Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Drug: Epoprostenol

Study type: Observational

Funder types: Industry

Identifiers

NCT01387191

112300

Details and patient eligibility

About

The objective of this study is to evaluate the incidence of adverse events in Japanese pulmonary arterial hypertension subjects treated with epoprostenol injection based on prescribing information under the conditions of general clinical practice and also to grasp the following items;

1. Unknown adverse reactions (especially, significant adverse reactions)
2. Adverse reaction onset status under practical drug use conditions
3. Factors possibly influential on safety
4. Factors possibly influential on efficacy
5. Patient's prognosis, efficacy and safety in long-term use

Enrollment: 748 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with cardiovascular disease

Exclusion criteria

• Subjects with hypersensitivity to epoprostenol
• Subjects with right cardiac failure during an acute exacerbation
• Subjects with severe left ventricular systolic dysfunction
• Subjects with serious left ventricular dysfunction
• Subjects whose pulmonary edema getting worse during dose initiation

Trial design

748 participants in 1 patient group

Subjects prescribed epoprostenol

Description:

Subjects with pulmonary arterial hypertension prescribed epoprostenol injection during study period

Treatment:

Drug: Epoprostenol