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临床试验/NCT01587638
NCT01587638已完成不适用

Use of Beta-blockers and Risk of New Onset Diabetes

GlaxoSmithKline0 个研究点目标入组 12,336 人开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
12,336
主要终点
Rate of New Onset Diabetes (NOD)

研究概览

简要总结

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.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Enrollment in a plan captured in the IMS LifeLink Health Plan Claims Database between July 1, 2000 and December 31, 2007
  • aged ≥18 years
  • at least one pharmacy claim for a beta-blocker of interest (carvedilol immediate-release [IR]/controlled-release [CR], atenolol, metoprolol succinate, or metoprolol tartrate)
  • Index date was the first chronologically occurring prescription for any beta-blocker during the enrollment period
  • Continuously eligible to receive healthcare services 6 months prior to and 3 months after the index date
  • at least 1 diagnosis of hypertension (International Classification of Disease, 9th Revision, Clinical Modification (ICD-9-CM): 401.xx-405.xx) during this time frame.

排除标准

  • Diagnosis of diabetes mellitus (ICD-9-CM: 250.xx) and/or a prescription for antidiabetic therapy in the 6 months prior to and/or 3 months after the index date

研究组 & 干预措施

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

干预措施: carvedilol (Drug)

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

干预措施: cardio selective betablocker (Drug)

结局指标

主要结局

Rate of New Onset Diabetes (NOD)

时间窗: 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)

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

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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Use of Beta-blockers and Risk of New Onset Diabetes | 临床试验