Background: Sitagliptin was the first dipeptidyl peptidase-4 (DPP-4) inhibitor approved in Japan. Its efficacy and safety have been demonstrated, both as monotherapy and in combination with oral antidiabetic agents or insulin. However, reduction of hemoglobin A1c (HbA1c) by sitagliptin is insufficient in some patients. Therefore, data from an observational study of sitagliptin as add-on therapy to insulin in patients with type 2 diabetes (ASSIST-K) were used to conduct factor analysis of the 12-month changes in HbA1c, body weight, estimated glomerular filtration rate (eGFR), and adverse events (AEs). Methods: At member institutions of Kanagawa Physicians Association specializing in diabetes, outpatients with type 2 diabetes receiving insulin were followed for 12 months after addition of sitagliptin. The HbA1c (National Glycohemoglobin Standardization Program), blood glucose (fasting/postprandial), body weight, eGFR, and AEs were evaluated at each specified time. Multivariate analysis was performed by using sex and age as explanatory variables and the following response variables: the change in HbA1c, body weight, or eGFR after 12 months of sitagliptin treatment, and occurrence of AEs. Results: Of 1,168 patients registered in the ASSIST-K study, 412 patients were included in this analysis, excluding those not receiving insulin before sitagliptin, those in whom the 12-month change in HbA1c could not be calculated, and those with missing data on explanatory variables. There was a significant decrease in HbA1c and eGFR, but no significant change in body weight. AEs observed in > 10 patients were severe hypoglycemia (14 patients, 3.4%) and constipation (13 patients, 3.2%). Factor analysis revealed the following points: 1) Concurrent dyslipidemia and baseline HbA1c influenced the 12-month change in HbA1c; 2) Baseline body mass index and HbA1c influenced the 12-month change in body weight; and 3) Concurrent dyslipidemia, baseline sulfonylurea treatment, baseline body mass index, and baseline eGFR influenced the 12-month change in eGFR. In addition, the risk of severe hypoglycemia or constipation was significantly influenced by baseline HbA1c. Conclusions: Patients with type 2 diabetes showing higher HbA1c levels after add-on sitagliptin therapy had concurrent dyslipidemia and a lower baseline HbA1c. Severe hypoglycemia or constipation was more likely to occur in patients with a low baseline HbA1c. J Endocrinol Metab. 2018;8(6):126-138 doi: https://doi.org/10.14740/jem540
The high frequency of gastroesophageal reflux disease (GERD) as a complication of scleroderma (systemic sclerosis, SSc) calls for treatment with powerful acid suppressants such as proton pump inhibitors (PPI). The present study used a GERD-specific questionnaire to assess the symptoms of GERD in SSc patients, and examine the effectiveness of rabeprazole (RPZ) for treating the symptoms of GERD.The Frequency Scale for the Symptoms of GERD (FSSG), a medical questionnaire developed in Japan for evaluating GERD, and the Visual Analogue Scale (VAS) were used to evaluate GERD symptoms and the degree of pain, respectively, in 151 SSc subjects. These tools were also used to assess the effect of 8 weeks' treatment with the PPI RPZ (10 mg/day).Data on age and gender, and FSSG and VAS scores before treatment and after 4 and 8 weeks' RPZ treatment, were available for 84 subjects. The mean FSSG score was 13.9+/-9.7 before treatment, 8.3+/-8.1 after 4 weeks of treatment, and 7.0+/-7.0 after 8 weeks of treatment; the score reduction was significant (p<0.001) indicating the effectiveness of RPZ in improving subjective GERD symptoms. The VAS scores revealed a significant improvement in pain after both 4 and 8 weeks compared with baseline scores. Six subjects experienced adverse effects and five discontinued the analysis during the period.Administration of RPZ 10 mg/day is effective for the control of the symptoms of GERD associated with SSc. In addition to assessing the symptoms of GERD, the FSSG questionnaire can be used to evaluate the therapeutic effect of drugs.
