Objective: The purpose of this study is to compare the clinical efficacy between original drugs and generic products.  Candidate drugs included two types of hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors, simvastatin and pravastatin, because of their importance at reducing the health expenditure for hyperlipidemia.
Design: We retrospectively evaluated the efficacy (total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein levels), safety (biochemical parameters), and medication adherence based on patient data.  We set the follow-up period at 6 months before and after substitution.  Data were analyzed by paired-sample t-tests (statistical significance level of 0.05).
Methods: The subjects included in this study were ambulatory patients visiting Nakajima Hospital for dyslipidemia treatment.  Selected patients included those taking both the original drug and the generic product; i.e., patients who had substituted the original drug Lipovas® for the generic product Simvastatin OHARA, or those who had substituted the original drug Mevalotin® for the generic drug Pravatin®.
Results: A total of 118 patients in the simvastatin study and 43 patients in the pravastatin study were candidates for the present study.  We found that there were no significant differences before and after substitution.  Even though there were differences in some of the biochemical parameters, the range remained within normal levels.  With regard to medication adherence, we found no significant differences.
Conclusion: In this study, we found no significant differences before and after substituting medications with generic drugs.  Additionally, we found no subjective symptom changes after substitution.  To develop clinical information on generic products and to store such information, it is important that pharmaceutical products be used appropriately.

Objective: Several drugs can cause analytical interference in clinical laboratory tests.  To prevent errors in clinical judgment as a result of false data, we investigated the information available on the interference of ethical drugs in these tests.
Methods: We examined the information available by collecting and evaluating information in package insert leaflets, collecting and evaluating clinical data on three drugs (bucillamin, captopril, and epalrestat) which affect clinical laboratory test results, and conducting a questionnaire survey of healthcare workers.
Results: From the information available on package inserts, 227 drugs were identified as having the potential to interfere with the chemical reactions used in clinical laboratory tests.  However, the insert information is not sufficient for use in clinical settings because the frequency rate and causative factors of interference are not stated clearly.  The clinical survey results reveal that 40% of patients taking bucillamine and 20% of patients taking epalrestat tested false-positive for urinary ketones.  According to the questionnaire results, medical technologists were more interested than pharmacists and physicians in how drugs affect clinical laboratory tests.
Conclusion: The information currently available on the interference of drugs in clinical laboratory tests is problematical, and it is therefore necessary to collect more clinical data for the proper interpretation and evaluation of abnormal laboratory values.

Orengedokuto, a Kampo formulation, has traditionally been used to treat various diseases, including hypertension with neuropsychiatric symptoms, gastritis, dermatitis, hematemesis and hemorrhagic stools. We report 8 cases of intractable hemorrhage that could not be controlled by Western medicine, but were successfully treated with orengedokuto. We elaborate on 3 cases, including 1 case treated by enema administration of orengedokuto, which was found to be a useful method. In a representative case, an 80-year-old man with aplastic anemia who was taking anticoagulants due to a history of mitral valve replacement presented with a chief complaint of black stool. Hemorrhagic gastritis was diagnosed. We repeatedly attempted endoscopic hemostatic therapy, but failed to achieve hemostasis. Oral administration of orengedokuto demonstrated hemostatic effects within a few days of starting treatment. In all 8 these cases, moreover, we observed quick clinical responses with no side effects. Although the hemostatic mechanism of orengedokuto remains unclear, we speculate that orengedokuto contains a short-acting component that affects primary hemostasis. As such, conventional orengedokuto may also have potential as a novel hemostatic agent.

BACKGROUND: Predictive factors for the efficacy of dipeptidyl peptidase-4 (DPP-4) inhibitors for lowering glycosylated hemoglobin (HbA1c) remain unclear in patients with type 2 diabetes mellitus. The aim of this study is therefore to clarify predictive factors of the efficacy of DPP-4 inhibitors for lowering HbA1c after 12 months of treatment. METHODS: A total of 191 consecutive type 2 diabetic patients (male sex 55%, mean age, 68.3+/-35.8 years), who had been treated with DPP-4 inhibitors for 12 months, were enrolled in this study and evaluated retrospectively. RESULTS: After 12 months of DPP-4 inhibitor treatment, random blood glucose level, and HbA1c level, decreased from 167+/-63 to 151+/-49 mg/dL (P<0.01), and from 7.5%+/-1.3% to 6.9%+/-0.9% (P<0.01) respectively, without severe side effects. Multiple regression analysis showed that predictors of DPP-4 inhibitor treatment efficacy in lowering HbA1c level after 12 months were a decrease in HbA1c level after 3 months of treatment, a high baseline HbA1c level, a low baseline body mass index, and the absence of coronary artery disease. CONCLUSION: Most suitable candidates for treatment with DPP-4 inhibitors are diabetics who are not obese and do not have coronary artery disease. In addition, long-term efficacy of DPP-4 inhibitors can be predicted by decrement of HbA1c after 3 months of treatment.
Blood Glucose ; Body Mass Index ; Coronary Artery Disease ; Diabetes Mellitus ; Diabetes Mellitus, Type 2* ; Dipeptidyl-Peptidase IV Inhibitors ; Hemoglobin A, Glycosylated ; Humans ; Retrospective Studies ; Treatment Outcome