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Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension
Pulmonary arterial hypertension is a progressive disease involving proliferative remodeling of the pulmonary vessels. Despite therapeutic advances, the disease-associated morbidity and mortality remain high. Sotatercept is a fusion protein that traps activins and growth differentiation factors involved in pulmonary arterial hypertension.
We conducted a multicenter, double-blind, phase 3 trial in which adults with pulmonary arterial hypertension (World Health Organization [WHO] functional class II or III) who were receiving stable background therapy were randomly assigned in a 1:1 ratio to receive subcutaneous sotatercept (starting dose, 0.3 mg per kilogram of body weight; target dose, 0.7 mg per kilogram) or placebo every 3 weeks. The primary end point was the change from baseline at week 24 in the 6-minute walk distance. Nine secondary end points, tested hierarchically in the following order, were multicomponent improvement, change in pulmonary vascular resistance, change in N-terminal pro-B-type natriuretic peptide level, improvement in WHO functional class, time to death or clinical worsening, French risk score, and changes in the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Physical Impacts, Cardiopulmonary Symptoms, and Cognitive/Emotional Impacts domain scores; all were assessed at week 24 except time to death or clinical worsening, which was assessed when the last patient completed the week 24 visit.
A total of 163 patients were assigned to receive sotatercept and 160 to receive placebo. The median change from baseline at week 24 in the 6-minute walk distance was 34.4 m (95% confidence interval [CI], 33.0 to 35.5) in the sotatercept group and 1.0 m (95% CI, -0.3 to 3.5) in the placebo group. The Hodges-Lehmann estimate of the difference between the sotatercept and placebo groups in the change from baseline at week 24 in the 6-minute walk distance was 40.8 m (95% CI, 27.5 to 54.1; P<0.001). The first eight secondary end points were significantly improved with sotatercept as compared with placebo, whereas the PAH-SYMPACT Cognitive/Emotional Impacts domain score was not. Adverse events that occurred more frequently with sotatercept than with placebo included epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure.
In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).
Journal Article
Macitentan and Morbidity and Mortality in Pulmonary Arterial Hypertension
In an event-driven trial, macitentan (an endothelin-receptor antagonist) at a dose of 3 or 10 mg was compared with placebo in patients with symptomatic pulmonary arterial hypertension. At a median of 115 weeks, both macitentan doses were associated with reduced morbidity and mortality.
Pulmonary arterial hypertension, a severe disease characterized by a sustained elevation of pulmonary vascular resistance, ultimately leads to right heart failure and death.
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Disease progression occurs despite the availability of drugs that are specific for the disorder.
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Endothelin-receptor antagonists, phosphodiesterase type 5 inhibitors, and prostacyclin and its analogues have been approved for the treatment of pulmonary arterial hypertension and adopted clinically on the basis of short-term trials (12 to 16 weeks) that have shown improvements in exercise capacity as measured by the distance walked in 6 minutes.
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However, current guidelines suggest that the primary end point in phase 3 . . .
Journal Article
Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension
In a trial comparing decompressive craniectomy with medical therapy in patients with traumatic brain injury and raised intracranial pressure refractory to medical therapy, decompressive craniectomy resulted in lower mortality and higher rates of vegetative state and severe disability.
After traumatic brain injury (TBI), intracranial pressure can be elevated owing to a mass effect from intracranial hematomas, contusions, diffuse brain swelling, or hydrocephalus.
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Intracranial hypertension can lead to brain ischemia by reducing the cerebral perfusion pressure.
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Intracranial hypertension after TBI is associated with an increased risk of death in most studies.
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The monitoring of intracranial pressure and the administration of interventions to lower intracranial pressure are routinely used in patients with TBI, despite the lack of level 1 evidence.
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Decompressive craniectomy is a surgical procedure in which a large section of the skull is removed and the underlying . . .
Journal Article
Correction: Kim et al. Neuroprotective Effect of Statins in a Rat Model of Chronic Ocular Hypertension. Int. J. Mol. Sci. 2021, 22, 12500
In the original publication [...]
Journal Article
Selexipag for the Treatment of Pulmonary Arterial Hypertension
Among over 1100 patients with pulmonary arterial hypertension who received selexipag, an oral selective IP prostacyclin-receptor agonist, or placebo, the risk of the composite end point of death or complication was lower with selexipag than with placebo at 1.3 years of follow-up.
Pulmonary arterial hypertension is a severe disease with a poor prognosis despite available treatment options.
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Current recommendations support the use of a combination of therapies that target the endothelin, nitric-oxide, and prostacyclin pathways.
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Despite the benefits of intravenous prostacyclin therapy,
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many patients with pulmonary arterial hypertension die without ever receiving this treatment.
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The burden and risks related to the administration of prostacyclin therapy are probably contributing factors.
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Selexipag is an oral selective IP prostacyclin-receptor agonist that is structurally distinct from prostacyclin.
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In a placebo-controlled, phase 2 trial involving patients who were already receiving treatment for pulmonary . . .
Journal Article
Inhaled Treprostinil in Pulmonary Hypertension Due to Interstitial Lung Disease
Patients with pulmonary hypertension due to interstitial lung disease were randomly assigned to inhaled treprostinil or placebo. At 16 weeks, there was a significant improvement in exercise capacity with inhaled treprostinil as compared with placebo as assessed by a 6-minute walk test.
Journal Article