No drug-drug interactions between selective prolyl-tRNA synthetase inhibitor, bersiporocin, and pirfenidone or nintedanib in healthy participants.

Bersiporocin, a potent and selective prolyl-tRNA synthetase inhibitor, is expected to show a synergistic effect with pirfenidone or nintedanib in patients with idiopathic pulmonary fibrosis. To validate the combination therapy of bersiporocin with pirfenidone or nintedanib, a randomized, open-label, two-part, one-sequence, three-period, three-treatment study was designed to evaluate the effect of drug-drug interactions (DDI) regarding their pharmacokinetics, safety, and tolerability in healthy participants. In addition, the pharmacokinetic profiles of the newly formulated, enteric-coated bersiporocin tablet were evaluated after single and multiple administrations.

Pharmacokinetics and Food Effect Between a 100-mg Sustained-Release Tablet and a 50-mg Immediate-Release Tablet of Vildagliptin in Healthy Subjects.

Vildagliptin is one of the dipeptidyl peptidase-4 inhibitors. This study aimed to compare vildagliptin exposure between 50-mg immediate-release (IR) and 100-mg new sustained-release (SR) tablets, and evaluate the food effect on the pharmacokinetics (PKs) of vildagliptin. A randomized, open-label, 3-period, 3-treatment, 6-sequence crossover study was conducted on healthy subjects.

Size-reduced fexuprazan 20 mg demonstrated the optimal bioavailability and bioequivalence with the reference formulation.

Fexuprazan (DWP14012), a potassium-competitive acid blocker, is a medical formulation prescribed to inhibit the secretion of gastric acid. The present study encompasses a comparative evaluation of pharmacokinetic (PK) analysis between the previous (reference) and size-reduced (test) formulation of fexuprazan 20 mg in healthy subjects. The study employed a randomized, open-label, single-dose, 2-sequence, 2-period, crossover design with a 7-day wash-out between periods.

An Open Label, Multi-Center, Non-Interventional Post-Marketing Surveillance to Monitor the Safety and Efficacy of ALTARGO® (Retapamulin) Administered in Korean Patients According to the Prescribing Information.

Background: With the approval of topical retapamulin ointment in 2011, it was officially required to conduct a post-marketing surveillance (PMS) study to obtain further data of its safety profile and effectiveness, in accordance with the requirement of the Korean Ministry of Food and Drug Safety (MFDS).

Objective: This study had prospectively designed to monitor safety and tolerability with the effectiveness of topical retapamulin in clinical practices.

Methods: Open label, multi-center, non-interventional observational study was done from May 2011 to October 2015.

Safety and Tolerability of the Dual 5-Alpha Reductase Inhibitor Dutasteride in the Treatment of Androgenetic Alopecia.

Background: After the approval of dutastride for androgenic alopecia (AGA) in 2009, Korean authority required a post-marketing surveillance to obtain further data on its safety profile.

Objective: The objective was to monitor adverse events (AEs) of dutasteride 0.5 mg in Korean AGA male patients in a clinical practice environment.

Changing Clinical Characteristics according to Insulin Resistance and Insulin Secretion in Newly Diagnosed Type 2 Diabetic Patients in Korea.

Background: The role of increased insulin resistance in the pathogenesis of type 2 diabetes has been emphasized in Asian populations. Thus, we evaluated the proportion of insulin resistance and the insulin secretory capacity in patients with early phase type 2 diabetes in Korea.

Methods: We performed a cross-sectional analysis of 1,314 drug-naive patients with newly diagnosed diabetes from primary care clinics nationwide.

Impact of global risk assessment on the evaluation of hypertensive patients treated by primary care physicians in Korea (a Nation-Wide, Multi-Center, Observational, Cross-Sectional, Epidemiologic Study to Evaluate the Proportion of Cardiovascular Risk Factors in Korean hypertensive patients: WONDER study).

Global cardiovascular risk evaluation and stratification is essential to identify high-risk hypertensive patients. However, it is uncertain how often the strategy is executed in real clinical practice. We sought to evaluate whether global risk evaluation might change the risk stratification in Korean hypertensive patients treated by primary care physicians.

Influence of insurance benefit criteria on the administration rate of osteoporosis drugs in postmenopausal females.

