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Post-marketing Surveillance of the Safety and Effectiveness of Rosiglitazone/Metformin in Korean Patients with Type 2 Diabetes.

Hankyu LEE ; So Hyun PARK ; Shin Young OH ; Yil Seob LEE

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(2):195-204. doi:10.12793/jkscpt.2012.20.2.195

BACKGROUND: To evaluate the safety and effectiveness of rosiglitazone/metformin in patients with type 2 (non-insulin-dependent) diabetes. METHODS: A total of 982 patients were enrolled by 19 physicians from November 2003 to November 2010. Patients treated with rosiglitazone/metformin at least once, were included in safety assessment. The incidences of adverse events (AEs) and serious adverse events (SAEs) were estimated. The effectiveness of rosiglitazone/metformin was evaluated through change in fasting blood glucose (FBG), 2-hour postprandial glucose (2hr PPG), Hemoglobin A1c (HbA1c). RESULTS: Of the 982 patients, 713 patients with the mean age of 56.4 +/- 11.5 years were included in the safety assessment. A total of 130 AEs were reported from 110 patients (15.4 %). The most frequent AEs were upper respiratory infection (2.4 %), oedema (2.2 %), gastritis (1.3 %), and weight increase (1.1 %). The incidence of unexpected AEs was 5.9 % (42/713, 47 AEs). Three SAEs such as bacterial pneumonia, hyperglycaemia, chest pain were reported in 2 patients. As it is about effectiveness, patients showed statistically significant reductions after treatment of rosiglitazone/metformin in FBG, 2hr PPG, and HbA1c (P<0.001 by paired t-test, for all). CONCLUSION: Our data suggest that rosiglitazone/metformin is well tolerated and effective in Korean patients with type 2 (non-insulin-dependent) diabetes.
Blood Glucose ; Chest Pain ; Fasting ; Gastritis ; Glucose ; Hemoglobins ; Humans ; Incidence ; Metformin ; Pneumonia, Bacterial ; Thiazolidinediones

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Post-marketing Surveillance of the Safety and Effectiveness of Rosiglitazone/Metformin in Korean Patients with Type 2 Diabetes.

Hankyu LEE ; So Hyun PARK ; Shin Young OH ; Yil Seob LEE

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(2):195-204. doi:10.12793/jkscpt.2012.20.2.195

BACKGROUND: To evaluate the safety and effectiveness of rosiglitazone/metformin in patients with type 2 (non-insulin-dependent) diabetes. METHODS: A total of 982 patients were enrolled by 19 physicians from November 2003 to November 2010. Patients treated with rosiglitazone/metformin at least once, were included in safety assessment. The incidences of adverse events (AEs) and serious adverse events (SAEs) were estimated. The effectiveness of rosiglitazone/metformin was evaluated through change in fasting blood glucose (FBG), 2-hour postprandial glucose (2hr PPG), Hemoglobin A1c (HbA1c). RESULTS: Of the 982 patients, 713 patients with the mean age of 56.4 +/- 11.5 years were included in the safety assessment. A total of 130 AEs were reported from 110 patients (15.4 %). The most frequent AEs were upper respiratory infection (2.4 %), oedema (2.2 %), gastritis (1.3 %), and weight increase (1.1 %). The incidence of unexpected AEs was 5.9 % (42/713, 47 AEs). Three SAEs such as bacterial pneumonia, hyperglycaemia, chest pain were reported in 2 patients. As it is about effectiveness, patients showed statistically significant reductions after treatment of rosiglitazone/metformin in FBG, 2hr PPG, and HbA1c (P<0.001 by paired t-test, for all). CONCLUSION: Our data suggest that rosiglitazone/metformin is well tolerated and effective in Korean patients with type 2 (non-insulin-dependent) diabetes.
Blood Glucose ; Chest Pain ; Fasting ; Gastritis ; Glucose ; Hemoglobins ; Humans ; Incidence ; Metformin ; Pneumonia, Bacterial ; Thiazolidinediones

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Results of 2012 KoNECT Certification Program of the Human Resource Project.

