Regular telephone follow-up was performed in 175 patients with CTEPH until July 2016 at 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, and 10 years after enrollment.
Logistic regression analysis was used to screen for factors predicting the AVT-positive rate in patients with CTEPH.
Between June 2005 and May 2013, 126 consecutive CTEPH cases were confirmed to be inoperable.
Treatment for CTEPH consisted of routine anticoagulation (with the aim of maintaining an international normalized ratio of 2.
The analysis of the CHEST-2 data cut-off showed that, at two years, mean exercise capacity of CTEPH
patients as measured by the 6MWD had increased by 50m compared to CHEST-1 trial baseline.
The availability of riociguat is a significant step forward: It means that patients with CTEPH
for the first time have an option if pulmonary endarterectomy (PEA), a highly specialized surgical procedure, is not an option for them or when the disease persists after surgery.
The consistency and robustness of the positive results from the clinical trial programs CHEST and PATENT are substantial: Riociguat has demonstrated significant and sustained clinical efficacy and safety in treatment-naive PAH patients and patients pre-treated with endothelin-receptor antagonists (ERAs) or prostanoid monotherapy, as well as in patients with inoperable CTEPH
or persistent or recurrent CTEPH
is a progressive disease, and the symptoms of breathlessness, dizziness and fainting severely impact daily activities of patients, said Dr.
The FDA s approval is a key milestone in our efforts to provide patients and physicians with a much-needed new treatment option for this rare, serious and potentially fatal disorder: It is the first drug to be approved for inoperable CTEPH
or for persistent or recurrent disease after surgery, and it is also an important new class of treatment for patients with PAH, said Dr.
PAH and CTEPH
are both life-threatening forms of pulmonary hypertension that cause significantly increased pressure in the pulmonary arteries.
To date, there is no pharmacological treatment available for CTEPH
In the first interim analysis in CHEST-2, riociguat was shown to be well tolerated with a good long-term safety profile in patients with CTEPH