South Florida Clinical Research Center, Hollywood, FL, USA.
Curr Med Res Opin. 2010 Jan;26(1):91-9. doi: 10.1185/03007990903382428.
Carisoprodol, a centrally active skeletal muscle relaxant, is widely used for the treatment of acute, painful musculoskeletal disorders. When administered at a dose of 350 mg four times daily, carisoprodol demonstrated significant clinical benefit in its early clinical development trials; however, some unfavorable side effects, such as drowsiness and dizziness, were reported. Recently, research was conducted to determine if a lower dose of carisoprodol would retain efficacy but improve tolerability compared to the higher 350-mg dose.
The purpose of this multicenter study was to compare the efficacy and safety of carisoprodol 250-mg tablets four times daily to 350-mg tablets four times daily and to placebo in patients with acute, painful musculoskeletal spasm of the lower back.
In this 1-week double-blind, placebo-controlled, parallel-group multicenter trial, patients 18 to 65 years of age with moderate to severe back spasm were randomly assigned to treatment with carisoprodol 250-mg tablets (n = 264), 350-mg tablets (n = 273), or matching placebo tablets (n = 269) three times daily and at bedtime.
The coprimary efficacy variables were patient-rated relief from starting backache and patient-rated global impression of change assessed on treatment day 3.
The carisoprodol 250-mg regimen was significantly more effective than placebo as assessed by both patient-rated relief from starting backache (p = 0.0001) and patient-rated global impression of change (p = 0.0046). There were no significant differences between the 250-mg and 350-mg dosages for the coprimary efficacy endpoints, and patients improved with or without sedation. Fewer than 1% of patients in the carisoprodol 250-mg group discontinued prematurely because of treatment-emergent adverse events, and no patient discontinued because of drowsiness.
When administered three times daily and at bedtime, carisoprodol 250 mg was as effective as 350 mg three times daily and at bedtime with a lower incidence of adverse events and fewer discontinuations of therapy due to adverse events. Patients improved whether or not they reported sedation as an adverse event.
卡立普多是一种中枢性骨骼肌松弛剂，广泛用于治疗急性、疼痛性肌肉骨骼疾病。在早期临床开发试验中，卡立普多以 350 毫克，每日四次的剂量给药时显示出显著的临床益处；然而，据报道，一些不利的副作用，如嗜睡和头晕。最近，研究旨在确定较低剂量的卡立普多是否会保留疗效，但改善耐受性与较高的 350 毫克剂量相比。
本多中心研究的目的是比较卡立普多 250 毫克片剂，每日四次与 350 毫克片剂，每日四次与安慰剂在治疗急性、疼痛性肌肉骨骼痉挛的下背部的患者中的疗效和安全性。
在这项为期 1 周的双盲、安慰剂对照、平行组多中心试验中，年龄在 18 至 65 岁之间的中度至重度背部痉挛患者被随机分配接受卡立普多 250 毫克片剂（n = 264）、350 毫克片剂（n = 273）或匹配的安慰剂片剂（n = 269），每日三次和睡前。
主要疗效变量是患者报告的开始背痛缓解和患者报告的治疗第 3 天的总体印象变化。
卡立普多 250 毫克治疗方案在患者报告的开始背痛缓解（p = 0.0001）和患者报告的总体印象变化（p = 0.0046）方面均显著优于安慰剂。两种主要疗效终点的 250 毫克和 350 毫克剂量之间没有显著差异，患者无论是否有镇静作用都有改善。卡立普多 250 毫克组中少于 1%的患者因治疗出现的不良事件提前停药，没有患者因嗜睡而停药。
当每日三次和睡前服用时，卡立普多 250 毫克与每日三次和睡前服用 350 毫克一样有效，不良反应发生率较低，因不良反应导致治疗中断的患者较少。无论患者是否报告镇静作为不良反应，患者都有所改善。
