1.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
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
2.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
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
3.Biopsy-Proven Immune Complex Glomerulonephritis Associated with Sunitinib in a Patient with a Gastrointestinal Stromal Tumor.
Hankyu LEE ; Hyang Rim LEE ; Kook Hwan OH ; Kyung Chul MOON ; Curie AHN ; Suhnggwon KIM ; Yung Jue BANG
Korean Journal of Nephrology 2010;29(5):644-649
Sunitinib, a multi-targeted tyrosine kinase inhibitor, is used for the treatment of renal cell carcinoma and gastrointestinal stromal tumors. Many adverse effects associated with sunitinib, including hypertension, proteinuria, and thrombotic microangiopathy, have been reported; however, the other forms of glomerulonephritis are very rare. We report a case of biopsy-confirmed immune complex glomerulonephritis in a patient with a gastrointestinal tumor who received sunitinib treatment. The proteinuria subsided partially after sunitinib was discontinued, but when the drug was reintroduced, it recurred.
Antigen-Antibody Complex
;
Carcinoma, Renal Cell
;
Gastrointestinal Stromal Tumors
;
Glomerulonephritis
;
Humans
;
Hypertension
;
Indoles
;
Protein-Tyrosine Kinases
;
Proteinuria
;
Pyrroles
;
Thrombotic Microangiopathies
4.Nonalcoholic Fatty Pancreas Disease
Hankyu JEON ; Min Kyu JUNG ; Jae Min LEE
Korean Journal of Pancreas and Biliary Tract 2023;28(4):95-102
Nonalcoholic fatty pancreas disease (NAFPD) is a condition characterized by theaccumulation of excess fat in the pancreas, commonly occurring in individuals withobesity. The diagnostic evaluation of NAFPD is mostly composed of image tests,but it is still less standardized. NAFPD is closely linked to metabolic syndrome, type2 diabetes, pancreatic exocrine insufficiency, acute pancreatitis, pancreatic fistula,pancreatic cancer, and nonalcoholic fatty liver disease (NAFLD). However, furtherresearch is needed to investigate the mechanisms underlying these relevant clinicalconsequences. In terms of treatment, strategies aimed at minimizing pancreaticfat accumulation through dietary modifications and regular exercise, similar to themanagement of NAFLD, may be beneficial.
5.Impact of non-hepatic hyperammonemia on mortality in intensive care unit patients: a retrospective cohort study
Jae Heon KIM ; Hankyu JEON ; Sang Soo LEE ; I Re HEO ; Jung Woo CHOI ; Hee Jin KIM ; Ra Ri CHA ; Jae Min LEE ; Hyun Jin KIM
The Korean Journal of Internal Medicine 2021;36(6):1347-1355
Background/Aims:
The effect of hyperammonemia on the mortality in patients with liver cirrhosis is well documented. However, little is known about the impact of hyperammonemia on mortality among intensive care unit patients without hepatic disease. We aimed to investigate factors associated with non-hepatic hyperammonemia among intensive care unit patients and to evaluate the factors related to the 7- and 90-day mortality.
Methods:
Between February 2016 and February 2020, 948 patients without hepatic disease who had 972 episodes of admission to the intensive care unit were retrospectively enrolled and classified as hyperammonemia grades 0 (≤ 80 µg/dL; 585 [60.2%]), 1 (≤ 160 µg/dL; 291 [29.9%]), 2 (≤ 240 µg/dL; 55 [5.7%]), and 3 (> 240 µg/dL; 41 [4.2%]). Factors associated with hyperammonemia and the 7- and 90-day mortality were evaluated by multivariate logistic regression analysis and Cox regression analysis, respectively. Kaplan-Meier survival curves for the 7- and 90-day mortality were constructed.
Results:
The independent risk factors for hyperammonemia were male sex (odds ratio, 1.517), age (0.984/year), acute brain failure (2.467), acute kidney injury (1.437), prothrombin time-international normalized ratio (2.272/unit), and albumin (0.694/g/dL). The 90-day mortality rate in the entire cohort was 24.3% and gradually increased with increasing hyperammonemia grade at admission (17.9%, 28.2%, 43.6%, and 61.0% in patients with grades 0, 1, 2, and 3, respectively). Additionally, non-hepatic hyperammonemia was an independent predictor of the 90- day mortality in intensive care unit patients.
Conclusions
Non-hepatic hyperammonemia is common (39.8%) and associated with the 90-day mortality among intensive care unit patients.
