Genomic-, phenotypic-, and toxicity-based safety assessment and probiotic potency of Bacillus coagulans IDCC 1201 isolated from green malt.

Probiotics are beneficial microorganisms, and the evaluation of their safety for human use in the food industry has become critical. This study examines the safety of Bacillus coagulans IDCC 1201 isolated from green malt by analyzing its genomic and phenotypic characteristics and determining its toxicity. The presence of antibiotic resistance and toxigenic genes and gene transferability were investigated using whole-genome analysis. The strain's hemolytic and enzyme activities, minimum inhibitory concentrations of antibiotics, and biogenic amine and D-lactate production were also examined. Furthermore, the principal properties of B. coagulans IDCC 1201 as probiotics, such as resistance to abiotic stress and intestinal adhesion, were studied. The whole-genome analysis demonstrated that B. coagulans IDCC 1201 had no antibiotic resistance or toxigenic genes; the strain was susceptible to the nine antibiotics proposed by the European Food Safety Authority. Moreover, this strain lacked hemolytic and ß-glucuronidase activities. Additionally, it was confirmed that B. coagulans IDCC 1201 produced undesirable metabolites, including biogenic amines or D-lactate, at a safe level. Finally, the strain exhibited functional potential as a probiotic in terms of abiotic tolerance, such as bile tolerance and intestinal adhesion in in vitro experiments. In conclusion, B. coagulans IDCC 1201 can be considered as a safe probiotic with regard to human health.

Safety assessment of Streptococcus thermophilus IDCC 2201 used for product manufacturing in Korea.

Safety evaluation of probiotics has become increasingly important for human consumption in food industry. The aims of this study were to assess safety of Streptococcus thermophilus IDCC 2201 through in vitro and in vivo tests. In results, this strain was found to be negative for hemolytic and ß-glucuronidase activity. In addition, thermophilus IDCC 2201 was susceptible to nine antibiotics suggested by EFSA. In accordance with MIC tests, whole-genome analysis indicated that S. thermophilus IDCC 2201 neither harbors antibiotic resistance nor toxigenic genes. Furthermore, none of the biogenic amines including tyramine and histamine was produced and negligible amounts of D-lactate were produced by S. thermophilus IDCC 2201. Finally, it was confirmed that there was no mortality and toxicity throughout single-dose oral toxicity tests in rats. Therefore, we report that S. thermophilus IDCC 2201 is considered to be safe for human consumption as probiotics.

Effects of delisting nonprescription combination drugs on health insurance expenditures for pharmaceuticals in Korea.

In November 2006, 727 combination drugs in 24 therapeutic classes were delisted in the national formulary in Korea to reduce the country's pharmaceutical expenditure, making these 727 drugs non-reimbursable. This study examines the effects of this delisting on national health insurance expenditures for pharmaceuticals. An interrupted time series analysis was conducted for the period from January 2005 to August 2007 by using administrative claims from Korea's National Health Insurance. The main outcome variable was the total pharmaceutical expenditure measured as a whole and based on the level of health care institutions and therapeutic classes. Comparison between exposure group (delisted drugs) and non-exposure group (listed drugs) were done. No changes in the level of or trend in the total pharmaceutical expenditure were detected. However, the delisting reduced pharmaceutical expenditures in clinics. Delisting effects were also observed according to therapeutic classes of drugs. The results indicate that any delisting should take into account the type of drug.

Trends of Incidence, Mortality, and Future Projection of Spinal Fractures in Korea Using Nationwide Claims Data.

Spinal fractures have been recognized as a major health concern. Our purposes were to evaluate the trends in the incidence and mortality of spinal fractures between 2008 and 2012 and predict the number of spinal fractures that will occur in Korea up to 2025, using nationwide data from the National Health Insurance Service (NHIS). A nationwide data set was evaluated to identify all new visits to medical institutes for spinal fractures in men and women aged 50 years or older between 2008 and 2012. The incidence, mortality rates and estimates of the number of spinal fractures were calculated using Poisson regression. The number of spinal fractures increased over the time span studied. Men and women experienced 14,808 and 55,164 vertebral fractures in 2008 and 22,739 and 79,903 in 2012, respectively. This reflects an increase in the incidence of spinal fractures for both genders (men, 245.3/100,000 in 2008 and 312.5/100,000 in 2012; women, 780.6/100,000 in 2008 and 953.4/100,000 in 2012). The cumulative mortality rate in the first year after spinal fractures decreased from 8.51% (5,955/69,972) in 2008 to 7.0% (7,187/102,642) in 2012. The overall standardized mortality ratio (SMR) of spinal fractures at 1 year post-fracture was higher in men (7.76, 95% CI: 7.63-7.89) than in women (4.70, 95% CI: 4.63-4.76). The total number of spinal fractures is expected to reach 157,706 in 2025. The incidence of spinal fractures increased in Korea in the last 5 years, and the socioeconomic burden of spinal fractures will continue to increase in the near future.

Risk of fractures in subjects with antihypertensive medications: A nationwide claim study.

