Objective: The use of generic drugs is promoted for the purpose of reductions of medical costs and patient’s copayment.  In general, it is thought that clinical effects of the original brand and the generic drugs are equal if they are bioequivalent.  However, it is necessary to inspect their therapeutic equivalence to use the generic drugs securely.  We, therefore, assessed the therapeutic equivalence and pharmacoeconomics by substitution of an original drug (Amaryl®) with a generic drug (Glimepiride [Tanabe]).
Methods: Therapeutic Equivalence: The total variation was calculated by using the HbA1c levels before it switched from Amaryl® to Glimepiride [Tanabe].  The tolerance limits were set as 1/4 of the total variation.  Pharmacoeconomics: The difference of drug prices and the difference of patient’s copayment were calculated.
Results: As the variation of HbA1c levels was within tolerance limits before and after switching from Amaryl® to Glimepiride [Tanabe], we evaluated that their therapeutic effect was equivalent.  The difference of drug prices after switching from the original to the generic one was 4,582.6 yen/year on average (minimum: 949.0 yen, maximum: 12,045.0 yen); the difference of patient’s copayment was 872.5 yen/year on average (minimum: 0 yen, maximum: 3,613.5 yen).  These data show that the use of the generic drugs is effective to reduce medical costs.
Conclusion: For further promoting the use of the generic drugs, we consider it essential to compare the therapeutic equivalence and the safety of the original and the generic drugs in clinical practice.

Objective: Management of low-density lipoprotein cholesterol (LDL-C) and triglyceride (TG) is important for patients with type 2 diabetes merger hyperlipidemia. Pemafibrate (PF) has different characteristics from conventional fibrates. In this study, we retrospectively compared the efficacy and safety of PF and bezafibrate (BF) in patients with type 2 diabetes merger hypertriglyceridemia.Methods: Patients who were administered PF (0.2 mg/day) or BF (400 mg/day) for 24 weeks or longer were included. Twenty patients in each group were extracted using propensity score matching (PS). PS was calculated using the patient background (before the start of administration) of PF or BF. We investigated lipid-related parameters (TG, high density lipoprotein cholesterol [HDL-C], and LDL-C) and other laboratory test parameters pre administration and 24 weeks post administration.Results: TG decreased significantly in both groups (p<0.05). However, there were no significant differences between the two groups in the TG treatment target (<150 mg/dL) achievement rate (p =1.00), TG change rate (p=0.84), and TG change amount (p=0.77). In addition, there were no significant changes in HDL-C and LDL-C in both groups. In the PF group, alanine transaminase (ALT) (p< 0.05), alkaline phosphatase (p<0.05) decreased. In the BF group, ALT (p<0.05) and γ-GTP (p<0.05) decreased. Both groups showed improvement in liver function after 24 weeks. eGFR (p<0.05) significantly decreased only BF group. There were no significant changes in renal function, creatine kinase (CK), or hemoglobin A1c (HbA1c) in either group.Conclusion: Our study suggests that there is no difference in the TG lowering effect and safety of PF and BF in type 2 diabetic patients.

We investigated the relationship between renal function assessment based on cystatin C (CsyC) and serum creatinine levels and the status of chemotherapy use in patients with gynecological cancer undergoing paclitaxel and carboplatin therapy. A significant positive correlation was found between estimated glomerular filtration rate from creatinine (eGFRcre) and eGFR from CsyC (eGFRcys) in the 98 patients included in the study. When eGFRcre and eGFRcys values were grouped according to GFR categories in the CKD severity classification, severe cases (eGFRcys < eGFRcre) were of more advanced age (P < 0.05) and had lower albumin levels (P < 0.01) than matched cases. Although no clear relationship was found between renal function assessment and chemotherapy status, the CysC and eGFRcys values tended to be higher and lower, respectively, in patients whose chemotherapy was deferred (P < 0.01 for CysC, P = 0.07 for eGFRcys). These results suggest that eGFRcre-based renal function assessment is overestimated compared with eGFRcys-based assessment in patients with gynecological cancer and may lead to carboplatin overdose or treatment deferral in elderly patients and patients with hypoalbuminemia.

