All Things ADUE
What was the primary endpoint of the ADUE Trial?
Change in PVR at EDBT from baseline to 16 weeks expressed in geometric mean.
What is the recommended maintenance dose of OPSYNVI (Macitentan/Tadalafil)?
10 mg / 40 mg
How many patients were in the SERAPHIN study?
742
How many patients were in the GRIPHON study?
1156
Name the functional classes of PAH in which REMODULIN has been studied.
FC II - IV
How many patients were randomized in the ADUE Trial?
N=187
Explain the effect alcohol consumption can have on a patient taking OPSYNVI.
Both alcohol and tadalafil are mild vasodilators. When taken together, blood-pressure-lowering effects of each individual component may be increased.
What is the most common overall adverse event in SERAPHIN?
Nasopharyngitis/ Pharyngitis
What was the risk reduction of the primary endpoint for UPTRAVI vs Placebo in the GRIPHON trial?
40%
What is the indication for AMBRISENTAN?
AMBRISENTAN is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients:
- To improve exercise ability and delay clinical worsening.
- In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability
PVR reduction was ____ greater with M/T FDC than Macitentan alone
29%
Name the 4 contraindications of OPSYNVI.
- Pregnancy
- Hypersensitivity
- Concomitant Organic Nitrates
- Concomitant Guanylate Cyclase Stimulants
In SERAPHIN, the risk of a significant morbidity or mortality event was reduced by ______% in the OPSUMIT arm vs Placebo.
45%
In a post-hoc analysis of GRIPHON, what was the risk reduction of UPTRAVI patients in FC II treated within 6 months post-PAH diagnosis?
64%
What is the indication statement for ADEMPAS?
ADEMPAS is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic Pulmonary Hypertension (CTEPH, WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class.
and
ADEMPAS is indicated for the treatment of adults with Pulmonary Arterial Hypertension (PAH, WHO Group 1) to improve WHO functional class and to delay clinical worsening.
PVR reduction was ____ greater than M/T FDC than Tadalafil alone.
28%
What is the full indication of OPSYNVI?
OPSYNVI is the combination of Macitentan and Tadalafil indicated for the chronic treatment of PAH (who group 1) and FC II-III. Individually, Macitentan reduces the risk of clinical worsening events and hospitalization, exercise ability.
In SERAPHIN, what was the percentage of risk reduction for the secondary endpoint of death due to PAH or hospitalization for PAH up to end of treatment for OPSUMIT compared to Placebo?
50%
Discuss how you would explain the dosing/ titration phase of UPTRAVI?
Starting dose of 200 mgc BID; titrate weekly by 200 mcg BID up to 1600 mcg BID or to highest tolerated dose.
Discuss TYVASO DPI's trial, BREEZE. What was it?
BREEZE was a three week open-label safety and tolerability trial with 51 patients taking TYVASO Inhalation Solution and switched to a corresponding dose of TYVASO DPI.
What were the top 3 adverse events reported in M/T FCD group?
- Headache
- Anemia
- Peripheral Edema
Name all Warnings/Precautions of OPSYNVI
- Embryo-fetal toxicity
- Hepatotoxicity
- Hypotension
- Hemoglobin Decrease
- Decreased Sperm Counts & Prolonged Erection
- Worsening Pulmonary Veno-occlusive Disease (PVOD)
- Vision Loss & Hearing Impairment
- Combination with Other PDE5s
Explain SERAPHIN's primary endpoint, including each component that would be considered an event
Time to first significant morbidity and mortality event:
- Time to death
- Atrial septostomy
- Lung transplantation
- Initiation of treatment with IV or subcutaneous prostanoids
- Worsening of events
What was the discontinuation rate in the UPTRAVI arm in the GRIPHON trial?
14.3%
What is the indication for WINREVAIR and how often is it dosed?
WINREVAIR is indicated for the treatment of adults with pulmonary Arterial Hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. It is administered once every 3 weeks by subcutaneous injection according to patient body weight.