Publications by authors named "Peter G Linde"

Article Synopsis
  • Pulmonary arterial hypertension (PAH) involves changes in lung blood vessels and poor outcomes, and the novel drug sotatercept aims to fix dysfunctional signaling in this process.* -
  • In a 24-week study with 106 participants, those receiving sotatercept showed significant improvements in pulmonary vascular resistance compared to the placebo group, particularly at dosages of 0.3 mg and 0.7 mg.* -
  • While sotatercept improved exercise capacity and reduced certain biomarkers, common side effects included lowered platelet count and increased hemoglobin, with one serious adverse event reported.*
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Article Synopsis
  • β-Thalassemia is a genetic blood disorder that causes issues with hemoglobin production, leading to the need for regular blood transfusions and potential complications like iron overload.
  • Luspatercept is the first approved therapy in the U.S. that helps improve anemia in adult patients with β-thalassemia who rely on these transfusions, showing effective dosage and reduced transfusion needs.
  • Studies indicate that luspatercept has a favorable safety profile and its administration is based on body weight, making it a promising alternative therapy for managing β-thalassemia.
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Article Synopsis
  • Luspatercept is a fusion protein that helps improve late-stage red blood cell development and has been studied in 260 patients with anemia from myelodysplastic syndromes.
  • The drug has predictable pharmacokinetics and its dosage varies from 0.125 to 1.75 mg/kg, with body weight being the main factor for determining the correct dose.
  • The findings indicate that higher serum levels of luspatercept improve the chances of patients achieving transfusion independence and experiencing fewer severe side effects, supporting a dose range of 1.0 to 1.75 mg/kg for effective long-term treatment.
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Background: Patients with transfusion-dependent β-thalassemia need regular red-cell transfusions. Luspatercept, a recombinant fusion protein that binds to select transforming growth factor β superfamily ligands, may enhance erythroid maturation and reduce the transfusion burden (the total number of red-cell units transfused) in such patients.

Methods: In this randomized, double-blind, phase 3 trial, we assigned, in a 2:1 ratio, adults with transfusion-dependent β-thalassemia to receive best supportive care plus luspatercept (at a dose of 1.

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Background: Patients with anemia and lower-risk myelodysplastic syndromes in whom erythropoiesis-stimulating agent therapy is not effective generally become dependent on red-cell transfusions. Luspatercept, a recombinant fusion protein that binds transforming growth factor β superfamily ligands to reduce SMAD2 and SMAD3 signaling, showed promising results in a phase 2 study.

Methods: In a double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients with very-low-risk, low-risk, or intermediate-risk myelodysplastic syndromes (defined according to the Revised International Prognostic Scoring System) with ring sideroblasts who had been receiving regular red-cell transfusions to receive either luspatercept (at a dose of 1.

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Background: In spite of its invasive nature and risks, kidney biopsy is currently required for precise diagnosis of many chronic kidney diseases (CKDs). Here, we explored the hypothesis that analysis of the urinary proteome can discriminate different types of CKD irrespective of the underlying mechanism of disease.

Methods: We used data from the proteome analyses of 1180 urine samples from patients with different types of CKD, generated by capillary electrophoresis coupled to mass spectrometry.

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Innovation in kidney diseases is not commensurate with the effect of these diseases on human health and mortality or innovation in other key therapeutic areas. A primary cause of the dearth in innovation is that kidney diseases disproportionately affect a demographic that is largely disenfranchised, lacking sufficient advocacy, public attention, and funding. A secondary and likely consequent cause is that the existing infrastructure supporting nephrology research pales in comparison with those for other internal medicine specialties, especially cardiology and oncology.

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Secondary hyperparathyroidism (SHPT) is one of the major complications of chronic kidney disease (CKD) and is associated with elevated serum intact parathyroid hormone (iPTH). Calcitriol, a non-selective vitamin D receptor agonist (VDRA) that suppresses iPTH is used for SHPT treatment, but its use is frequently complicated by hypercalcemia. Paricalcitol, a selective VDRA, demonstrated efficacy in iPTH suppression compared to maxacalcitol in a Phase 2 study (M11-609) in Japanese subjects.

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Background: A phase 3 randomized clinical trial was designed to test whether bardoxolone methyl, a nuclear factor erythroid-2-related factor 2 (Nrf2) activator, slows progression to end-stage renal disease in patients with stage 4 chronic kidney disease and type 2 diabetes mellitus. The trial was terminated because of an increase in heart failure in the bardoxolone methyl group; many of the events were clinically associated with fluid retention.

Methods And Results: We randomized 2,185 patients with type 2 diabetes mellitus (T2DM) and stage 4 chronic kidney disease (CKD) (estimated glomerular filtration rate 15 to <30 mL min(-1) 1.

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Background: Bardoxolone methyl, an Nrf2-activating and nuclear factor-κB-inhibiting semisynthetic oleanane triterpenoid compound, was evaluated in a phase 3 trial (BEACON) in patients with type 2 diabetes mellitus (T2DM) and stage 4 chronic kidney disease (CKD). The trial was terminated because of an increase in heart failure events in the bardoxolone methyl group, many of which appeared related to fluid retention. Thus, additional analyses were conducted to explain these serious adverse events.

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