A gastroretentive gabapentin formulation for the treatment of painful diabetic peripheral neuropathy: Efficacy and tolerability in a double-blind, randomized, controlled clinical trial

Sandercock, David; Cramer, Marilou; Biton, Victor; Cowles, Verne E.

doi:10.1016/j.diabres.2012.03.010

Cited by 31 publications

(26 citation statements)

References 25 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A meta-analysis of 20 trials (7, 14–17, 19, 21, 22, 25–28, 32–37) showed that for adverse events that were possibly or probably related to the study drug and could lead to treatment discontinuation and drug withdrawal, the gabapentin group had a 1.45-times higher risk than the placebo group (RR = 1.38; 95% CI: 1.08–1.76; Figure 3); For adverse events that were possibly or probably related to the study drug and could lead to treatment discontinuation and drug withdrawal, the incidences in the gabapentin group and the placebo group were 8.19 and 5.37% ( P < 0.001), respectively. Sixteen trials (14, 17, 19, 21, 22, 25–29, 31–34, 36) reported serious adverse effects. However, other than one case of headache (34), one case of serious dizziness and drowsiness (21), and one case of vision disturbance (19), no serious adverse effects were associated with the use of gabapentin.…”

Section: Resultsmentioning

confidence: 99%

Efficacy and Tolerability of Gabapentin in Adults with Sleep Disturbance in Medical Illness: A Systematic Review and Meta-analysis

Liu

Karim

et al. 2017

Front. Neurol.

View full text Add to dashboard Cite

Background and purposeThe aim of this study was to systematically review the efficacy and tolerability of gabapentin in the treatment of sleep disturbance in patients with medical illness.MethodsPubMed was searched for randomized, double-blinded, placebo-controlled trials that reported sleep changes during gabapentin treatment up to November 2015.FindingsThis review included 26 studies involving 4,684 participants. Except for Composite Endpoint 3 [standardized mean difference (SMD) = 0.09, 95% confidence interval (CI): −0.05–0.22] compared with the placebo group, the gabapentin group showed superior outcomes on our endpoints: Composite Endpoint 1 (SMD = 0.50, 95% CI: 0.28–0.71), Composite Endpoint 2 (SMD = −0.53, 95% CI: −0.77 to −0.30), Composite Endpoint 4 (SMD = −0.38, 95% CI: −0.58 to −0.19), Composite Endpoint 5 [risk ratio (RR) = 1.79, 95% CI: 1.24–2.58], and Composite Endpoint 6 (RR = 0.48, 95% CI: 0.32–0.72). However, the patients in the gabapentin group showed worse tolerance than those in the placebo group (RR = 1.38, 95% CI: 1.08–1.76).ImplicationsThis study is the first to systematically assess the clinical value of gabapentin for the treatment of sleep disorders. We found that regardless the type of sleep outcomes, gabapentin displayed stable treatment efficacy for sleep disturbance in patients with medical illness. However, when an average dose of approximately 1,800 mg/day was used, the risk of treatment discontinuation or drug withdrawal was relatively high. We recommend that further studies confirm these findings in patients with primary sleep disorders.

show abstract

Section: Resultsmentioning

confidence: 99%

Efficacy and Tolerability of Gabapentin in Adults with Sleep Disturbance in Medical Illness: A Systematic Review and Meta-analysis

Liu

Karim

et al. 2017

Front. Neurol.

View full text Add to dashboard Cite

show abstract

“…During the first four weeks of active treatment, the dose will be increased to a maximal tolerated dose or to the target ceiling dose of 3000 mg/d, whichever is reached first. This target dose was chosen on the basis of previous trials that suggested efficacy and tolerability of comparable doses of G-IR when used to treat symptomatic neuropathy [21–23], recent trials of G-ER in the treatment of diabetic peripheral neuropathy (PDN) [24], post herpetic neuralgia [25] and menopausal hot flashes [56,57], and from dosage range recommendations from a panel of international experts on vulvodynia [10]. Moreover, the dose-response curve observed in neuropathic pain trials (without disproportionate dropout rates), necessitates higher doses to establish efficacy [21].…”