Sook Jin SEONG ; Mi Sun LIM ; Suna OAK ; Joomi LEE ; Sung Min PARK ; Jeonghyeon PARK ; Jeong Ju SEO ; Hae Won LEE ; Sang Goo SHIN ; Min Soo PARK ; Young Ran YOON

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(2):182-194. doi:10.12793/jkscpt.2012.20.2.182

BACKGROUND: In recent years, clinical trials have considerably increased and relevant education programs to clinical trials have been developed and implemented since 2008 in Korea. To enhance the quality as well as global competitiveness of clinical trial professionals (CTPs), a certification program of the human resource is needed. Accordingly, in Korea the first and the second certification examinations were implemented in February and October 2012, respectively. In this paper, introduction of the certification program of the human resource is described, and results of the certification examinations and questionnaire survey are presented. METHODS: Data including the examination results and questionnaire survey was collected by cooperative officials in Korea National Enterprise for Clinical Trials. Applicants who were selected eligible for examination by the steering committee were asked to complete questionnaires provided with the test papers on the day of the certification examination. RESULTS: In the first certification examination, a total of 221 eligible participants completed the examination. 99.5 % of the participants responded the questionnaire survey. In the second examination, a total of 223 applicants participated. The examination consisted of 50 multiple-choice questions with cut-off score of 70 per cent score.176 & 194 CTPs passed the first & second examinations respectively. CONCLUSION: This paper that described the results of the two certification tests and questionnaire surveys might be helpful in establishment and activation of the certification program in the future. Quality improvement of CTPs and international competitiveness of clinical trial in Korea can be anticipated by the certification program.
Certification ; Cytidine Triphosphate ; Humans ; Korea ; Quality Improvement ; Surveys and Questionnaires ; Silanes

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Results of 2012 KoNECT Certification Program of the Human Resource Project.

Sook Jin SEONG ; Mi Sun LIM ; Suna OAK ; Joomi LEE ; Sung Min PARK ; Jeonghyeon PARK ; Jeong Ju SEO ; Hae Won LEE ; Sang Goo SHIN ; Min Soo PARK ; Young Ran YOON

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(2):182-194. doi:10.12793/jkscpt.2012.20.2.182

BACKGROUND: In recent years, clinical trials have considerably increased and relevant education programs to clinical trials have been developed and implemented since 2008 in Korea. To enhance the quality as well as global competitiveness of clinical trial professionals (CTPs), a certification program of the human resource is needed. Accordingly, in Korea the first and the second certification examinations were implemented in February and October 2012, respectively. In this paper, introduction of the certification program of the human resource is described, and results of the certification examinations and questionnaire survey are presented. METHODS: Data including the examination results and questionnaire survey was collected by cooperative officials in Korea National Enterprise for Clinical Trials. Applicants who were selected eligible for examination by the steering committee were asked to complete questionnaires provided with the test papers on the day of the certification examination. RESULTS: In the first certification examination, a total of 221 eligible participants completed the examination. 99.5 % of the participants responded the questionnaire survey. In the second examination, a total of 223 applicants participated. The examination consisted of 50 multiple-choice questions with cut-off score of 70 per cent score.176 & 194 CTPs passed the first & second examinations respectively. CONCLUSION: This paper that described the results of the two certification tests and questionnaire surveys might be helpful in establishment and activation of the certification program in the future. Quality improvement of CTPs and international competitiveness of clinical trial in Korea can be anticipated by the certification program.
Certification ; Cytidine Triphosphate ; Humans ; Korea ; Quality Improvement ; Surveys and Questionnaires ; Silanes

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Targeted Plasma Metabolite Profiling of Metformin in Healthy Korean Volunteers.

Ho Seob LIHM ; Jaemin CHA ; Jeong Ju SEO ; Jeonghyeon PARK ; Joomi LEE ; Hae Won LEE ; Kyun Seop BAE ; Woomi KIM ; Young Ran YOON

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(2):175-181. doi:10.12793/jkscpt.2012.20.2.175

BACKGROUND: Metformin is an effective oral antihyperglycaemic agent for type 2 diabetes mellitus, with a variety of metabolic effects. In addition to controlling blood glucose level, it has been appeared to decrease the long-period complications of diabetes, including macrovascular disease. Few reports have addressed the metabolite profiling of metformin. The study was to evaluate if targeted metabolic profiling approach is sensitive enough to predict the therapeutic effects of metformin after a single oral dose. METHODS: A randomized, open-label, single-dose study was conducted in twenty eight healthy Korean male volunteers. To determine the concentrations of endogenous metabolites in their pre-dose and post-dose plasma samples, blood samples were collected before and at 2 and 6 h after a single oral dose of 500 mg metformin. Both Modular P/Modular D analyzer and ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS)-based metabolic profiling was performed. RESULTS: We quantified pre-dose and post-dose creatinine, blood urea nitrogen (BUN), lactic acid, 7 amino acids (lysine, glutamic acid, alanine, valine, leucine, phenylalanine, tryptophan), and 5 lysophosphatidylcholines (14:0, 16:0, 17:0, 18:0, and 18:1) using autoanalyser and UPLC-MS/MS. The postdose levels of alanine, lactic acid, glutamic acid, lysine, valine, leucine, phenylalanine, tryptophan, and lysoPC (18:1) were slightly decreased with statistical significance, but there is no clinical significance. CONCLUSION: In order to explore the potential endogenous metabolites associated with the therapeutic effects of metformin, further study including non-targeted (global) metabolite profiling is needed.
Alanine ; Amino Acids ; Blood Glucose ; Blood Urea Nitrogen ; Chromatography, Liquid ; Creatinine ; Diabetes Mellitus, Type 2 ; Glutamic Acid ; Humans ; Lactic Acid ; Leucine ; Lysine ; Lysophosphatidylcholines ; Male ; Metformin ; Phenylalanine ; Plasma ; Tandem Mass Spectrometry ; Tryptophan ; Valine