BACKGROUND: The effect of antihypertensives on fracture has important clinical implications, since antihypertensives are frequently prescribed with lifelong exposure. This study aimed to compare risk of fracture between antihypertensive medication classes and non-users among adults. METHODS: Nationwide claim data from January 1, 2007 to December 31, 2011 were analyzed. Among 8,315,709 subjects with antihypertensive prescriptions in nationwide medical claim database in South Korea, 528,522 subjects, who initiated single-drug antihypertensives or non-users, were analyzed. Subjects were classified as non-user, alpha-blocker (AB), angiotensin-converting-enzyme-inhibitor (ACEI), angiotensin-receptor-blocker (ARB), beta-blocker (BB), calcium-channel-blocker (CCB), and diuretic users. Subjects with combination antihypertensive medications were excluded. RESULTS: A total of 16,805 fracture outcomes were observed during mean follow-up duration of 1.9 years. Fracture rate per 10,000 person-years varied significantly across type of antihypertensives, with ARB having the lowest rate (152.7, 95% confidence interval (CI) 145.4-160.4), and AB having the highest rate (323.7, 95% CI 237.4-441.4). Non-users had fracture rates (152.2, 95% CI 148.7-155.7) similar to ARB users. In models adjusting for age, gender, comorbidity score, diagnosis of diabetes, diagnosis of osteoporosis, osteoporosis treatment, and osteoporosis related diseases, AB users (adjusted hazard ratio (aHR)=2.26), ACEI users (aHR=1.68), diuretic users (aHR=1.45), CCB users (aHR=1.23), and BB users (aHR=1.15) showed significantly increased risk of fractures compared with non-users (P<0.05). Only the fracture risk of ARB users (aHR=1.00, 95% CI 0.95-1.05) was not significantly different from the non-users. CONCLUSIONS: The use of antihypertensives except for ARB is associated with increased risk of fracture, with ACEI and AB having higher risk among hypertensive adults.

Effective policy initiatives to constrain lipid-lowering drug expenditure growth in South Korea.

BACKGROUND: The rapid growth of prescription drug expenditures is a major problem in South Korea. Accordingly, the South Korean government introduced a positive listing system in 2006. They also adopted various price reduction policies. Nevertheless, the total expenditure for lipid-lowering drugs have steadily increased throughout South Korea. The present study explores the factors that have influenced the increased expenditures of lipid-lowering drugs with a particular focus on the effects of statins in this process. METHODS: This paper investigates the National Health Insurance claims data for prescribed lipid-lowering drugs collected between January 1, 2005 and December 31, 2009. We specifically focused on statins and assessed the yearly variation of statin expenditure by calculating the increased rate of paired pharmaceutical expenditures over a 2 year period. Our study classified statins into three categories: new entrants, core medicines and exiting medicines. For core medicines, we further examined influencing factors such as price, amount of drugs consumed by volume, and prescription changes (substitutes for other drug). RESULTS: Statin expenditure showed an average annual increase of 25.7% between 2005 and 2009. Among the different statins, the expenditure of atorvastatin showed a 36.6% annual increase rate, which was the most dramatic among all statins. Also we divided expenditure for core medicines by the price factor, volume factor, and prescription change. The result showed that annual weighted average prices of individual drug decreased each year, which clearly showed that price influenced statin expenditure in a negative direction. The use of generic drugs containing the same active ingredient as name-brand drugs increased and negatively affected statin expenditure (Generic Mix effect). However, the use of relatively expensive ingredients within statin increase, Ingredient Mix effect contributed to increased statin expenditure (Ingredient Mix effect). In particular, the volume effect was found to be critical for increasing statin expenditure as the amount of statin consumed increased steadily throughout the study period. CONCLUSIONS: The recent rapid increase in statin expenditure can largely be attributed to an increase in consumption volume. In order to check drug expenditures effectively in our current situation, in which chronic diseases remain steadily on the rise, it is necessary to not only have supply-side initiatives such as price reduction, but also demand-side initiatives that could control drug consumption volume, for example: educational programs for rational prescription, generic drug promotional policies, and policies providing prescription targets.

Burden of osteoporosis in adults in Korea: a national health insurance database study.

We evaluated the number of osteoporosis patients under treatment and secular trends in 2005-2008 in South Korea. We investigated nationwide data regarding the number of osteoporosis patients under treatment in South Korea using data from the Health Insurance Review and Assesment Service (HIRA), which includes nationwide information [corrected]. Reimbursement records from the HIRA database between 1 January 2004 and 31 December 2008 were investigated. Patients aged ≥30 years old with osteoporosis were identified based on a study-defined algorithm using prescription data and diagnostic codes. During the study periods, the number of patients receiving medical treatment related to osteoporosis increased from 1,034,399 to 1,392,189 for women and from 120,496 to 171,902 for men. The calculated proportion of osteoporosis patients under treatment in the general population over 50 years of age was 6.1% for men and 33.3% for women, and in the general population over 30 years of age was 2.7% for men and 16.6% for woman. More than 40% of patients (59.1% for women; 41.2% for men) were treated with medication indicated only for osteoporosis. About 4-7% of osteoporosis patients had a past medical history suggesting a secondary cause of osteoporosis. More than 80% of all osteoporosis patients were women older than 50 years, reflecting the pronounced burden of osteoporosis among postmenopausal women. This study demonstrated a substantial increasing trend in medical claims related to osteoporosis in 2005-2008 among adults in Korea and a pronounced burden of osteoporosis among postmenopausal women.