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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Drug: sildenafil citrate

Detailed Description

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 (Actual): 227

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
• Ireland
  • Dublin, Ireland, 7
    • Mater Misericordiae Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients at least 18 years of age diagnosed with pulmonary arterial hypertension (PAH; per Dana Point classification) and treated with sildenafil citrate for their PAH

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sildenafil ≥20mg three times daily; Subjects receiving sildenafil ≥20mg three times daily for the treatment of PAH	Drug: sildenafil citrate; Sildenafil citrate, 20mg oral tablets, taken at least three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline, Year 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Year 1, 2, 3, 4
Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4	RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.	Baseline, Year 1, 2, 3, 4
Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4	mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.	Baseline, Year 1, 2, 3, 4
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4	PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm).	Baseline, Year 1, 2, 3, 4
Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4	CI: calculated as COsys divided by BSA.	Baseline, Year 1, 2, 3, 4
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4	PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.	Baseline, Year 1, 2, 3, 4
Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4	Borg dyspnea scale: 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all;0.5=very very slight (just noticeable); 1=very slight; 2=slight breathlessness; 3=moderate; 4=some what severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum.	Baseline, Year 1, 2, 3, 4

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 1, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Pulmonary arterial hypertension; Revatio; sildenafil citrate
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: A1481297