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A Phase 3 Randomized Trial of Voxelotor in Sickle Cell Disease

by Nduba, Videlis , Ataga, Kenneth I , Achebe, Maureen M , Tonda, Margaret , Intondi, Allison , Howard, Jo , Abboud, Miguel R , Telfer, Paul , Vichinsky, Elliott , Tong, Barbara , Brown, R. Clark , Ware, Russell E , Tsitsikas, Dimitris A , Diuguid, David L , Lehrer-Graiwer, Joshua , El-Beshlawy, Amal , Hoppe, Carolyn C , Alkindi, Salam , Hassab, Hoda , Elghandour, Ashraf , Kanter, Julie , Gordeuk, Victor R

in Adults / Age / Anemia / Bilirubin / Drug dosages / Evidence-based medicine / FDA approval / Hemoglobin / Hydroxyurea / Laboratories / Oral administration / Pathophysiology / Pharmaceuticals / Polymerization / Reticulocytes / Sickle cell disease / Thalassemia

2019

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A Phase 3 Randomized Trial of Voxelotor in Sickle Cell Disease

2019

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A Phase 3 Randomized Trial of Voxelotor in Sickle Cell Disease

2019

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Journal Article

A Phase 3 Randomized Trial of Voxelotor in Sickle Cell Disease

Nduba, Videlis,

Ataga, Kenneth I,

Achebe, Maureen M,

Tonda, Margaret,

Intondi, Allison,

Howard, Jo,

Abboud, Miguel R,

Telfer, Paul,

Vichinsky, Elliott,

Tong, Barbara,

Brown, R. Clark,

Ware, Russell E,

Tsitsikas, Dimitris A,

Diuguid, David L,

Lehrer-Graiwer, Joshua,

El-Beshlawy, Amal,

Hoppe, Carolyn C,

Alkindi, Salam,

Hassab, Hoda,

Elghandour, Ashraf,

Kanter, Julie,

Gordeuk, Victor R

2019

Overview

In a trial evaluating two daily-dose levels of voxelotor, which binds to sickle hemoglobin and prevents polymerization under hypoxic conditions, hemoglobin levels increased by more than 1 g per deciliter in approximately half the patients who received the drug, and markers of hemolysis decreased. Toxic effects were mainly low grade and not different from those with placebo.

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Publisher

Massachusetts Medical Society

Subject

Adults

/ Age

/ Anemia

/ Bilirubin

/ Drug dosages

/ Evidence-based medicine

/ FDA approval