Availability and utilization of cardiovascular fixed-dose combination drugs in the United States

American Heart Journal

Volumn 169, Issue 3, 2015, Pages 379-386.e1

  Wang, Bo ^a   Choudhry, Niteesh K ^a   Gagne, Joshua J ^a   Landon, Joan ^a   Kesselheim, Aaron S ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMLODIPINE; AMLODIPINE PLUS ATORVASTATIN; BIGUANIDE DERIVATIVE; CARDIOVASCULAR AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; GLIPIZIDE PLUS METFORMIN; HYDROCHLOROTHIAZIDE PLUS IRBESARTAN; HYDROCHLOROTHIAZIDE PLUS LISINOPRIL; HYDROCHLOROTHIAZIDE PLUS LOSARTAN; HYDROCHLOROTHIAZIDE PLUS TRIAMTERENE; HYDROCHLOROTHIAZIDE PLUS VALSARTAN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LISINOPRIL; METFORMIN; METFORMIN PLUS PIOGLITAZONE; SIMVASTATIN; SIMVASTATIN PLUS SITAGLIPTIN; ANTIDIABETIC AGENT; ANTILIPEMIC AGENT; DRUG COMBINATION;

ADULT; ARTICLE; COHORT ANALYSIS; DIABETES MELLITUS; DRUG BIOAVAILABILITY; DRUG FORMULATION; DRUG USE; DRUG UTILIZATION; DYSLIPIDEMIA; HUMAN; HYPERTENSION; MAJOR CLINICAL STUDY; PHARMACOLOGICAL PARAMETERS; PRESCRIPTION; PRIORITY JOURNAL; CARDIOVASCULAR DISEASES; CLINICAL PRACTICE; COMORBIDITY; DRUG COMBINATION; DYSLIPIDEMIAS; FOOD AND DRUG ADMINISTRATION; STATISTICS AND NUMERICAL DATA; UNITED STATES;

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CARDIOVASCULAR DISEASES; COMORBIDITY; DIABETES MELLITUS; DRUG COMBINATIONS; DYSLIPIDEMIAS; HUMANS; HYPERTENSION; HYPOGLYCEMIC AGENTS; HYPOLIPIDEMIC AGENTS; LISINOPRIL; METFORMIN; PHYSICIAN'S PRACTICE PATTERNS; SIMVASTATIN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84926186595     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2014.12.014     Document Type: Article

References (33)

