• 약학회지
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• 제45권2호
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• pp.220-226
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• 2001

A bioequivalence study of Lovastati $n^{TM}$ tablets (Dong Sung Pharmaceutical Co., Korea) to Mevaco $r^{TM}$ tablets (Choong Wae Pharmaceutical Co., Korea) was conducted according to the guidelines (No. 98-56) of Korea Food and Drug Administration (KFDA). Each tablet contained 20 mg of lovastatin. Eighteen healthy Korean male subjects received each formulation at a lovastatin dose of 80 mg (i.e., four tablets) in a 2 $\times$ 2 crossover study. There was a washout period of a week between the dose of the two formulations. Plasma concentrations of lovastatin acid were monitored by a GC/MS method for over a period of 12hr after each administration. The area under the plasma concentration-time curve from time zero to 12hr (AUC) was calculated by a linear trapezoidal method. The maximum plasma drug concentration ( $C_{max}$) and the time to reach $C_{max}$ ( $T_{max}$) were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) of these parameters revealed that there are no differences in AUC and $C_{max}$ between the formulations. The apparent differences between the formulations in these parameters were 4.87 and 8.03% for AUC and $C_{max}$, respectively. Minimum detectable differences (%) at $\alpha$=0.1 and 1-$\beta$=0.8 were 17.84 and 15.36% for AUC and $C_{max}$ respectively. The 90% confidence intervals were -15.30~5.56 and -17.02-0.95% for AUC and $C_{max}$, respective1y. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Mevaco $r^{TM}$ tablets and Dong Sung Lovastati $n^{TM}$ tablets are bioequivalent.ivalent.ent.alent.ent.

• 한국임상약학회지
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• 제29권4호
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• pp.254-266
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• 2019

Background: Patients with cardiovascular risks are recommended to use statins and antiplatelet agents to prevent major cerebro-cardiovascular events (MACCE). Antiplatelet agents also possess anti-inflammatory and antioxidant effects, in addition to their inhibitory activity on platelets. The differences in clinical outcomes in ischemic heart disease (IHD) based on the type of antiplatelet therapy combined with statin treatment were investigated in this study. Methods: We conducted a retrospective cohort study using electronic medical records of IHD patients from January 2010 to December 2014 at Ajou University Hospital. Patients on combination therapy of antiplatelet drugs and statins were grouped based on antiplatelet drug types: clopidogrel, cilostazol, or sarpogrelate. Propensity score matching was applied to balance the baseline of the groups of clopidogrel vs. cilostazol and the groups of clopidogrel vs. sarpogrelate. The incidence and risk of MACCE as primary outcomes were assessed between the groups of antiplatelet drugs. Results: Among the approximately 128,500 patients with IHD, 1,049 patients had taken a combination therapy of statin and antiplatelet agents. The cohorts of patients administered clopidogrel, cilostazol, or sarpogrelate were 906, 79, and 64, respectively. The incidence of MACCE was not significantly different among the cohorts (p=0.58), and there were no differences between clopidogrel vs. cilostazol (p=0.72) or clopidogrel vs. sarpogrelate (p=1.00) after propensity score matching. Conclusion: There was no difference in the incidence of MACCE based on the type of antiplatelet drug (clopidogrel, cilostazol, or sarpogrelate) in combination with a statin in patients with IHD.

• 지질동맥경화학회지
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• 제3권2호
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• pp.97-104
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• 2014

Objective: The aim of this study is to compare the clinical benefits between high-intensity and low-to moderate-intensity statin therapy in patients with acute myocardial infarction (AMI). Methods: A total of 1,230 patients in the Korea AMI Registry (KAMIR) were enrolled. Patients were divided into two groups according to the dosage of statin for the secondary prevention after AMI. The primary endpoint was composite of major adverse cardiac events (MACEs) including cardiac death, non-fatal MI, repeat revascularization during the 12 months of clinical follow-up. Result: The primary endpoint occurred in 101 patients (11.3%) from the low-to moderate-intensity statin group and 45 patients (13.4%) from the high-intensity statin group. The cumulative incidence of MACEs during 12-month follow-up was not significantly different between the two groups (p=0.323). After multi-variate analysis, MACEs-free survival rate was not significantly different between the two groups. Conclusion: High-intensity statin therapy did not show additional clinical benefit over low-to moderate-intensity statin therapy after AMI.

