Trials Sponsors Conditions Drugs Pricing

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

Time to Dementia Onset
Time to dementia onset includes: Alzheimer's disease, vascular dementia, senile, presenile, or unspecified dementia, or dementia in other diseases classified elsewhere. Please refer to uploaded protocol for full definition. Analysis 1-'as-treated' follow-up approach: In this approach, we followed patients from cohort entry until treatment discontinuation or switch to the comparator treatment, insurance disenrollment, death, or administrative endpoint (December 2018). Treatment discontinuation was defined as occurring 90 days after the expected days supply. of the most recently filled prescription to accommodate suboptimal adherence during treatment periods. Analysis 2-'as-started' follow-up approach incorporating a 6-month 'induction' period. Analysis 3-incorporating a 6-month 'symptoms to diagnosis' period Analysis 4-high-specificity outcome definition Study accessed Medicare files (Jan 2008-Dec 2018) between September 1, 2021 to October 4, 2022.
Median follow up times: 1) 168 days (exp), 151 days (ref) 2) 693 days (exp), 720 days (ref) 3) 382 days (exp), 358 days (ref) 4) 169 days (exp), 151 days (ref)

Study Arms (2)

PDE5 inhibitors

Exposure group

Drug: PDE5 inhibitor

Endothelin receptor antagonists

Reference group

Drug: Endothelin Receptor Antagonists

Interventions

PDE5 inhibitorDrug

PDE5 inhibitors (sildenafil, tadalafil) claim is used as the exposure group.

PDE5 inhibitors

Endothelin Receptor AntagonistsDrug

Endothelin receptor antagonists (bosentan, ambrisentan, macitentan) claim is used as the reference group.

Endothelin receptor antagonists

Eligibility Criteria

Age65 Years+

Sexall

Age GroupsOlder Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

This study will employ a new user, active comparator, observational cohort study design comparing PDE5 inhibitors (sildenafil, tadalafil) to endothelin receptor antagonists (bosentan, ambrisentan, macitentan). The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of study drugs (cohort entry/index date). Follow-up for the outcome (dementia) differs between analyses. Follow-up begins the day after drug initiation (analysis 1, 3, 4); 180 days after drug initiation (analysis 2).

You may qualify if:

Sponsors & Collaborators

Rutgers University
Othercollaborator
National Institute on Aging (NIA)
NIHcollaborator
Johns Hopkins University

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Phosphodiesterase 5 InhibitorsEndothelin Receptor Antagonists

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phosphodiesterase InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Results Point of Contact

Title: Rishi J Desai, PhD
Organization: Brigham and Women's Hospital

Study Officials

Madhav Thambisetty, MD, PhD
National Institute on Aging (NIA)
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

13,021 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor of Medicine

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 9, 2021

Study Start

September 1, 2021

Actual (reported)

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

PDE5 inhibitors

Endothelin receptor antagonists

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

PDE5 inhibitors

Endothelin receptor antagonists

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations