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.

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.

A literature review and meta-analysis of safety profiles of SGLT2 inhibitors in Japanese patients with diabetes mellitus.

The safety profiles of sodium-glucose co-transporter 2 (SGLT2) inhibitors may depend on races/ethnicities. We aimed to assess the safety profiles of SGLT2 inhibitors in Japanese patients with diabetes mellitus (DM). The electronic databases MEDLINE, CENTRAL, and Ichushi-web were searched for studies with no language restriction from their inception to August 2019. Trials were included in the analysis if they were randomized controlled trials (RCTs) comparing the effects of SGLT2 inhibitors with a placebo in Japanese patients with DM > 18 years and reporting HbA1c and at least 1 adverse event. We calculated risk ratios with 95% CIs and used a random-effects model. Of the 22 RCTs included in our review, only 1 included patients with type 1 DM. The durations of RCTs ranged between 4 and 24 weeks. In comparison with a placebo, SGLT2 inhibitors were associated with similar risks of hypoglycemia, urinary tract infection, genital infection, hypovolemia, and fracture. The outcomes of treatment with SGLT2 inhibitors among Japanese patients with DM suggest favorable safety profiles. However, further evidence from studies with a longer duration, involving more diverse populations, such as patients with different types of DM, or including individual SGLT2 inhibitors is needed to resolve the limitations of the present study.

[Antidepressant Medication Use and Development of Hyperglycemia and Diabetes Mellitus: A Japanese Adverse Drug Event Report Database Study].

Few studies have examined the relationship between the use of antidepressants and the onset of hyperglycemia and diabetes mellitus in Japan. We herein explored the possibility of this relationship using the Japanese Adverse Drug Event Report database (JADER). The present study included 20 individual antidepressants, consisting of 6 subclasses, which have been approved for use in Japan. We used Standardized MedDRA Queries 20000041 to extract patients who developed hyperglycemia/new onset diabetes mellitus (NODM) in JADER between April 2004 and September 2016. We calculated reporting odds ratios (RORs) with 95% confidence intervals (CI). We also calculated odds ratios defined as the ratio of odds of hyperglycemia/NODM to all other adverse drug events (ADEs) by the age cut-off group or sex in the cases of antidepressants. The lower limit of 95%CI of RORs for 13 antidepressants (imipramine, clomipramine, nortriptyline, amitriptyline, amoxapine, maprotiline, mianserin, sertraline, paroxetine, escitalopram, duloxetine, mirtazapine, and trazodone), which included all subclasses, exceeded 1. Younger age group was associated with hyperglycemia/NODM for 5 antidepressants (imipramine, amitriptyline, maprotiline, duloxetine, and trazodone), and female was associated with the ADEs for trazodone, although these results should be interpreted cautiously. Healthcare personnel need to be aware that the use of antidepressants may lead to hyperglycemia/NODM.

Clinical relevance between sodium-glucose co-transporter 2 inhibitors and lipid profiles in Asian patients with type 2 diabetes mellitus: a systematic review with a meta-analysis of randomized controlled trials.

BACKGROUND: Few systematic reviews have examined the effects of sodium-glucose co-transporter 2 inhibitors (SGLT2is) on lipid profiles in Asian patients with type 2 diabetes mellitus. We conducted a systematic review with a meta-analysis to summarize the available literature and confirm the effects of SGLT2is on lipid profiles in these patients. METHODS: We searched the electronic databases MEDLINE, CENTRAL, and Ichushi-web for studies from the dates of their earliest publication to July 2018, and there was no language restriction. Trials were included if they were randomized controlled trials (RCTs) (1) comparing the effects of SGLT2is with a placebo in Asian patients with type 2 diabetes mellitus (18 years or older), and (2) reporting HbA1c and at least one lipid parameter, such as triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), or low-density lipoprotein cholesterol (LDL-C). The weighted mean difference with a 95% confidence interval (CI) was calculated using a random-effects model. RESULTS: Among the 630 studies retrieved, 17 RCTs that included 4485 patients were ultimately included in our review. Fourteen RCTs were conducted in Japan. The durations of RCTs ranged between 12 and 24 weeks. SGLT2is significantly improved HbA1c [mean difference - 0.80 (95%CI - 0.96 to - 0.64)%, p < 0.00001], TG [mean difference - 16.42 (95%CI - 22.71 to - 10.12) mg/dL, p < 0.00001], and HDL-C [mean difference 3.36 (95%CI 2.73 to 3.98) mg/dL, p < 0.00001], but significantly deteriorated LDL-C [mean difference 3.00 (95%CI 1.18 to 4.82) mg/dL, p < 0.001]. The LDL-C/HDL-C ratio was not significantly different between SGLT2is and a placebo [mean difference - 0.01 (95%CI - 0.08 to 0.06), p < 0.74]. CONCLUSION: The present results suggest that in Asian patients with type 2 diabetes mellitus, TG and HDL-C values were better, while LDL-C values were worse with SGLT2is than with a placebo. However, the negative impact of SGLT2is on lipid profiles was modest. Further RCTs with a longer duration or conducted in other Asian countries are needed to provide further evidence to support the clinical relevance of changes in lipid profiles. The present results will be informative for SGLT2is users with concerns regarding the effects of SGLT2is on lipid profiles.

