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Clinical Trial
. 2014 Aug;34(8):565-76.
doi: 10.1007/s40261-014-0209-y.

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

David M Biondi  1 , Jim Xiang, Mila Etropolski, Bruce Moskovitz
Affiliations
Clinical Trial

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

David M Biondi et al. Clin Drug Investig. 2014 Aug.

Abstract

Background and objectives: 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.

Conclusion: 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).

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Figures

Fig. 1
Fig. 1
Mean heart rate over time for a patients with a listed medical history of hypertension and b patients with at least one listed concomitant antihypertensive medication (safety population). BL baseline, bpm beats per minute, CR controlled release, ER extended release
Fig. 2
Fig. 2
Categories of heart rate changes from baseline at endpoint for patients with a listed medical history of hypertension and for patients with at least one listed concomitant antihypertensive medication (safety population). bpm beats per minute, CR controlled release, ER extended release
Fig. 3
Fig. 3
Mean systolic blood pressure over time for a patients with a listed medical history of hypertension and b patients with at least one listed concomitant antihypertensive medication (safety population). BL baseline, CR controlled release, ER extended release, SBP systolic blood pressure
Fig. 4
Fig. 4
Categories of systolic blood pressure changes from baseline at endpoint for patients with a listed medical history of hypertension and for patients with at least one listed concomitant antihypertensive medication (safety population). CR controlled release, ER extended release
Fig. 5
Fig. 5
Mean diastolic blood pressure over time for a patients with a listed medical history of hypertension and b patients with at least one listed concomitant antihypertensive medication (safety population). BL baseline, CR controlled release, DBP diastolic blood pressure, ER extended release
Fig. 6
Fig. 6
Categories of diastolic blood pressure changes from baseline at endpoint for patients with a listed medical history of hypertension and for patients with at least one listed concomitant antihypertensive medication (safety population). CR controlled release, ER extended release
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