title: Evaluation of blood pressure and heart rate in patients with hypertension who received tapentadol extended release for chronic pain: a post hoc, pooled data analysis.
abstract: OBJECTIVE
  Hypertension is one of the most common co-existing conditions in patients with chronic pain, and the potential effects of an analgesic on heart rate and blood pressure are of particular concern for patients with hypertension. The purpose of this analysis was to evaluate changes in blood pressure and heart rate with tapentadol extended release (ER) treatment in patients with hypertension.
  
  
  METHODS
  We performed a post hoc analysis of data pooled from three randomized, placebo- and active-controlled, phase III studies of tapentadol ER for managing chronic osteoarthritis knee (NCT00421928, NCT00486811) or low back (NCT00449176) pain (15-week, double-blind treatment period). Data were independently analyzed for patients with a listed medical history of hypertension at baseline and patients with at least one listed concomitant antihypertensive medication at baseline. Heart rate, systolic blood pressure (SBP), and diastolic blood pressure (DBP) were measured at each visit.
  
  
  RESULTS
  In patients with a listed medical history of hypertension (n = 1,464), least-squares mean (LSM [standard error (SE)]) changes from baseline to endpoint with placebo, tapentadol ER, and oxycodone HCl controlled release (CR), respectively, were -0.7 (0.44), 0.2 (0.43), and -0.9 (0.45) beats per minute (bpm) for heart rate; -2.4 (0.64), -2.7 (0.64), and -3.7 (0.67) mmHg for SBP; and -1.0 (0.39), -1.3 (0.39), and -2.3 (0.41) mmHg for DBP; in patients with at least one listed concomitant antihypertensive medication (n = 1,376), the LSM (SE) changes from baseline to endpoint were -0.6 (0.45), 0.1 (0.44), and -0.7 (0.47) bpm for heart rate; -1.8 (0.66), -3.3 (0.65), and -3.7 (0.69) mmHg for SBP; and -0.7 (0.40), -1.4 (0.40), and -2.3 (0.42) mmHg for DBP.
  
  
  CONCLUSIONS
  No clinically meaningful mean changes in heart rate or blood pressure were observed for the evaluated cohorts of patients with hypertension who were treated with tapentadol ER (100-250 mg twice daily).
authors.affiliation: US Medical Affairs, Janssen Scientific Affairs, LLC, 1125 Trenton Harbourton Road, Titusville, NJ, 08560, USA, dbiondi@its.jnj.com.
authors.forename: David M
authors.initials: DM
authors.lastname: Biondi
authors.forename: Jim
authors.initials: J
authors.lastname: Xiang
authors.forename: Mila
authors.initials: M
authors.lastname: Etropolski
authors.forename: Bruce
authors.initials: B
authors.lastname: Moskovitz
mesh_terms: D000368:Aged; D001794:Blood Pressure / Q000187:drug effects* / Q000502:physiology; D059350:Chronic Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006339:Heart Rate / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D010636:Phenols / Q000008:administration & dosage*; D017450:Receptors, Opioid, mu / Q000819:agonists*; D013223:Statistics as Topic; D000077432:Tapentadol
chemical_list: D003692:Delayed-Action Preparations; D010636:Phenols; D017450:Receptors, Opioid, mu; D000077432:Tapentadol