Effects of resistant dextrin for weight loss in overweight adults: a systematic review with a meta-analysis of randomized controlled trials.

BACKGROUND: Randomized controlled trials (RCTs) reported that resistant dextrin (RD) exerted pleiotropic effects on humans. However, limited information is available on the effects of RD for weight loss. We conducted a systematic review with a meta-analysis to summarize the available literature and compare the efficacy of RD for weight loss with that of a placebo in overweight adults. METHODS: We searched the electronic databases MEDLINE, EMBASE, The Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, Web of Science, ClincalTrials.gov, and Japana Centra Revuo Medicina (Ichushi-web) for studies from their onset to November 2016, and there was no language restriction. Trials were included if they were RCTs (1) comparing the effects of RD with a placebo in adults (18 years or older), (2) reporting body mass index, and (3) including overweight/obese subjects as defined by the authors of RCTs. The weighted mean difference with a 95% confidence interval (CI) was calculated using a random-effects model. RESULTS: Of the 484 studies retrieved, 3 RCTs involving 275 subjects were included in our review. The durations of RCTs ranged between 8 and 12 weeks. All RCTs were conducted in Asian countries. RD significantly improved body mass index [mean difference -0.39 (95% CI -0.57 to -0.21) kg/m2, p < 0.01] and body weight [mean difference -0.81 (95% CI -0.93 to -0.69) kg, p < 0.01] in overweight adults. CONCLUSION: Our review suggests that RD exerts beneficial effects for weight loss in overweight adults. More RCTs with different populations and longer follow-ups are needed in order to confirm that supplementation with RD has beneficial effects for weight loss in overweight adults. We consider this review to provide important information for the future submission of food with health claims.

[Meta-analysis-based examination regarding the efficacy of angiotensin II receptor blockers and calcium channel blockers in borderline diabetes and diabetes patients].

We performed a meta-analysis to assess antihypertensive effect, lipid metabolism, insulin resistance index, and body weight changes in patients with borderline diabetes and diabetes treated with angiotensin II receptor blockers (ARB) and dihydropyridine calcium channel blockers (CCB). Literatures for analysis were searched in MEDLINE, the Cochrane Library, and Japana Centra Revuo Medicina. Reports on randomized controlled trials in which the therapeutic results in borderline and diabetic patients were compared between those treated with ARB and CCB were retrieved, and 16 reports met the objective of this study. The efficacy in the two drug treatment groups were divided into 8 outcomes and evaluated. The efficacy outcomes on handling continuous data were integrated using the weighted mean difference, in which the random-effects model was selected for the statistical model. The statistical heterogeneity of each outcome was also tested. The systolic and diastolic blood pressures were significantly reduced in the CCB compared to the ARB treatment group. No significant differences were noted between the two groups in the triglyceride or low-density lipoprotein cholesterol level or body weight changes. It was shown that the CCB was more effective than ARB for the improvement of systolic and diastolic blood pressures in patients with borderline diabetes and diabetes, while no significant differences were noted in the efficacy other than the antihypertensive effect between ARB and CCB treatment groups. This study would provide information in selecting antihypertensive agents for borderline and diabetic patients.

Lipids behavior and adverse effects for oral antidiabetic agents in patients with Type 2 diabetes treated with sulfonylureas alone based on systematic review.

The secondary and adverse effects when biguanides, alpha-glycosidase inhibitor or thiazolidine derivative was used with sulphonylurea agent (SU) as compared with those with SU alone in Type 2 diabetes patients by using Systematic Review. Two-agent concurrent treatment groups, taken from studies in which subjects were assigned to a group given only a sulfonylurea agent and a group given a sulfonylurea agent with the other glycemic control agent (combination of a sulfonylurea agent and a biguanide agent (I), combination of a sulfonylurea agent and an alpha-glucosidase inhibitor (II), and combination of a sulfonylurea agent and thiazolidinedione (III)), were studied in a randomized controlled trial. The secondary efficacy outcome measures were total cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, and change in body weight. The incidence of hypoglycemia, feeling of fullness, diarrhea, liver dysfunction, and edema was investigated as a safety outcome measure, and the clinical significance of concurrent treatment with a sulfonylurea agent in addition to the other glycemic control agent was investigated. With respect to (II), an antidiabetic effect was showed. As for (III), it had the disadvantage of increased body weight. Furthermore, increase of HDL-C levels, in particular, was observed. The improving effect of (III) on serum lipids may be clinically effective for considering the pathologic condition of diabetes, which is often complicated by hyperlipidemia.