BACKGROUND: We compared daily pain, home analgesic use, and utilization among ambulatory adults in the randomized multicenter study of hydroxyurea in sickle cell anemia (MSH). We related the fetal hemoglobin (HbF) hydroxyurea response to these response variables. METHODS: Patients rated their sickle cell pain intensity (0-9), use of analgesics, and visits for pain daily. Diaries were collected biweekly, and intensity was collapsed into single interval ratings. The interval proportions of days of analgesic use and medical visits for pain were also calculated. Group comparisons were made by intention to treat as well as by HbF change levels from baseline to 2 years of treatment (placebo and low, medium, high, or very high response). RESULTS:A total of 134 (44.8%) enrollees completed 2 years of follow-up. Pain intensity correlated with analgesic use (r = 0.83, P > 0.0001) and utilization (r = 0.50, P < 0.0001). Pain intensity was lower for patients on hydroxyurea (2.51 ± 0.062 vs 2.82 ± 0.063 placebo, F(1270) = 11.65, P = 0.0007). The difference, though small, appeared early and was sustained. Analgesic use and utilization were also slightly lower (analgesic use: F (1270) = 11.97, P = 0.0006; utilization: F(1270) = 32.0, P < 0.0001). Each was statistically significantly lower among hydroxyurea patients with higher HbF treatment responses to hydroxyurea. CONCLUSIONS:Hydroxyurea usage led to a small, statistically significant reduction in daily pain, analgesic use, and utilization in adults in MSH, corroborating previously shown larger reductions in crises and mortality. The degree of daily symptomatic reduction was related to the size of the HbF treatment response, further confirming HbF response as a useful laboratory correlate. Wiley Periodicals, Inc.
RCT Entities:
BACKGROUND: We compared daily pain, home analgesic use, and utilization among ambulatory adults in the randomized multicenter study of hydroxyurea in sickle cell anemia (MSH). We related the fetal hemoglobin (HbF) hydroxyurea response to these response variables. METHODS:Patients rated their sickle cell pain intensity (0-9), use of analgesics, and visits for pain daily. Diaries were collected biweekly, and intensity was collapsed into single interval ratings. The interval proportions of days of analgesic use and medical visits for pain were also calculated. Group comparisons were made by intention to treat as well as by HbF change levels from baseline to 2 years of treatment (placebo and low, medium, high, or very high response). RESULTS: A total of 134 (44.8%) enrollees completed 2 years of follow-up. Pain intensity correlated with analgesic use (r = 0.83, P > 0.0001) and utilization (r = 0.50, P < 0.0001). Pain intensity was lower for patients on hydroxyurea (2.51 ± 0.062 vs 2.82 ± 0.063 placebo, F(1270) = 11.65, P = 0.0007). The difference, though small, appeared early and was sustained. Analgesic use and utilization were also slightly lower (analgesic use: F (1270) = 11.97, P = 0.0006; utilization: F(1270) = 32.0, P < 0.0001). Each was statistically significantly lower among hydroxyureapatients with higher HbF treatment responses to hydroxyurea. CONCLUSIONS:Hydroxyurea usage led to a small, statistically significant reduction in daily pain, analgesic use, and utilization in adults in MSH, corroborating previously shown larger reductions in crises and mortality. The degree of daily symptomatic reduction was related to the size of the HbF treatment response, further confirming HbF response as a useful laboratory correlate. Wiley Periodicals, Inc.
Authors: Samir K Ballas; Robert L Bauserman; William F McCarthy; Oswaldo L Castro; Wally R Smith; Myron A Waclawiw Journal: Am J Hematol Date: 2010-08 Impact factor: 10.047
Authors: Otis W Brawley; Llewellyn J Cornelius; Linda R Edwards; Vanessa Northington Gamble; Bettye L Green; Charles E Inturrisi; Andra H James; Danielle Laraque; Magda H Mendez; Carolyn J Montoya; Brad H Pollock; Lawrence Robinson; Aaron P Scholnik; Melissa Schori Journal: NIH Consens State Sci Statements Date: 2008 Feb 27-29
Authors: Otis W Brawley; Llewellyn J Cornelius; Linda R Edwards; Vanessa Northington Gamble; Bettye L Green; Charles Inturrisi; Andra H James; Danielle Laraque; Magda Mendez; Carolyn J Montoya; Brad H Pollock; Lawrence Robinson; Aaron P Scholnik; Melissa Schori Journal: Ann Intern Med Date: 2008-05-05 Impact factor: 25.391
Authors: Martin H Steinberg; Franca Barton; Oswaldo Castro; Charles H Pegelow; Samir K Ballas; Abdullah Kutlar; Eugene Orringer; Rita Bellevue; Nancy Olivieri; James Eckman; Mala Varma; Gloria Ramirez; Brian Adler; Wally Smith; Timothy Carlos; Kenneth Ataga; Laura DeCastro; Carolyn Bigelow; Yogen Saunthararajah; Margaret Telfer; Elliott Vichinsky; Susan Claster; Susan Shurin; Kenneth Bridges; Myron Waclawiw; Duane Bonds; Michael Terrin Journal: JAMA Date: 2003-04-02 Impact factor: 56.272
Authors: Martin H Steinberg; William F McCarthy; Oswaldo Castro; Samir K Ballas; F Danny Armstrong; Wally Smith; Kenneth Ataga; Paul Swerdlow; Abdullah Kutlar; Laura DeCastro; Myron A Waclawiw Journal: Am J Hematol Date: 2010-06 Impact factor: 10.047
Authors: S Charache; G J Dover; R D Moore; S Eckert; S K Ballas; M Koshy; P F Milner; E P Orringer; G Phillips; O S Platt Journal: Blood Date: 1992-05-15 Impact factor: 22.113
Authors: Mark E Lowe; Marc T Goodman; Gregory A Coté; Marshall J Glesby; Mark Haupt; Nicholas J Schork; Vikesh K Singh; Dana K Andersen; Stephen J Pandol; Aliye Uc; David C Whitcomb Journal: Pancreas Date: 2018 Nov/Dec Impact factor: 3.327
Authors: Susan E Creary; Chase Beeman; Joseph Stanek; Kathryn King; Patrick T McGann; Sarah H O'Brien; Robert I Liem; Jane Holl; Sherif M Badawy Journal: Pediatr Blood Cancer Date: 2022-04-04 Impact factor: 3.838
Authors: Vivien A Sheehan; Jacy R Crosby; Aniko Sabo; Nicole A Mortier; Thad A Howard; Donna M Muzny; Shannon Dugan-Perez; Banu Aygun; Kerri A Nottage; Eric Boerwinkle; Richard A Gibbs; Russell E Ware; Jonathan M Flanagan Journal: PLoS One Date: 2014-10-31 Impact factor: 3.240