Resumen

CORTEZ, Alejandro et al. Plan for REMODULIN® active pharmacovigilance (TREPROSTINIL). AVFT [online]. 2014, vol.33, n.1, pp.20-25. ISSN 0798-0264.

Background: Pulmonary Arterial Hypertension (PAH) is a serious condition. Treatment is based on prostacyclin analogues. Subcutaneous treprostinil has an effect on exercise capacity and improvement in symptoms, quality of life and pulmonary hemodynamics. Methodology: This was a Phase IV study in patients with PAH. At each visit a general clinic and evaluation of exercise capacity, Borg dyspnea scale, signs and symptoms of PAH functional class and safety was conducted. Results: 34 patients were recruited. The mean age was 46 ± 20.2 years. Twenty six had functional class IV (NYHA) and eight class III; at the end, 76% was functional class II and 24% class III. At baseline, distance walked in 6 minutes was 104.62 m and at the end was increased to 293 ± 82.5 m (p < 0.001). The Borg dyspnea ranged from 6 ± 2.12 to 3.29 ± 1.7 (p < 0.001). Pulmonary arterial pressure decreased from 28.9 ± 76.58 mmHg to 45 ± 11.8 mmHg (p < 0.001). Dose was increased from 2.63 ± 2.5 to 16.38 ± 11.5 ng / kg / min. The main adverse event was pain at the site of administration; others presented headache, nausea and diarrhea, which did not need treatment withdrawal. A case of cellulitis requiring treatment withdrawal. Conclusion: It was shown that the product is effective and safe in the treatment of PAH, improving distance walked, reducing dyspnea scale and pulmonary artery pressure. There were no serious adverse events.

Palabras clave : Treprostinil; pulmonary arterial hypertension; pharmacovigilance.