• Korean Circulation Journal
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• v.52 no.4
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• pp.324-337
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• 2022

Background and Objectives: Identifying patients with high bleeding risk (HBR) is important when making decisions for antiplatelet therapy strategy. This study evaluated the impact of ticagrelor monotherapy after 3-month dual antiplatelet therapy (DAPT) according to HBR in acute coronary syndrome (ACS) patients treated with drug eluting stents (DESs). Methods: In this post-hoc analysis of the TICO trial, HBR was defined by 2 approaches: meeting Academic Research Consortium for HBR (ARC-HBR) criteria or Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent DAPT (PRECISE-DAPT) score ≥25. The primary outcome was a 3-12 months net adverse clinical event (composite of major bleeding and adverse cardiac and cerebrovascular events). Results: Of the 2,980 patients without adverse events during the first 3 months after DES implantation, 453 (15.2%) were HBR by ARC-HBR criteria and 504 (16.9%) were HBR by PRECISE-DAPT score. The primary outcome rate was higher in HBR versus non-HBR patients (by ARC-HBR criteria: hazard ratio [HR], 2.87; 95% confidence interval [CI], 1.76-4.69; p<0.001; by PRECISE-DAPT score: HR, 3.09; 95% CI, 1.92-4.98; p<0.001). Ticagrelor monotherapy after 3-month DAPT was associated with lower primary outcome rate than ticagrelor-based 12-month DAPT regardless of HBR by ARC-HBR criteria, with similar magnitudes of therapy effect for HBR and non-HBR patients (p-interaction=0.400). Results were consistent by PRECISE-DAPT score (p-interaction=0.178). Conclusions: In ACS patients treated with DESs, ticagrelor monotherapy after 3-month DAPT was associated with lower rate of adverse clinical outcomes regardless of HBR, with similar magnitudes of therapy effect between HBR and non-HBR.

• Korean Journal of Clinical Pharmacy
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• v.24 no.1
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• pp.1-8
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• 2014

Objective: Currently, rivaroxaban is widely used clinically for thromboprophylaxis after surgery. However, there are concerns on effectiveness and safety of rivaroxaban for its proper use. We aimed to evaluate the effectiveness and safety of rivaroxaban in orthopaedic patients after total hip replacement surgery in a large medical centre after the preferred formulary was switched from enoxaparin to rivaroxaban. Methods: The study was conducted on the patients who underwent hip arthroplasty surgery at the department of Orthopaedic Surgery at Seoul St. Mary's Hospital, South Korea. Electronic medical records were retrospectively reviewed to identify patients treated with rivaroxaban following total hip replacement between February 2011 and March 2012. Evaluation criteria included indications for use, dose, initiation and duration of therapy, drug interactions, adverse reactions, and status of health care reimbursement. The patients who were on enoxaparin were also reviewed as a reference. Results: We identified 57 patients who received rivaroxaban and 50 who received enoxaparin. All patients were prescribed the drugs for Korean Food and Drug Administration-approved indications. No thromboembolic or bleeding events were observed in either group. However, only 5.3% of rivaroxaban- treated patients had an appropriate length of prophylaxis and only 3.5% began rivaroxaban treatment at the recommended time. Surprisingly, 47.4% of rivaroxaban-treated patients received rivaroxaban despite being ineligible for reimbursement benefits. Conclusion: Rivaroxaban was generally well tolerated clinically. However, the duration of treatment, the time of initiation and patient eligibility for reimbursement require improvements, emphasising the need for education which indicates the area of pharmacists' involvement.

