1.Dapagliflozin's Effects on Glycemia and Cardiovascular Risk Factors and Incidence of Adverse Events in Patients with Type 2 Diabetes.
Hye Jin LEE ; Min Jung GEUM ; Jae Song KIM ; Kim KIM ; Eun Sun SON
Korean Journal of Clinical Pharmacy 2017;27(4):214-220
BACKGROUND: Dapagliflozin is an oral selective inhibitor of sodium-glucose cotransporter 2(SGLT2), the kidney transporter chiefly responsible for glucose reabsorption from the glomerular filtrate. Because this mechanism does not require the action of insulin, dapagliflozin rarely causes hypoglycemia. Dapagliflozin may affect blood glucose control as well as blood pressure and the body weight which are one of the cardiovascular disease risk factors. However, dehydration and ketoacidosis are reported as the side effects of the dapagliflozin treatment and the safety issues have been occurred. The aim of this study is to analyze the effectiveness and adverse events of dapagliflozin in Korean patients. METHODS: From December 2014 to August 2015, we retrospectively reviewed the electronic medical records of type 2 diabetes patients who were prescribed dapagliflozin at Severance Hospital. RESULTS: A total of 202 Korean patients were enrolled in this study. The effectiveness in the reduction of blood glucose was statistically significant(p < 0.001). Dapagliflozin decreased 0.74% of HbA1c after 24 weeks. Significantly more participants achieved the target HbA1c level(HbA1c < 7%) after 24 weeks(n=42, 35.3%) than before taking dapagliflozin(n=21, 17.6%). Blood pressure decreased 5.7 mmHg s ystolic b lood p ressure(SBP), 1.9 mmHg d iastolic b lood p ressure(DBP) a fter 24 weeks. M ore than o ne q uarter of participants(n=35, 29.4%) experienced weight loss. Most common adverse event was genitourinary symptoms. CONCLUSION: In this study, the effectiveness of dapagliflozin in improving glycemic control, blood pressure control, and weight loss was statistically significant. However, elderly and female patients, who have higher incidence of adverse events, should use dapagliflozin cautiously.
2.Efficacy and Safety of Aerosolized Colistin in the Treatment of Ventilator-Associated Pneumonia: A Systematic Review and Meta-analysis.
Minwoo PAIK ; Kyeonghye JEUNG ; Eun Young KIM
Korean Journal of Clinical Pharmacy 2017;27(4):207-213
BACKGROUND: It is recommended to use aerosolized (AS) colistin in patients undergoing mechanical ventilation therapy as an adjunctive in the latest guidelines, in spite of high nephrotoxicity and limited studies. In this study, systematic reviews and metaanalyzes were conducted to evaluate the safety and efficacy of AS colistin in patients with ventilator-associated pneumonia. METHODS: Two authors independently searched related literature published from Pubmed and EMBASE until July 2016 and included a study comparing adjunctive AS colistin with intravenous (IV) colistin monotherapy. The primary outcome was the clinical response rate, the secondary outcome was the overall mortality, and nephrotoxicity. The publication bias was evaluated using the Egger's test. RESULTS: Of the total 279 articles, nine were finally included in the final analysis. There was a significant difference between the adjunctive AS colistin group and the IV colistin monotherapy group for the treatment-response rate (odds ratio (OR), 1.56; 95% CI, 1.14–2.14; p = 0.005; I² = 36%), although there was no significant difference in overall mortality (OR, 0.77; 95% CI, 0.57–1.04; p = 0.09; I² = 20%). However, there was no significant difference between the two groups in nephrotoxicity (OR, 1.13; 95% CI, 0.74–1.74; p = 0.57; I² = 4%). CONCLUSION: The addition of aerosolized colistin to IV colistin monotherapy showed better results in terms of efficacy than IV colistin monotherapy and did not show any significant difference in terms of total mortality and nephrotoxicity. Additional large-scale studies of this need to be verified.
3.Hormone Therapy Review for Perimenopausal Symptoms: Focused on Perimenopausal Women without Other Risk Factors.
