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, Jim Xiang, Mila Etropolski, Bruce Moskovitz, David M Biondi, Jim Xiang, Mila Etropolski, Bruce Moskovitz

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).

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

References

    1. Caporali R, Cimmino MA, Sarzi-Puttini P, et al. Comorbid conditions in the AMICA study patients: effects on the quality of life and drug prescriptions by general practitioners and specialists. Semin Arthritis Rheum. 2005;35:31–37. doi: 10.1016/j.semarthrit.2005.02.004.
    1. van den Bussche H, Koller D, Kolonko T, et al. Which chronic diseases and disease combinations are specific to multimorbidity in the elderly? Results of a claims data based cross-sectional study in Germany. BMC Public Health. 2011;11:101. doi: 10.1186/1471-2458-11-101.
    1. Schnitzer TJ. Update on guidelines for the treatment of chronic musculoskeletal pain. Clin Rheumatol. 2006;25(Suppl 7):22–29. doi: 10.1007/s10067-006-0203-8.
    1. Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, part II: OARSI evidence-based, expert consensus guidelines. Osteoarthr Cartil. 2008;16:137–162. doi: 10.1016/j.joca.2007.12.013.
    1. Zhang W, Nuki G, Moskowitz RW, et al. OARSI recommendations for the management of hip and knee osteoarthritis: part III: changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthr Cartil. 2010;18:476–499. doi: 10.1016/j.joca.2010.01.013.
    1. Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007;147:478–491. doi: 10.7326/0003-4819-147-7-200710020-00006.
    1. Chou R, Huffman LH. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007;147:505–514. doi: 10.7326/0003-4819-147-7-200710020-00008.
    1. Sudano I, Flammer AJ, Periat D, et al. Acetaminophen increases blood pressure in patients with coronary artery disease. Circulation. 2010;122:1789–1796. doi: 10.1161/CIRCULATIONAHA.110.956490.
    1. Snowden S, Nelson R. The effects of nonsteroidal anti-inflammatory drugs on blood pressure in hypertensive patients. Cardiol Rev. 2011;19:184–191. doi: 10.1097/CRD.0b013e31821ddcf4.
    1. Zhang J, Ding EL, Song Y. Adverse effects of cyclooxygenase 2 inhibitors on renal and arrhythmia events: meta-analysis of randomized trials. JAMA. 2006;296:1619–1632. doi: 10.1001/jama.296.13.jrv60015.
    1. CYMBALTA® (duloxetine hydrochloride) delayed-release capsules [package insert]. Indianapolis: Eli Lilly and Company; 2011.
    1. Stahl SM, Grady MM, Moret C, et al. SNRIs: their pharmacology, clinical efficacy, and tolerability in comparison with other classes of antidepressants. CNS Spectr. 2005;10:732–747.
    1. Mayer AF, Schroeder C, Heusser K, et al. Influences of norepinephrine transporter function on the distribution of sympathetic activity in humans. Hypertension. 2006;48:120–126. doi: 10.1161/01.HYP.0000225424.13138.5d.
    1. Tzschentke TM, Christoph T, Kögel B, et al. (−)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride (tapentadol HCl): a novel m-opioid receptor agonist/norepinephrine reuptake inhibitor with broad-spectrum analgesic properties. J Pharmacol Exp Ther. 2007;323:265–276. doi: 10.1124/jpet.107.126052.
    1. Tzschentke TM, De Vry J, Terlinden R, et al. Tapentadol hydrochloride. Analgesic, mu-opioid receptor agonist, noradrenaline reuptake inhibitor. Drugs Future. 2006;31:1053–1061. doi: 10.1358/dof.2006.031.12.1047744.
    1. Tzschentke TM, Jahnel U, Kogel B, et al. Tapentadol hydrochloride: a next-generation, centrally acting analgesic with two mechanisms of action in a single molecule. Drugs Today (Barc). 2009;45:483–496.
    1. Nucynta® ER (tapentadol) extended-release oral tablets C-II [package insert]. Raritan: Janssen Pharmaceuticals, Inc.; 2011.
    1. Afilalo M, Etropolski MS, Kuperwasser B, et al. Efficacy and safety of tapentadol extended release compared with oxycodone controlled release for the management of moderate to severe chronic pain related to osteoarthritis of the knee: a randomized, double-blind, placebo- and active-controlled phase III study. Clin Drug Investig. 2010;30:489–505. doi: 10.2165/11533440-000000000-00000.
    1. Wild JE, Grond S, Kuperwasser B, et al. Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain. Pain Pract. 2010;10:416–427. doi: 10.1111/j.1533-2500.2010.00397.x.
    1. Buynak R, Shapiro DY, Okamoto A, et al. Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled phase III study. Expert Opin Pharmacother. 2010;11:1787–1804. doi: 10.1517/14656566.2010.497720.
    1. Schwartz S, Etropolski M, Shapiro DY, et al. Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial. Curr Med Res Opin. 2011;27:151–162. doi: 10.1185/03007995.2010.537589.
    1. Lange B, Kuperwasser B, Okamoto A, et al. Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain. Adv Ther. 2010;27:381–399. doi: 10.1007/s12325-010-0036-3.
    1. Etropolski M, Shapiro D, Okamoto A, et al. An analysis of changes in vital signs and electrocardiogram measurements with tapentadol prolonged release (PR) treatment [abstract no. F644]. 7th Congress of the European Federation of IASP Chapters; 21–24 Sep 2011; Hamburg.
    1. Czapla MA, Gozal D, Alea OA, et al. Differential cardiorespiratory effects of endomorphin 1, endomorphin 2, DAMGO, and morphine. Am J Respir Crit Care Med. 2000;162:994–999. doi: 10.1164/ajrccm.162.3.9911102.
    1. Kearney PM, Baigent C, Godwin J, et al. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ. 2006;332:1302–1308. doi: 10.1136/bmj.332.7553.1302.
    1. Pham K, Hirschberg R. Global safety of coxibs and NSAIDs. Curr Top Med Chem. 2005;5:465–473. doi: 10.2174/1568026054201640.

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