• The Korean Journal of Medicine
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• v.99 no.5
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• pp.253-262
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• 2024

Background/Aims: Drug-eluting balloons (DEBs) represent a novel therapeutic approach for patients with small coronary artery disease. However, further studies are needed to compare the clinical efficacy of DEBs versus drug-eluting stents (DESs). Methods: In total, 492 patients (age, 67.9 ± 11.0 years; 339 men) with small coronary artery lesions (diameter < 2.75 mm) were randomly assigned to group I (DEB) (n = 104; age, 67.2 ± 10.7 years; 83 men) and group II (DES) (n = 388; age, 68.0 ± 11.1 years; 254 men). For inverse probability of treatment weighting (IPTW) analysis, the study population was stratified into groups I (n = 269) and II (n = 280). We compared the incidences of major adverse cardiac events (MACE) between the two groups during 12 months of clinical follow-up. Results: Group I had shorter device lengths (22.4 ± 5.8 mm) compared with group II (27.4 ± 9.3 mm; p < 0.001). Additionally, devices in group I were smaller in diameter (2.4 ± 0.1 mm) compared with those in group II (2.6 ± 0.1 mm; p < 0.001). Left ventricular ejection fraction (LVEF) was lower in group I (53.8% ± 12.6%) than in group II (58.6% ± 11.9%; p < 0.001). After IPTW, no significant differences in LVEF were observed between groups I and II. During 12 months of follow-up, the incidence of total MACE did not differ between the two groups. Conclusions: No significant differences were observed in clinical efficacy between DEB and DES for the treatment of small coronary artery disease. Therefore, DEB can be considered a viable alternative to DES in patients with small coronary artery disease.

• Gut and Liver
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• v.12 no.6
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• pp.694-703
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• 2018

Background/Aims: Limited data exist comparing the safety and efficacy of direct-acting antivirals (DAAs) in hepatitis C virus (HCV) monoinfected and HCV/human immunodeficiency virus (HIV) coinfected patients in the real-world clinic practice setting. Methods: All HCV monoinfected and HCV/HIV coinfected patients treated with DAAs between January 2014 and October 2017 in community clinic settings were retrospectively analyzed. Pretreatment baseline patient characteristics, treatment efficacy, factors affecting sustained virologic response at 12 weeks (SVR12) after treatment, and adverse reactions were compared between the groups. Results: A total of 327 patients were included in the study, of which 253 were HCV monoinfected, and 74 were HCV/HIV coinfected. There was a statistically significant difference observed in SVR12 when comparing HCV monoinfection and HCV/HIV coinfection (94% and 84%, respectively, p=0.005). However, there were no significant factors identified as a predictor of a reduced response. The most common adverse effect was fatigue (27%). No significant drug interaction was observed between DAA and antiretroviral therapy. None of the patients discontinued the treatment due to adverse events. Conclusions: In a real-world setting, DAA regimens have lower SVR12 in HCV/HIV coinfection than in HCV monoinfection. Further studies involving a higher number of HCV/HIV coinfected patients are needed to identify real predictors of a reduced response.

• Parasites, Hosts and Diseases
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• v.47 no.3
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• pp.299-302
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• 2009

The incidence of imported malaria has been increasing in Korea. Were viewed data retrospectively to evaluate the epidemiology, clinical features, and outcomes of imported malaria from 1995 to 2007 in a university hospital. All patients diagnosed with imported malaria were included. Imported malaria was defined as a positive smear for malaria that was acquired in a foreign country. A total of 49 patients (mean age, 35.7 year; M: F = 38 : 11)were enrolled. The predominant malarial species was Plasmodium falciparum (73.5%), and the most frequent area of acquisition was Africa (55.1%), followed by Southeast Asia (22.4%) and South Asia (18.4%). Fourteen-patients (30.6%) suffered from severe malaria caused by P. falciparum and 1 patient (2.0%) died of multiorgan failure. Most of the patients were treated with mefloquine (79.2%) or quinine (10.2%); other antimalarial agents had to be given in 13.2% treated with mefloquine and 44.4% with quinine due to adverse drug events (ADEs). P. falciparum was the most common cause of imported malaria, with the majority of cases acquired from Africa, and a significant number of patients had severe malaria. Alternative antimalarial agents with lower rates of ADEs might be considered for effective treatment instead of mefloquine and quinine.

