000			03448nam a2200313 4500
001			ESSALUD
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008			t pe ||||| |||| 00| 0 spa d
040			_aBMG
041			_aspa
100			_aSingla, Neil _eAutor _953819
245			_aPhase 2b Trial of a NaV1.8 inhibitor for acute pain
300			_apáginas: 454-464
520			_aBackground: 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. 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%). Conclusions: LTG-001 led to significantly greater reductions in pain scores than placebo over the course of 48 hours after abdominoplasty.
650			_aDERMATOLOGÍA _97479
650			_aMEDICINA DE URGENCIAS _953820
650			_aNEUROLOGÍA
650			_aOBSTETRICIA
650			_aOFTALMOLOGÍA _932364
650			_aORTOPEDIA _925652
700			_aP. Katz, Nathaniel _953821
700			_aVaughn, Ben _953822
700			_aRogier, Timothy _953823
700			_aBertoch, Todd _953824
700			_aMinkowitz, Harold _953825
700			_aLoflin, Mallory _953826
773	0		_022717 _922638 _dMassachusetts NEJM Group _oNEJM005 _tThe New England Journal of Medicine _wESSALUD _x0028-4793
942			_cARTICULOS _e2026-07-31 _zSQB
999			_c22752 _d22752