Safety and efficacy of succimer in toddlers with blood lead levels of 20-44 μg/dL

W. J. Rogan, R. L. Bornschein, Jr Chisolm J.J., A. I. Damokosh, D. W. Dockery, M. E. Fay, R. L. Jones, G. G. Rhoads, N. B. Ragan, M. Salganik, D. F. Schwarz, J. H. Ware, R. P. Wedeen, Janet Rose Serwint, M. Brophy, C. T. Davoli, Martha Bridge Denckla, M. R. Farfel, Gary William Goldstein, J. RubinO. Berger, K. N. Dietrich, C. Wesolowski, S. Wilkins, G. Maynard-Wentzel, M. E. Mortensen, S. Adubato, M. Elsafty, M. Heenehan, A. Sheffet, A. Ty, C. Campbell, F. M. Gill, J. Guinn, F. Henretig, D. Knight, J. Radcliffe, D. F. Schwarz, B. B. Bowman, E. Gunter, D. Huff, D. T. Miller, D. C. Paschal, A. J. Bernstein, T. V. Kotlov, C. R. Angle, J. Faison, S. H. Gehlbach, B. Gray-Little, S. A. James, L. A. Moye, H. L. Needleman

Research output: Contribution to journalArticle

Abstract

Although lead encephalopathy has virtually disappeared from the United States, thousands of children still have sufficient lead exposure to produce cognitive impairment. It is not known whether treating children with blood lead levels <45 μg/dL (2.2 μM) is beneficial and can be done with acceptable safety. We conducted a 780-child, placebo-controlled, randomized trial of up to three courses of succimer in children with blood lead levels of 20-44 μg/dL (1.0-2.1 μM). Children were aged 12-33 mo, 77% were African-American, 7% were Hispanic, and they lived in deteriorating inner city housing. Placebo-treated children had a gradual decrease in blood lead level. Succimer-treated children had an abrupt drop in blood lead level, followed by rebound. The mean blood lead level of the succimer-treated children during the 6 mo after initiation of treatment was 4.5 μg/dL (95% confidence intervals, 3.7 to 5.3 μg/dL; 0.22 μM, 0.18 to 0.26 μM) lower than that of placebo-treated children. There were more scalp rashes in succimer-treated children (3.5% versus 1.3%) and an unanticipated excess of trauma. Succimer lowers blood lead level with few side effects. The unanticipated excess of trauma requires confirmation.

Original languageEnglish (US)
Pages (from-to)593-599
Number of pages7
JournalPediatric Research
Volume48
Issue number5
StatePublished - 2000
Externally publishedYes

Fingerprint

Succimer
Safety
Placebos
Wounds and Injuries
Brain Diseases
Exanthema
Scalp
Hispanic Americans
African Americans
Randomized Controlled Trials
Lead
Confidence Intervals

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Rogan, W. J., Bornschein, R. L., Chisolm J.J., J., Damokosh, A. I., Dockery, D. W., Fay, M. E., ... Needleman, H. L. (2000). Safety and efficacy of succimer in toddlers with blood lead levels of 20-44 μg/dL. Pediatric Research, 48(5), 593-599.

Safety and efficacy of succimer in toddlers with blood lead levels of 20-44 μg/dL. / Rogan, W. J.; Bornschein, R. L.; Chisolm J.J., Jr; Damokosh, A. I.; Dockery, D. W.; Fay, M. E.; Jones, R. L.; Rhoads, G. G.; Ragan, N. B.; Salganik, M.; Schwarz, D. F.; Ware, J. H.; Wedeen, R. P.; Serwint, Janet Rose; Brophy, M.; Davoli, C. T.; Denckla, Martha Bridge; Farfel, M. R.; Goldstein, Gary William; Rubin, J.; Berger, O.; Dietrich, K. N.; Wesolowski, C.; Wilkins, S.; Maynard-Wentzel, G.; Mortensen, M. E.; Adubato, S.; Elsafty, M.; Heenehan, M.; Sheffet, A.; Ty, A.; Campbell, C.; Gill, F. M.; Guinn, J.; Henretig, F.; Knight, D.; Radcliffe, J.; Schwarz, D. F.; Bowman, B. B.; Gunter, E.; Huff, D.; Miller, D. T.; Paschal, D. C.; Bernstein, A. J.; Kotlov, T. V.; Angle, C. R.; Faison, J.; Gehlbach, S. H.; Gray-Little, B.; James, S. A.; Moye, L. A.; Needleman, H. L.

