ANGIOTENSIN AGENTS AND REDUCTION OF THE PRESCRIPTION OF ANTIDEPRESSANT DRUGS: A RETROSPECTIVE COHORT STUDY USING REAL-WORLD DATA
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Patients treated with an antidepressant drug
研究概览
简要总结
A retrospective cohort study will be performed by analyzing data obtained from the Catalan Southern Metropolitan data warehouse system, which collects data from both hospitalized and primary care patients from the Bellvitge University Hospital's area of influence. The investigators will begin by gathering information only on patients treated with antihypertensive drugs, which then will be stratified in two groups: 1) Angiotensin Agents group; 2) Other Antihypertensive Agents (Non-Angiotensin Agents) group. Afterwards, a separated analysis will be performed to assess the effects of ARBs and ACEIs separately on the prescription of antidepressant drugs.
详细描述
Hypertension is a multifactorial disease and an important risk factor for cardiovascular and cerebrovascular diseases. Also, major depression is commonly found on these patients. Together, they represent a substantial burden for patients and their families, with an increased morbimortality and reduced life-quality. It also has a major social impact by increasing healthcare assistance demand and by affecting patients' daily-life productivity, therefore generating direct and indirect health-associated costs.
The Renin-Angiotensin System is one of the known pathways that modulate systemic and central nervous system inflammation. Basic research studies have shown ARBs-related allosteric changes on receptors implicated on the pathophysiology of schizophrenia and depression, and also a pharmacological reversal of depression-like behavior in rats after the administration of losartan. Human research studies have also presented evidence that points towards an antidepressant effect of some antihypertensive drugs.
A retrospective cohort study will be performed by analyzing data obtained from the Catalan Southern Metropolitan data warehouse system, which collects data from both hospitalized and primary care patients from the Bellvitge University Hospital's area of influence. The investigators will begin by gathering information only on patients treated with antihypertensive drugs, which then will be stratified in two groups: 1) Angiotensin Agents group; 2) Other Antihypertensive Agents (Non-Angiotensin Agents) group. Afterwards, a separated analysis will be performed to assess the effects of ARBs and ACEIs separately on the prescription of antidepressant drugs.
Our primary objective is to estimate the prevalence, incidence, and clearance (incidence of antidepressant drugs withdrawal) of antidepressant drugs prescription in hypertensive patients under treatment with angiotensin agents (ARBs and/or ACEIs).
Our secondary objectives are as follows:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that had an antihypertensive drug prescribed between January 1st, 2015 and December 31st, 2017, whose ATC codes can be obtained from the 'DATA WAREHOUSE' database
- •Age ≥ 18 years old
- •Both genders
- •Patients with information available on the 'DATA WAREHOUSE' database
- •Patients with a clinical visit or prescription done afterwards the date when the information for the study was last collected (this way we ensure that the patient included on the study remained alive after the end of the observation period)
排除标准
- •Lack of information about the beginning of treatment with an antihypertensive and/or with an antidepressant drug.
研究组 & 干预措施
Other Antihypertensive Drugs
Hypertensive patients under pharmacological treatment with non-angiotensin agents (diuretics, calcium channel blockers and/or β-blockers alone or combined among them)
干预措施: Without an Antidepressant Drug (Drug)
Angiotensin Agents and Other Antihypertensive Drugs
Hypertensive patients under combined pharmacological treatment with Angiotensin Agents (ACEIs and/or ARBs) and Other Antihypertensives (non-angiotensin agents)
干预措施: With an Antidepressant Drug (Drug)
ARBs only
Hypertensive patients under pharmacological treatment with ARBs
干预措施: With an Antidepressant Drug (Drug)
ARBs only
Hypertensive patients under pharmacological treatment with ARBs
干预措施: Without an Antidepressant Drug (Drug)
ACEIs only
Hypertensive patients under pharmacological treatment with ACEIs
干预措施: With an Antidepressant Drug (Drug)
ACEIs only
Hypertensive patients under pharmacological treatment with ACEIs
干预措施: Without an Antidepressant Drug (Drug)
ARBs + ACEIs
Hypertensive patients under pharmacological treatment with ARBs and ACEIs
干预措施: With an Antidepressant Drug (Drug)
ARBs + ACEIs
Hypertensive patients under pharmacological treatment with ARBs and ACEIs
干预措施: Without an Antidepressant Drug (Drug)
Other Antihypertensive Drugs
Hypertensive patients under pharmacological treatment with non-angiotensin agents (diuretics, calcium channel blockers and/or β-blockers alone or combined among them)
干预措施: With an Antidepressant Drug (Drug)
Angiotensin Agents and Other Antihypertensive Drugs
Hypertensive patients under combined pharmacological treatment with Angiotensin Agents (ACEIs and/or ARBs) and Other Antihypertensives (non-angiotensin agents)
干预措施: Without an Antidepressant Drug (Drug)
结局指标
主要结局
Patients treated with an antidepressant drug
时间窗: 3 years
Number of patients under treatment with antidepressant drug
Patients treated with antihypertensive drugs
时间窗: 3 years
Number of patients under treatment with antihypertensive drugs
次要结局
- Patients treated with other antihypertensive drugs(3 years)
- Patients diagnosed with Hypertension(3 years)
- Patients treated with ACEIs(3 years)
- Patients treated with ARBs(3 years)
- Patients diagnosed with Depression(3 years)
- Patients treated with Amitriptyline(3 years)
- Patients treated with Duloxetine(3 years)
研究者
Sebastian Videla
Head of the Clinical Research Support Unit
Hospital Universitari de Bellvitge