Background: It is unclear whether dipeptidyl peptidase-4 inhibitors decrease hemoglobin A 1c (HbA 1c ) in a glucose-dependent manner in patients on insulin therapy who have impaired insulin secretion. This study investigated factors influencing the efficacy of sitagliptin when used concomitantly with insulin to treat type 2 diabetes mellitus (T2DM) in the real-world setting. Methods: A retrospective study was conducted of 1,004 T2DM patients at 36 Japanese clinics associated with the Diabetes Task Force of the Kanagawa Physicians Association. Eligible patients had been on insulin for at least 6 months, with a baseline HbA 1c of 7.0% (53 mmol/mol) or higher. Baseline characteristics and laboratory data from 495 patients were subjected to multiple regression analysis to identify factors influencing the change of HbA 1c . Results: Most patients (n = 809) received sitagliptin at a dose of 50 mg. In the 1,004 patients, HbA 1c decreased by 0.74% (6 mmol/mol) and body weight increased by 0.1 kg after 6 months of combination therapy. Multiple regression analysis showed that a higher baseline HbA 1c , older age, and lower body mass index influenced the change of HbA 1c after 6 months. Hypoglycemic symptoms occurred in 7.4%, but none were severe. Conclusions: These results emphasize the importance of a higher HbA 1c at the commencement of sitagliptin therapy in patients on insulin. Glucose-dependent suppression of glucagon secretion by sitagliptin may be useful in patients with impaired insulin secretion. Sitagliptin can be used concomitantly with insulin irrespective of the insulin regimen, duration of insulin treatment, and concomitant medications. J Clin Med Res. 2015;7(8):607-612 doi: http://dx.doi.org/10.14740/jocmr2149w
Ipragliflozin is a selective sodium glucose co-transporter 2 inhibitor. The ASSIGN-K study is investigating the efficacy and safety of ipragliflozin for type 2 diabetes mellitus (T2DM) in the real-world clinical setting.Japanese T2DM patients with inadequate glycemic control despite diet and exercise with/without pharmacotherapy were enrolled in an investigator-driven, multicenter, prospective, observational study examining the efficacy and safety of ipragliflozin treatment (50 mg/day for 52 weeks). We performed interim analysis after 24 weeks.In 367 patients completing 24-week ipragliflozin therapy, hemoglobin A1c (HbA1c) decreased significantly from 8.07% at baseline to 7.26% in week 24 (P < 0.001). The change in HbA1c from treatment initiation to week 24 was -0.88% in patients < 65 years old versus -0.55% in those ≥ 65 years and -0.92% in men versus -0.70% in women (all P < 0.001). When baseline HbA1c was < 7%, 7% to < 8%, and ≥ 8%, the change was -0.18%, -0.45%, and -1.48%, respectively (P = 0.5352, P < 0.001, and P < 0.001, respectively). When baseline body mass index (BMI) was < 25, 25 to < 30, and ≥ 30, the change was -1.05%, -0.65%, and -0.87%, respectively (all P < 0.001). Multiple regression analysis showed that HbA1c decreased more in patients with a higher baseline HbA1c or shorter duration of diabetes. An HbA1c < 7% was achieved in 33.3% of the patients, and their baseline HbA1c was significantly lower than that of patients failing to achieve it (P < 0.001). Adverse events (AEs) occurred in 106/451 patients (23.5%), including 29.1% of patients aged 65 or older. Common AEs were vulvovaginal candidiasis (3.1%) and genital pruritus (1.8%). Serious AEs included urinary tract infection, unstable angina, and ketosis, which occurred in patients who did not suspend medication during acute illness.Ipragliflozin significantly improved HbA1c in T2DM patients with inadequate glycemic control. Improvement in HbA1c was significant irrespective of age, sex, baseline HbA1c, or BMI, but efficacy was greater with a higher baseline HbA1c and shorter duration of diabetes. For safe continuation of treatment, patients should be advised to suspend medication during acute illness.
Background: Sitagliptin, the first dipeptidyl peptidase-4 inhibitor, has demonstrated efficacy and safety as monotherapy and as add-on therapy to oral antidiabetic agents or insulin. However, there have been few reports about sitagliptin in elderly patients. The ASSIST-K observational study was performed in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin as add-on therapy to insulin. Changes of hemoglobin A1c (HbA1c), body weight, and the estimated glomerular filtration rate (eGFR), as well as adverse events, were investigated over 12 months in age-stratified groups. Methods: Among outpatients with T2DM treated at member institutions of Kanagawa Physicians Association, those starting sitagliptin as add-on therapy to insulin were followed for 12 months. HbA1c (National Glycohemoglobin Standardization Program), body weight, and eGFR were the efficacy endpoints, while adverse events were investigated to assess safety. Patients were stratified into three age groups (=< 64 years, 65 - 74 years, and >= 75 years) for comparison of the endpoints. Results: Among 937 patients on insulin before starting sitagliptin, 821 patients were analyzed after excluding those without HbA1c data at baseline and 12 months. The two groups of elderly patients (65 - 74 years and >=75 years) had more complications and their HbA1c was lower at initiation of sitagliptin therapy. The dose of sitagliptin, daily number of insulin injections, and number of concomitant oral antidiabetic agents were all lower in the elderly patients. HbA1c showed a significant decrease after initiation of sitagliptin in all age groups, and there were no significant intergroup differences in the change of HbA1c at 12 months. Body weight did not change significantly in any group. eGFR decreased significantly in all groups, with no significant intergroup differences at 12 months. Regarding adverse events, there were no significant intergroup differences in the incidence of severe hypoglycemia, gastrointestinal symptoms, or constipation. Conclusions: Despite baseline differences in demographic factors and medications, sitagliptin showed good efficacy and safety in all age groups of patients receiving it as add-on therapy to insulin during routine management of T2DM. Adding sitagliptin to insulin achieves similar efficacy and safety outcomes at 12 months in both elderly and non-elderly T2DM patients. J Clin Med Res. 2019;11(5):311-320 doi: https://doi.org/10.14740/jocmr3677
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