severe pulmonary hypertension
severe pulmonary hypertension |
| Posted: 08 Mar 2019 03:28 AM PST In this 24-week trial including 105 patients recruited from six European expert centres in Austria, Czech Republic, Germany, and Poland, researchers tested subcutaneous treprostinil in patients with chronic thromboembolic pulmonary hypertension (CTEPH), classified as non-operable, or with persistent or recurrent pulmonary hypertension after pulmonary endarterectomy. In 1:1 ratio, continuous high-dose subcutaneous treprostinil (target dose around 30 ng/kg per min at week 12) or low-dose subcutaneous treprostinil (target dose around 3 ng/kg per min at week 12) were randomly administered to patients in WHO functional class III or IV with a 6-min walk distance of 150–400 m. High-dose was received by 53 (50%) patients and low-dose by 52 (50%). Safety of subcutaneous treprostinil was established. Its efficacy was proved by the observed improved exercise capacity in patients with severe CTEPH. For patients of WHO functional class III or IV and those who do not tolerate other therapies or need combination treatment, subcutaneous treprostinil affords a parenteral treatment option. Read the full article on The Lancet Respiratory Medicine  |
| Transition from PDE5i to Adempas Without Washout Period Deemed Safe - Pulmonary Hypertension News Posted: 06 Mar 2019 04:00 AM PST Transition from phosphodiesterase-5 inhibitors (PDE5i) — such as United Therapeutics' Adcirca (taladafil) and Pfizer's Revatio (sildenafil) — to Bayer's Adempas (riociguat), a soluble guanylate cyclase (sGC) stimulator, without a washout period is a viable option for some patients with pulmonary hypertension, a small study suggests. The study, "Successful Transition from Phosphodiesterase-5 Inhibitors to Riociguat Without a Washout Period in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension: A Pilot Cohort Study," was published in the journal Heart, Lung and Circulation. Pulmonary arterial hypertension (PAH) is a rare, life-threatening disorder caused by a narrowing of the arteries in the lungs, leading to high blood pressure. Over the last decade, therapies have substantially improved, with the generation of PAH-specific drugs with different mechanisms of action that can be combined to provide the best possible outcome for each patient. PDE5i and sGCs are both vasodilator compounds — agents that induce blood vessels' widening and relaxation. They do so in different ways, but cannot be used as a therapeutic combination. "Because sGC stimulator cannot be co-administered with a PDE5i because of the risk of systemic [low blood pressure], drug transition is considered in patients with an intolerance or inadequate clinical response to PDE5i," the researchers stated. Patients who transition from one medication to another, immediately or with a short washout period, may develop hemodynamic instability — a medical condition in which the body's circulatory system fails to maintain a constant blood circulation because of lack of blood pressure. "A previous study [RESPITE trial, NCT02007629] suggested that selected patients with PAH may benefit from switching from PDE5i to sGC stimulator with a washout period. However, the feasibility of transitioning from a PDE5i to an sGC stimulator and the washout period required for transition have not been clearly established," the researchers said. Therefore, a team of Japanese investigators set out to test whether transitioning from Adcirca and Revatio (PDE5i) to Adempas (an sGC stimulator) would be safe without a washout period in patients with PAH and chronic thromboembolic pulmonary hypertension (CTEPH). The pilot cohort study enrolled six patients with PAH and one with CTEPH, who had already received dual- or triple-combination therapy. All patients were monitored for signs of hemodynamic instability by heart catheterization, a procedure in which a thin catheter is inserted into blood vessels and threaded into the heart to diagnose and treat heart problems. Three patients switched from PDE5i treatment to Adempas because of side effects (severe headaches) associated with PDE5i treatment; four switched because of inadequate therapy response. Results showed that all patients transitioned successfully without a washout period, with no signs of hemodynamic instability. Immediately after the transition, pulmonary vascular resistance (PVR, a measure of heart strain induced by high blood pressure in the lungs) dropped (from 797 to 518 dyne/s/cm–5), as well as systemic blood pressure (a significant drop from 121 to 100 mmHg) in all patients. The most common side effects associated with PDE5i disappeared after transition to Adempas. "Transition from a PDE5i to [Adempas] without washout periods is safe. This transition may be a viable option for patients with PAH and side effects, such as headache, caused by PDE5i or who experience an inadequate response to combination therapy including PDE5i," the team concluded.  |
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