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McDonagh M, Peterson K, Thakurta SG, et al. Drug Class Review: Fixed Dose Combination Drug Products for the Treatment of Type 2 Diabetes and Hyperlipidemia: Final Report [Internet]. Portland (OR): Oregon Health & Science University; 2007 Oct.

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Drug Class Review: Fixed Dose Combination Drug Products for the Treatment of Type 2 Diabetes and Hyperlipidemia

Drug Class Review: Fixed Dose Combination Drug Products for the Treatment of Type 2 Diabetes and Hyperlipidemia: Final Report [Internet].

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References

1.
Chobanian AV, Bakris GL, Black HR. et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report.[see comment][erratum appears in JAMA. 2003 Jul 9;290(2):197] JAMA. 2003 May 21;289(19):2560–2572. [PubMed: 12748199]
2.
National Cholesterol Education Program Expert Panel on Detection EaToHBCiA. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report.[see comment] Circulation. 2002 Dec 17;106(25):3143–3421. [PubMed: 12485966]
3.
American Diabetes A. Standards of medical care in diabetes.[erratum appears in Diabetes Care. 2005 Apr;28(4):990] Diabetes Care. 2005 Jan;28(Suppl 1):S4–S36. [PubMed: 15618112]
4.
McDonald HP, Garg AX, Haynes RB. Interventions to Enhance Patient Adherence to Medication Prescriptions: Scientific Review. JAMA. 2002 December 11;288(22):2868–2879. [PubMed: 12472329]
5.
Haynes RB. Interventions for enhancing medication adherence. The Cochrane Collabortaion. 2005 [PubMed: 16235271]
6.
Influence of adherence to treatment and response of cholesterol on mortality in the coronary drug project. New England Journal of Medicine. 1980;303(18):1038–1041. [PubMed: 6999345]
7.
Simpson SH, Eurich DT, Majumdar SR. et al. A meta-analysis of the association between adherence to drug therapy and mortality.[see comment] BMJ. 2006 Jul 1;333(7557):15. [PMC free article: PMC1488752] [PubMed: 16790458]
8.
Anonymous Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33) Lancet. 1998;352(9131):837–853. [PubMed: 9742976]
9.
Helfand M, Carson S, Kelley C. Drug Class Review on HMG-CoA Reductase Inhibitors (Statins). http://www​.ohsu.edu/drugeffectiveness​/reports​/documents/Statins​%20Final%20Report​%20Update%204%20Unshaded.pdf]. Accessed July 5, 2007. [PubMed: 20496454]
10.
Collaborators CTT. Efficacy and safety of cholesterol-lowering treatment: Prosoective meta-analysis of data from 90056 participants in 14 randomised trials of statins. Lancet. 2005;366:1267–1278. [PubMed: 16214597]
11.
Robinson JG, Smith B, Maheshwari N, Schrott H. Pleiotropic effects of statins: Benefit beyond Cholesterol Reduction. Journal of the American College of Cardiology. 2005;46(10):1855. [PubMed: 16286171]
12.
NIH. Third report of the nationall cholesterol education program: detection, evaluation and treatment of high blood cholesterol in adults 2004.
13.
Moulds RFW. Combination Products: love them or loathe them? Australian Prescriber. 2001;24(5):127–129.
14.
Bailey CJ. Whence and whither the fixed-dose combination? Diabetes Vasc Dis Res. 2005;2:51–53. [PubMed: 16305058]
15.
Bakris GL. Achieving blood pressure goals: is fixed dose combination therapy the answer? Journal of Clinical Hypertension (Greenwich)) 2003;5:2–3. [PubMed: 12941991]
16.
Sica DA. Fixed dose combination therapy-is it time for this approach to hypertension and dyslipidemia management? Journal of Clinical Hypertension (Greenwich)) 2004;6:164–167. [PubMed: 15073469]
17.
Wofford JL. History of fixed dose combination therapy for hypertension [comment] Archives of Internal Medicine. 1997;157:1044. [PubMed: 9140279]
18.
Bissonnette S, Habib R, Sampalis F, Boukas S. Efficacy and tolerability of ezetimibe 10mg/day coadministered with statins in patients with hypercholesterolemia who do not achieve target LDL-C while on statin monotherapy: A Canadian, multicenter, prospective study-the ezetrol add-on study. Canadian Journal of Cardiology. 2006;22(12):1035–1044. [PMC free article: PMC2568964] [PubMed: 17036098]
19.
