Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.227 enrolled

Overview

The objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three times daily for the treatment of PAH.

The study design proposed is a retrospective chart review going back five years (01 April 2006 estimate) from the time of study initiation (31 March 2011 estimate). Within this five-year period, study index will occur the first time an adult patient begins sildenafil for the treatment of PAH for a period of at least three months. The patient has to be taking sildenafil at doses ≥ 20mg tid for the treatment of PAH.

Study Type

OBSERVATIONAL

Enrollment

227

Conditions

Pulmonary Arterial Hypertension

Interventions

sildenafil citrateDRUG

Sildenafil citrate, 20mg oral tablets, taken at least three times daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must be at least 18 years of age at study index; * Patients must have a diagnosis of PAH. PAH is conventionally defined as a mean pulmonary arterial pressure (PAP) of \> 25 mmHg and a pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg and a pulmonary vascular resistance (PVR) ≥ 240 dynes/s/cm-5 at right heart catheterization; * Patients must have initiated sildenafil for the treatment of their PAH; at dose ≥ 20 mg tid within 5 years prior to study initiation Exclusion Criteria: * Patient has known contraindications to sildenafil at study index; * Patient participated in an investigational study of sildenafil treatment for PAH during the period beginning 6 months prior to study index

Locations (2)

Medizinische Hochschule Hannover

Hanover, Germany

Mater Misericordiae Hospital

Dublin, Ireland

Outcomes

Primary Outcomes

Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1

6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.

Time frame: Baseline, Year 1

Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2

6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.

Time frame: Baseline, Year 2

Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3

6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.

Time frame: Baseline, Year 3

Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4

6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.

Time frame: Baseline, Year 4

Secondary Outcomes

Change From Baseline in New York Heart Association, World Health Organization (NYHA/WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Year 1, 2, 3 and 4

NYHA/WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class, deterioration = increase in functional class, no change = no change in functional class. Number of participants in each functional class was reported.

Time frame: Baseline, Year 1, 2, 3, 4

Data from ClinicalTrials.gov

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