• 한국임상약학회지
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• 제31권3호
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• pp.198-204
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• 2021

Background: Cardiovascular (CV) disease is known as one of the major causes of death from disease worldwide. Statin therapy plays a pivotal role in atherosclerotic cardiovascular disease (ASCVD) lowering the LDL-cholesterol level effectively. The purpose of this study was to evaluate the association of the intensity of statin therapy in adult patients of Korea and the risk of ASCVD of the patient group. Methods: We used data from sample of patients from the Health Insurance Review and Assessment Service (HIRA-NPS-2018). We analyzed the patterns of prescribing statins including types of statin, statin intensity, and number of patients with ASCVD or risk of ASCVD. Results: 155,512 patients were included in the analysis, and 27,950 patients (18.0%) was over 75 years. High-intensity statin usage was increased in ASCVD patients compared with the low-intensity statin use. The OR (odds ratio) of high-intensity statin were increased in myocardial infarction patients compared with low-intensity statin use showing the highest OR; 12.40 (95% CI; 9.48-16.22). At patient groups of angina, ischemic heart disease and carotid disease, high-intensity statin prescription rate was increased compared with low-intensity statin. However, there was no statistical significance between both statin prescription rates in patients of peripheral arterial disease, abdominal aneurysm, diabetic mellitus and atherosclerosis. Conclusion: The statin prescription rate showed intensity increasing tendency according to the risk of ASCVD. More aggressive statin therapy might be beneficial for the ASCVD patients based on the recent guidelines of dyslipidemia.

• 한국임상약학회지
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• 제28권4호
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• pp.320-332
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• 2018

Background: This study was performed to clarify the effect of SLCO1B1 T521C on statin-induced myotoxicity. Methods: The PubMed, Embase, Ovid, and Cochrane Library databases were searched for all published studies between database inception and April 2018. Using Review Manager 5, the pooled odds ratio (OR) and corresponding 95% confidence interval (CI) were determined to assess the effect of SLCO1B1 T521C on statin-induced myotoxicity by using different genetic models. Results: Eleven observational studies and one randomized controlled trial were included in the meta-analysis. The pooled analysis showed that the incidence of statin-induced myotoxicity was significantly associated with the SLCO1B1 521C variant allele. Among patients using statins, the incidence of myotoxicity was higher in those carrying the 521TC or 521CC variant than in those carrying the 521TT variant in the dominant model (TC + CC vs TT, OR: 1.57; 95% CI: 1.20, 2.05; p = 0.001). The 521TC genotype was associated with a higher risk of myotoxicity than the 521TT genotype (OR: 1.42; 95% CI: 1.09, 1.86; p = 0.009). Furthermore, the incidence of myotoxicity was higher in 521CC carriers than in 521TC carriers (OR: 1.40; 95% CI: 1.06, 1.83; p = 0.02) and noticeably higher in 521CC carriers than in 521TT carriers (OR: 2.26; 95% CI: 1.23, 4.17; p = 0.009). Conclusion: The identification of individuals with the SLCO1B1 521C variant allele prior to the initiation of statin therapy might be useful to predict the risk of toxicity development, determine the individual dose, and prevent myotoxicity.

• 한국의류산업학회지
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• 제23권6호
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• pp.726-743
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• 2021

This study tried to examine the fashion design and style of representative K-Pop boy groups BTS and SEVENTEEN appearing on music shows. The data collection was conducted on 4 music programs(Inkigayo, Music Bank, Show! Music Core, M COUNTDOWN) and YouTube(www.youtube.com) for each boy who worked for 5 years from January 2016 to December 2020. Result analysis utilized the stage scenes and music videos of the title songs of BTS and Seventeen. As for the fashion design and style characteristics of BTS, it was found that overall, the color, pattern, and decoration of the bottom were minimized, and the style was changed mainly by the top of the denim pants. As for Seventeen's fashion design and style characteristics, it was analyzed that plain simple slacks, bright and modest chromatic colors, and geometric and stylistic patterns with street retro sensibility were relatively emphasized, and natural and romantic images appeared a lot. As a result of examining the differences in fashion design and style characteristics between BTS and Seventeen, significant differences were found in color, tone, color scheme, material type, material combination, detail, trimming, pattern, accessories, and fashion image. Overall, it was found that both groups minimized the use of decorative elements such as patterns, details, and trimmings.

• 약학회지
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• 제50권2호
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• pp.118-123
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• 2006

The aim of this study was to investigate the effect of fluvastatin on the pharmacokinetics of diltiazem and its active metabolite, desacetyldiltiazem, in rats. Pharmacokinetic parameters of diltiazem and desacetyldiltiazem were deter-mined after an oral administration of diltiazem (15 mg/kg) to rats pretreated with fluvastatin (0.5 and 1.5 mg/kg). Compared with the control (given diltiazem alone), the pretreatment of fluvastatin significantly (p<0.05) increased the area under the plasma concentration (AUC), peak plasma concentration $(C_{max})\;and\;K_a$ of diltiazem. Relative bioavailability $(RB\%)$ of diltiazem increased from 1.36- to 1.55-fold. However there were no significant changes in $t_{max},\;K_{el}\;and\;t_{1/2}$ of diltiazem. The pretreatment of fluvastatin also altered the pharmacokintic parameters of desacetyldiltiazem. The pretreatment of fluvastatin (1.5 mg/kg) significantly (p<0.05) increased the AUC of desacetyldiltiazem, whereas the metabolite parent ratio (MR) of desacetyldiatlazem was decreased significantly (p<0.05), suggesting that fluvastatin might inhibit the metabolism of diltiazem. The pretreatment of fluvastatin enhanced the bioavailability of diltiazem in a dose dependent manner at doses ranging from 0.5 to 1.5 mg/kg. further studies for the drug Interaction will be needed in the clinical trials when dilitazem is administrated concomitantly with fluvastatin in humans.

