Efficacy and safety of twice‐daily tramadol hydrochloride bilayer sustained‐release tablets with an immediate release component for postherpetic neuralgia: Results of a Phase III, randomized, double‐blind, placebo‐controlled, treatment‐withdrawal study
Background: We investigated the efficacy and safety of twice‐daily bilayer sustained‐release tramadol hydrochloride tablets (35% immediate‐release; 65% sustained‐release) in patients with postherpetic neuralgia. Methods: This was a Phase III treatment‐withdrawal study with 1–4‐week dose‐escalation,...
| Publicado en: | Pain Practice Vol. 23; no. 3; pp. 277 - 290 |
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| Autores principales: | , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Wiley-Blackwell
Mar2023
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=162267842&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 162267842 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15307085 HYN jtl: Pain Practice issn: 15307085 maglogo: Y pubinfo: dt: Mar2023 vid: 23 iid: 3 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 162267842 160951954 162267842 162267842 10.1111/papr.13190 162267842 ppf: 277 ppct: 13 formats: fmt: – @attributes: type: T – @attributes: type: C – @attributes: type: P tig: atl: Efficacy and safety of twice‐daily tramadol hydrochloride bilayer sustained‐release tablets with an immediate release component for postherpetic neuralgia: Results of a Phase III, randomized, double‐blind, placebo‐controlled, treatment‐withdrawal study aug: au: Kawai, Shinichi Hasegawa, Jun Ito, Hideki Fukuuchi, Yasuo Nakano, Hideshi Ohtani, Hideaki Sasaki, Kazutaka Adachi, Takeshi affil: Department of Inflammation & Pain Control Research, Toho University School of Medicine, Tokyo, Japan sug: subj: Neuralgia, Postherpetic Drug Therapy Tramadol Pharmacodynamics Patient Safety Delayed-Action Preparations Pharmacokinetics Drug Efficacy Tramadol Administration and Dosage Drug Administration Methods Human Randomized Controlled Trials Random Assignment Japan Scales Adult Analgesics, Opioid Pharmacodynamics Dose-Response Relationship, Drug Treatment Withdrawal Confidence Intervals Substance Dependence Evaluation Tramadol Adverse Effects Adverse Drug Event Evaluation Adult: 19-44 years ab: Background: We investigated the efficacy and safety of twice‐daily bilayer sustained‐release tramadol hydrochloride tablets (35% immediate‐release; 65% sustained‐release) in patients with postherpetic neuralgia. Methods: This was a Phase III treatment‐withdrawal study with 1–4‐week dose‐escalation, 1‐week fixed‐dose, and 4‐week randomized, double‐blind, placebo‐controlled withdrawal periods performed at 43 medical institutions in Japan. Patients aged ≥20 years, ≥3 months after the onset of herpes zoster with localized, persistent pain despite fixed‐dose analgesics for ≥2 weeks before enrollment were eligible. Patients started tramadol at 100 mg/day and its dose escalated to a maximum of 400 mg/day to achieve a reduction in their Numeric Rating Scale (NRS) for pain of ≥2 points. Eligible patients were randomized to continue tramadol or switched to placebo for 4 weeks (double‐blind period). Patients were withdrawn due to inadequate analgesia (NRS deteriorated on ≥2 consecutive days) or their request. Results: Overall, 252 patients started tramadol and 173 were randomized (tramadol: 85; placebo: 88). Tramadol was superior to placebo for the primary endpoint (time from randomization to an inadequate analgesic effect) with log‐rank test p = 0.0005. The hazard ratio was 0.353 (95% confidence interval 0.190–0.657) in favor of tramadol and fewer patients in the tramadol group experienced inadequate analgesic effects (16.9% vs. 39.8%). Adverse events in ≥10% of patients in the open‐label period were constipation (43.8%), nausea (34.9%), somnolence (18.5%), and dizziness (11.6%). The frequencies of adverse events in the double‐blind period were similar in both groups. Conclusion: Sustained‐release tramadol tablets with an immediate‐release component are effective and well tolerated for managing postherpetic neuralgia. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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