Phase 2b Trial of a NaV1.8 inhibitor for acute pain (Registro nro. 22752)
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| 000 -Cabecera | |
|---|---|
| Campo de control interno | 03448nam a2200313 4500 |
| 001 - Número de control | |
| control field | ESSALUD |
| 007 - Tipo material - Descripcion fisica - info general | |
| Tipo material - Descripcion fisica - info general | ta |
| 008 - Elementos de Longitud Fija - Información General | |
| Elementos de Longitud Fija - Información | t pe ||||| |||| 00| 0 spa d |
| 040 ## - Origen de la Catalogación | |
| Origen de la Catalogación | BMG |
| 041 ## - Idioma | |
| Idioma | spa |
| 100 ## - Autor | |
| Autor | Singla, Neil |
| Rol del Autor | Autor |
| 9 (RLIN) | 53819 |
| 245 ## - Titulo | |
| Titulo | Phase 2b Trial of a NaV1.8 inhibitor for acute pain |
| 300 ## - Páginas | |
| Paginación | páginas: 454-464 |
| 520 ## - Resumen | |
| Resumen | Background: Nav1.8, a voltage-gated sodium channel expressed in the peripheral nervous system, has a critical role in pain signaling. Previous trials of NaV1.8 inhibitors have shown effectiveness in reducing postoperative pain. Methods: We conducted a phase 2b, double-blind, randomized, placebo-controlled trial to evaluate LTG-001, a selective Nav1.8 inhibitor, in patients with moderate-to-severe pain after abdominoplasty. Patients were randomly assigned in a 1:1:1:1 ratio to receive a 300-mg loading dose of LTG-001, followed by 150 mg every 12 hours (low-dose group); a 450-mg loading dose of LTG-001, followed by 300 mg every 12 hours (high-dose group); hydrocodone bitartrate–acetaminophen (5 mg of hydrocodone bitartrate and 325 mg of acetaminophen) every 6 hours; or placebo every 6 hours. All doses were administered orally over a 48-hour period. The primary end point was the time-weighted sum of the pain-intensity difference (SPID) over the 48-hour treatment period (SPID48), based on scores on the Numeric Pain Rating Scale (range, 0 to 10, with higher values indicating more severe pain; higher SPID48 values indicate greater pain reduction). Secondary end points included the amount of opioid rescue medication consumed in morphine milligram equivalents (MME) and no receipt of opioid rescue medication.<br/>Results: A total of 343 patients underwent randomization. The least-squares mean SPID48 was 161.05 (95% confidence interval [CI], 142.93 to 179.16) in the low-dose group, 185.30 (95% CI, 167.26 to 203.34) in the high-dose group, 164.08 (95% CI, 146.02 to 182.14) in the hydrocodone bitartrate–acetaminophen group, and 123.22 (95% CI, 105.23 to 141.21) in the placebo group. The least-squares mean difference in the SPID48 between LTG-001 and placebo was significant for each dose (low dose: 37.82 [P=0.003]; high dose: 62.08 [P<0.001]), and that between hydrocodone bitartrate–acetaminophen and placebo was 40.86. High-dose LTG-001, but not low-dose LTG-001, was associated with significantly lower opioid use than placebo (11.00 MME vs. 18.35 MME, P=0.01), as well as a significantly higher percentage of patients who received no opioid rescue medication (52% vs. 22%, P<0.001). High-dose LTG-001 was associated with a higher incidence of pyrexia than placebo (7% vs. 2%) and a higher incidence of presyncope (6% vs. 1%).<br/>Conclusions: LTG-001 led to significantly greater reductions in pain scores than placebo over the course of 48 hours after abdominoplasty. |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | DERMATOLOGÍA |
| 9 (RLIN) | 7479 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | MEDICINA DE URGENCIAS |
| 9 (RLIN) | 53820 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | NEUROLOGÍA |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | OBSTETRICIA |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | OFTALMOLOGÍA |
| 9 (RLIN) | 32364 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | ORTOPEDIA |
| 9 (RLIN) | 25652 |
| 700 ## - Autor Personal | |
| Autor Personal | P. Katz, Nathaniel |
| 9 (RLIN) | 53821 |
| 700 ## - Autor Personal | |
| Autor Personal | Vaughn, Ben |
| 9 (RLIN) | 53822 |
| 700 ## - Autor Personal | |
| Autor Personal | Rogier, Timothy |
| 9 (RLIN) | 53823 |
| 700 ## - Autor Personal | |
| Autor Personal | Bertoch, Todd |
| 9 (RLIN) | 53824 |
| 700 ## - Autor Personal | |
| Autor Personal | Minkowitz, Harold |
| 9 (RLIN) | 53825 |
| 700 ## - Autor Personal | |
| Autor Personal | Loflin, Mallory |
| 9 (RLIN) | 53826 |
| 773 0# - Revista (Relacion con el numero) | |
| Host Biblionumber | 22717 |
| Host Itemnumber | 22638 |
| Ciudad, Editorial | Massachusetts NEJM Group |
| Codigo barras item/ejemplar | NEJM005 |
| Titulo de la Revista | The New England Journal of Medicine |
| Número de control de registro | ESSALUD |
| ISSN | 0028-4793 |
| 942 ## - Elementos de Koha | |
| Tipo de Documento | Artículos |
| Fecha procesamiento | 2026-07-31 |
| Catalogador | SQB |
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