Pharmacogenomic information in the Warning section of drug labels: A comparison between labels in the United States and those in five other countries/regions.

WHAT IS KNOWN AND OBJECTIVE: Clinically validated pharmacogenomic information useful for patient selection and/or dose adjustment is included in drug labels. However, the label information may differ among countries. This commentary summarizes the pharmacogenomic information on drug labels in different countries. COMMENT: We selected six drugs, namely, clopidogrel, atomoxetine, irinotecan, mercaptopurine, abacavir and carbamazepine and compared the pharmacogenomic information in the "Warning" section of these drug labels in the United States and 5 other countries/regions. WHAT IS NEW AND CONCLUSION: The pharmacogenomic information in drug labels is not well harmonized across countries/regions, possibly due to differences in population characteristics such as relevant allele frequencies, variable genetic test availability and differences in insurance coverage. Further and periodical investigations of this issue would be useful.

Development of a novel algorithm for detecting glucocorticoid-induced diabetes mellitus using a medical information database.

WHAT IS KNOWN AND OBJECTIVE: Glucocorticoid-induced diabetes mellitus (GIDM) increases the risk of diabetes mellitus (DM)-related complications but is generally difficult to detect in clinical settings. The criteria for diagnosing GIDM have not been established. Recently, medical information databases (MIDs) have been used in post-marketing surveillance (PMS) studies. We conducted a pharmacoepidemiological study to develop an algorithm for detecting GIDM using MID. METHODS: We selected 1214 inpatients who were newly prescribed with a typical glucocorticoid, prednisolone, during hospitalization from 2008 to 2014 from an MID of Hamamatsu University Hospital in Japan. GIDM was screened based on fasting blood glucose (FBG) and haemoglobin A1c (HbA1c) levels according to the current Japan Diabetes Society (JDS) DM criteria, and its predictability was evaluated by an expert's review of medical records. We investigated further candidate screening factors using receiver operating characteristics analysis. RESULTS: Sixty-three inpatients were identified by the JDS DM criteria. Of these, 33 patients were definitely diagnosed as having GIDM by expert's review (positive predictive value = 52·4%). To develop a highly predictive algorithm, we compared the characteristics of inpatients diagnosed with definite GIDM and those diagnosed as non-GIDM. The maximum levels of HbA1c in patients with GIDM were significantly higher than those of patients with non-GIDM (66·9 mmol/mol vs. 58·7 mmol/mol, P < 0·001). The patients with GIDM had significantly higher relative increase in maximum level of HbA1c (RIM-HbA1c) than those with non-GIDM (0·3 vs. 0·03, P < 0·001). However, we did not observe a significant difference in those of fasting blood glucose (FBG) levels. We applied the RIM-HbA1c as a second screening factor to improve the detection of GIDM. It showed that a 13% increase in RIM-HbA1c separated patients with from patients without GIDM. WHAT IS NEW AND CONCLUSIONS: Patients with GIDM had significantly higher RIM-HbA1c than patients with non-GIDM. There was a 13% increase in RIM-HbA1c in patients with GIDM compared to the others. Our detection algorithm for GIDM using an MID achieved high sensitivity and specificity, and was superior to one based only on the current JDS DM criteria. Our results suggest that monitoring changes in HbA1c levels is important for detecting GIDM and adds to current diagnostic criteria for type 2 DM.

Evaluating measles surveillance: comparison of sentinel surveillance, mandatory notification, and data from health insurance claims.

Inadequate notification is a recognized problem of measles surveillance systems in many countries, and it should be monitored using multiple data sources. We compared data from three different surveillance sources in 2007: (1) the sentinel surveillance system mandated by the Act on Prevention of Infectious Diseases and Medical Care for Patients Suffering Infectious Diseases, (2) the mandatory notification system run by the Aichi prefectural government, and (3) health insurance claims (HICs) submitted to corporate health insurance societies. For each dataset, we examined the number of measles cases by month, within multiple age groups, and in two categories of diagnostic test groups. We found that the sentinel surveillance system underestimated the number of adult measles cases. We also found that HIC data, rather than mandatory notification data, were more likely to come from individuals who had undergone laboratory tests to confirm their measles diagnosis. Thus, HIC data may provide a supplementary and readily available measles surveillance data source.