In: Pediatric Research, Vol. 48, No. 5, 2000, p. 593-599.

Research output: Contribution to journalArticle

Rogan, WJ, Bornschein, RL, Chisolm J.J., J, Damokosh, AI, Dockery, DW, Fay, ME, Jones, RL, Rhoads, GG, Ragan, NB, Salganik, M, Schwarz, DF, Ware, JH, Wedeen, RP, Serwint, JR, Brophy, M, Davoli, CT, Denckla, MB, Farfel, MR, Goldstein, GW, Rubin, J, Berger, O, Dietrich, KN, Wesolowski, C, Wilkins, S, Maynard-Wentzel, G, Mortensen, ME, Adubato, S, Elsafty, M, Heenehan, M, Sheffet, A, Ty, A, Campbell, C, Gill, FM, Guinn, J, Henretig, F, Knight, D, Radcliffe, J, Schwarz, DF, Bowman, BB, Gunter, E, Huff, D, Miller, DT, Paschal, DC, Bernstein, AJ, Kotlov, TV, Angle, CR, Faison, J, Gehlbach, SH, Gray-Little, B, James, SA, Moye, LA & Needleman, HL 2000, 'Safety and efficacy of succimer in toddlers with blood lead levels of 20-44 μg/dL', Pediatric Research, vol. 48, no. 5, pp. 593-599.
Rogan WJ, Bornschein RL, Chisolm J.J. J, Damokosh AI, Dockery DW, Fay ME et al. Safety and efficacy of succimer in toddlers with blood lead levels of 20-44 μg/dL. Pediatric Research. 2000;48(5):593-599.
Rogan, W. J. ; Bornschein, R. L. ; Chisolm J.J., Jr ; Damokosh, A. I. ; Dockery, D. W. ; Fay, M. E. ; Jones, R. L. ; Rhoads, G. G. ; Ragan, N. B. ; Salganik, M. ; Schwarz, D. F. ; Ware, J. H. ; Wedeen, R. P. ; Serwint, Janet Rose ; Brophy, M. ; Davoli, C. T. ; Denckla, Martha Bridge ; Farfel, M. R. ; Goldstein, Gary William ; Rubin, J. ; Berger, O. ; Dietrich, K. N. ; Wesolowski, C. ; Wilkins, S. ; Maynard-Wentzel, G. ; Mortensen, M. E. ; Adubato, S. ; Elsafty, M. ; Heenehan, M. ; Sheffet, A. ; Ty, A. ; Campbell, C. ; Gill, F. M. ; Guinn, J. ; Henretig, F. ; Knight, D. ; Radcliffe, J. ; Schwarz, D. F. ; Bowman, B. B. ; Gunter, E. ; Huff, D. ; Miller, D. T. ; Paschal, D. C. ; Bernstein, A. J. ; Kotlov, T. V. ; Angle, C. R. ; Faison, J. ; Gehlbach, S. H. ; Gray-Little, B. ; James, S. A. ; Moye, L. A. ; Needleman, H. L. / Safety and efficacy of succimer in toddlers with blood lead levels of 20-44 μg/dL. In: Pediatric Research. 2000 ; Vol. 48, No. 5. pp. 593-599.
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abstract = "Although lead encephalopathy has virtually disappeared from the United States, thousands of children still have sufficient lead exposure to produce cognitive impairment. It is not known whether treating children with blood lead levels <45 μg/dL (2.2 μM) is beneficial and can be done with acceptable safety. We conducted a 780-child, placebo-controlled, randomized trial of up to three courses of succimer in children with blood lead levels of 20-44 μg/dL (1.0-2.1 μM). Children were aged 12-33 mo, 77{\%} were African-American, 7{\%} were Hispanic, and they lived in deteriorating inner city housing. Placebo-treated children had a gradual decrease in blood lead level. Succimer-treated children had an abrupt drop in blood lead level, followed by rebound. The mean blood lead level of the succimer-treated children during the 6 mo after initiation of treatment was 4.5 μg/dL (95{\%} confidence intervals, 3.7 to 5.3 μg/dL; 0.22 μM, 0.18 to 0.26 μM) lower than that of placebo-treated children. There were more scalp rashes in succimer-treated children (3.5{\%} versus 1.3{\%}) and an unanticipated excess of trauma. Succimer lowers blood lead level with few side effects. The unanticipated excess of trauma requires confirmation.",
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T1 - Safety and efficacy of succimer in toddlers with blood lead levels of 20-44 μg/dL

AU - Rogan, W. J.