6.2 Cases of Severe Hyperchloremic Metabolic Acidosis after Orthotopic Neobladder Replacement and Augmentation Enterocystoplasty.
Hankyu LEE ; Hui Kyuoung SUN ; Dong Ki KIM ; Kook Hwan OH ; Yon Su KIM ; Curie AHN ; Jin Suk HAN ; Sunhngwon KIM ; Cheol KWAK ; Seungjune OH ; Kwon Wook JOO
Korean Journal of Nephrology 2010;29(5):600-605
The use of intestinal segments in the reconstruction and plasty of urinary bladder for malignant or nonmalignant conditions is widely accepted. Metabolic derangements including hyperchloremic metabolic acidosis and malabsorption of lipid may occur after surgery. Main pathophysiology of hyperchloremic metabolic acidosis is the exchange of urinary chloride with luminal bicarbonate and duration of urine in contact with the intestinal mucosa can affect the severity of metabolic acidosis. We experienced two cases of severe hyperchloremic metabolic acidosis which developed in patients with chronic kidney disease, urinary tract infection and orthotopic neobladder or augmentation enterocystoplasty for the treatment of bladder cancer and neurogenic bladder, respectively.
Acidosis
;
Humans
;
Intestinal Mucosa
;
Phenobarbital
;
Renal Insufficiency, Chronic
;
Urinary Bladder
;
Urinary Bladder Neoplasms
;
Urinary Bladder, Neurogenic
;
Urinary Diversion
;
Urinary Tract Infections
7.Etiology and Outcomes of Patients with Extreme Hyperbilirubinemia in Korea:A Retrospective Cohort Study
Ji Yoon KWAK ; Hankyu JEON ; Seong Je KIM ; Ji Hee HAN ; Ra Ri CHA ; Sang Soo LEE
The Korean Journal of Gastroenterology 2024;84(1):9-16
Background:
/Aim: Extreme hyperbilirubinemia is occasionally observed in intensive care unit (ICU) and non-ICU settings. This study examined the etiologies of extreme hyperbilirubinemia (bilirubin level ≥12 mg/dL) and the factors associated with the 30-day mortality.
Methods:
This retrospective observational cohort study identified 439 patients with extreme hyperbilirubinemia at the Gyeongsang National University Changwon Hospital between 2016 and 2020. The patients were classified into three groups and 11 diseases according to their etiology. The risk factors associated with 30-day mortality at the baseline were investigated using the Cox proportional hazards model.
Results:
Of 439 patients with extreme hyperbilirubinemia, 287, 78, and 74 were in the liver cirrhosis/malignancy group, the ischemic injury group, and the benign hepatobiliary-pancreatic etiological group, respectively, with corresponding 30-day mortality rates of 42.9%, 76.9%, and 17.6%. The most common disease leading to hyperbilirubinemia was a pancreatobiliary malignancy (28.7%), followed by liver cirrhosis (17.3%), hepatocellular carcinoma (10.9%), and liver metastases (8.4%). The etiologies of hyperbilirubinemia, obstructive jaundice, infection, albumin level, creatinine level, and prothrombin time-international normalized ratio were independently associated with the 30-day mortality.
Conclusions
This study suggests three etiologies of extreme hyperbilirubinemia in the ICU and non-ICU settings. The prognosis of patients with extreme hyperbilirubinemia depends largely on the etiology and the presence of obstructive jaundice.
8.Etiology and Outcomes of Patients with Extreme Hyperbilirubinemia in Korea:A Retrospective Cohort Study
Ji Yoon KWAK ; Hankyu JEON ; Seong Je KIM ; Ji Hee HAN ; Ra Ri CHA ; Sang Soo LEE
The Korean Journal of Gastroenterology 2024;84(1):9-16
Background:
/Aim: Extreme hyperbilirubinemia is occasionally observed in intensive care unit (ICU) and non-ICU settings. This study examined the etiologies of extreme hyperbilirubinemia (bilirubin level ≥12 mg/dL) and the factors associated with the 30-day mortality.
Methods:
This retrospective observational cohort study identified 439 patients with extreme hyperbilirubinemia at the Gyeongsang National University Changwon Hospital between 2016 and 2020. The patients were classified into three groups and 11 diseases according to their etiology. The risk factors associated with 30-day mortality at the baseline were investigated using the Cox proportional hazards model.