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Targeted Plasma Metabolite Profiling of Metformin in Healthy Korean Volunteers.

Ho Seob LIHM ; Jaemin CHA ; Jeong Ju SEO ; Jeonghyeon PARK ; Joomi LEE ; Hae Won LEE ; Kyun Seop BAE ; Woomi KIM ; Young Ran YOON

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(2):175-181. doi:10.12793/jkscpt.2012.20.2.175

BACKGROUND: Metformin is an effective oral antihyperglycaemic agent for type 2 diabetes mellitus, with a variety of metabolic effects. In addition to controlling blood glucose level, it has been appeared to decrease the long-period complications of diabetes, including macrovascular disease. Few reports have addressed the metabolite profiling of metformin. The study was to evaluate if targeted metabolic profiling approach is sensitive enough to predict the therapeutic effects of metformin after a single oral dose. METHODS: A randomized, open-label, single-dose study was conducted in twenty eight healthy Korean male volunteers. To determine the concentrations of endogenous metabolites in their pre-dose and post-dose plasma samples, blood samples were collected before and at 2 and 6 h after a single oral dose of 500 mg metformin. Both Modular P/Modular D analyzer and ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS)-based metabolic profiling was performed. RESULTS: We quantified pre-dose and post-dose creatinine, blood urea nitrogen (BUN), lactic acid, 7 amino acids (lysine, glutamic acid, alanine, valine, leucine, phenylalanine, tryptophan), and 5 lysophosphatidylcholines (14:0, 16:0, 17:0, 18:0, and 18:1) using autoanalyser and UPLC-MS/MS. The postdose levels of alanine, lactic acid, glutamic acid, lysine, valine, leucine, phenylalanine, tryptophan, and lysoPC (18:1) were slightly decreased with statistical significance, but there is no clinical significance. CONCLUSION: In order to explore the potential endogenous metabolites associated with the therapeutic effects of metformin, further study including non-targeted (global) metabolite profiling is needed.
Alanine ; Amino Acids ; Blood Glucose ; Blood Urea Nitrogen ; Chromatography, Liquid ; Creatinine ; Diabetes Mellitus, Type 2 ; Glutamic Acid ; Humans ; Lactic Acid ; Leucine ; Lysine ; Lysophosphatidylcholines ; Male ; Metformin ; Phenylalanine ; Plasma ; Tandem Mass Spectrometry ; Tryptophan ; Valine

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Retrospective Analysis of Adverse Reactions to Iodinated Contrast Media in Korean.

Hee Hyun KIM ; Ji Yeob CHOI ; Min Kyung OH ; Eun Young KIM ; Jong Ryul GHIM ; Seok Jin CHOI ; Jae Gook SHIN

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(2):165-174. doi:10.12793/jkscpt.2012.20.2.165

BACKGROUND: This study was performed to evaluate the prevalence and risk factors on the adverse reactions caused by iodinated contrast media (CM) for computed tomography (CT) examination in a university hospital. METHODS: Clinical and demographic data among outpatients with CM use were collected at 0000 University Busanpaik Hospital in Busan, Korea between 2008 and 2010. Adverse reaction rate was calculated by the number of adverse reaction among total outpatients with CM use, which was stratified by seasons and sex. The association of risk factors on adverse reaction was investigated using logistic regression model. RESULTS: The total outpatients and events of administered CMs were 27,587 and 48,616, respectively. The administered CMs were iopromide, iohexol, iobitridol, and iodixanol. Adverse reactions occurred in 300 outpatients among the total outpatients (1.1 %). The number of outpatients administered CM more than twice were 8,348. Among them, outpatients who experienced adverse reaction(s) more than once and twice were 124 (1.5 %) and 26 (0.3 %), respectively. Adverse reaction rate was significantly different by sex(p=0.01). The other risk factors were cancer history (OR 2.57, 95 % CI 2.00-3.31) and previous CM administration (OR 1.89, 95 % CI 1.47-2.44). Urticaria was the most frequent symptoms. CONCLUSION: Total adverse reaction rate was 1.1 % with most common symptom in skin system. Related risk factors were female, cancer history, and previous CM administration. These results were similar to previous studies and will be contribute to clinical practice and future research especially in Koreans.
Contrast Media ; Female ; Humans ; Iohexol ; Korea ; Logistic Models ; Outpatients ; Prevalence ; Retrospective Studies ; Risk Factors ; Seasons ; Skin ; Triiodobenzoic Acids ; Urticaria

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Retrospective Analysis of Adverse Reactions to Iodinated Contrast Media in Korean.