Objective: The use of generic drugs is promoted to reduce medical costs and copayments. However, tumor agents are expensive and generic drugs are not widelyused. Thus, it is necessaryto evaluate the safetyof generic drugs in more detail. We compared the incidence of adverse events between the original drug (Gemzar®: GEM) and generic drug (Gemcitabine [Sandoz]: GE-GEM) using propensityscore (PS) matching.Methods: We investigated adverse events in patients who received one course of GEM or GE-GEM. The patient background (age,sex, BSA, cancer type, stage, metastasis, surgical history, and radiotherapy) and administration status (administration route and RDI) were used to calculate the PS.Results: Among all patients (GEM: 51, GE-GEM: 54), a significantlygreater number in the GE-GEM group had cancer metastasis. On comparison of adverse events, there were significantlymore cases of vascular pain (p＜0.05) in the GEM group, and manycases of nausea (p＝0.08) and rash (p＝0.08). Fortypatients in each group were extracted byPS matching. There were no significant differences in the patient background between the groups, and on comparison of adverse events, the two groups did not significantly differ.Conclusion: Our studysuggested that there is no difference in side effects between Gemzar® and gemcitabine [Sandoz]. To compare the incidence of adverse events, it is useful to use PS matching in clinical practice.

Hospitalized patients often have insomnia, and in many cases it is necessary to administer hypnotics. Although the hypnotics currently used in Japan are mainly benzodiazepine receptor agonists, there is an associated risk of falling due to muscle relaxant action, and carryover effect. It is believed that orexin receptor antagonists, which have a different mechanism of action from conventional hypnotics, have no muscle relaxant action and are thus considered to be much safer. Therefore, in this study we compared fall rate according to the class of hypnotics that the patient had been taking. 　　We analyzed hospitalized patients taking orexin receptor antagonists (ORB), benzodiazepines (BZDs), and non-BZDs, who had falls and were treated in our hospital from April 1, 2017 to December 31, 2017. Patients were grouped according to the drug they were taking before the fall occurred and the fall rate was calculated and compared. The total number of falls in the target patients was 45, and the total number of people prescribed hypnotics in the study period was 1682. Fall rate by classification of hypnotics was the lowest in the ORB group at 1.45％, which was significantly lower than that of the BZD group, suggesting the possibility that ORBs have minimal influence on falls. In addition, the fall rate in the non-BZD group was significantly lower than that of the BZD group.

In hemodialysis, an adsorbent is used to remove phosphorus from the blood.Because phosphorus adsorbents contain iron, they may cause iron excess, and appropriate management is thus required.In recent years, the use of sucroferric oxyhydroxide (SO), which has become available, is said to be associated with lower iron absorption and is less likely to cause iron excess, as compared with conventional ferric citrate hydrate (FCH). However, in clinical trials of SO conducted in Japan, serum ferritin (Ft) and transferrin saturation (TSAT) tended to increase, and this may cause iron excess similar to FCH. Therefore, we report here on the phosphorus adsorption effect and the influence on iron-related benefit of SO.Among 12 patients, iron-related abnormalities were observed in 3 patients and adverse events such as diarrhea and nausea were observed in 7 patients.In 8 patients who continued taking SO for up to 24 weeks, serum phosphorus (P) decreased, Ft and TSAT increased, Hb, Fe, Ca did not change significantly, and the dose of erythropoiesis-stimulating agents (ESA) decreased. The rate of change of Ft was greater in 5 patients with iron deficiency than in 3 patients with non-ferrous deficiency. SO administration tended to decrease P and improve iron deficiency.In addition, there was a decrease in the dose of ESA, suggesting the possibility of contributing to pharmaceutical cost reduction.Conversely, in patients with iron deficiency, iron-related abnormalities were observed in 3 patients, and about half had adverse events with subjective symptoms 4 weeks after the start of treatment with SO.Therefore, the administration of SO takes into account the effects on iron-related values as well as FCH, it is thus considered important to adjust the dose of SO or ESA depending on the condition while monitoring clinical laboratory values and adverse events from the beginning of administration.