Time to recovery in patients with acute painful musculoskeletal conditions treated with extended-release or immediate-release cyclobenzaprine

Advances in Therapy

Volumn 28, Issue 4, 2011, Pages 295-303

  Landy, Stephen ^b   Altman, Charles A ^a   Xie, Fang ^a  

^a CEPHALON INC   (United States)

^b UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

Author keywords

Acute; Cyclobenzaprine; Low back pain; Muscle spasm; Neck pain; Skeletal muscle relaxant

Indexed keywords

CYCLOBENZAPRINE; PLACEBO;

ANALGESIA; ARTICLE; BODY MOVEMENT; CONSTIPATION; CONVALESCENCE; DIARRHEA; DIZZINESS; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG FORMULATION; DRUG WITHDRAWAL; DYSPEPSIA; HEADACHE; HUMAN; IMMEDIATE RELEASE FORMULATION; MUSCULOSKELETAL PAIN; PAIN ASSESSMENT; PARALLEL DESIGN; PATIENT SATISFACTION; POST HOC ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SOMNOLENCE; SUSTAINED RELEASE FORMULATION; TREATMENT OUTCOME; XEROSTOMIA;

ACUTE DISEASE; ADMINISTRATION, ORAL; ADULT; AMITRIPTYLINE; DELAYED-ACTION PREPARATIONS; DISORDERS OF EXCESSIVE SOMNOLENCE; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; MUSCLE RELAXANTS, CENTRAL; MUSCLE, SKELETAL; PAIN; PATIENT SATISFACTION; RECOVERY OF FUNCTION; SPASM; THERAPEUTIC EQUIVALENCY; TIME FACTORS; TREATMENT OUTCOME;

EID: 79958187014     PISSN: 0741238X     EISSN: 18658652     Source Type: Journal    
DOI: 10.1007/s12325-011-0008-2     Document Type: Article

References (30)

