Tapentadol ER Safe and Effective Analgesic in Patients with Hypertension
AUSTIN, TX—At the American Pain Society's 30th Annual Scientific Meeting, David Biondi, DO, and colleagues from Ortho-McNeil Janssen discussed study data showing that tapentadol ER does not significantly affect blood pressure (BP) or heart rate (HR) and thus, may be used for analgesia in patients with hypertension. Tapentadol is a centrally acting analgesic with µ-opioid receptor agonist and norepinephrine reuptake inhibitor activity.
Study investigators performed an analysis of pooled data from three similarly designed Phase 3, 15-week, randomized, double-blind, placebo- and active-controlled studies of tapentadol ER for moderate-to-severe chronic osteoarthritis knee pain or low back pain (NCT00421928, NCT00486811, NCT00449176). These post-hoc analyses evaluated systolic BP (SBP), diastolic BP (DBP), and HR in two cohorts—patients with a medical history of hypertension and patients taking concomitant antihypertensive medication. Results showed no clinically relevant changes in mean BP or HR measurements with placebo (n=946), tapentadol ER (100–250mg twice daily; n=920), or oxycodone HCl CR (20–50mg twice daily; n=831). The majority of patients treated were found to have an increase of no more than 10 beats per minute (bpm) for those with a history of hypertension (placebo 85.8%; tapentadol ER 83.8%; oxycodone CR 84.5%) and for those taking concomitant antihypertensive medications (placebo 85.5%; tapentadol ER 82.9%; oxycodone CR 84%). See Table.
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, Dr. Biondi concluded. The results showed no clinically relevant changes in BP or HR with tapentadol ER (100–250mg twice daily) or oxycodone HCl CR (20–50mg twice daily) and suggest that tapentadol ER is a reasonable treatment option for chronic pain management in patients with hypertension.