ABSTRACT
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.
Subject(s)
Humans , Blood Glucose , Chest Pain , Fasting , Gastritis , Glucose , Hemoglobins , Incidence , Metformin , Pneumonia, Bacterial , ThiazolidinedionesABSTRACT
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.
Subject(s)
Humans , Blood Glucose , Chest Pain , Fasting , Gastritis , Glucose , Hemoglobins , Incidence , Metformin , Pneumonia, Bacterial , ThiazolidinedionesABSTRACT
BACKGROUND: It is getting more difficult to involve appropriate investigators in clinical trials. Knowing what investigators want from sponsor initiated clinical trials would help industry cooperate with investigators more efficiently. This study aims to describe the incentives for investigators choosing to participate or not and perform well in sponsored clinical trials. METHODS: Investigators who have participated in GSK sponsored clinical trials were interviewed face-to-face or through e-mail using the standardized questionnaire. Investigators were asked to choose five items and determine the ranking or those five items. RESULTS: Questionnaires answered by 122 investigators were collected. The top three incentives were "Academic merit" (108, 88.5 %), "Expectation of treatment potentially helpful to patient" (101, 82.8 %), and "Access to new treatments" (92, 75.4 %). The disincentives and the factors affecting an investigator's performance were analyzed separately because of the different questionnaire between investigators for medicine and vaccine. Investigators for medicine choose as disincentives "Insufficient time" (43, 61.4 %), "Difficult protocol" (41, 58.6 %), and "Adverse event concerns" (41, 58.6 %). Vaccine investigators pointed out "Limited support staff" (41, 78.8 %), "Insufficient time" (40, 76.9 %), and "Difficult blood sampling" (333, 63.5 %) as disincentives. Factors adversely affecting an investigator's performance showed similar results to those of disincentives. CONCLUSION: Investigators focused on academic curiosity and patients and insufficient time mostly inhibits them from participating and performing clinical trials. Our results would help industry cooperate with investigators more efficiently, finally making companies perform clinical trials more effectively.
Subject(s)
Humans , Electronic Mail , Exploratory Behavior , Motivation , Surveys and Questionnaires , Research PersonnelABSTRACT
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.
Subject(s)
Humans , Acidosis , Intestinal Mucosa , Phenobarbital , Renal Insufficiency, Chronic , Urinary Bladder , Urinary Bladder Neoplasms , Urinary Bladder, Neurogenic , Urinary Diversion , Urinary Tract InfectionsABSTRACT
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.