A randomized, double-blind, placebo-controlled study of an oral, extended-release formulation of phentermine/topiramate for the treatment of obstructive sleep apnea in obese adults

Sleep

Volumn 35, Issue 11, 2012, Pages 1529-1539

  Winslow, David H ^a   Bowden, Charles H ^b   DiDonato, Karen P ^a   McCullough, Pamela A ^a  

^a Kentucky Research Group   (United States)

^b Menlo Park and VIVUS   (United States)

Author keywords

Apnea hypopnea index; Obesity; Obstructive sleep apnea; Phentermine; Topiramate

Indexed keywords

PHENTERMINE; PLACEBO; TOPIRAMATE;

ADULT; AGED; APNEA HYPOPNEA INDEX; ARTICLE; BLOOD PRESSURE MEASUREMENT; BODY MASS; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; CORRELATION ANALYSIS; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSGEUSIA; FEMALE; GASTROENTERITIS; HEART RATE; HUMAN; HYPESTHESIA; IRRITABILITY; LIFESTYLE MODIFICATION; MALE; NEPHROLITHIASIS; NONREM SLEEP; OBESITY; OXYGEN SATURATION; PARESTHESIA; PATIENT COUNSELING; PHASE 2 CLINICAL TRIAL; POLYSOMNOGRAPHY; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; REM SLEEP; RHINOPHARYNGITIS; SIDE EFFECT; SINUSITIS; SLEEP DISORDERED BREATHING; SLEEP QUALITY; SYSTOLIC BLOOD PRESSURE; UPPER RESPIRATORY TRACT INFECTION; WEIGHT REDUCTION; WELLBEING; XEROSTOMIA;

ADMINISTRATION, ORAL; ADULT; AGED; ANTI-OBESITY AGENTS; APPETITE DEPRESSANTS; DELAYED-ACTION PREPARATIONS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; FRUCTOSE; HUMANS; MALE; MIDDLE AGED; OBESITY; PHENTERMINE; POLYSOMNOGRAPHY; PROSPECTIVE STUDIES; SLEEP APNEA, OBSTRUCTIVE; TREATMENT OUTCOME;

EID: 84868277159     PISSN: 01618105     EISSN: 15509109     Source Type: Journal    
DOI: 10.5665/sleep.2204     Document Type: Article

References (61)