Sampalis F, Bissonnette S, Habib R, Boukas S. Reduction is estimated risk of coronary artery disease after use of ezetimibe with statin. The Annals of Pharmacotherapy. 2007;41:1345–1351. [PubMed: 17666579]
20.
Gerrits CM, Bhattacharya M, Manthena SRB, Perez A, Kupfer S. A comparison of pioglitazone and rosiglitazone for hospitalization for acute myocardial infarction in type 2 diabetes. Pharmacoepidemiology and Drug Safety. 2007 [PubMed: 17674425]
21.
Harris RP, Helfand M, Woolf SH. et al. Current methods of the third U.S. Preventive Services Task Force. American Journal of Preventive Medicine. 2001;20(3S):21–35. [PubMed: 11306229]
22.
Anonymous. Undertaking systematic reviews of research on effectiveness: CRD's guidance for those carrying out or commissioning reviews CRD Report Number 4 (2nd edition). York, UK: NHS Centre for Reviews and Dissemination; 2001. 4 (2nd edition).
23.
Bruce S, Park JS, Fiedorek FT, Howlett HCS. Beta-cell response to metformin-glibenclamide combination tablets (Glucovance) in patients with type 2 diabetes. International Journal of Clinical Practice. 2006 Jul;60(7):783–790. [PubMed: 16846398]
24.
Garber AJ, Donovan DS Jr., Dandona P, Bruce S, Park J-S. Efficacy of glyburide/metformin tablets compared with initial monotherapy in type 2 diabetes. Journal of Clinical Endocrinology & Metabolism. 2003 Aug;88(8):3598–3604. [PubMed: 12915642]
25.
Blonde L, Rosenstock J, Mooradian AD, Piper BA, Henry D. Glyburide/metformin combination product is safe and efficacious in patients with type 2 diabetes failing sulphonylurea therapy. Diabetes, Obesity & Metabolism. 2002 Nov;4(6):368–375. [PubMed: 12406033]
26.
Marre M, Howlett H, Lehert P, Allavoine T. Improved glycaemic control with metformin-glibenclamide combined tablet therapy (Glucovance) in Type 2 diabetic patients inadequately controlled on metformin. Diabetic Medicine. 2002 Aug;19(8):673–680. [PubMed: 12147149]
27.
Garber AJ, Larsen J, Schneider SH, Piper BA, Henry D. Glyburide/Metformin Initial Therapy Study G. Simultaneous glyburide/metformin therapy is superior to component monotherapy as an initial pharmacological treatment for type 2 diabetes. Diabetes, Obesity & Metabolism. 2002 May;4(3):201–208. [PubMed: 12047399]
28.
Erle G, Lovise S, Stocchiero C. et al. A comparison of preconstituted, fixed combinations of low-dose glyburide plus metformin versus high-dose glyburide alone in the treatment of type 2 diabetic patients. Acta Diabetologica. 1999 Jun;36(12):61–65. [PubMed: 10436254]
29.
Melikian C, White TJ, Vanderplas A, Dezii CM, Chang E. Adherence to oral antidiabetic therapy in a managed care organization: a comparison of monotherapy, combination therapy, and fixed-dose combination therapy. Clinical Therapeutics. 2002 Mar;24(3):460–467. [PubMed: 11952029]
30.
Blonde L, Wogen J, Kreilick C, Seymour AA. Greater reductions in A1C in type 2 diabetic patients new to therapy with glyburide/metformin tablets as compared to glyburide co-administered with metformin. Diabetes, Obesity & Metabolism. 2003 Nov;5(6):424–431. [PubMed: 14617228]
31.
Goldstein BJ, Pans M, Rubin CJ. Multicenter, randomized, double-masked, parallel-group assessment of simultaneous glipizide/metformin as second-line pharmacologic treatment for patients with type 2 diabetes mellitus that is inadequately controlled by a sulfonylurea. Clinical Therapeutics. 2003 Mar;25(3):890–903. [PubMed: 12852706]
32.
Center for Drug Evaluation and Research. Metaglip Medical Review. http://www​.fda.gov/cder​/foi/nda/2002/21-460_Metaglip_Medr​.pdf]. Accessed July 13, 2007.
33.
Rosenstock J, Rood JA, Cobitz AR, Biswas N, Chou H, Garber A. Initial treatment with rosiglitazone/metformin fixed-dose combination therapy compared with monotherapy with either rosiglitazone or metformin in patients with uncontrolled type 2 diabetes. Diabetes, Obesity & Metabolism. 2006;8(6):650–660. [PubMed: 17026489]
34.
