Use of Beta-blockers and Risk of New Onset Diabetes
This study used an observational, retrospective cohort design to compare the presence and timing of new-onset diabetes (NOD) between hypertensive patients initiating therapy with carvedilol immediate-release (IR) and carvedilol controlled-release (CR) vs the following cardioselective beta blockers (BBs): atenolol, metoprolol succinate, and metoprolol tartrate (referred to hereafter as 'other BB').
The aim of the study was to investigate the likelihood of developing NOD among hypertensive patients initiating carvedilol therapy vs other BB therapy in a real world setting derived from data contained in a large United States (US) managed care database.
|Study Design:||Time Perspective: Retrospective|
|Official Title:||Use of Beta-blockers and Risk of New Onset Diabetes|
- Rate of New Onset Diabetes (NOD) [ Time Frame: From index event (BB prescription) to NOD outcome event (DM diagnosis or antidiabetic Rx) during the effective dates of the database (up to 7 years) ] [ Designated as safety issue: Yes ]Rate of NOD per 100 person years. NOD was defined as at least two medical claims with a Diabetes Mellitus diagnosis (ICD-9-CM: 250.xx) or a prescription fill of an antidiabetic medication
|Study Start Date:||April 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Hypertensive users of Beta blocker
Patients aged ≥18 years and at least 1 diagnosis of hypertension (ICD-9-CM: 401.xx-405.xx) during this time frame in a US Managed care population
carvedilol immediate-release (IR) and carvedilol controlled-release (CR)
Other Name: carvedilol immediate-release (IR) and carvedilol controlled-releaseDrug: cardio selective betablocker
atenolol, metoprolol succinate, and metoprolol tartrate
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587638
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|