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Effectiveness and Safety of Tapentadol Prolonged Release ( PR ) Versus a Combination of Tapentadol PR and Pregabalin for the Management of Severe , Chronic Low Back Pain With a Neuropathic Component : A Randomized , Double-blind , Phase 3b Study . OBJECTIVE To evaluate the effectiveness and tolerability of tapentadol PR monotherapy versus tapentadol PR/pregabalin combination therapy for severe , chronic low back pain with a neuropathic component . METHODS Eligible patients had painDETECT " unclear " or " positive " ratings and average pain intensity ≥ 6 ( 11-point NRS-3 [ average 3-day pain intensity ] ) at baseline . Patients were titrated to tapentadol PR 300 mg/day over 3 weeks . Patients with ≥ 1-point decrease in pain intensity and average pain intensity ≥ 4 were randomized to tapentadol PR ( 500 mg/day ) or tapentadol PR ( 300 mg/day ) /pregabalin ( 300 mg/day ) during an 8-week comparative period . RESULTS In the per-protocol population ( n = 288 ) , the effectiveness of tapentadol PR was clinically and statistically comparable to tapentadol PR/pregabalin based on the change in pain intensity from randomization to final evaluation ( LOCF ; LSMD [ 95 % CI ] , -0.066 [ -0.57 , 0.43 ] ; P < 0.0001 for noninferiority ) . Neuropathic pain and quality-of-life measures improved significantly in both groups . Tolerability was good in both groups , in line with prior trials in the high dose range of 500 mg/day for tapentadol PR monotherapy , and favorable compared with historical combination trials of strong opioids and anticonvulsants for combination therapy . The incidence of the composite of dizziness and/or somnolence was significantly lower with tapentadol PR ( 16.9 % ) than tapentadol PR/pregabalin ( 27.0 % ; P = 0.0302 ) . CONCLUSIONS Tapentadol PR 500 mg is associated with comparable improvements in pain intensity and quality-of-life measures to tapentadol PR 300 mg/pregabalin 300 mg , with improved central nervous system tolerability , suggesting that tapentadol PR monotherapy may offer a favorable treatment option for severe low back pain with a neuropathic component .
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Intervention_Pharmacological
Tapentadol
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Intervention_Pharmacological
Combination of Tapentadol PR and Pregabalin
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Intervention_Pharmacological
tapentadol PR
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Intervention_Pharmacological
tapentadol PR/pregabalin
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Intervention_Pharmacological
tapentadol
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Intervention_Pharmacological
tapentadol PR ( 300 mg/day ) /pregabalin
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Outcome_Other
Effectiveness and Safety
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Outcome_Other
effectiveness and tolerability
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Outcome_Pain
decrease in pain intensity
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Outcome_Pain
average pain intensity
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Outcome_Other
( n = 288 ) , the
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Outcome_Mental
for noninferiority ) .
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Outcome_Pain
Neuropathic pain and quality-of-life
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Outcome_Adverse-effects
of the composite of dizziness
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Outcome_Pain
associated with comparable improvements in pain intensity and quality-of-life
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Participant_Condition
Chronic Low Back Pain With a Neuropathic Component
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Participant_Condition
severe , chronic low back pain with a neuropathic component .
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Participant_Condition
severe low back pain