Vanderpoel DR, Hussein MA, Watson-Heidari T, Perry A. Adherence to a fixed-dose combination of rosiglitazone maleate/metformin hydrochloride in subjects with type 2 diabetes mellitus: a retrospective database analysis. Clinical Therapeutics. 2004 Dec;26(12):2066–2075. [PubMed: 15823770]
35.
Chou HS. Initial treatment with fixed-dose combination rosiglitazone/glimepiride in patients with previously untreated type 2 diabetes. Diabetes, Obesity & Metabolism. 2007 [PubMed: 17645558]
36.
Takeda Pharmaceuticals North America Inc. Duetact® Product Information and Data Dossier: Submitted to the Drug Effectiveness Review Project; 2007.
37.
Takeda Pharmaceuticals North America Inc. ACTOplus Met® Product Information and Data Dossier: Submitted to the Drug Effectiveness Review Project; 2007.
38.
Merck & Co. Inc. Vytorin(r) Product Information and Data Dossier: Submitted to the Drug Effectiveness Review Project; 2007.
39.
Schectman JM, Nadkarni MM, Voss JD. The association between diabetes metabolic control and drug adherence in an indigent population. Diabetes Care. 2002 Jun;25(6):1015–1021. [PubMed: 12032108]
40.
Mateo J, Gil-Guillen VF, Mateo E. et al. Multifactorial approach and adherence to prescribed oral medications in patients with type 2 diabetes. International Journal of Clinical Practice. 2006;60:422–428. [PubMed: 16620354]
41.
Lau DT, Nau DP. Oral antihyperglycemic medication nonadherence and subsequent hospitalization among individuals with type 2 diabetes. Diabetes Care. 2004 Sep;27(9):2149–2153. [PubMed: 15333476]
42.
Krapek K, King K, Warren SS. et al. Medication adherence and associated hemoglobin A1c in type 2 diabetes. Annals of Pharmacotherapy. 2004 Sep;38(9):1357–1362. [PubMed: 15238621]
43.
Hays R, Kravitz R, Mazel R. et al. The impact of patient adherence on health outcomes for patients with chronic disease in the Medical Outcomes Study. Journal of Behavioral Medicine. 1994;17:347–360. [PubMed: 7966257]
44.
Grant RW, Devita NG, Singer DE. et al. Polypharmacy and medication adherence in patients with type 2 diabetes. Diabetes Care. 2003;26:1408–1412. [PubMed: 12716797]
45.
Brown JB, Nichols GA, Glauber HS, Bakst A. Ten-year follow-up of antidiabetic drug use, nonadherence, and mortality in a defined population with type 2 diabetes mellitus. Clinical Therapeutics. 1999 Jun;21(6):1045–1057. [PubMed: 10440626]
46.
Balkrishnan R, Rajagopalan R, Camacho F, Huston S, Murray F, Anderson R. Predictors of medication adherence and associated health care costs in an older population with type 2 diabetes mellitus: a longitudinal cohort study. Clinical Therapeutics. 2003;25(11):2958–2971. [PubMed: 14693318]
47.
Duckworth W, Marcelli M, Padden M. et al. Improvements in glycemic control in type 2 diabetes patients switched from sulfonylurea coadministered with metformin to glyburide-metformin tablets. Journal of Managed Care Pharmacy. 2003 May–Jun;9(3):256–262. [PubMed: 14613469]
48.
Garber A, Marre M, Blonde L. et al. Influence of initial hyperglycaemia, weight and age on the blood glucose lowering efficacy and incidence of hypoglycaemic symptoms with a single-tablet metformin-glibenclamide therapy (Glucovance) in type 2 diabetes. Diabetes, Obesity & Metabolism. 2003 May;5(3):171–179. [PubMed: 12681024]
49.
Garber AJ, Bruce S, Fiedorek FT. Durability of efficacy and long-term safety profile of glyburide/metformin tablets in patients with type 2 diabetes mellitus: an open-label extension study. Clinical Therapeutics. 2002 Sep;24(9):1401–1413. [PubMed: 12380632]
50.
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2005;28(Suppl. 1):S37–S42. [PubMed: 15618111]
51.
Tarlov AR, Ware JE, Greenfield S, Nelson EC, Perrin E, Zubkoff M. The Medical Outcomes Study: An Application of Methods for Monitoring the Results of Medical Care. JAMA : the Journal of the American Medical Association. 1989;262(7):925–930. [PubMed: 2754793]
52.
Hunninghake DB, McGovern ME, Koren M. et al. A dose-ranging study of a new, once-daily, dual-component drug product containing niacin extended-release and lovastatin. Clinical Cardiology. 2003 Mar;26(3):112–118. [PubMed: 12685616]
53.
