RheothRx (Poloxamer 188) injection for the acute painful episode of sickle cell disease

A pilot study

Patricia Adams-Graves, Amos Kedar, Mabel Koshy, Martin Steinberg, Robert Veith, Daniel Ward, Rebekah Crawford, Suzanne Edwards, James Bustrack, Martin Emanuele

Research output: Contribution to journalArticle

85 Citations (Scopus)

Abstract

RheothRx (Glaxo Wellcome Inc, Research Triangle Park, NC; poloxamer 188) Injection is a nonionic surfactant with hemorrheologic properties that suggest it may be useful in treating acute painful episodes (vasoocclusive crises) of sickle cell disease (SCD). We conducted a randomized, double- blind, placebo-controlled pilot study to evaluate the safety and efficacy of poloxamer, formulated as RheothRx Injection, in 50 patients with SCD. Patients with moderate to severe painful episodes requiring parenteral analgesics were randomized to receive a 48-hour infusion of either RheothRx or placebo. Pain was assessed every 4 hours. Efficacy endpoints included: (1) painful episode duration, (2) days of hospitalization, (3) quantity of analgesics used, and (4) pain intensity scores. Three subgroups of patients were considered for efficacy analyses based on the actual duration of the study drug infusion and the completeness of pain score data collection. Compared with placebo and depending on the subgroup, RheothRx-treated patients showed a 16% to 45% decrease in duration of painful episodes, a 1 - to 2-day reduction in hospital stay, a threefold to fivefold reduction in analgesic requirements, and a 1-point reduction (using a 5-point scale) in average pain intensity scores at 72 hours. RheothRx was well tolerated; no clinically significant differences were observed between treatments with respect to adverse experiences or other safety measures. In addition, there were no differences between treatment groups in the incidence of recurrent painful episodes. In this study, RheothRx significantly reduced total analgesic use and pain intensity and showed trends to shorter duration of painful episodes and total days of hospitalization. In patients with moderate to severe vasoocclusive pain, RheothRx was safe and may offer a therapeutic benefit.

Original languageEnglish (US)
Pages (from-to)2041-2046
Number of pages6
JournalBlood
Volume90
Issue number5
StatePublished - Sep 1 1997

Fingerprint

Poloxamer
Sickle Cell Anemia
Analgesics
Pain
Injections
Drug infusion
Placebos
Nonionic surfactants
Hospitalization
Safety
Surface-Active Agents
Length of Stay
Therapeutics
Incidence
Research
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

Cite this

Adams-Graves, P., Kedar, A., Koshy, M., Steinberg, M., Veith, R., Ward, D., ... Emanuele, M. (1997). RheothRx (Poloxamer 188) injection for the acute painful episode of sickle cell disease: A pilot study. Blood, 90(5), 2041-2046.

RheothRx (Poloxamer 188) injection for the acute painful episode of sickle cell disease : A pilot study. / Adams-Graves, Patricia; Kedar, Amos; Koshy, Mabel; Steinberg, Martin; Veith, Robert; Ward, Daniel; Crawford, Rebekah; Edwards, Suzanne; Bustrack, James; Emanuele, Martin.

In: Blood, Vol. 90, No. 5, 01.09.1997, p. 2041-2046.

Research output: Contribution to journalArticle

Adams-Graves, P, Kedar, A, Koshy, M, Steinberg, M, Veith, R, Ward, D, Crawford, R, Edwards, S, Bustrack, J & Emanuele, M 1997, 'RheothRx (Poloxamer 188) injection for the acute painful episode of sickle cell disease: A pilot study', Blood, vol. 90, no. 5, pp. 2041-2046.
Adams-Graves P, Kedar A, Koshy M, Steinberg M, Veith R, Ward D et al. RheothRx (Poloxamer 188) injection for the acute painful episode of sickle cell disease: A pilot study. Blood. 1997 Sep 1;90(5):2041-2046.
Adams-Graves, Patricia ; Kedar, Amos ; Koshy, Mabel ; Steinberg, Martin ; Veith, Robert ; Ward, Daniel ; Crawford, Rebekah ; Edwards, Suzanne ; Bustrack, James ; Emanuele, Martin. / RheothRx (Poloxamer 188) injection for the acute painful episode of sickle cell disease : A pilot study. In: Blood. 1997 ; Vol. 90, No. 5. pp. 2041-2046.
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