Results:
Of 439 patients with extreme hyperbilirubinemia, 287, 78, and 74 were in the liver cirrhosis/malignancy group, the ischemic injury group, and the benign hepatobiliary-pancreatic etiological group, respectively, with corresponding 30-day mortality rates of 42.9%, 76.9%, and 17.6%. The most common disease leading to hyperbilirubinemia was a pancreatobiliary malignancy (28.7%), followed by liver cirrhosis (17.3%), hepatocellular carcinoma (10.9%), and liver metastases (8.4%). The etiologies of hyperbilirubinemia, obstructive jaundice, infection, albumin level, creatinine level, and prothrombin time-international normalized ratio were independently associated with the 30-day mortality.
Conclusions
This study suggests three etiologies of extreme hyperbilirubinemia in the ICU and non-ICU settings. The prognosis of patients with extreme hyperbilirubinemia depends largely on the etiology and the presence of obstructive jaundice.
9.Etiology and Outcomes of Patients with Extreme Hyperbilirubinemia in Korea:A Retrospective Cohort Study
Ji Yoon KWAK ; Hankyu JEON ; Seong Je KIM ; Ji Hee HAN ; Ra Ri CHA ; Sang Soo LEE
The Korean Journal of Gastroenterology 2024;84(1):9-16
Background:
/Aim: Extreme hyperbilirubinemia is occasionally observed in intensive care unit (ICU) and non-ICU settings. This study examined the etiologies of extreme hyperbilirubinemia (bilirubin level ≥12 mg/dL) and the factors associated with the 30-day mortality.
Methods:
This retrospective observational cohort study identified 439 patients with extreme hyperbilirubinemia at the Gyeongsang National University Changwon Hospital between 2016 and 2020. The patients were classified into three groups and 11 diseases according to their etiology. The risk factors associated with 30-day mortality at the baseline were investigated using the Cox proportional hazards model.
Results:
Of 439 patients with extreme hyperbilirubinemia, 287, 78, and 74 were in the liver cirrhosis/malignancy group, the ischemic injury group, and the benign hepatobiliary-pancreatic etiological group, respectively, with corresponding 30-day mortality rates of 42.9%, 76.9%, and 17.6%. The most common disease leading to hyperbilirubinemia was a pancreatobiliary malignancy (28.7%), followed by liver cirrhosis (17.3%), hepatocellular carcinoma (10.9%), and liver metastases (8.4%). The etiologies of hyperbilirubinemia, obstructive jaundice, infection, albumin level, creatinine level, and prothrombin time-international normalized ratio were independently associated with the 30-day mortality.
Conclusions
This study suggests three etiologies of extreme hyperbilirubinemia in the ICU and non-ICU settings. The prognosis of patients with extreme hyperbilirubinemia depends largely on the etiology and the presence of obstructive jaundice.
10.Etiology and Outcomes of Patients with Extreme Hyperbilirubinemia in Korea:A Retrospective Cohort Study
Ji Yoon KWAK ; Hankyu JEON ; Seong Je KIM ; Ji Hee HAN ; Ra Ri CHA ; Sang Soo LEE
The Korean Journal of Gastroenterology 2024;84(1):9-16
Background:
/Aim: Extreme hyperbilirubinemia is occasionally observed in intensive care unit (ICU) and non-ICU settings. This study examined the etiologies of extreme hyperbilirubinemia (bilirubin level ≥12 mg/dL) and the factors associated with the 30-day mortality.
Methods:
This retrospective observational cohort study identified 439 patients with extreme hyperbilirubinemia at the Gyeongsang National University Changwon Hospital between 2016 and 2020. The patients were classified into three groups and 11 diseases according to their etiology. The risk factors associated with 30-day mortality at the baseline were investigated using the Cox proportional hazards model.
Results:
Of 439 patients with extreme hyperbilirubinemia, 287, 78, and 74 were in the liver cirrhosis/malignancy group, the ischemic injury group, and the benign hepatobiliary-pancreatic etiological group, respectively, with corresponding 30-day mortality rates of 42.9%, 76.9%, and 17.6%. The most common disease leading to hyperbilirubinemia was a pancreatobiliary malignancy (28.7%), followed by liver cirrhosis (17.3%), hepatocellular carcinoma (10.9%), and liver metastases (8.4%). The etiologies of hyperbilirubinemia, obstructive jaundice, infection, albumin level, creatinine level, and prothrombin time-international normalized ratio were independently associated with the 30-day mortality.
Conclusions
This study suggests three etiologies of extreme hyperbilirubinemia in the ICU and non-ICU settings. The prognosis of patients with extreme hyperbilirubinemia depends largely on the etiology and the presence of obstructive jaundice.