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Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: a double-blind placebo-controlled trial.

Arezzo JC, Rosenstock J, Lamoreaux L, Pauer L - BMC Neurol (2008)

Bottom Line: Secondary efficacy measures included weekly MPS and proportion of responders (patients achieving >or=50% reduction in MPS from baseline to endpoint).Significant pain improvement among pregabalin-treated patients was evident at week 1 and sustained at every weekly timepoint.Pregabalin 600 mg/d (300 mg BID) effectively reduced pain, was well tolerated, and had no statistically significant or clinically meaningful effect on NC in patients with painful DPN.

View Article: PubMed Central - HTML - PubMed

Affiliation: Albert Einstein College of Medicine, New York, NY, USA. Arezzo@aecom.yu.edu

ABSTRACT

Background: Recent consensus guidelines recommend pregabalin as a first-tier treatment for painful diabetic peripheral neuropathy (DPN). We evaluated the efficacy of pregabalin 600 mg/d (300 mg dosed BID) versus placebo for relieving DPN-associated neuropathic pain, and assessed its safety using objective measures of nerve conduction (NC).

Methods: In this randomized, double-blind, placebo-controlled trial, the primary efficacy measure was endpoint mean pain score (MPS) from daily pain diaries (11-point scale). NC velocity and sensory and motor amplitudes were assessed at baseline, endpoint, and end of follow-up (2 weeks post-treatment). At each timepoint, the median-motor, median-sensory, ulnar-sensory, and peroneal-motor nerves were evaluated. Secondary efficacy measures included weekly MPS and proportion of responders (patients achieving >or=50% reduction in MPS from baseline to endpoint). After 1-weeks' dosage escalation, pregabalin-treated patients received 300 mg BID for 12 weeks.

Results: Eighty-two patients received pregabalin and 85 placebo. Mean durations were 10 years for diabetes and approximately 5 years for painful DPN. Pregabalin-treated patients had lower MPS than controls (mean difference, -1.28; p <.001). For all four nerves, 95% CIs for median differences in amplitude and velocity from baseline to endpoint and baseline to follow-up included 0 (ie, no significant difference vs. placebo). Significant pain improvement among pregabalin-treated patients was evident at week 1 and sustained at every weekly timepoint. More pregabalin-treated patients (49%) than controls (23%) were responders (p <.001).

Conclusion: Pregabalin 600 mg/d (300 mg BID) effectively reduced pain, was well tolerated, and had no statistically significant or clinically meaningful effect on NC in patients with painful DPN.

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Related in: MedlinePlus

Weekly least-squares mean pain scores.
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Figure 2: Weekly least-squares mean pain scores.

Mentions: Supplemental analyses of the primary efficacy parameter included weekly mean pain scores and proportion of responders. Improvement in the pregabalin group was evident at week 1 (p <.0001), the first timepoint evaluated, and this improvement was maintained at every weekly timepoint through week 13 (Figure 2; p ≤.03). At endpoint, a greater proportion of patients in the pregabalin group (49%) met the responder criterion (≥50% reduction in mean pain score from baseline to endpoint) than did those in the placebo group (23%; p <.001).


Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: a double-blind placebo-controlled trial.

Arezzo JC, Rosenstock J, Lamoreaux L, Pauer L - BMC Neurol (2008)

Weekly least-squares mean pain scores.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2565674&req=5

Figure 2: Weekly least-squares mean pain scores.
Mentions: Supplemental analyses of the primary efficacy parameter included weekly mean pain scores and proportion of responders. Improvement in the pregabalin group was evident at week 1 (p <.0001), the first timepoint evaluated, and this improvement was maintained at every weekly timepoint through week 13 (Figure 2; p ≤.03). At endpoint, a greater proportion of patients in the pregabalin group (49%) met the responder criterion (≥50% reduction in mean pain score from baseline to endpoint) than did those in the placebo group (23%; p <.001).

Bottom Line: Secondary efficacy measures included weekly MPS and proportion of responders (patients achieving >or=50% reduction in MPS from baseline to endpoint).Significant pain improvement among pregabalin-treated patients was evident at week 1 and sustained at every weekly timepoint.Pregabalin 600 mg/d (300 mg BID) effectively reduced pain, was well tolerated, and had no statistically significant or clinically meaningful effect on NC in patients with painful DPN.

View Article: PubMed Central - HTML - PubMed

Affiliation: Albert Einstein College of Medicine, New York, NY, USA. Arezzo@aecom.yu.edu

ABSTRACT

Background: Recent consensus guidelines recommend pregabalin as a first-tier treatment for painful diabetic peripheral neuropathy (DPN). We evaluated the efficacy of pregabalin 600 mg/d (300 mg dosed BID) versus placebo for relieving DPN-associated neuropathic pain, and assessed its safety using objective measures of nerve conduction (NC).

Methods: In this randomized, double-blind, placebo-controlled trial, the primary efficacy measure was endpoint mean pain score (MPS) from daily pain diaries (11-point scale). NC velocity and sensory and motor amplitudes were assessed at baseline, endpoint, and end of follow-up (2 weeks post-treatment). At each timepoint, the median-motor, median-sensory, ulnar-sensory, and peroneal-motor nerves were evaluated. Secondary efficacy measures included weekly MPS and proportion of responders (patients achieving >or=50% reduction in MPS from baseline to endpoint). After 1-weeks' dosage escalation, pregabalin-treated patients received 300 mg BID for 12 weeks.

Results: Eighty-two patients received pregabalin and 85 placebo. Mean durations were 10 years for diabetes and approximately 5 years for painful DPN. Pregabalin-treated patients had lower MPS than controls (mean difference, -1.28; p <.001). For all four nerves, 95% CIs for median differences in amplitude and velocity from baseline to endpoint and baseline to follow-up included 0 (ie, no significant difference vs. placebo). Significant pain improvement among pregabalin-treated patients was evident at week 1 and sustained at every weekly timepoint. More pregabalin-treated patients (49%) than controls (23%) were responders (p <.001).

Conclusion: Pregabalin 600 mg/d (300 mg BID) effectively reduced pain, was well tolerated, and had no statistically significant or clinically meaningful effect on NC in patients with painful DPN.

Show MeSH
Related in: MedlinePlus