Section: Methodsmentioning

confidence: 99%

“…Numerous RCTs of immediate-release gabapentin (G-IR) (1800–3600 mg/d in three divided doses) [20–23] and recent RCTS with gabapentin extended release (G-ER) (1800–3000 mg/d in single or two divided doses) [24,25], have shown superiority over placebo in treating neuropathic pain. Gabapentin is listed as a first choice treatment in three evidence-based consensus guidelines on neuropathic pain, as well as being suggested as effective from data based on three retrospective trials in vulvodynia [26–31], buts its efficacy in this population has not been empirically tested [32].…”

Section: Introductionmentioning

confidence: 99%

Rationale and design of a multicenter randomized clinical trial of extended release gabapentin in provoked vestibulodynia and biological correlates of response

Brown

Foster

Wan

et al. 2013

Contemporary Clinical Trials

View full text Add to dashboard Cite

Introduction Few randomized controlled trials (RCTs) have been conducted to establish evidence-based management protocols for provoked vestibulodynia (PVD), a chronic vulvar pain condition affecting approximately 14 million women in the U.S. We describe the rationale and design of an NIH funded multicenter clinical trial utilizing an extended release formulation of gabapentin (G-ER), an intervention that preliminary data suggest may be efficacious for this condition. Objectives 1) to determine if pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with G-ER compared to when treated with placebo and 2) to determine if G-ER reduces vulvar mechanical hyperalgesia, vaginal muscle pain to palpation, the number and intensity of somatic tenderpoints, spontaneous and provoked pain to intradermal capsaicin with an accompanying increase in cardiac beat-to-beat variability and to identify mechanistically-based PVD subtypes. Additional outcomes include subject reported intercourse pain and summative 24-hour pain. Methods This 16-week, randomized, double-blind, placebo-controlled, crossover study will enroll 120 women 18 years and older who report tenderness localized to the vulvar vestibule, pain with tampon insertion, and, when sexually active, insertional dyspareunia. Electronically entered daily diaries will be used to determine if pain is lower in PVD subjects when treated with G-ER (up to 3000 mg/d) compared to when treated with placebo. Psychophysiological measures will be obtained at baseline and after 2 weeks at the maximum tolerated dose. Conclusion We will conduct the first multicenter RCT to confirm efficacy of an agent that is currently used in clinical practice for treating PVD.

show abstract

“…Gabapentin gastro-retentive formulation (Gr-G) caused benefit compared with placebo with regard to 24 h pain score, with greater than 50% reduction in 34.8% of patients [17]. Evaluation of the Pd-G did not improve pain compared with placebo.…”

Section: Newer Gabapentin Formulationsmentioning

confidence: 99%

Neuropathic pain

Hurley

Adams

Benzon³

2013

Current Opinion in Anaesthesiology

View full text Add to dashboard Cite

The literature reveals that neuropathic pain is underdiagnosed and often undertreated or treated with ineffective or untested modalities. Evolving definitions of neuropathic pain has broadened the range of therapeutic approaches and brought current treatment paradigms under increased scrutiny. The lack of a mechanism-based approach to treatment may be responsible for the lackluster responses seen in most neuropathic pain conditions.

show abstract

A gastroretentive gabapentin formulation for the treatment of painful diabetic peripheral neuropathy: Efficacy and tolerability in a double-blind, randomized, controlled clinical trial

Cited by 31 publications

References 25 publications

Efficacy and Tolerability of Gabapentin in Adults with Sleep Disturbance in Medical Illness: A Systematic Review and Meta-analysis

Efficacy and Tolerability of Gabapentin in Adults with Sleep Disturbance in Medical Illness: A Systematic Review and Meta-analysis

Rationale and design of a multicenter randomized clinical trial of extended release gabapentin in provoked vestibulodynia and biological correlates of response

Neuropathic pain

Contact Info

Product

Resources

About