Insull W Jr., McGovern ME, Schrott H. et al. Efficacy of extended-release niacin with lovastatin for hypercholesterolemia: assessing all reasonable doses with innovative surface graph analysis. Archives of Internal Medicine. 2004 May 24;164(10):1121–1127. [PubMed: 15159270]
54.
Bays HE, Dujovne CA, McGovern ME. et al. Comparison of once-daily, niacin extended-release/lovastatin with standard doses of atorvastatin and simvastatin (the ADvicor Versus Other Cholesterol-Modulating Agents Trial Evaluation [ADVOCATE]) American Journal of Cardiology. 2003a Mar 15;91(6):667–672. [PubMed: 12633795]
55.
Food and Drug Administration. Advicor Product Label. 2007 July 5;2005
56.
Rubenfire M. Impact of Medical Subspecialty on Patient Compliance to Treatment Study G. Safety and compliance with once-daily niacin extended-release/lovastatin as initial therapy in the Impact of Medical Subspecialty on Patient Compliance to Treatment (IMPACT) study. American Journal of Cardiology. 2004 Aug 1;94(3):306–311. [PubMed: 15276093]
57.
Kashyap ML, McGovern ME, Berra K. et al. Long-term safety and efficacy of a once-daily niacin/lovastatin formulation for patients with dyslipidemia. American Journal of Cardiology. 2002 Mar 15;89(6):672–678. [PubMed: 11897208]
58.
LaFleur J, Thompson CJ, Joish VN, Charland SL, Oderda GM, Brixner DI. Adherence and persistence with single-dosage form extended-release niacin/lovastatin compared with statins alone or in combination with extended-release niacin. Annals of Pharmacotherapy. 2006 Jul–Aug;40(78):1274–1279. [PubMed: 16849622]
59.
Ballantyne CM, Abate N, Yuan Z, King TR, Palmisano J. Dose-comparison study of the combination of ezetimibe and simvastatin (Vytorin) versus atorvastatin in patients with hypercholesterolemia: the Vytorin Versus Atorvastatin (VYVA) study. American Heart Journal. 2005 Mar;149(3):464–473. [PubMed: 15864235]
60.
Barrios V, Amabile N, Paganelli F. et al. Lipid-altering efficacy of switching from atorvastatin 10 mg/day to ezetimibe/simvastatin 10/20 mg/day compared to doubling the dose of atorvastatin in hypercholesterolaemic patients with atherosclerosis or coronary heart disease. International Journal of Clinical Practice. 2005 Dec;59(12):1377–1386. [PubMed: 16351668]
61.
Goldberg RB, Guyton JR, Mazzone T. et al. Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia: the VYTAL study. Mayo Clinic Proceedings. 2006 Dec;81(12):1579–1588. [PubMed: 17165637]
62.
Catapano AL, Davidson MH, Ballantyne CM. et al. Lipid-altering efficacy of the ezetimibe/simvastatin single tablet versus rosuvastatin in hypercholesterolemic patients. Current Medical Research & Opinion. 2006 Oct;22(10):2041–2053. [PubMed: 17022864]
63.
Bays HE, Ose L, Fraser N. et al. A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia. Clinical Therapeutics. 2004 Nov;26(11):1758–1773. [PubMed: 15639688]
64.
Hildemann SK, Barho C, Karmann B, Darius H, Bestehorn K. Dual cholesterol inhibition with ezetimibe/simvastatin in pre-treated hypercholesterolaemic patients with coronary heart disease or diabetes mellitus: prospective observational cohort studies in clinical practice. Current Medical Research & Opinion. 2007 Apr;23(4):713–719. [PubMed: 17407627]
65.
Food and Drug Administration. Vytorin FDA Medical Review. 2007 July 5;2004
66.
Catapano A, Brady WE, King TR, Palmisano J. Lipid altering-efficacy of ezetimibe co-administered with simvastatin compared with rosuvastatin: a meta-analysis of pooled data from 14 clinical trials. Current Medical Research & Opinion. 2005 Jul;21(7):1123–1130. [PubMed: 16004682]
67.
Parris ES, Lawrence DB, Mohn LA, Long LB. Adherence to statin therapy and LDL cholesterol goal attainment by patients with diabetes and dyslipidemia. Diabetes Care. 2005 Mar;28(3):595–599. [PubMed: 15735194]
Copyright & 2007, Oregon Health & Science University, Portland, Oregon.
Bookshelf ID: NBK10485

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