the students gained from it. A total of 244 students role-played a scenario in which a pharmacist visited a patient at home and provided pharmaceutical management services. After completing the practicum, the students completed (i) a questionnaire survey consisting of six questions that assessed their level of understanding of the role of pharmacists in home medical care and (ii) a rubric survey that evaluated their learning achievement. In addition, they submitted practicum portfolios describing the patients' living conditions, physical conditions, and background as well as the services that required consideration of said variables. Their responses to the portfolio item "What were noticed through the practicum" were analyzed using the grounded theory approach. After the practicum, 45% and 53% of the students reported having a full and partial understanding of a pharmacists' role in home medical care. The students' mean ± standard deviation rubric score was 3.0 ± 0.4. They classified monitoring drug use, support for improving medication adherence, and observation to identify side effects early as major service categories in home medical care. The practicum led the students to perceive the need for communication with patients and various healthcare professionals to improve their readiness for practical training.