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Clinical Review Report: Slexipag (Uptravi) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2017 Sep.

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Clinical Review Report: Slexipag (Uptravi) [Internet].

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APPENDIX 6Summary of Other Studies

Aim

To review the available safety data for the GRIPHON open-label, uncontrolled extension study (Study 303).

Summary

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Table 19Baseline Patient Characteristics (Study 303)

CharacteristicaStudy 303
Selexipag/selexipag
▬		Placebo/selexipag
▬
Female▬▬
Age, years, mean (SD)▬▬
6MWD, m, mean (SD)▬▬
NYHA/WHO functional class, n (%)
  I▬▬
  II▬▬
  III▬▬
  IV▬▬

6MWD = six-minute walk distance; NYHA = New York Heart Association; SD = standard deviation; WHO = World Health Organization.

a

Baseline visit for GRIPHON study.

Source: Clinical Study Report.8

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Table 20Disposition of Patients in Study 303

Study 303
Selexipag/selexipagPlacebo/selexipag
Randomized in GRIPHON trial, N▬▬
Enrolled in Study 303, n (%)▬▬
Discontinued study and performed EOS visit, n (%)▬▬
Discontinued study and did not perform EOS visit, n (%)▬▬
  Died▬▬
  Withdrawal of consent▬▬
  Lost to follow-up▬▬
  Administrative reason▬▬
Total duration of follow-up, weeks, median (range)▬▬

EOS= end of study.

Source: Clinical Study Report,8 with additional data from the manufacturer.29

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Table 21Harms in Study 303

Study 303
Selexipag/selexipag
▬		Placebo/selexipagAll patients
Any adverse event, n (%)▬▬▬
Headache▬▬▬
Diarrhea▬▬▬
PAH▬▬▬
Pain in jaw▬▬▬
Nausea▬▬▬
Right ventricular failure▬▬▬
Vomiting▬▬▬
Peripheral edema▬▬▬
Pain in extremity▬▬▬
Myalgia▬▬▬
Dizziness▬▬▬
Arthralgia▬▬▬
Flushing▬▬▬
Notable harms, n (%)
Syncope▬▬▬
Presyncope▬▬▬
Anemiaa▬▬▬
Hemorrhage▬▬▬
Decrease in hemoglobin to < 100 and/or < 80 g/L▬▬▬
Gastrointestinal disorder (SOC)▬▬▬
SAE, n (%)▬▬▬
Worsening of PAH▬▬▬
Right ventricular failure▬▬▬
Adverse event leading to treatment discontinuation, n (%)▬▬▬
PAH▬▬▬
Right ventricular failure▬8 (5)10 (5)

NR = not reported; PAH = pulmonary arterial hypertension; SAE= serious adverse event; SOC = system organ classification.

a

Includes anemia, iron deficiency anemia, pancytopenia and decreased hemoglobin.

Source: Clinical Study Report.8

Copyright © 2017 Canadian Agency for Drugs and Technologies in Health.

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Bookshelf ID: NBK533866
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