1. Caples SM, Gami AS, Somers VK. Obstructive sleep apnea. Ann Intern Med 2005;142:187-97.
2. Flemons WW. Clinical practice. Obstructive sleep apnea. N Engl J Med 2002;347:498-504.
3. Wolk R, Shamsuzzaman AS, Somers VK. Obesity, sleep apnea, and hy-pertension. Hypertension 2003;42:1067-74.
4. Young T, Skatrud J, Peppard PE. Risk factors for obstructive sleep apnea in adults. JAMA 2004;291:2013-6.
5. Grote L, Hedner J, Grunstein R, Kraiczi H. Therapy with nCPAP: in-complete elimination of sleep related breathing disorder. Eur Respir J 2000;16:921-7.
6. Chowdhuri S. Continuous positive airway pressure for the treatment of sleep apnea. Otolaryngol Clin North Am 2007;40:807-27.
7. Kakkar RK, Berry RB. Positive airway pressure treatment for obstructive sleep apnea. Chest 2007;132:1057-72.
8. George CF. Sleep apnea, alertness, and motor vehicle crashes. Am J Respir Crit Care Med 2007;176:954-6.
9. Marshall NS, Wong KK, Liu PY, Cullen SR, Knuiman MW, Grunstein RR. Sleep apnea as an independent risk factor for all-cause mortality: the Busselton Health Study. Sleep 2008;31:1079-85.
10. Meslier N, Gagnadoux F, Giraud P, et al. Impaired glucose-insulin me-tabolism in males with obstructive sleep apnoea syndrome. Eur Respir J 2003;22:156-60.
11. Punjabi NM, Workshop P. Do sleep disorders and associated treatments impact glucose metabolism? Drugs 2009;69 Suppl 2:13-27.
12. Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: im-plications for cardiac and vascular disease. JAMA 2003;290:1906-14.
13. Tasali E, Ip MS. Obstructive sleep apnea and metabolic syndrome: al-terations in glucose metabolism and infammation. Proc Am Thorac Soc 2008;5:207-17.
14. Tasali E, Mokhlesi B, Van Cauter E. Obstructive sleep apnea and type 2 diabetes: interacting epidemics. Chest 2008;133:496-506.
15. Young T, Finn L, Peppard PE, et al. Sleep disordered breathing and mortality: eighteen-year follow-up of the Wisconsin sleep cohort. Sleep 2008;31:1071-8.
16. Leinum CJ, Dopp JM, Morgan BJ. Sleep-disordered breathing and obe-sity: pathophysiology, complications, and treatment. Nutr Clin Pract 2009;24:675-87.
17. Eckert DJ, Malhotra A. Pathophysiology of adult obstructive sleep apnea. Proc Am Thorac Soc 2008;5:144-53.
18. Schwartz AR, Patil SP, Laffan AM, Polotsky V, Schneider H, Smith PL. Obesity and obstructive sleep apnea: pathogenic mechanisms and thera-peutic approaches. Proc Am Thorac Soc 2008;5:185-92.
19. Foster GD, Borradaile KE, Sanders MH, et al. A randomized study on the effect of weight loss on obstructive sleep apnea among obese pa-tients with type 2 diabetes: the Sleep AHEAD study. Arch Intern Med 2009;169:1619-26.
20. Johansson K, Hemmingsson E, Harlid R, et al. Longer term effects of very low energy diet on obstructive sleep apnoea in cohort derived from randomised controlled trial: prospective observational follow-up study. BMJ 2011;342:d3017.
21. Tuomilehto HP, Seppa JM, Partinen MM, et al. Lifestyle intervention with weight reduction: frst-line treatment in mild obstructive sleep apnea. Am J Respir Crit Care Med 2009;179:320-7.
22. Grunstein RR, Stenlof K, Hedner JA, Peltonen M, Karason K, Sjostrom L. Two year reduction in sleep apnea symptoms and associated diabetes incidence after weight loss in severe obesity. Sleep 2007;30:703-10.
23. Haines KL, Nelson LG, Gonzalez R, et al. Objective evidence that bar-iatric surgery improves obesity-related obstructive sleep apnea. Surgery 2007;141:354-8.
24. Peppard PE, Young T, Palta M, Dempsey J, Skatrud J. Longitudinal study of moderate weight change and sleep-disordered breathing. JAMA 2000;284:3015-21.
25. Yee BJ, Phillips CL, Banerjee D, Caterson I, Hedner JA, Grunstein RR. The effect of sibutramine-assisted weight loss in men with obstructive sleep apnoea. Int J Obes 2007;31:161-8.
26. Wadden TA, Berkowitz RI, Womble LG, et al. Randomized trial of lifestyle modifcation and pharmacotherapy for obesity N Engl J Med 2005;353:2111-20.
27. Gadde KM, Allison DB, Ryan DH, et al. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and asso-ciated comorbidities in overweight and obese adults (CONQUER): a ran-domised, placebo-controlled, phase 3 trial. Lancet 2011;377:1341-52.
28. Adipex-P [package insert]. In. Sellersville, PA: Teva Pharmaceuticals USA, 2005.
29. Bonow RO, Carabello BA, Chatterjee K, et al. 2008 Focused update in-corporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guide-lines (Writing Committee to Revise the 1998 Guidelines for the Manage-ment of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiog-raphy and Interventions, and Society of Thoracic Surgeons. Circulation 2008;118:e523-661.
30. Hamidovic A, Childs E, Conrad M, King A, de Wit H. Stress-induced changes in mood and cortisol release predict mood effects of amphet-amine. Drug Alcohol Depend 2010;109:175-80.
31. Jick H, Vasilakis C, Weinrauch LA, Meier CR, Jick SS, Derby LE. A pop-ulation-based study of appetite-suppressant drugs and the risk of cardiac-valve regurgitation. N Engl J Med 1998;339:719-24.