1. Connelly C. Patients with low back pain: how to identify the few who need extra attention. Postgrad Med. 1996;100:143-146,150,155-156.
2. Rubin M. Low back pain: differentiating mechanical and medical causes. Hosp Med. 1995;31:23-32.
3. Borenstein DG, Korn S. Efficacy of a low-dose regimen of cyclobenzaprine hydrochloride in acute skeletal muscle spasm: results of two placebo-controlled trials. Clin Ther. 2003;25:1056-1073. (Pubitemid 36532578)
4. Toth PP, Urtis J. Commonly used muscle relaxant therapies for acute low back pain: a review of carisoprodol, cyclobenzaprine hydrochloride, and metaxalone. Clin Ther. 2004;26:1355-1367. (Pubitemid 39572151)
5. Cady R, Farmer K, Schreiber C. Skeletal muscle relaxants: a new rationale for choice. Prim Care Spec Ed. 2003;7:1-4.
6. 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.
7. 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.
8. Share NN, MacFarlane CS. Cyclobenzaprine: novel centrally acting skeletal muscle relaxant. Neuropharmacology. 1975;14:675-684.
9. Baratta RR. A double-blind study of cyclobenzaprine and placebo in the treatment of acute musculoskeletal conditions of the low back. Curr Ther Res Clin Exp. 1982;32:646-652. (Pubitemid 13193065)
10. Steingard PM, Schilberg WL, Peterson KD. Multiclinic study of a muscle relaxant for treatment of acute musculoskeletal disorders. Osteopath Ann. 1980;8:44-58. (Pubitemid 11223070)
11. Bianchi M. Evaluation of cyclobenzaprine for skeletal muscle spasm of local origin. In: Clinical Evaluation of Flexeril (Cyclobenzaprine HCl/ MSD). Minneapolis, MN: Postgraduate Medicine Communications; 1978:25-29.
12. Brown BR Jr, Womble J. Cyclobenzaprine in intractable pain syndromes with muscle spasm. JAMA. 1978;240:1151-1152. (Pubitemid 9040088)
13. Aiken DW. Cyclobenzaprine in the treatment of acute skeletal muscle spasm of local origin. In: Clinical Evaluation of Flexeril (Cyclobenzaprine HCl/MSD). Minneapolis, MN: Postgraduate Medicine Communications; 1978:30-33.
14. Aiken DW. A comparative study of the effects of cyclobenzaprine, diazepam and placebo in the treatment of acute musculoskeletal conditions of the low back. In: Clinical Evaluation of Flexeril (Cyclobenzaprine HCl/MSD). Minneapolis, MN: Postgraduate Medicine Communications; 1978:34-38.
15. Nibbelink DW, Strickland SC, McLean LF, et al. Cyclobenzaprine, diazepam and placebo in the treatment of skeletal muscle spasm of local origin. Clin Ther. 1978;1:409-424. (Pubitemid 10220919)
16. Scheiner JJ. Cyclobenzaprine in the treatment of local muscle spasm. In: Clinical Evaluation of Flexeril (Cyclobenzaprine HCl/MSD). Minneapolis, MN: Postgraduate Medicine Communications; 1978:39-48.
17. Amrix product information. Frazer, PA: Cephalon, Inc.; 2008.
18. Darwish M, Hellriegel ET, Xie F. Single-dose pharmacokinetics of once-daily cyclobenzaprine extended release 30 mg versus cyclobenzaprine immediate release 10 mg three times daily in healthy young adults: a randomized, open-label, two-period crossover, single-centre study. Clin Drug Investig. 2008;28:793-801.
19. Malanga GA, Ruoff GE, Weil AJ, et al. Cyclobenzaprine ER for muscle spasm associated with low back and neck pain: two randomized, double-blind, placebo-controlled studies of identical design. Curr Med Res Opin. 2009;25:1179-1196.
20. World Medical Association. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. Available at: http://www.wma.net/en/30publications/10policies/b3/17c.pdf. Accessed April 26, 2010.
21. International Conference on Harmonisation Working Group. International Conference on Harmonisation Working Group: ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6 (R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; June 10, 1996; Washington, DC. Available at: http://www.ich.org/ fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/E6-R1/Step4/ E6-R1--Guideline.pdf. Accessed February 28, 2011.
22. Flexeril product information. Fort Washington, PA: McNeil Consumer & Specialty Pharmaceuticals; 2001.
23. Weil AJ, Ruoff GE, Nalamachu S, et al. Efficacy and tolerability of cyclobenzaprine extended release for acute muscle spasm: a pooled analysis. Postgrad Med. 2010;122:158-169.
24. Nibbelink DW, Strickland SC. Cyclobenzaprine (Flexeril™): report of a postmarketing surveillance program. Curr Ther Res. 1980;28:894-903. (Pubitemid 11210682)
25. Katz WA, Dube J. Cyclobenzaprine in the treatment of acute muscle spasm: review of a decade of clinical experience. Clin Ther. 1988;10:216-228.
26. Malanga GA, Nadler SF, Lipetz JS. Pharmacologic treatment of low back pain. In: Lox DM, ed. Physical Medicine and Rehabilitation: State of the Art Review. Philadelphia, PA: Hanley and Belfus; 1999:531-549.
27. Darwish M, Chang S, Hellriegel ET. A pharmacokinetic comparison of single doses of once-daily cyclobenzaprine extended-release 15 mg and 30 mg: a randomized, double-blind, twoperiod crossover study in healthy volunteers. Clin Ther. 2009;31:108-114.
28. Greenberg RN. Overview of patient compliance with medication dosing: a literature review. Clin Ther. 1984;6:592-599. (Pubitemid 14064945)
29. Waddell G. The clinical course of low back pain. In: The Back Pain Revolution. Edinburgh, UK: Churchill Livingstone; 1998:103-117.
30. Rizzo JA, Abbott TA III, Berger ML. The labor productivity effects of chronic backache in the United States. Med Care. 1998;36:1471-1488. (Pubitemid 128456367)