Coffee consumption but not green tea consumption is associated with adiponectin levels in Japanese males.

PURPOSE: Coffee is among the most widely consumed beverages in the world. Numerous epidemiological studies have reported a significant inverse association between coffee consumption and risk of type 2 diabetes mellitus, but the underlying mechanisms are still not fully understood. Therefore, we conducted an epidemiological study to clarify the relationship between coffee consumption and adiponectin levels in Japanese males. We also evaluated whether green tea consumption affected adiponectin levels. METHODS: We carried out a cross-sectional study. The subjects were 665 male employees in Japan. Coffee consumption was assessed, using a self-administered questionnaire, as the number of times per week and cups per day respondents drank, and subjects were grouped into four levels (non, 1-5 times/week, 1-2 cups/day and ≥3 cups/day). RESULTS: The means of adiponectin levels were positively associated with coffee consumption. A dose-response relationship was found between coffee consumption and circulating adiponectin levels. The relationship remained significant after adjustment for potential confounding factors (P for trend <0.05). However, green tea consumption was not significantly associated with adiponectin levels (P for trend = 0.90). CONCLUSIONS: We not only revealed that habitual coffee consumption is associated with higher adiponectin levels in Japanese males but also found a dose-dependent association between coffee consumption and adiponectin levels. Therefore, our study suggested that coffee components might play an important role in the elevation of adiponectin level.

Coffee but not green tea consumption is associated with prevalence and severity of hepatic steatosis: the impact on leptin level.

BACKGROUND/OBJECTIVES: Most of the studies that have investigated the association between coffee consumption and hepatic steatosis have been experimental and small-scale clinical studies. As a result, epidemiological studies are scarce. To clear the association, we conducted a cross-sectional study and investigated the effects of coffee consumption with those of green tea consumption. SUBJECTS/METHODS: We analyzed 1024 Japanese male workers. The diagnosis of hepatic steatosis was based on ultrasonography. We divided coffee and green tea consumption into the following three categories: non-drinker; 1-2 cups/day and ⩾3 cups/day. To investigate the association between hepatic steatosis and coffee or green tea consumption, we calculated the odds ratio (OR) and adjusted the means of leptin levels on each severity of hepatic steatosis. RESULTS: A total of 265 of our subjects (25.9%) were diagnosed with hepatic steatosis. The ORs of the group of subjects who drank >3 cups of coffee/day was significantly lower compared with that of the noncoffee drinker group (OR 0.59, 95% confidence intervals 0.38-0.90, P=0.03). Although there was a significant difference between coffee consumption and leptin level only in the asymptomatic group, we found a decreasing trend in the asymptomatic and moderate-severe hepatic steatosis group. We did not find the same relationships in green tea consumption. CONCLUSIONS: Although we did not find an association between hepatic steatosis and green tea consumption, coffee may have beneficial effects on hepatic steatosis. In addition, we produced one possible hypothesis that coffee consumption negatively associates with leptin levels in hepatic steatosis.

Is heat shock protein 60 associated with type 2 diabetes mellitus?

AIMS: HSP60 plays a protective role against heat, oxidative injury and ultraviolet. Recently, animal and clinical studies have suggested that HSP60 plays a role in various diseases. However, few epidemiological studies have demonstrated an association between HSP60 levels and type 2 diabetes mellitus. Therefore, an epidemiological study was conducted to examine the association of HSP60 with type 2 diabetes mellitus. METHODS: This study included 83 type 2 diabetes mellitus patients and 161 controls that were recruited from male employees who received annual health check-ups between 2005 and 2007. The serum HSP60 levels were measured using the ELISA method. RESULTS: Because the HSP60 levels were not detectable (<3.125 ng/mL) in 48.0% of the study subjects, HSP60 levels were divided into two categories (detectable or undetectable). A logistic regression analysis showed that the subjects in the undetectable had a 2.03 times higher risk of diabetes mellitus than those in the detectable after adjustment for age, BMI and rate of hypertension medication. CONCLUSIONS: This study was the first epidemiological study to demonstrate an association between type 2 diabetes mellitus and HSP60, thus suggesting that HSP60 may play an important role in the type 2 diabetes mellitus pathology.