1. National Heart, Lung, and Blood Institute Expert Panel Report 3: guidelines for diagnosis and management of asthma 2007 Department of Health and Human Services [Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf. Accessed December 7, 2014]
2. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services Available at http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf [Accessed December 7, 2014]
3. P.A. James, S. Oparil, and B.L. Carter 2014 Evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8) JAMA 311 2014 507 520
4. N.J. Stone, J. Robinson, and A.H. Lichtenstein 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines Circulation 129 2014 S1 S45
5. S.E. Inzucchi, R.M. Bergenstal, and J.B. Buse Management of hyperglycemia in type 2 diabetes: a patient-centered approach Diabetes Care 35 2012 1364 1379
6. A.K. Gupta, S. Arshad, and N.R. Poulter Compliance, safety, and effectiveness of fixed-dose combinations of antihypertensive agents: a meta-analysis Hypertension 55 2010 399 407
7. F. Pan, M.E. Chernew, and A.M. Fendrick Impact of fixed-dose combination drugs on adherence to prescription medications J Gen Intern Med 23 2008 611 614
8. J. Wang, C. Huang, and Y. Hung The acarbose/metformin fixed-dose combination study investigators. Acarbose plus metformin fixed-dose combination outperforms acarbose monotherapy for type 2 diabetes Diabetes Res Clin Pract 102 2013 16 24
9. US Food and Drug Administration Guidance for industry: new chemical entity exclusivity determinations for certain fixed-combination drug products http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM386685.pdf [Accessed December 7, 2014]
10. C.D. Fryar, R. Hirsch, and M.S. Eberhardt Hypertension, high serum total cholesterol, and diabetes: racial and ethnic prevalence differences in US adults, 1999-2006 NCHS data brief, no 36 2010 National Center for Health Statistics Hyattsville, MD
11. H.C. Wijeysundera, M. Machado, and F. Farahati Association of temporal trends in risk factors and treatment uptake with coronary heart disease mortality, 1994-2005 JAMA 303 2010 1841 1847
12. E.S. Ford, U.A. Ajani, and J.B. Croft Explaining the decrease in U.S. deaths from coronary disease, 1980-2000 N Engl J Med 356 2007 2388 2398
13. N.K. Chouhdry, S. Setoguchi, and R. Levin Trends in adherence to secondary prevention medications in elderly post-myocardial infarction patients Pharmacoepidemiol Drug Saf 17 2008 1189 1196
14. N.K. Choudhry, J. Avorn, and R.J. Glynn For the Post-Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) Trial. Full coverage for preventive medications after myocardial infarction N Engl J Med 365 2011 2088 2097
15. S. Baroletti, and H. Dell'Orfano Medication adherence in cardiovascular disease Circulation 121 2010 1455 1458
16. P.M. Eng, C.B. Johannes, and C.C. Chiang Survey of disability, medication use, and medication satisfaction among members with rheumatoid arthritis of a large health care plan database Pharmacoepidemiol Drug Saf 14 2005 S1 S218
17. N.K. Choudhry, W.H. Shrank, and R.L. Levin Measuring concurrent adherence to multiple related medications Am J Manag Care 15 2009 457 464
18. US Food and Drug Administration Drugs@FDA: FDA approved drug products http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ [Accessed April 9, 2014]
19. S. Frantz The trouble with making combination drugs Nat Rev Drug Discov 5 2006 881 882
20. US Food and Drug Administration Center for Drug Evaluation and Research - application number: 22-100: medical review(s) http://www.accessdata.fda.gov/drugsatfda-docs/nda/2007/022100s000-MedR-P1.pdf [Accessed April 9, 2014]
21. US Food and Drug Administration Center for Drug Evaluation and Research - application number: 21-990: medical review(s) http://www.accessdata.fda.gov/drugsatfda-docs/nda/2007/021990s000-MedR.pdf [Accessed April 9, 2014]
22. US Food and Drug Administration Center for Drug Evaluation and Research - application number: 21-532: medical review(s) http://www.accessdata.fda.gov/drugsatfda-docs/nda/2003/21-532-Benicar-Medr-P1.pdf [Accessed December 7, 2014]
23. US Food and Drug Administration CFR - Code of Federal Regulations Title 21 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.108 [Accessed December 7, 2014]
24. D.G. Orloff Fixed combination drugs for cardiovascular disease risk reduction: regulatory approach Am J Cardiol 96 2005 28K 33K
25. US Food and Drug Administration Center for Drug Evaluation and Research - application number: 202-343: medical review(s) http://www.accessdata.fda.gov/drugsatfda-docs/nda/2011/202343Orig1s000MedR.pdf [Accessed December 7, 2014]
26. US Food and Drug Administration Center for Drug Evaluation and Research - application number: 21-540: medical review(s) http://www.accessdata.fda.gov/drugsatfda-docs/nda/2004/021540-S000-MEDR.pdf [Accessed December 7, 2014]
27. US Food and Drug Administration Prescription Drug User Fee Rates for Fiscal Year 2015 Fed. Reg. 79 2014 44807 44811 [ http://www.gpo.gov/fdsys/pkg/FR-2014-08-01/pdf/2014-18113.pdf ]
28. N.K. Choudhry, S. Dugani, and W.H. Shrank Despite increased use and sales of statins in India, per capita prescription rates remain far below high-income countries Health Aff 33 2014 273 282
29. N.J. Wald, and M.R. Law A strategy to reduce cardiovascular disease by more than 80% BMJ 326 2003 1419
30. The Indian Polycap Study (TIPS). Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomised trial Lancet 373 2009 1341 1351
31. S. Thom, N. Poulter, and J. Field Effects of a fixed-dose combination strategy on adherence and risk factors in patients with or at high risk of CVD JAMA 310 2013 918 929
32. US Food and Drug Administration Guidance for industry: fixed dose combinations, co-packaged drug products, and single-entity versions of previously approved antiretrovirals for the treatment of HIV http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079742.pdf [Accessed December 7, 2014]
33. US Food and Drug Administration FDA: more than 150 antiretroviral drugs available through PEPFAR for worldwide HIV/AIDS relief http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm313042.htm [Accessed December 7, 2014]