Background: Preventive measures need to be implemented to lower the incidence of osteoporotic fractures. Osteoporotic fractures increase morbidity and mortality as well as impose a socioeconomic burden; however, current research is limited to the administration rates of osteoporosis drugs for Korean postmenopausal females.

Methods: This study represents a nationwide, observational, and cross-sectional survey that investigates the administration rates of osteoporosis drugs based upon a bone mineral density (BMD) test performed on Korean postmenopausal patients who visited outpatient orthopedic clinics.

Prevalence of ocular symptoms in patients with allergic rhinitis: Korean multicenter study.

Background: Allergic rhinitis (AR) is often accompanied by multiple ocular symptoms. This study aimed to evaluate the prevalence of ocular symptoms and the impact of ocular symptoms on the quality of life in patients with AR.

Methods: One thousand one hundred seventy-four patients with AR were enrolled from 24 centers in Korea.

A Validation Study for the Korean Version of Chronic Obstructive Pulmonary Disease Assessment Test (CAT).

Background: Health status measure is not only important for clinical research studies but also for clinical practices of chronic obstructive pulmonary disease (COPD) patients. The objective of this study is to evaluate the validity of the Korean Version of COPD Assessment Test (CAT) in primary care clinics as well as in referral hospitals.

Methods: Smokers or ex-smokers, aged 40 years or older, with a smoking history of >10 pack-years; and a COPD diagnosis in the past 6 months or more, were recruited from 4 primary care clinics and 2 referral hospitals.

Osteoporosis Patient Treatment Satisfaction Questionnaire in postmenopausal women intermittently treated with oral bisphosphonates: the BRAVO study.

The Osteoporosis Patient Treatment Satisfaction Questionnaire (OPSAT-Q) is a psychometric measure of patient satisfaction with bisphosphonate treatment for osteoporosis. The study was a multicenter, nationwide, cross-sectional, patient-reported outcome study conducted to evaluate treatment satisfaction and quality of life using the OPSAT-Q in patients receiving oral bisphosphonate therapy. This study enrolled postmenopausal women from 43 hospitals and 112 clinics who had intermittently taken oral bisphosphonates for treatment of osteoporosis.

Virologic response to therapy increases health-related quality of life for patients with chronic hepatitis B.

Background & Aims: We evaluated changes in health-related quality of life (HRQoL) in a longitudinal study of patients given antiviral therapy for chronic hepatitis B (CHB).

Methods: We analyzed changes in HRQoL reported by 2856 Korean patients with CHB who started first-line or rescue antiviral therapy from January 2007 to June 2007; the mean age of the study subjects was 43.3 years, 72% were male, 80% were positive for hepatitis B e antigen, 20% had cirrhosis, and 13% had concomitant disease.

Prevalence of diabetic nephropathy in primary care type 2 diabetic patients with hypertension: data from the Korean Epidemiology Study on Hypertension III (KEY III study).

Background: The prevalence of albuminuria is known to be higher in hypertensive compared to normotensive nondiabetic patients. In addition, systolic blood pressure (BP) is found to be an independent risk factor for albuminuria in type 2 diabetes mellitus (T2DM). Based on these findings, the prevalence of albuminuria is expected to be higher in T2DM with hypertension relative to T2DM without hypertension, but it has been largely unexplored.

Comparison of monthly ibandronate versus weekly risedronate in preference, convenience, and bone turnover markers in Korean postmenopausal osteoporotic women.

Patient preferences, convenience, and bone turnover markers were evaluated for the monthly ibandronate over the weekly risedronate regimen in Korean postmenopausal osteoporotic women. This was a 6-month, prospective, randomized, open-label, multicenter study with a two-period and two-sequence crossover treatment design. After a 30-day screening period, eligible participants with postmenopausal osteoporosis were randomized to receive either monthly oral ibandronate 150 mg for 3 months followed by weekly oral risedronate 35 mg for 12 weeks (sequence A) or the same regimen in reverse order (sequence B).

Rash in adult patients receiving lamotrigine to treat bipolar I disorder in Korea: a multicenter, prospective, naturalistic, open-label trial.

The goal of this study was to assess the incidence of rash occurring in patients received lamotrigine to treat bipolar I disorder in a real world setting in Korea. We included a heterogeneous sample with multiple medications and medical comorbidities. Lamotrigine was added to the current therapy regime for DSM-IV bipolar I patients on an open-label basis for 12 weeks.