• Korean Journal of Clinical Pharmacy
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• v.21 no.2
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• pp.90-99
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• 2011

Health Insurance Review & Assessment Service (HIRA) claims database has a high potential to detect signals of new drug interactions. The aim of this study was to evaluate the usefulness of information component (IC) and relative risk (RR) as a tool for signal detection, and to analyze the possible drug interactions caused by clopidogrel using HIRA claims database. This study was performed in elderly patients over 65 years of age who administered clopidogrel from January 2005 to June 2006 in South Korea. Serious Adverse Events (SAEs) as drug interactions of clopidogrel were defined as any ambulatory hospitalization for ischemic diseases within comcomitant medication period of clopidogrel. Information Component (IC) and Relative Risk (RR) were calculated to compare the proportion of drug-SAE pairs in order to select drug specific SAEs. IC and RR signals of clopidogrel drug interaction were screened when IC's 95% confidence interval was greater than 0 and RR's 95% confidence interval was greater than 1 respectively. All detected signals were compared to references such as $Micromedex^{(R)}$ and 2010 Drug Interaction $Facts^{TM}$. Sensitivity, specificity, positive predicted value and negative predicted value were used to evaluate usefulness of this method. Among 13,252,930 cases of elderly patients who co-administered clopidogrel and other drugs, 47,485 cases were detected as SAE. Of these, one-hundred nine cases were detected by the IC-based data-mining approach and ninety one cases were detected by the RR-based data-mining approach. Total One-hundred sixty three unrecognized signals were detected by IC or RR. Twelve signals from IC-based data-mining (57.1%) were corresponded with drug interactions from references and eight signals from RR-based data-mining (38.1%) were corresponded with drug interactions from references. These signals include proton pump inhibitors, calcium channel blockers and HMG CoA reductase Inhibitors, which were known to affect CYP450 metabolism. Further studies using HIRA claims database are necessary to develop appropriate data-mining measure.

• Journal of the Korean Society of Radiology
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• v.13 no.3
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• pp.381-389
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• 2019

Although the development of Drug-eluting stent (DES) improved the ISR significantly more than the Bare metal stent (BMS), the coronary stent restenosis (ISR) treatment still has a high recurrence rate. This study is compared the efficacy of DEB with that of DES implantation in patients with ISR. Among 4,316 patients who underwent coronary stent implantation at the Chonnam National University Hospital between November 2012 and December 2016, 187 patients developed ISR on follow-up coronary angiography ($66.3{\pm}11.0years$, 123 males) were enrolled and divided into two groups according to revascularization method as group I (DEB group; n=127) and group II (DES group; n=60). Primary end point was defined as major adverse cardiac events (MACEs), composite of cardiac death (CD), myocardial infaction (MI), target lesion revascularization (TLR) and stent thrombosis (ST) during two-year follow-up between the two groups. There were no differences in the baseline characteristics and angiographic findings except that prevalence of device length was shorter ($21.1{\pm}5.3$ vs. $25.3{\pm}9.6 mm$, p<0.002) in group I.Two-year MACE were not different in the two groups (8.7%vs.10.0%, p=0.789). The incidences of cardiac death (0%vs.0%, p=1.000), MI (1.6%vs.6.7%, p=0.085), TLR(8.7% vs. 10.0%, p=0.789) and ST (0% vs. 0%, p=1000). DEB demonstrated comparable risk reduction for MACEs compared with DES in patients with ISR during two-year follow-up. DEB might be good alternative for the treatment of ISR in patients with ISR.

• Korean Journal of Clinical Pharmacy
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• v.20 no.3
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• pp.278-287
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• 2010