AU - Bornschein, R. L.

AU - Chisolm J.J., Jr

AU - Damokosh, A. I.

AU - Dockery, D. W.

AU - Fay, M. E.

AU - Jones, R. L.

AU - Rhoads, G. G.

AU - Ragan, N. B.

AU - Salganik, M.

AU - Schwarz, D. F.

AU - Ware, J. H.

AU - Wedeen, R. P.

AU - Serwint, Janet Rose

AU - Brophy, M.

AU - Davoli, C. T.

AU - Denckla, Martha Bridge

AU - Farfel, M. R.

AU - Goldstein, Gary William

AU - Rubin, J.

AU - Berger, O.

AU - Dietrich, K. N.

AU - Wesolowski, C.

AU - Wilkins, S.

AU - Maynard-Wentzel, G.

AU - Mortensen, M. E.

AU - Adubato, S.

AU - Elsafty, M.

AU - Heenehan, M.

AU - Sheffet, A.

AU - Ty, A.

AU - Campbell, C.

AU - Gill, F. M.

AU - Guinn, J.

AU - Henretig, F.

AU - Knight, D.

AU - Radcliffe, J.

AU - Schwarz, D. F.

AU - Bowman, B. B.

AU - Gunter, E.

AU - Huff, D.

AU - Miller, D. T.

AU - Paschal, D. C.

AU - Bernstein, A. J.

AU - Kotlov, T. V.

AU - Angle, C. R.

AU - Faison, J.

AU - Gehlbach, S. H.

AU - Gray-Little, B.

AU - James, S. A.

AU - Moye, L. A.

AU - Needleman, H. L.

PY - 2000

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N2 - Although lead encephalopathy has virtually disappeared from the United States, thousands of children still have sufficient lead exposure to produce cognitive impairment. It is not known whether treating children with blood lead levels <45 μg/dL (2.2 μM) is beneficial and can be done with acceptable safety. We conducted a 780-child, placebo-controlled, randomized trial of up to three courses of succimer in children with blood lead levels of 20-44 μg/dL (1.0-2.1 μM). Children were aged 12-33 mo, 77% were African-American, 7% were Hispanic, and they lived in deteriorating inner city housing. Placebo-treated children had a gradual decrease in blood lead level. Succimer-treated children had an abrupt drop in blood lead level, followed by rebound. The mean blood lead level of the succimer-treated children during the 6 mo after initiation of treatment was 4.5 μg/dL (95% confidence intervals, 3.7 to 5.3 μg/dL; 0.22 μM, 0.18 to 0.26 μM) lower than that of placebo-treated children. There were more scalp rashes in succimer-treated children (3.5% versus 1.3%) and an unanticipated excess of trauma. Succimer lowers blood lead level with few side effects. The unanticipated excess of trauma requires confirmation.

AB - Although lead encephalopathy has virtually disappeared from the United States, thousands of children still have sufficient lead exposure to produce cognitive impairment. It is not known whether treating children with blood lead levels <45 μg/dL (2.2 μM) is beneficial and can be done with acceptable safety. We conducted a 780-child, placebo-controlled, randomized trial of up to three courses of succimer in children with blood lead levels of 20-44 μg/dL (1.0-2.1 μM). Children were aged 12-33 mo, 77% were African-American, 7% were Hispanic, and they lived in deteriorating inner city housing. Placebo-treated children had a gradual decrease in blood lead level. Succimer-treated children had an abrupt drop in blood lead level, followed by rebound. The mean blood lead level of the succimer-treated children during the 6 mo after initiation of treatment was 4.5 μg/dL (95% confidence intervals, 3.7 to 5.3 μg/dL; 0.22 μM, 0.18 to 0.26 μM) lower than that of placebo-treated children. There were more scalp rashes in succimer-treated children (3.5% versus 1.3%) and an unanticipated excess of trauma. Succimer lowers blood lead level with few side effects. The unanticipated excess of trauma requires confirmation.

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