PURPOSE: Diabetes mellitus has long been widely considered to be associated with an increased risk of urinary tract infection (UTI), but information on incidence rates are scarce and risk factor data have been conflicting. The aim was to estimate UTI incidence and evaluate potential risk factors for UTI in patients with type 2 diabetes included in recent clinical trials. METHODS: Type 2 diabetes patients from 10 AstraZeneca phase III diabetes clinical trials (n=6016, mean 57.4 years, 50.7% female) conducted during 2004-2007 were included. Patients free of UTI at baseline were followed for up to 6 months after inclusion in the trials. UTI was considered present if any term sorting under the MedDRA high-level term "UTIs" was recorded as an adverse event. RESULTS: In all, 142 patients had an adverse event for UTI, corresponding to an incidence of 59.5/1000 person-years for all patients (91.5/1000 in women, 28.2/1000 in men) and a cumulative incidence of 2% during 6 months. Female gender was associated with an increased incidence [relative risk (RR) 3.4; 95% confidence interval (CI) 2.3-5.1] and also higher age (RR 2.5 [95% CI 1.4-4.8] for ages ≥ 70 years vs. 40-49 years). No increased incidence was associated with body mass index (25-29, 30+ vs. <25 kg/m(2) ), HbA1c (<8% vs. >8%), race (Black, Oriental vs. Caucasian) or drug treatment (study drug, comparator vs. placebo). A history of immune system disorder conveyed a twofold higher risk for UTI. CONCLUSION: UTI is common among female patients with type 2 diabetes and older patients of both genders.
PURPOSE:Diabetes mellitus has long been widely considered to be associated with an increased risk of urinary tract infection (UTI), but information on incidence rates are scarce and risk factor data have been conflicting. The aim was to estimate UTI incidence and evaluate potential risk factors for UTI in patients with type 2 diabetes included in recent clinical trials. METHODS:Type 2 diabetespatients from 10 AstraZeneca phase III diabetes clinical trials (n=6016, mean 57.4 years, 50.7% female) conducted during 2004-2007 were included. Patients free of UTI at baseline were followed for up to 6 months after inclusion in the trials. UTI was considered present if any term sorting under the MedDRA high-level term "UTIs" was recorded as an adverse event. RESULTS: In all, 142 patients had an adverse event for UTI, corresponding to an incidence of 59.5/1000 person-years for all patients (91.5/1000 in women, 28.2/1000 in men) and a cumulative incidence of 2% during 6 months. Female gender was associated with an increased incidence [relative risk (RR) 3.4; 95% confidence interval (CI) 2.3-5.1] and also higher age (RR 2.5 [95% CI 1.4-4.8] for ages ≥ 70 years vs. 40-49 years). No increased incidence was associated with body mass index (25-29, 30+ vs. <25 kg/m(2) ), HbA1c (<8% vs. >8%), race (Black, Oriental vs. Caucasian) or drug treatment (study drug, comparator vs. placebo). A history of immune system disorder conveyed a twofold higher risk for UTI. CONCLUSION:UTI is common among female patients with type 2 diabetes and older patients of both genders.
Authors: Ingrid Nygaard; Linda Brubaker; Toby C Chai; Alayne D Markland; Shawn A Menefee; Larry Sirls; Gary Sutkin; Phillipe Zimmern; Amy Arisco; Liyuan Huang; Sharon Tennstedt; Anne Stoddard Journal: Int Urogynecol J Date: 2011-05-11 Impact factor: 2.894
Authors: Hamdan Z Hamdan; Eman Kubbara; Amar M Adam; Onab S Hassan; Sarah O Suliman; Ishag Adam Journal: Ann Clin Microbiol Antimicrob Date: 2015-04-21 Impact factor: 3.944