32. Lile JA, Babalonis S, Emurian C, Martin CA, Wermeling DP, Kelly TH. Comparison of the behavioral and cardiovascular effects of intranasal and oral d-amphetamine in healthy human subjects. J Clin Pharmacol 2011;51:888-98.
33. Rothman RB, Ayestas MA, Dersch CM, Baumann MH. Aminorex, fenfu-ramine, and chlorphentermine are serotonin transporter substrates. Implica-tions for primary pulmonary hypertension. Circulation 1999;100:869-75.
34. Rothman RB, Baumann MH, Dersch CM, et al. Amphetamine-type cen-tral nervous system stimulants release norepinephrine more potently than they release dopamine and serotonin. Synapse 2001;39:32-41.
35. Rosenstock J, Hollander P, Gadde KM, et al. A randomized, double-blind, placebo-controlled, multicenter study to assess the effcacy and safety of topiramate controlled release in the treatment of obese type 2 diabetic patients. Diabetes Care 2007;30:1480-6.
36. Bray GA, Hollander P, Klein S, et al. A 6-month randomized, placebo-controlled, dose-ranging trial of topiramate for weight loss in obesity Obes Res 2003;11:722-33.
37. Tonstad S, Tykarski A, Weissgarten J, et al. Effcacy and safety of topira-mate in the treatment of obese subjects with essential hypertension. Am J Cardiol 2005;96:243-51.
38. Toplak H, Hamann A, Moore R, et al. Effcacy and safety of topiramate in combination with metformin in the treatment of obese subjects with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Int J Obes 2007;31:138-46.
39. Wilding J, Van Gaal L, Rissanen A, Vercruysse F, Fitchet M. A random-ized double-blind placebo-controlled study of the long-term effcacy and safety of topiramate in the treatment of obese subjects. Int J Obes Relat Metab Disord 2004;28:1399-410.
40. Garvey WT, Ryan DH, Look M, et al. Two-year sustained weight loss and metabolic benefts with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-con-trolled, phase 3 extension study. Am J Clin Nutr 2012;95:297-308.
41. Brownell K. The LEARN program for weight management. Dallas: The Life Style Company, 2000.
42. Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res 1989;28:193-213.
43. Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 1991;14:540-5.
44. Johns MW. Reliability and factor analysis of the Epworth Sleepiness Scale. Sleep 1992;15:376-81.
45. Ware JE Jr., Sherbourne CD. The MOS 36-item short-form health sur-vey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.
46. Heymsfeld SB, Greenberg AS, Fujioka K, et al. Recombinant leptin for weight loss in obese and lean adults: a randomized, controlled, dose-esca-lation trial. JAMA 1999;282:1568-75.
47. Leniger T, Thone J, Wiemann M. Topiramate modulates pH of hippocam-pal CA3 neurons by combined effects on carbonic anhydrase and Cl-/ HCO3- exchange. Br J Pharmacol 2004;142:831-42.
48. Magill RA, Waters WF, Bray GA, et al. Effects of tyrosine, phentermine, caffeine D-amphetamine, and placebo on cognitive and motor perfor-mance defcits during sleep deprivation. Nutr Neurosci 2003;6:237-46.
49. Young T, Peppard PE, Taheri S. Excess weight and sleep-disordered breathing. J Appl Physiol 2005;99:1592-9.
50. Case CC, Jones PH, Nelson K, O'Brian Smith E, Ballantyne CM. Im-pact of weight loss on the metabolic syndrome. Diabetes Obes Metab 2002;4:407-14.
51. Espeland L, Hogevold HE, Stenvik A. A 3-year patient-centred follow-up of 516 consecutively treated orthognathic surgery patients. Eur J Orthod 2008;30:24-30.
52. Eveloff SE. Treatment of obstructive sleep apnea: no longer just a lot of hot air. Chest 2002;121:674-7.
53. Sadatsafavi M, Marra CA, Ayas NT, Stradling J, Fleetham J. Cost-effec-tiveness of oral appliances in the treatment of obstructive sleep apnoea-hypopnoea. Sleep Breath 2009;13:241-52.
54. Won CH, Li KK, Guilleminault C. Surgical treatment of obstructive sleep apnea: upper airway and maxillomandibular surgery. Proc Am Thorac Soc 2008;5:193-9.
55. Valentino RM, Foldvary-Schaefer N. Modafnil in the treatment of exces-sive daytime sleepiness. Cleve Clin J Med 2007;74:561-6, 8-71.
56. Javaheri S. Acetazolamide improves central sleep apnea in heart fail-ure: a double-blind, prospective study. Am J Respir Crit Care Med 2006;173:234-7.
57. Tojima H, Kunitomo F, Kimura H, Tatsumi K, Kuriyama T, Honda Y. Ef-fects of acetazolamide in patients with the sleep apnoea syndrome. Tho-rax 1988;43:113-9.
58. Masa JF, Corral J, Pereira R, et al. Therapeutic decision-making for sleep apnea and hypopnea syndrome using home respiratory polygraphy: a large multicentric study. Am J Respir Crit Care Med 2011;184:964-71.
59. Logue J, Murray HM, Welsh P, et al. Obesity is associated with fatal coro-nary heart disease independently of traditional risk factors and depriva-tion. Heart 2011;97:564-8.
60. Somers VK, Dyken ME, Clary MP, Abboud FM. Sympathetic neural mechanisms in obstructive sleep apnea. J Clin Invest 1995;96:1897-904.
61. Mohsenin V. Sleep-disordered breathing: implications in cerebrovascular disease. Prev Cardiol 2003;6:149-54.