• 한국임상약학회지
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• 제17권1호
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• pp.33-37
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• 2007

The purpose of this study was to investigate the effect of atorvastatin on the pharmacokinetics of diltiazem (15 mg/kg) after oral administration of diltiazem with or without atorvastatin (0.5, 1.5 and 3.0 mg/kg) in rats. Coadministration of atorvastatin increased significantly (p<0.05, 3.0 mg/kg) the plasma concentration-time curve (AUC) and the peak concentration $(C_{max})$ of diltiazem compared to the control group. The total plasma clearance (CL/F) of diltiazem was decreased significantly (p<0.05, 3.0 mg/kg) compared to the control group. The relative bioavailability (RB%) of diltiazem was increased from 1.14- to 1.49-fold. Coadministration of atorvastatin did not significantly change the elimination rate constant $(K_{el})$, terminal half-life $(T_{1/2})$ and the time to reach the peak concentration $(T_{max})$ of diltiazem. Based on these results, we can make a conclusion that the significant changes of these pharmacokinetic parameters might be due to atorvastatin, which possesses the potency to inhibit the metabolizing enzyme (CYP3A4) in the liver and intestinal mucosa, and also inhibit the P-glycoprotein (P-gp) efflux pump in the intestinal mucosa.

• 생명과학회지
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• 제26권11호
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• pp.1345-1354
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• 2016

원형탈모증은 흔하게 발병하고 두피와 전신에 모발의 탈락을 일으키는 모낭조직 특이 자가면역질환이다. 모낭은 자체적으로 면역체계와 내분비 환경을 가지고 각 모발주기 단계에 따라 다른 면역 상태를 나타내는 특이한 기관이다. 성장기 모낭의 면역특권의 파괴는 모낭상피 MHC class I 발현과 자가반응성 CD8+T세포에 대한 자가항원 발현을 유도하는 자가면역의 공격을 일으키고 원형탈모증을 유발한다. 임상적 실험적 연구에 의하면, 심리적 스트레스도 모낭 면역/호르몬 체계에 영향을 미쳐 원형탈모증의 유도에 관여할 수 있다고 지적한다. 원형탈모증의 핵심적인 병리기전은 면역특권 수호자(ACTH, ${\alpha}-MSH$와 $TGF-{\beta}$ 등), 자연살해세포그룹 2D-양성(NKG2D+) 세포(NK 세포와 CD8+T 세포 등)와 스트레스 호르몬(CRH와 substance P)과 관련되어 있다. 효과적인 치료법은 여전히 요구되고 있다. 앞으로 치료목표 중의 하나는 스트레스를 포함한 모낭 면역특권을 개선하는 것일 것이다. 최근 연구는 건선, 아토피피부염, 류마티스 관절염 같은 다른 자가면역질환에서 사용되는 JAK억제제와 면역조절제, Tregs, 혈소판풍부혈장요법, 스타틴과 프로스타글란딘 유사제가 원형탈모증에 효과적이라고 보고하였다. 본 논문은 모낭주위 내분비/면역과 관련된 발병기전에 대한 새로운 이해와 원형탈모증의 새로운 치료법에 대해 고찰하였다.

• Journal of Pharmaceutical Investigation
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• 제38권4호
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• pp.249-254
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• 2008

Solid dispersions of poorly water-soluble drug, atorvastatin, were prepared with Eudragit L100 to improve the solubility by spray dryer. To investigate the correlation between physicochemical properties and dissolution rate of solid dispersions, the samples were characterized by scanning electron microscopy (SEM), differential scanning calorimeter (DSC) and fourier transform infrared spectroscopy (FT-IR). SEM and DSC were found that atorvastatin is amorphous in the Eudragit L100 solid dispersion. FT-IR was used to analyze the salt formation by interaction between atorvastatin and Eudragit L100. The dissolution rate of solid dispersed atorvastatin was markedly increased compared to drug powder in stimulated intestinal juice (pH 6.8). Thus, the solid dispersed atorvastatin using the spray drying method with Eudragit L100 may be effective for the bioavailability.