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| Name | Class |
|---|---|
| Institut d'Investigació Biomèdica de Bellvitge | OTHER |
| Institut Català de la Salut | OTHER |
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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.
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:
I. For ARBs:
II. For ACEIs:
III. For other antihypertensive drugs (i.e., non-angiotensin agents: CCBs, β-blockers, and diuretics):
IV. To perform an exploratory comparative analysis among the different antihypertensive drugs sub-cohorts.
The protocol (Final Version: February 18th, 2021) was approved by the local Institutional Review Board (Ethic-and-Clinical-Investigation- Committee, code HUB-FC-2020-01, date April 20th, 2021). The study findings will be submitted to peer-reviewed journals and presented at relevant national and international scientific meetings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARBs only | Hypertensive patients under pharmacological treatment with ARBs |
| |
| ACEIs only | Hypertensive patients under pharmacological treatment with ACEIs |
| |
| ARBs + ACEIs | Hypertensive patients under pharmacological treatment with ARBs and ACEIs |
| |
| 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) |
| |
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| With an Antidepressant Drug | Drug | Current users of an antidepressant drug. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients treated with antihypertensive drugs | Number of patients under treatment with antihypertensive drugs | 3 years |
| Patients treated with an antidepressant drug | Number of patients under treatment with antidepressant drug | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patients diagnosed with Hypertension | Number of patients diagnosed with Hypertension | 3 years |
| Patients diagnosed with Depression | Number of patients diagnosed with Depression |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with antihypertensive drugs within the Bellvitge University Hospital's influence area (Barcelona's southern metropolitan area).
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| Name | Affiliation | Role |
|---|---|---|
| Sebastián Videla, MD, PhD | Head of the Clinical Research Support Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20483169 | Background | Annerbrink K, Jonsson EG, Olsson M, Nilsson S, Sedvall GC, Anckarsater H, Eriksson E. Associations between the angiotensin-converting enzyme insertion/deletion polymorphism and monoamine metabolite concentrations in cerebrospinal fluid. Psychiatry Res. 2010 Sep 30;179(2):231-4. doi: 10.1016/j.psychres.2009.04.018. Epub 2010 May 16. | |
| 22188425 |
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| Without an Antidepressant Drug | Drug | Non-current users of an antidepressant drug. |
|
| 3 years |
| Patients treated with ARBs | Number of patients treated with ARBs | 3 years |
| Patients treated with ACEIs | Number of patients treated with ACEIs | 3 years |
| Patients treated with other antihypertensive drugs | Number of patients treated with other antihypertensive drugs (i.e., non-ARBs and non-ACEIs). | 3 years |
| Patients treated with Amitriptyline | Number of patients treated with Amitriptyline, since this is an antidepressant drug commonly used to treat neuropathic pain in our usual practice. | 3 years |
| Patients treated with Duloxetine | Number of patients treated with Duloxetine, since this is an antidepressant drug commonly used to treat neuropathic pain in our usual practice. | 3 years |
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| Background | Goodman and Gilman's: The Pharmacological Basis of Therapeutics, 13th edition, New York: McGraw-Hill Medical, 2018. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003863 | Depression |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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