Background Based on non-clinical data, it is expected that azilsartan, an angiotensin II receptor blocker, will help improve insulin resistance in addition to its hypotensive action. The present study is aimed to explore the effect of azilsartan compared to telmisartan on insulin sensitivity in hypertensive patients in the clinical setting. Methods This multicenter, randomized, open-label, parallel-group exploratory study was conducted in Japan. We randomized adult patients (≥20 years old) with grade I or II essential hypertension and coexisting type 2 diabetes (1:1) to receive either oral azilsartan (20 mg/day;17 patients) or telmisartan (40 mg/day;16 patients) for 12 weeks. The primary endpoint was the change in the homeostasis model assessment ratio of insulin resistance (HOMA-R) from the baseline at the end of the treatment period. We also evaluated its safety and efficacy on other diabetes-related variables and blood pressure. Findings The mean changes in HOMA-R at the end of treatment were 0.22 (95% CI, −1.09–1.52) in the azilsartan group and −0.23 (95% CI, −0.72–0.27) in the telmisartan group. We found no clinically remarkable changes between the groups in diabetes-related variables such as fasting blood glucose, fasting insulin, HbA1c (NGSP), HOMA-β, or 1,5-anhydroglucitol. Reductions in clinic systolic and diastolic blood pressure were observed at week 4 and the reduced levels were maintained throughout the treatment period in both groups. No serious treatment-emergent adverse events (TEAEs) were observed. Only one drug-related TEAE (mild decrease in blood pressure) was reported in one patient in the azilsartan group. Conclusion Neither azilsartan nor telmisartan had any clinically remarkable effects on insulin resistance parameters when administered for 12 weeks to patients with grade I or II essential hypertension and coexisting type 2 diabetes mellitus. Azilsartan (20 mg/day) and telmisartan (40 mg/day) exerted comparable antihypertensive effects. Trial registration ClinicalTrials.gov NCT02079805
Background Pain catastrophizing and self-efficacy are useful for predicting pain; these are associated with pain intensity and facilitate evaluation of psychological factors. However, it remains unclear whether the effects are direct or indirect in patients with frozen shoulder; the impact on each variable has also not been clarified. Thus, this study aimed to examine the structural relationship between pain catastrophizing, self-efficacy, and pain intensity in patients with frozen shoulder. Methods Participants who were diagnosed with frozen shoulder between January 2016 and March 2017 were recruited from a single orthopedic clinic. Patients aged 18 years or older, who had been symptomatic for < 1 year and reported localized pain in one shoulder, experienced night pain, and had restricted active and passive shoulder motions were included. Pain intensity (Numerical Rating Scale (NRS)), pain catastrophizing (Pain Catastrophizing Scale (PCS)), and self-efficacy (Pain Self-Efficacy Questionnaire (PSEQ)) were measured at the first examination, and the relationship was examined using the Bayesian estimation method. The model was modified repeatedly based on the posterior prediction p value, deviance information criterion (DIC), and Bayesian information criterion (BIC); the model with the highest explanatory power was adopted as the final model. Results Ninety-three patients diagnosed with frozen shoulder were included in this study. On path analysis, the model in which pain intensity affected psychological factors had the most explanation. The convergence index potential scale reduction was below 1.1, and the convergence of the estimate was confirmed. The posterior prediction p value was 0.25, DIC = 1328.705, and BIC = 1356.872; the validity of the fit of the model was confirmed. The path coefficients from the NRS to the PSEQ, from the NRS to the PCS, and from the PSEQ to the PCS scores were − 0.232 (95% confidence interval (CI), − 0.406 to − 0.033), 0.259 (95% CI, 0.083–0.419), and − 0.504 (95% CI, − 0.646 to − 0.334), respectively; these values were statistically significant (p < 0.05). Conclusion Our results show that pain intensity increases the risk of chronic pain including pain catastrophizing and self-efficacy and that pain catastrophizing increases by decreasing self-efficacy in patients with frozen shoulder.
IntroductionThis open-label, parallel-group, exploratory study examined the effects of two dipeptidyl peptidase 4 (DPP4) inhibitors on glycemic variability (GV) in patients with type 2 diabetes.MethodsRandomized patients with glycated hemoglobin A1c of at least 6.5% to less than 8.5% received trelagliptin 100 mg (n = 13) once weekly or alogliptin 25 mg (n = 14) once daily for 29 days. Continuous glucose monitoring was performed before the start of the treatment period (baseline) and from day 21 to 29, inclusive. The primary endpoint was change from baseline in the standard deviation (SD) of 24-h blood glucose values, measured daily for 7 days (day 22–28) of the treatment period. Secondary and additional efficacy endpoints included changes in glycemic parameters and the rate of DPP4 inhibition, respectively. Adverse events (AEs) were monitored to assess safety.ResultsMean change from baseline in the SD of 24-h blood glucose (95% confidence interval) at day 28 was − 7.35 (− 15.13, 0.44) for trelagliptin and − 11.63 (− 18.67, − 4.59) for alogliptin. In both treatment groups, glycemic parameters improved and the rate of DPP4 inhibition was maintained. Three patients reported AEs; no severe treatment-emergent AEs were reported in either group.ConclusionOnce-weekly trelagliptin and once-daily alogliptin improved glycemic control and reduced GV without inducing hypoglycemia.Trial RegistrationClinicalTrials.gov (NCT02771093) and JAPIC (JapicCTI-163250).FundingTakeda Pharmaceutical Company, Ltd.
[Purpose] This study compared lower garment-lifting postural control characteristics during toilet-related activities between healthy participants and a post-stroke patient, and studied changes in the stroke patient’s characteristics during rehabilitation. [Participants and Methods] Six healthy individuals and one stroke participant with right hemiparesis were asked to lift a pair of pants with the left arm while on the toilet. During the process, we measured the mean percentage of body weight (%BW) on each leg and the foot center of pressure (COP) using portable force plates. Measurements were conducted twice for the stroke participant during rehabilitation. [Results] In healthy participants, the %BW and respective COP indices for both legs were not different during lifting, but the COP sway velocity and excursion were greater in the anterior-posterior (AP) than the lateral axis in both legs. In the stroke participant, no marked change was seen in the high %BW of the non-paretic leg while lifting during rehabilitation, but both legs’ COP positional asymmetry improved on the AP axis and the COP sway velocity and excursion of the non-paretic leg increased. [Conclusion] Facilitating selective COP mobility on the AP axis of the non-paretic leg during lower garment lifting could become an effective intervention for stroke patients.
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