The main objective of this study is to evaluate the cost-effectiveness of tafluprost compared with latanoprost in primry open Angle Glaucoma (POAG) or ocular hypertension OH patients in Korea. A decision analytic model was developed from a societal perspective to estimate clinical outcome, drug cost and glaucoma related cost. The model assumes branch like following: successful treatment, switching to other drug, adding other drug, laser or surgery. Treatment success rate is defined as the percentage of patients with elevated IOP achieving <20% reduction, and discontinuation rate is the percentage of patients who were withdrawn due to severe adverse events. A model that is comprised of 1 month cycle length has 1 year. Treatment success rate and discontinuation rate were obtained from published literatures searched in database. Resource utilizations and costs were calculated with national health insurance data and clinical expert opinions. Sensitivity analyses were performed on crucial parameters. Tafluprost is less costly than latanoprost, $609.0 vs $651.2 expected cost. Thus tafluprost was shown to be dominant compared with latanoprost. The results of sensitivity analysis revealed stable across most of the included parameters. According to this study, tafluprost shows more clinical outcome for 1 year than latanoprost. In addition, first-line treatment of tafluprost is a more cost-minimizing strategy associated with POAG or OH compared with latanoprost.

• Biomolecules & Therapeutics
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• v.30 no.1
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• pp.19-27
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• 2022

Epidermal growth factor receptor (EGFR) is a receptor tyrosine kinase widely expressed in many cancers such as non-small cell lung cancer (NSCLC), pancreatic cancer, breast cancer, and head and neck cancer. Mutations such as L858R in exon 21, exon 19 truncation (Del19), exon 20 insertions, and others are responsible for aberrant activation of EGFR in NSCLC. First-generation EGFR tyrosine kinase inhibitors (TKIs) such as gefitinib and erlotinib have clinical benefits for EGFR-sensitive (L858R and Del19) NSCLC patients. However, after 10-12 months of treatment with these inhibitors, a secondary T790M mutation at the gatekeeper position in the kinase domain of EGFR was identified, which limited the clinical benefits. Second-generation EGFR irreversible inhibitors (afatinib and dacomitinib) were developed to overcome this T790M mutation. However, their lack of selectivity toward wild-type EGFR compromised their clinical benefits due to serious adverse events. Recently developed third-generation irreversible EGFR TKIs (osimertinib and lazertinib) are selective toward driving mutations and the T790M mutation, while sparing wild-type EGFR activity. The latest studies have concluded that their efficacy was also compromised by additional acquired mutations, including C797S, the key residue cysteine that forms covalent bonds with irreversible inhibitors. Because second- and third-generation EGFR TKIs are irreversible inhibitors, they are not effective against C797S containing EGFR triple mutations (Del19/T790M/C797S and L858R/T790M/C797S). Therefore, there is an urgent unmet medical need to develop next-generation EGFR TKIs that selectively inhibit EGFR triple mutations via a non-irreversible mechanism.

• Journal of Medicine and Life Science
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• v.21 no.3
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• pp.62-71
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• 2024

The incidence of diabetes is continuously increasing worldwide, resulting in a considerable socioeconomic burden. Glycemic control using traditional diabetes medications prevents microvascular complications; however, there is no objective evidence that it prevents macrovascular complications. In the 21st century, concerns have arisen that strict glycemic control and the diabetes drug rosiglitazone might increase mortality. This led the United States Food and Drug Administration to establish guidelines that require that cardiovascular outcome trials (CVOTs) with 3-point major adverse cardiovascular events (3-P MACE) as the primary endpoints be performed for new diabetes drugs. Since then, 20 CVOTs have been reported. Dipeptidyl peptidase 4 inhibitors do not increase the incidence of cardiovascular disease; however, saxagliptin increases the risk of heart failure. Sodium-glucose cotransporter inhibitors (SGLT2is) and glucagon-like peptide 1 receptor agonists (GLP-1RAs) not only have proven cardiovascular safety but also have shown results beyond expectations by reducing the incidence of cardiovascular diseases. Additionally, SGLT2is have been reported to markedly prevent heart failure and kidney disease. The reduction in 3-P MACE by GLP-1RAs was observed only with long-acting agents; long-acting GLP-1RAs also markedly reduced renal endpoints. However, no preventive effect against heart failure was observed with GLP-1RAs. The preventive effects of both drug types against cardiovascular and kidney diseases appear to be independent of glycemic control. In conclusion, based on CVOT results, it is necessary to actively prescribe SGLT2is and GLP-1RAs to prevent cardiovascular disease in patients with diabetes, regardless of glycemic control.