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- W2079277687 abstract "Tapentadol is a centrally-acting analgesic with μ-opioid receptor agonist and norepinephrine reuptake inhibitor activity. An analysis of pooled data from 3 similarly-designed 15-week, randomized, double-blind, placebo- and active-controlled, phase 3 studies of tapentadol ER for moderate-to-severe chronic osteoarthritis knee pain (NCT00421928, NCT00486811) or low back pain (NCT00449176) found no clinically relevant changes in mean BP or HR measurements with placebo (n=946), tapentadol ER (100-250mg bid; n=920), or oxycodone HCl CR (20-50mg bid; n=831). This post-hoc analysis of those pooled data evaluated systolic BP (SBP), diastolic BP (DBP), and HR in 2 cohorts—patients with a medical history of hypertension and patients with a concomitant anti-hypertensive medication. In patients with a history of hypertension, the least squares mean (LSM [SE]) change from baseline to endpoint in BP and HR with placebo (n=459), tapentadol ER (n=462), and oxycodone CR (n=413), respectively, was SBP, −2.4 (0.64), −2.7 (0.64), and −3.7 (0.67) mmHg; DBP, −1.0 (0.39), −1.3 (0.39), and −2.3 (0.41) mmHg; HR, −0.7 (0.44), 0.2 (0.43), and −0.9 (0.45) beats-per-minute (bpm). In patients with a concomitant anti-hypertensive medication, the LSM (SE) change from baseline to endpoint in BP and HR with placebo (n=429), tapentadol ER (n=434), and oxycodone CR (n=387), respectively, was SBP, −1.8 (0.66), −3.3 (0.65), and −3.7 (0.69) mmHg; DBP, −0.7 (0.40), −1.4 (0.40), and −2.3 (0.42) mmHg; HR, −0.6 (0.45), 0.1 (0.44), and −0.7 (0.47) bpm. There were no significant differences between tapentadol ER and placebo or oxycodone CR in the LSM changes from baseline to endpoint in SBP, DBP, or HR. These results showed no clinically relevant changes in BP or HR with tapentadol ER (100-250mg bid) or oxycodone HCl CR (20-50mg bid) and suggest that tapentadol ER is a reasonable treatment option for chronic pain management in patients with hypertension. Ortho-McNeil Janssen Scientific Affairs, LLC, supported this analysis." @default.
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- W2079277687 date "2011-04-01" @default.
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- W2079277687 title "A post hoc pooled data analysis to evaluate blood pressure (BP) and heart rate (HR) measurements in patients with a current or prior history of hypertension who received tapentadol ER, oxycodone CR, or placebo in chronic pain studies" @default.
- W2079277687 doi "https://doi.org/10.1016/j.jpain.2011.02.225" @default.
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