Korean Journal of Clinical Pharmacy 2017;27(4):199-206
As the population ages, the life of women after menopause becomes much longer than the past, and the quality of life of old age becomes increasingly principal issue. There is a period that women experience the physical symptoms of menopause, although there are differences in degree, and the management of this period is a suitable time for women to improve their quality of life. According to the menopausal hormone therapy (MHT) and Timing Hypothesis, which has been proven in the Kronos Early Estrogen Prevention Study (KEEPS) and the Early vs Late Intervention Trial with Estradiol (ELITE) study, a relatively young woman before and after menopause can benefit from long-term beneficial effects such as prevention of osteoporosis and cardiovascular disease by early initiation of hormone therapy to alleviate menopausal symptoms. MHT should be considered for all women in healthy (without other important diseases) menopausal years, expecting to improve their quality of life through symptom relief in menopausal women and, in the long term, to prevent cardiovascular disease and osteoporosis. When applying hormone therapy to individuals, it is necessary to establish various treatment strategies according to the menopausal symptoms of individual patients (individualization of treatment) and judge the suitability of clinical application.
4.Current Guidelines on the Management of Dyslipidemia.
Yunjeong CHOI ; Song LEE ; Ju Young KIM ; Kyung Eun LEE
Korean Journal of Clinical Pharmacy 2017;27(4):276-283
OBJECTIVE: Dyslipidemia is recognized as a prominent risk factor for cardiovascular and cerebrovascular diseases but it is manageable through therapeutic and lifestyle intervention. Interpreting the latest guidelines is essential for an application of recommendation from guidelines into clinical practice. Therefore, this study aimed to compare the most recent guidelines on dyslipidemia treatment recommendations in Korea and USA. METHODS: This study analyzed and compared 2015 Korean guidelines for the management of dyslipidemia, 2013 American College of Cardiology/American Heart Association (ACC/AHA) guideline and 2016 supportive guidelines from ACC. RESULTS: A comparison was made focused on the following: target patients based on cardiovascular risk assessment, target goal, and treatment strategies including statin and non-statin therapies. Four target patient groups by risk were suggested in 2015 Korean guideline and cardiovascular risk factors were also considered for initiation of lipid lowering therapy. Titrated statin regimen was recommended by Korean guideline to reach LDL cholesterol and non-HDL cholesterol target level. In 2013 ACC/AHA guideline, four statin benefit group was introduced considering ASCVD risk and high intensity statin or intermediate intensity statin use were recommended without dose titration. 2016 update was to support non-statin therapy based on updated evidence and new consideration of ezetimibe, PCSK9-inhibitor and bile acid sequestrant was brought up. CONCLUSION: Guidelines are continuously updating as new and important clinical data are constantly released along with the advent of newly approved drugs for lipid disorder. This article provides resources that facilitates uptake of these recommendations into clinical practice.
5.The Effects of Acupuncture and Herbal Medicine for the Treatment of Whabyung: A Meta-analysis.
Yeri KIM ; Sun Yong CHUNG ; Eun Ji CHOI ; Eun CHO
Korean Journal of Clinical Pharmacy 2017;27(4):267-275
BACKGROUND AND OBJECTIVE: Whabyung is a Korean cultural disorder characterized by a combination of emotional stress and physical symptoms. Acupuncture, herbal medicines and other complementary medicinal treatments are used to treat the symptoms of whabyung. The purpose of this study is to investigate the effects of acupuncture treatment and herbal medicine treatments on anger, anxiety and depression of whabyung. METHODS: Using PubMed, CENTRAL, AMED, MEDLINE, EMBASE, MEDLINE, CINAHL, Cnii, CNKI, J-SATGE, PsycArticles, KISS, KoreaMed, kmbase, NDSL, RISS, OASIS and Korean Traditional Knowledge Portal, articles published by March 2017 for whabyung or whabyung-related syndrome were searched. The quality of selected articles was evaluated using RoB and RoBANS. The effects of acupuncture and herbal medicines on anger, anxiety, and depression levels of whabyung patients were considered for meta-analyses. RESULTS: Of the total 2408 articles retrieved from the database, 11 were finally selected and 4 articles were used for meta-analyses. Acupuncture reduced whabyung patients' anger and anxiety. Especially, the state anxiety was significantly reduced (effect size= −0.676, p= .026). Herbal medicine had effects on reducing anxiety and state anger while trait anger was increased without statistical significance. CONCLUSION: The present study showed the effectiveness of acupuncture and herbal medicines for whabyung patients in general. However, considering the limited availability of articles and the heterogeneity between them included for the meta-analysis, the results should be generalized with caution. In the future, more studies within the structure of evidence-based medicine need to be conducted to generate objective and valid evidences of korean medicine.
