AIMS AND OBJECTIVES: To investigate the relationship between patients' characteristics, use of concomitant anti-diabetic therapies and the incidence of hypoglycaemia, an acute complication of the treatment of diabetes mellitus reported by general practitioners (GPs) during the first 9 months of the treatment with pioglitazone. METHODS: We used data collected for the Prescription-Event Monitoring (PEM) study conducted by the Drug Safety Research Unit for patients prescribed pioglitazone between November 2000 and June 2001 by their GP in England. A Cox proportional-hazards regression model was used to assess this relationship. RESULTS: The original pioglitazone PEM cohort included 12,772 patients (mean age 60.9 years); 53% (6777) were male. A total of 77 patients experienced at least one hypoglycaemic episode (9.64 per 1000 patient-years). Women were estimated to have twice the hazard of having a hypoglycaemic event compared with men [hazard ratio (HR) 2.05; confidence interval (CI) 1.24, 3.41]. Patients taking combination therapy with sulfonylurea or insulin were estimated to have approximately three and four times the hazard of having an event compared with those who were not taking these adjunctive therapies [HR=3.11 (CI 1.64, 5.88); HR=4.15 (CI 1.74, 9.91), respectively]. Patients treated with adjunctive metformin were 25% less likely to experience hypoglycaemia than those who did not take concomitant metformin (HR=0.75; CI 0.44, 1.27). CONCLUSIONS: This study has shown that the treatment with pioglitazone was associated with a low incidence of hypoglycaemia. The factors possibly increasing the risk of hypoglycaemia were concomitant therapy with sulfonylurea or insulin and female gender.
AIMS AND OBJECTIVES: To investigate the relationship between patients' characteristics, use of concomitant anti-diabetic therapies and the incidence of hypoglycaemia, an acute complication of the treatment of diabetes mellitus reported by general practitioners (GPs) during the first 9 months of the treatment with pioglitazone. METHODS: We used data collected for the Prescription-Event Monitoring (PEM) study conducted by the Drug Safety Research Unit for patients prescribed pioglitazone between November 2000 and June 2001 by their GP in England. A Cox proportional-hazards regression model was used to assess this relationship. RESULTS: The original pioglitazone PEM cohort included 12,772 patients (mean age 60.9 years); 53% (6777) were male. A total of 77 patients experienced at least one hypoglycaemic episode (9.64 per 1000 patient-years). Women were estimated to have twice the hazard of having a hypoglycaemic event compared with men [hazard ratio (HR) 2.05; confidence interval (CI) 1.24, 3.41]. Patients taking combination therapy with sulfonylurea or insulin were estimated to have approximately three and four times the hazard of having an event compared with those who were not taking these adjunctive therapies [HR=3.11 (CI 1.64, 5.88); HR=4.15 (CI 1.74, 9.91), respectively]. Patients treated with adjunctive metformin were 25% less likely to experience hypoglycaemia than those who did not take concomitant metformin (HR=0.75; CI 0.44, 1.27). CONCLUSIONS: This study has shown that the treatment with pioglitazone was associated with a low incidence of hypoglycaemia. The factors possibly increasing the risk of hypoglycaemia were concomitant therapy with sulfonylurea or insulin and female gender.
Authors: Claes Ohlsson; Ann Hammarstedt; Liesbeth Vandenput; Niina Saarinen; Henrik Ryberg; Sara H Windahl; Helen H Farman; John-Olov Jansson; Sofia Movérare-Skrtic; Ulf Smith; Fu-Ping Zhang; Matti Poutanen; Shahram Hedjazifar; Klara Sjögren Journal: Am J Physiol Endocrinol Metab Date: 2017-06-27 Impact factor: 4.310
Authors: Oliver Schnell; Hasan Alawi; Tadej Battelino; Antonio Ceriello; Peter Diem; Anne-Marie Felton; Wladyslaw Grzeszczak; Kari Harno; Peter Kempler; Ilhan Satman; Bruno Vergès Journal: J Diabetes Sci Technol Date: 2012-05-01
Authors: David C Klonoff; Lawrence Blonde; George Cembrowski; Antonio Roberto Chacra; Guillaume Charpentier; Stephen Colagiuri; George Dailey; Robert A Gabbay; Lutz Heinemann; David Kerr; Antonio Nicolucci; William Polonsky; Oliver Schnell; Robert Vigersky; Jean-François Yale Journal: J Diabetes Sci Technol Date: 2011-11-01