TY - JOUR
T1 - Efficacy and safety of 4-aminopyridine in patients with long-term spinal cord injury
T2 - A randomized, double-blind, placebo-controlled trial
AU - Grijalva, Israel
AU - Guízar-Sahagún, Gabriel
AU - Castañeda-Hernández, Gilberto
AU - Mino, Dolores
AU - Maldonado-Julián, Héctor
AU - Vidal-Cantú, Guadalupe
AU - Ibarra, Antonio
AU - Serra, Omar
AU - Salgado-Ceballos, Hermelinda
AU - Arenas-Hernández, Rita
PY - 2003/7/1
Y1 - 2003/7/1
N2 - Objectives. To study the efficacy and safety of 4-aminopyridine (4-AP), and to document sensorimotor changes after discontinuation of the drug in patients with long-term spinal cord injury. Design. Randomized, double-blind, placebo-controlled trial. Setting. Clinical research unit. Patients. Twenty-seven patients with long-term spinal cord injury. Intervention. Patients were randomized to receive either oral 4-AP 5 mg/day, which was increased by 5 mg/week to a maximum dosage of 30 mg/day, or placebo for 12 weeks. They switched to the opposite treatment for the next 12 weeks. Measurements and Main Results. Twenty-five patients finished the study. The results from the first 12 weeks were used to test efficacy. Positive gains in motor function, sensation, and independence occurred more frequently in patients receiving 4-AP (69%) than those receiving placebo (46%). Significant functional improvement was also noted in those treated with 4-AP (Χ2, p=0.042). When each evaluation scale was considered separately, significant improvement was seen only in motor function (4-AP 92% vs placebo 46%, Fisher exact test, p=0.03). Persistent effects of the drug were assessed at week 24 in the group that initially received 4-AP. A persistent, significant 4-AP effect was observed in evaluations of sensation and independence (67% and 83% of patients, respectively; Wilcoxon signed rank test, p=0.032 and 0.042, respectively). Fourteen (56%) patients had 26 adverse reactions. One moderate adverse reaction - posterior tibial artery vasospasm - and 25 mild adverse reactions, such as dry mouth, dizziness, nausea, gastritis, oral and peripheral paresthesia, resolved adequately. Six (24%) patients experienced transitory alterations of enzyme levels (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and creatine kinase) and thrombocytopenia. Conclusion. Patients who received 4-AP showed significant improvement in motor function, and a persistent effect on sensation and independent function occurred. The drug is safe; however, after starting 4-AP therapy, patients must be carefully monitored for the possible occurrence of peripheral vasospasm.
AB - Objectives. To study the efficacy and safety of 4-aminopyridine (4-AP), and to document sensorimotor changes after discontinuation of the drug in patients with long-term spinal cord injury. Design. Randomized, double-blind, placebo-controlled trial. Setting. Clinical research unit. Patients. Twenty-seven patients with long-term spinal cord injury. Intervention. Patients were randomized to receive either oral 4-AP 5 mg/day, which was increased by 5 mg/week to a maximum dosage of 30 mg/day, or placebo for 12 weeks. They switched to the opposite treatment for the next 12 weeks. Measurements and Main Results. Twenty-five patients finished the study. The results from the first 12 weeks were used to test efficacy. Positive gains in motor function, sensation, and independence occurred more frequently in patients receiving 4-AP (69%) than those receiving placebo (46%). Significant functional improvement was also noted in those treated with 4-AP (Χ2, p=0.042). When each evaluation scale was considered separately, significant improvement was seen only in motor function (4-AP 92% vs placebo 46%, Fisher exact test, p=0.03). Persistent effects of the drug were assessed at week 24 in the group that initially received 4-AP. A persistent, significant 4-AP effect was observed in evaluations of sensation and independence (67% and 83% of patients, respectively; Wilcoxon signed rank test, p=0.032 and 0.042, respectively). Fourteen (56%) patients had 26 adverse reactions. One moderate adverse reaction - posterior tibial artery vasospasm - and 25 mild adverse reactions, such as dry mouth, dizziness, nausea, gastritis, oral and peripheral paresthesia, resolved adequately. Six (24%) patients experienced transitory alterations of enzyme levels (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and creatine kinase) and thrombocytopenia. Conclusion. Patients who received 4-AP showed significant improvement in motor function, and a persistent effect on sensation and independent function occurred. The drug is safe; however, after starting 4-AP therapy, patients must be carefully monitored for the possible occurrence of peripheral vasospasm.
UR - http://www.scopus.com/inward/record.url?scp=0038043570&partnerID=8YFLogxK
U2 - 10.1592/phco.23.7.823.32731
DO - 10.1592/phco.23.7.823.32731
M3 - Artículo
C2 - 12885095
AN - SCOPUS:0038043570
SN - 0277-0008
VL - 23
SP - 823
EP - 834
JO - Pharmacotherapy
JF - Pharmacotherapy
IS - 7
ER -