6.Influence of Oxygen to Population Pharmacokinetics/Pharmacodynamics of Alcohol in Healthy Volunteers.
Byungjeong SONG ; Hyun Moon BACK ; Si Young HWANG ; Jung Woo CHAE ; Hwi Yeol YUN ; Kwang Il KWON
Korean Journal of Clinical Pharmacy 2017;27(4):258-266
OBJECTIVE: To develop a population pharmacokinetics (PK)/pharmacodynamics (PD) model for alcohol in healthy volunteers and to elucidate individual characteristics to affects alcohol's PK or PD including dissolved oxygen. METHODS: Following multiple intakes of total 540 mL alcohol (19.42 v/v%) to healthy volunteer, blood alcohol concentration was measured using a Breathe alcohol analyser (Lion SD-400 Alcolmeter®). A sequential population PK/PD modeling was performed using NONMEM (ver 7.3). RESULTS: Eighteen healthy volunteer were included in the study. PK model of alcohol was well explained by one-compartment model with first-order absorption and Michaelis-Menten elimination kinetics. K(a), V/F, V(max), K(m) is 8.1 hr⁻¹, 73.7 L, 9.65 g/hr, 0.041 g/L, respectively. Covariate analysis revealed that gender significantly influenced V(max) (Male vs Female, 9.65 g/hr vs 7.38 g/hr). PD model of temporary systolic blood pressure decreasing effect of alcohol was explained by biophase model with inhibitory E(max) model. K(e0), I(max), E(0), IC(50) were 0.23 hr⁻¹, 44.9 mmHg, 138 mmHg, 0.693 g/L, respectively. CONCLUSION: Model evaluation results suggested that this PK/PD model was robust and has good precision.
7.Prescribing Pattern and Safety Analysis of Nonsteroidal Anti-inflammatory Drug and Gastro- Protective Agent following Reimbursement Guidelines Relaxation.
Mi Hye HAN ; Eunsun NOH ; Jin Hyun NAM ; Sang Won LEE ; Eui Kyung LEE
Korean Journal of Clinical Pharmacy 2017;27(4):250-257
OBJECTIVE: The prevalence rate of osteoarthritis in Koreans aged 50 years or older is 14.3%, and the total amount of medical costs is more than KRW 1 trillion. Recently, the reimbursement guidelines for osteoarthritis treatment have changed. METHODS: In this study, we sought to describe prescription patterns of nonsteroidal anti-inflammatory drugs (NSAIDs) and gastro-protective agent (GPA) and analyze the clinical and economic impacts of the new policy using the national health insurance claims data. The incidence of upper gastrointestinal adverse event by policy change was identified through the odds ratio, and changes in medicine and medical costs related to osteoarthritis through mean and median. RESULTS: There were 204,552 patients before the reimbursement guidelines relaxation and 239,710 after it, a 17.2% rise. The prescription ratio was 3.3% for the patients prescribed with COX-2 selective NSAIDs alone and 1.3% for those with both COX-2 selective NSAIDs and GPA combination before the reimbursement guidelines relaxation. The reimbursement guidelines relaxation significantly increased their ratios to 6.9% and 2.8%, respectively. Gastrointestinal adverse events significantly reduced by 1.21%p after reimbursement guidelines relaxation. The average medicine cost per person increased significantly to KRW 140,291 from KRW 137,323 after the reimbursement guidelines relaxation, while the average medical cost per person slightly decreased from KRW 311,605 to KRW 310,755 after the relaxation, showing no meaningful difference. CONCLUSION: The reimbursement guidelines relaxation may influence on decreasing the upper gastrointestinal adverse event, increasing the medicine costs and maintaining the medical costs for osteoarthritis.
8.A Survey of Pharmacy Students' Perceptions of National Drug Supply Strategy through Public Pharmaceutical Companies.
