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document
Combination hydrocodone and ibuprofen versus combination codeine and acetaminophen for the treatment of chronic pain . OBJECTIVE The objective of this study was to compare the effectiveness of combination hydrocodone 7.5 mg and ibuprofen 200 mg with that of combination codeine 30 mg and acetaminophen 300 mg for the treatment of chronic pain . BACKGROUND Hydrocodone 7.5 mg with ibuprofen 200 mg is the only approved fixed-dose combination analgesic containing an opioid and ibuprofen . METHODS In this randomized , parallel-group , double-blind , repeated-dose , active-comparator , 4-week , multicenter study , 469 patients were randomly assigned to receive a 1-tablet ( n = 156 ) or 2-tablet ( n = 153 ) dose of combination hydrocodone 7.5 mg and ibuprofen 200 mg ( HI1 and HI2 , respectively ) or a 2-tablet dose of combination codeine 30 mg and acetaminophen 300 mg ( CA , n = 160 ) , the active comparator , every 6 to 8 hours as needed for pain . Efficacy was measured through pain relief scores , number of daily doses of study medication , number of daily doses of supplemental analgesics , number of patients who discontinued therapy due to an unsatisfactory analgesic response , and global assessment scores . RESULTS Of the 469 patients , 255 ( 54.4 % ) were female and 214 ( 45.6 % ) were male . The mean age was 51.1 years . Types of chronic pain included back ( 214 ; 45.6 % ) , arthritic ( 145 ; 30.9 % ) , other musculoskeletal ( 65 ; 13.9 % ) , cancer ( 6 ; 1.3 % ) , diabetic neuropathic ( 3 ; 0.6 % ) , postherpetic neuralgic ( 5 ; 1.1 % ) , other neurologic ( 21 ; 4.5 % ) , and other unclassified chronic pain ( 10 ; 2.1 % ) . During the 48 hours prior to the study , 351 ( 74.8 % ) patients had been treated with opioid or opioid-nonopioid combination analgesics . The overall mean daily pain relief score was significantly greater in the HI2 group ( 2.25+/-0.89 ) than in the HI1 group ( 1.98+/-0.87 ) ( P = 0.003 ) or the CA group ( 1.85+/-0.96 ) ( P < 0.001 ) . The overall mean number of daily doses of study medication was significantly less in the HI2 group ( 2.94+/-0.99 ) than in the HI1 group ( 3.23+/-0.76 ) ( P = 0.036 ) or the CA group ( 3.26+/-0.75 ) ( P = 0.014 ) . The overall mean number of daily doses of supplemental analgesics was significantly less in the HI2 group ( 0.24+/-0.49 ) than in the HI1 group ( 0.34+/-0.58 ) ( P = 0.021 ) or CA group ( 0.49+/-0.85 ) ( P = 0.010 ) . The number of patients who discontinued treatment due to an unsatisfactory analgesic response was significantly less in the HI2 group ( 2 ; 1.3 % ) than in the CA group ( 12 ; 7.5 % ) ( P = 0.008 ) . HI2 was more effective than HI1 and CA as measured by pain relief scores for week 1 ( P < 0.001 vs HI1 and CA ) , week 2 ( P < 0.001 vs HI1 and CA ) , and week 3 ( P = 0.008 vs HI1 and P < 0.001 vs CA ) ; daily doses of study medication for week 1 ( P = 0.019 vs HI1 and P = 0.011 vs CA ) ; daily doses of supplemental analgesics for week 1 ( P = 0.010 vs HI1 and CA ) ; and global assessment scores for week 1 ( P = 0.018 vs HI1 and P < 0.001 vs CA ) , week 2 ( P = 0.005 vs HI1 and P < 0.001 vs CA ) , and week 4 ( P = 0.013 vs HI1 and P = 0.023 vs CA ) . There were no significant differences between HI1 and CA in any efficacy variable . There were no significant differences in the number of patients experiencing adverse events in the HI2 ( 127 ; 83 % ) , HI1 ( 124 ; 79.5 % ) , and CA ( 129 ; 80.6 % ) groups . However , the mean number of patients who discontinued treatment due to adverse events was significantly greater in the HI2 group ( 40 ; 26.1 % ) than in the HI1 group ( 23 ; 14.7 % ) ( P = 0.013 ) . CONCLUSIONS The results of this study suggest that 2-tablet doses of combination hydrocodone 7.5 mg and ibuprofen 200 mg may be more effective than either 1-tablet doses of this combination or 2-tablet doses of combination codeine 30 mg and acetaminophen 300 mg . Moreover , 1-tablet doses of combination hydrocodone 7.5 mg and ibuprofen 200 mg may be as effective as 2-tablet doses of combination codeine 30 mg and acetaminophen 300 mg .
4027
Intervention_Pharmacological
hydrocodone and ibuprofen
4028
Intervention_Pharmacological
codeine and acetaminophen
4029
Intervention_Pharmacological
hydrocodone
4030
Intervention_Pharmacological
ibuprofen
4031
Intervention_Pharmacological
codeine
4032
Intervention_Pharmacological
acetaminophen
4033
Intervention_Pharmacological
Hydrocodone
4034
Intervention_Pharmacological
ibuprofen
4035
Intervention_Pharmacological
combination hydrocodone 7.5 mg and ibuprofen 200 mg
4036
Intervention_Pharmacological
codeine 30 mg and acetaminophen 300 mg
4037
Intervention_Pharmacological
hydrocodone
4038
Intervention_Pharmacological
ibuprofen
4039
Intervention_Pharmacological
codeine
4040
Intervention_Pharmacological
acetaminophen
4041
Intervention_Pharmacological
combination hydrocodone 7.5 mg and ibuprofen
4042
Intervention_Pharmacological
codeine
4043
Intervention_Pharmacological
acetaminophen
4044
Outcome_Pain
pain relief scores
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Outcome_Other
number of daily doses of study medication
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Outcome_Other
number of daily doses of supplemental analgesics
4047
Outcome_Other
number of patients who discontinued therapy due to an unsatisfactory analgesic response
4048
Outcome_Pain
overall mean daily pain relief score
4049
Outcome_Other
overall mean number of daily doses of study medication
4050
Outcome_Other
overall mean number of daily doses of supplemental analgesics
4051
Outcome_Other
number of patients who discontinued treatment due to an unsatisfactory analgesic response
4052
Outcome_Pain
pain relief scores
4053
Outcome_Other
daily doses of study medication
4054
Outcome_Other
daily doses of supplemental analgesics
4055
Outcome_Other
efficacy
4056
Outcome_Adverse-effects
number of patients experiencing adverse events
4057
Outcome_Other
mean number of patients who discontinued treatment due to adverse events
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Participant_Condition
chronic pain
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Participant_Sample-size
469
4060
Participant_Sample-size
469
4061
Participant_Sample-size
255
4062
Participant_Sex
female
4063
Participant_Sample-size
214
4064
Participant_Sex
male
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Participant_Age
51.1 years
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Participant_Condition
chronic pain
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Participant_Condition
back
4068
Participant_Condition
arthritic
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Participant_Condition
other musculoskeletal
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Participant_Condition
cancer
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Participant_Condition
diabetic neuropathic
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Participant_Condition
postherpetic neuralgic
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Participant_Condition
other neurologic
4074
Participant_Condition
unclassified chronic pain