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From the Department of Psychiatry (B.A.F., J.G.K., K.M.C., E.P., I.S., J.C., H.A.S.), Department of Biostatistics (E.P.), Department of Neurology (C.B.B.), Department of Medicine (E.D., J.D.), and New York State Psychiatric Institute (B.A.F., J.G.K., K.M.C., E.P., I.S., J.C., H.A.S.), Columbia University, New York; and Department of Cell and Molecular Biology, University of Rhode Island, Kingston (D.R.N.).
Address correspondence and reprint requests to Dr Fallon, Columbia University, 1051 Riverside Drive, Unit 69, New York, NY 10032 baf1{at}columbia.edu
Background: Optimal treatment remains uncertain for patients with cognitive impairment that persists or returns after standard IV antibiotic therapy for Lyme disease.
Methods: Patients had well-documented Lyme disease, with at least 3 weeks of prior IV antibiotics, current positive IgG Western blot, and objective memory impairment. Healthy individuals served as controls for practice effects. Patients were randomly assigned to 10 weeks of double-masked treatment with IV ceftriaxone or IV placebo and then no antibiotic therapy. The primary outcome was neurocognitive performance at week 12—specifically, memory. Durability of benefit was evaluated at week 24. Group differences were estimated according to longitudinal mixed-effects models.
Results: After screening 3368 patients and 305 volunteers, 37 patients and 20 healthy individuals enrolled. Enrolled patients had mild to moderate cognitive impairment and marked levels of fatigue, pain, and impaired physical functioning. Across six cognitive domains, a significant treatment-by-time interaction favored the antibiotic-treated group at week 12. The improvement was generalized (not specific to domain) and moderate in magnitude, but it was not sustained to week 24. On secondary outcome, patients with more severe fatigue, pain, and impaired physical functioning who received antibiotics were improved at week 12, and this was sustained to week 24 for pain and physical functioning. Adverse events from either the study medication or the PICC line were noted among 6 of 23 (26.1%) patients given IV ceftriaxone and among 1 of 14 (7.1%) patients given IV placebo; these resolved without permanent injury.
Conclusion: IV ceftriaxone therapy results in short-term cognitive improvement for patients with posttreatment Lyme encephalopathy, but relapse in cognition occurs after the antibiotic is discontinued. Treatment strategies that result in sustained cognitive improvement are needed.
Abbreviations: CDC = Centers for Disease Control and Prevention; LMM = longitudinal mixed-effects models; NAART-R = North American Adult Reading Test-Revised; PCS = Physical Component Scale; ITT = intent-to-treat; VAS = visual analog scale; WMS-III = Wechsler Memory Scale.
Supplemental data at www.neurology.org
Editorial, page 986
e-Pub ahead of print on October 10, 2007, at www.neurology.org.
Primary location of research: Columbia University Medical Center, New York.
This study was funded by a grant from NINDS to Dr. Fallon (R01- NS38636).
Disclosure: Roche Pharmaceuticals supplied ceftriaxone free of charge for this study but were not involved in any other aspect of the study. Dr. Fallon has given expert testimony at hearings related to Lyme disease and its treatment. The other authors report no conflicts of interest.
Received February 12, 2006. Accepted in final form June 26, 2007.
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  P. W.B. Ricks, R. B. Stricker, L. Johnson JD, MBA, and J. J. Halperin PROLONGED LYME DISEASE TREATMENT: ENOUGH IS ENOUGH Neurology, October 21, 2008; 71(17): 1379 - 1381. [Full Text] [PDF]
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