Hee Hyun KIM ; Ji Yeob CHOI ; Min Kyung OH ; Eun Young KIM ; Jong Ryul GHIM ; Seok Jin CHOI ; Jae Gook SHIN

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(2):165-174. doi:10.12793/jkscpt.2012.20.2.165

BACKGROUND: This study was performed to evaluate the prevalence and risk factors on the adverse reactions caused by iodinated contrast media (CM) for computed tomography (CT) examination in a university hospital. METHODS: Clinical and demographic data among outpatients with CM use were collected at 0000 University Busanpaik Hospital in Busan, Korea between 2008 and 2010. Adverse reaction rate was calculated by the number of adverse reaction among total outpatients with CM use, which was stratified by seasons and sex. The association of risk factors on adverse reaction was investigated using logistic regression model. RESULTS: The total outpatients and events of administered CMs were 27,587 and 48,616, respectively. The administered CMs were iopromide, iohexol, iobitridol, and iodixanol. Adverse reactions occurred in 300 outpatients among the total outpatients (1.1 %). The number of outpatients administered CM more than twice were 8,348. Among them, outpatients who experienced adverse reaction(s) more than once and twice were 124 (1.5 %) and 26 (0.3 %), respectively. Adverse reaction rate was significantly different by sex(p=0.01). The other risk factors were cancer history (OR 2.57, 95 % CI 2.00-3.31) and previous CM administration (OR 1.89, 95 % CI 1.47-2.44). Urticaria was the most frequent symptoms. CONCLUSION: Total adverse reaction rate was 1.1 % with most common symptom in skin system. Related risk factors were female, cancer history, and previous CM administration. These results were similar to previous studies and will be contribute to clinical practice and future research especially in Koreans.
Contrast Media ; Female ; Humans ; Iohexol ; Korea ; Logistic Models ; Outpatients ; Prevalence ; Retrospective Studies ; Risk Factors ; Seasons ; Skin ; Triiodobenzoic Acids ; Urticaria

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Inhibitory Effects of 6-Gingerol on Cytochrome P450 in Human Liver Microsomes.

Soo Yeon JOO ; Young Chai LIM

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2011;19(1):52-58.

No abstract available.
Catechols ; Cytochrome P-450 Enzyme System ; Cytochromes ; Fatty Alcohols ; Humans ; Liver ; Microsomes, Liver

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Current Status of Clinical Research Coordinator's Employment.

Ihn Sook JEONG ; Sangmin CHOE ; Ji Hong SHON ; Won Ock KIM

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2011;19(1):40-51.

BACKGROUND: This study was aimed to investigate the current two years' clinical research coordinators (CRCs) employment and estimate total number of CRCs in Korea. METHODS: The participants were administrative officers or head CRCs in institutions designated by Korea Food & Drug Administration (KFDA). Data on the current status of CRCs' employment was collected with self-administered questionnaires or telephone interview. And total number of CRCs in Korea was estimated based on ratio between the number of the KFDA approved clinical trials and current number of CRCs. RESULTS: The number of CRCs was 1381 at 36 centers in 2009 and 1444 at 37 centers in 2010. About 79 percent of CRCs were employed by investigators. The estimated number of CRCs was from 1677 to 1763 at 135 centers in 2009 and from 1802 to 1890 at 142 centers in 2010 based on number of clinical trials approved by KFDA. Two third of regional clinical trial centers (RCTCs) had written employment policy, and 25 percent of RCTCs employed CRCs in a regular position. All RCTCs had educational programs for CRCs and supported CRCs for training outside. 75 percent of RCTCs provided ID card for CRCs belonging to investigators to access to hospital document. Half of RCTCs had CRC registration system in hospital-wide. CONCLUSION: The number of CRCs in Korea can be easily estimated with the number of KFDA approved clinical trials. Majority of RCTCs still employed CRCs in an irregular position, which should be switched to regular position to reduce the CRCs' unsatisfaction. It is also needed to develop centralized CRC management system for CRCs belonging to investigators.
Calcium Hydroxide ; Employment ; Head ; Humans ; Interviews as Topic ; Korea ; Surveys and Questionnaires ; Research Personnel ; Zinc Oxide

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