Sung Ryul JEON ; Jung Eun HA ; Hyun Soon SOHN
Korean Journal of Clinical Pharmacy 2017;27(4):238-249
BACKGROUND: Currently establishment of public pharmaceutical companies became an issue for securing stable supply of national essential drugs in order to respond appropriately to national public health crisis. Pharmacy students as future pharmacists need to be interested in drug related issues under the discussion in our society. This study aimed to investigate perceptions of pharmacy students on the national drug supply strategy through public pharmaceutical companies. METHODS: A 20-items questionnaire designed for this study was used. Pharmacy students nationwide were enrolled in July 2017. They responded to questions through on-line survey program. Data were analyzed descriptively. RESULTS: 160 students from 26 pharmacy schools participated. 5th and 6th grade students accounted for two-thirds, and one third aspired future jobs in pharmaceutical industry. Among responders, 71.3% was unaware of current national essential drugs, 52.5% did not know the Rare and Essential Drug Center, and 91.9% was unaware of the legislation on the supply and management of essential drugs. 82.5% favored the establishment of public pharmaceutical companies. 80.6% agreed that government should intervene in pharmaceutical market for ensuring drug accessibilities, 73.8% agreed that public pharmaceutical companies make possible to reach a goal of stable supply of pharmaceuticals, and 85.1% agreed that active compulsory license by public pharmaceutical companies is necessary. CONCLUSION: We found that pharmacy students recognized the need for governmental control to achieve social values of pharmaceuticals. More attention and participation of the pharmacy students as well as pharmacists in the process of national debate on public pharmaceutical companies are expected.
9.Pharmacists' Perception for the Current and Future Pharmaceutical Services.
Korean Journal of Clinical Pharmacy 2017;27(4):228-237
OBJECTIVE: We conducted a survey to understand the current state of pharmacy services and pharmacists' thoughts in the future of the community pharmacy setting. METHODS: A questionnaire was distributed to 229 pharmacists and gathered from 95 respondents. RESULTS: We asked to pharmacists about what the ideal pharmacy duty should be in the next 10 years at the community pharmacy setting in Korea. For this question, the respondents said drug counselling (19.4%), dispensing (13.8%), longterm care of chronic disease and healthcare education (12.8%), and OTC counselling (11.5%). When asked about how much time they were spending doing certain tasks in the pharmacy, the main tasks were dispensing (23.5%), counselling (17.1%), prescription review (10.1%), and OTC counselling (5.5%). When asked about what the most important duty of a pharmacist was, medication counselling (45.4%) was the most important task that they identified and the reasons for not being able to fulfill this role properly was time shortage (78.9%) followed by the lack of counselling spaces, up-to-date knowledges, and focus on financial gains over patient counselling. CONCLUSION: Korean pharmacists are mainly focusing on dispensing in their daily work. Their basic responsibilities can be easily mechanized over the next few years, but the social expectations of disease-prevention and public health promotion both in current and future can not be replaced by such mechanical measures. Therefore, pharmaceutical services in Korea should be developed in more diverse and professional ways.
10.Analysis of Adverse Drug Reaction Reports using Text Mining.
Korean Journal of Clinical Pharmacy 2017;27(4):221-227
BACKGROUND: As personalized healthcare industry has attracted much attention, big data analysis of healthcare data is essential. Lots of healthcare data such as product labeling, biomedical literature and social media data are unstructured, extracting meaningful information from the unstructured text data are becoming important. In particular, text mining for adverse drug reactions (ADRs) reports is able to provide signal information to predict and detect adverse drug reactions. There has been no study on text analysis of expert opinion on Korea Adverse Event Reporting System (KAERS) databases in Korea. METHODS: Expert opinion text of KAERS database provided by Korea Institute of Drug Safety & Risk Management (KIDS-KD) are analyzed. To understand the whole text, word frequency analysis are performed, and to look for important keywords from the text TF-IDF weight analysis are performed. Also, related keywords with the important keywords are presented by calculating correlation coefficient. RESULTS: Among total 90,522 reports, 120 insulin ADR report and 858 tramadol ADR report were analyzed. The ADRs such as dizziness, headache, vomiting, dyspepsia, and shock were ranked in order in the insulin data, while the ADR symptoms such as vomiting, 어지러움, dizziness, dyspepsia and constipation were ranked in order in the tramadol data as the most frequently used keywords. CONCLUSION: Using text mining of the expert opinion in KIDS-KD, frequently mentioned ADRs and medications are easily recovered. Text mining in ADRs research is able to play an important role in detecting signal information and prediction of ADRs.