TY - JOUR
T1 - A double-blind, parallel-group, placebo-controlled, multicentre study of acetyl l-carnitine in the symptomatic treatment of antiretroviral toxic neuropathy in patients with HIV-1 infection
AU - Youle, Mike
AU - Osio, Maurizio
AU - Cassetti, Isabel
AU - Bologna, Rosa
AU - Zala, Carlos
AU - Losso, Marcelo
AU - Lourtau, Leonardo
AU - Defanti, Carlo Alberto
AU - Causarano, Ignazio Renzo
AU - Di Palma, Franco
AU - Landonio, Simona
AU - Muscia, Francesco
AU - Scarpini, Elio
AU - De Riz, Milena
AU - Porazzi, Daniele
AU - La Spina, Isidoro
AU - Ubiali, Emilio
AU - Foresti, Camillo
AU - Pastore, Giuseppe
AU - Maggi, Paolo
AU - Colomba, Angelo
AU - Fundarò, Salvatore
AU - Pizzigallo, Eligio
AU - D'Alessandro, Margherita
AU - Dini, Marco
AU - Cingolati, Marco
AU - Di Gregorio, Pietro
AU - Bollo, Mario
AU - Patti, Francesco
AU - Pantò, Grazia
AU - Calvani, Menotti
AU - Iannuccelli, Maurizio
AU - Levy, Itzchak
AU - Burke, Michael
AU - Werner, Ben
AU - Portegies, Peter
AU - Weber, Jonathan
AU - Sharma, Ramesh
AU - Wilkins, Edmund
AU - Bonnington, Alec
AU - Johnson, Margaret
AU - Sabin, Caroline
PY - 2007/5
Y1 - 2007/5
N2 - Background: Nucleoside reverse transcriptase inhibitors (NRTIs) disrupt neuronal mitochondrial DNA synthesis, resulting in antiretroviral toxic neuropathy (ATN). Acetyl-l-carnitine (ALCAR) enhances neurotrophic support of sensory neurones, potentially providing symptom relief and nerve regeneration. Objective: The objective of the study was to assess the safety and efficacy compared to placebo of intramuscular ALCAR in HIV-positive patients with symptomatic distal symmetrical polyneuropathy. Methods: Ninety patients were enrolled and randomized to receive ALCAR [500 mg twice a day (bid); n = 43] or placebo (n = 47) intramuscularly twice daily for 14 days followed by 42 days of oral ALCAR 1000 mg bid. Assessment of pain was obtained using the Visual Analogue Scale (VAS), Total Symptom Score (TSS), Clinical Global Impression of Change, McGill Pain Questionnaire (MPQ), and the need for rescue analgesics. Results: There was no statistically significant difference in changes in VAS over 14 days between groups for the intent-to-treat (ITT) population, but for the efficacy-evaluable (EE) population ALCAR treatment produced a significantly greater reduction in pain compared with placebo (P = 0.022). The proportion of patients with an improvement in TSS over 14 days was greater in the ALCAR group compared with the placebo group, but the differences were not statistically significant. During the open-label phase, patients experienced an improvement in pain, as measured by the VAS, TSS and McGill Pain Questionnaire. Conclusion: ALCAR, administered twice a day intramuscularly to HIV-1-infected patients with symptomatic ATN, significantly reduced weekly mean pain ratings on the VAS compared with placebo. Treatment with oral ALCAR improved symptoms for the patient group as a whole. Intramuscular and oral ALCAR was generally safe and well tolerated.
AB - Background: Nucleoside reverse transcriptase inhibitors (NRTIs) disrupt neuronal mitochondrial DNA synthesis, resulting in antiretroviral toxic neuropathy (ATN). Acetyl-l-carnitine (ALCAR) enhances neurotrophic support of sensory neurones, potentially providing symptom relief and nerve regeneration. Objective: The objective of the study was to assess the safety and efficacy compared to placebo of intramuscular ALCAR in HIV-positive patients with symptomatic distal symmetrical polyneuropathy. Methods: Ninety patients were enrolled and randomized to receive ALCAR [500 mg twice a day (bid); n = 43] or placebo (n = 47) intramuscularly twice daily for 14 days followed by 42 days of oral ALCAR 1000 mg bid. Assessment of pain was obtained using the Visual Analogue Scale (VAS), Total Symptom Score (TSS), Clinical Global Impression of Change, McGill Pain Questionnaire (MPQ), and the need for rescue analgesics. Results: There was no statistically significant difference in changes in VAS over 14 days between groups for the intent-to-treat (ITT) population, but for the efficacy-evaluable (EE) population ALCAR treatment produced a significantly greater reduction in pain compared with placebo (P = 0.022). The proportion of patients with an improvement in TSS over 14 days was greater in the ALCAR group compared with the placebo group, but the differences were not statistically significant. During the open-label phase, patients experienced an improvement in pain, as measured by the VAS, TSS and McGill Pain Questionnaire. Conclusion: ALCAR, administered twice a day intramuscularly to HIV-1-infected patients with symptomatic ATN, significantly reduced weekly mean pain ratings on the VAS compared with placebo. Treatment with oral ALCAR improved symptoms for the patient group as a whole. Intramuscular and oral ALCAR was generally safe and well tolerated.
KW - Acetyl-l-carnitine
KW - Antiretroviral toxic neuropathy
KW - HIV
KW - Neuropathy
KW - Reverse transcriptase inhibitors
UR - http://www.scopus.com/inward/record.url?scp=34247873189&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34247873189&partnerID=8YFLogxK
U2 - 10.1111/j.1468-1293.2007.00467.x
DO - 10.1111/j.1468-1293.2007.00467.x
M3 - Article
C2 - 17461852
AN - SCOPUS:34247873189
VL - 8
SP - 241
EP - 250
JO - HIV Medicine
JF - HIV Medicine
SN - 1464-2662
IS - 4
ER -