Corrections to: Once-daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study

Arnold, Lesley M.; Arsenault, Pierre; Huffman, Cynthia; Patrick, Jeffrey; Messig, Michael; Chew, Marci L.; Sanin, Luis; Scavone, Joseph M.; Pauer, L.; Clair, Andrew

doi:10.1080/03007995.2017.1292446

Cited by 6 publications

(2 citation statements)

References 28 publications

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“…Both the primary efficacy end point (ie, time to loss of therapeutic response) and a key secondary end point (ie, mean change from baseline) in a double‐blind, placebo‐controlled, randomized withdrawal trial of pregabalin ER (165‐660 mg) demonstrated the efficacy of pregabalin ER in patients with postherpetic neuralgia . In a trial of similar design evaluating pregabalin ER (330‐495 mg) in adults with fibromyalgia, the primary efficacy end point (ie, time to loss of therapeutic response) was met, but the trial did not demonstrate efficacy in a key secondary end point (ie, mean change from baseline) . Similarly, a double‐blind, randomized, placebo‐controlled trial of pregabalin ER (165‐330 mg) in adults with partial onset seizures did not demonstrate that pregabalin is effective in reducing seizure frequency below that of placebo .…”

Section: Discussionmentioning

confidence: 99%

“…8,15 In a trial of similar design evaluating pregabalin ER (330-495 mg) in adults with fibromyalgia, the primary efficacy end point (ie, time to loss of therapeutic response) was met, but the trial did not demonstrate efficacy in a key secondary end point (ie, mean change from baseline). 8,16,30 Similarly, a double-blind, randomized, placebo-controlled trial of pregabalin ER (165-330 mg) in adults with partial onset seizures did not demonstrate that pregabalin is effective in reducing seizure frequency below that of placebo. 8,17 In all 3 trials, the safety profile of pregabalin ER was comparable to that reported previously for the IR formulation.…”

Section: Discussionmentioning

confidence: 99%

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Population Pharmacokinetics of Pregabalin Extended‐Release in Healthy Volunteers and Patients With Postherpetic Neuralgia, Fibromyalgia, and Partial‐Onset Seizures

Chew

Xie³

et al. 2019

The Journal of Clinical Pharma

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A population pharmacokinetic (PK) model was developed to characterize the properties of pregabalin extended‐release (ER) in healthy volunteers and was subsequently applied to patient data from efficacy/safety studies investigating pregabalin ER for postherpetic neuralgia, fibromyalgia, and partial‐onset seizures. The impact of demographic and other covariates on PK was assessed, and various dosing scenarios were simulated to inform pregabalin ER dosing/administration instructions. Phase 1 and 3 models were developed using data from 14 phase 1 studies (12 627 samples from 335 participants receiving pregabalin immediate‐release [IR] or ER) and 3 phase 3 studies (2591 samples from 1235 patients receiving pregabalin ER), respectively. Final phase 1 and 3 models adequately characterized the data. Several covariates were statistically significant, but renal function (creatinine clearance) was considered the only clinically relevant covariate. The relationship between creatinine clearance and pregabalin clearance was reasonably consistent between phase 1 and 3 models and with that reported previously with pregabalin IR data alone. Patients with moderate renal impairment who received pregabalin ER 82.5 mg once daily (QD) had similar predicted area under the plasma concentration–time curve and peak plasma concentration values as patients with normal/mild renal impairment who received 165 mg QD. Ranges in predicted PK parameters after switching from pregabalin IR administered in the morning to ER after a meal at 3, 6, or 9 pm were similar. Administration of a missed evening dose at bedtime with food or the next morning with food did not result in clinically important changes in predicted PK parameters.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Population Pharmacokinetics of Pregabalin Extended‐Release in Healthy Volunteers and Patients With Postherpetic Neuralgia, Fibromyalgia, and Partial‐Onset Seizures

Chew

Xie³

et al. 2019

The Journal of Clinical Pharma

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Pregabalin for pain in fibromyalgia in adults

Derry¹,

Cording

Wiffen

et al. 2016

Cochrane Database of Systematic Reviews

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Pregabalin 300 to 600 mg produces a major reduction in pain intensity over 12 to 26 weeks with tolerable adverse events for a small proportion of people (about 10% more than placebo) with moderate or severe pain due to fibromyalgia. The degree of pain relief is known to be accompanied by improvements in other symptoms, quality of life, and function. These results are similar to other effective medicines in fibromyalgia (milnacipran, duloxetine).

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Effect of the Gastrointestinal Prokinetic Agent Erythromycin on the Pharmacokinetics of Pregabalin Controlled-Release in Healthy Individuals: A Phase I, Randomized Crossover Trial

et al. 2015

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Corrections to: Once-daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study

Cited by 6 publications

References 28 publications

Population Pharmacokinetics of Pregabalin Extended‐Release in Healthy Volunteers and Patients With Postherpetic Neuralgia, Fibromyalgia, and Partial‐Onset Seizures

Population Pharmacokinetics of Pregabalin Extended‐Release in Healthy Volunteers and Patients With Postherpetic Neuralgia, Fibromyalgia, and Partial‐Onset Seizures

Pregabalin for pain in fibromyalgia in adults

Effect of the Gastrointestinal Prokinetic Agent Erythromycin on the Pharmacokinetics of Pregabalin Controlled-Release in Healthy Individuals: A Phase I, Randomized Crossover Trial

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