Long-term safety and tolerability of saxagliptin add-on therapy in older patients (aged ≥ 65 years) with type 2 diabetes

Clinical Interventions in Aging

Volumn 9, Issue , 2014, Pages 1479-1487

  Iqbal, Nayyar ^a   Allen, Elsie ^a   Öhman, Peter ^b  

^a BRISTOL MYERS SQUIBB   (United States)

^b ASTRAZENECA   (United Kingdom)

Author keywords

Glyburide; Metformin; Older patients; Saxagliptin; Thiazolidinedione

Indexed keywords

GLIBENCLAMIDE; GLUCOSE; HEMOGLOBIN A1C; METFORMIN; PIOGLITAZONE; PLACEBO; ROSIGLITAZONE; SAXAGLIPTIN; ADAMANTANE; DIPEPTIDE; INCRETIN;

ADD ON THERAPY; ADVERSE OUTCOME; AGED; ARTHRALGIA; ARTICLE; BACKACHE; BODY MASS; BRONCHITIS; CLINICAL EVALUATION; CLINICAL FEATURE; CONTROLLED STUDY; COUGHING; CREATININE CLEARANCE; DIARRHEA; DIZZINESS; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GLUCOSE BLOOD LEVEL; HEADACHE; HUMAN; HYPERTENSION; HYPOGLYCEMIA; INCIDENCE; INFLUENZA; LIMB PAIN; LONG TERM CARE; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PATIENT ASSESSMENT; PERIPHERAL EDEMA; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHINOPHARYNGITIS; RISK FACTOR; SKIN DISEASE; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; ANALOGS AND DERIVATIVES; DIABETES MELLITUS, TYPE 2; DOUBLE BLIND PROCEDURE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ADAMANTANE; AGED; DIABETES MELLITUS, TYPE 2; DIPEPTIDES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INCRETINS; MALE; MIDDLE AGED; PLACEBOS; RISK FACTORS; TREATMENT OUTCOME;

EID: 84907518944     PISSN: 11769092     EISSN: 11781998     Source Type: Journal    
DOI: 10.2147/CIA.S68193     Document Type: Article

References (25)

1. Centers for Disease Control and Prevention. National diabetes statistics report: estimates of diabetes and its burden in the United States, 2014. Available from: http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Accessed June 11, 2014.
2. Brown AF, Mangione CM, Saliba D, Sarkisian CA. Guidelines for improving the care of the older person with diabetes mellitus. J Am Geriatr Soc. 2003;51(Suppl 5):S265-S280.
3. Kirkman MS, Briscoe VJ, Clark N, et al. Diabetes in older adults: a consensus report. J Am Geriatr Soc. 2012;60:2342-2356.
4. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35: 1364-1379.
5. Paolisso G. Pathophysiology of diabetes in elderly people. Acta Biomed. 2010;81 Suppl 1:47-53.
6. Kyrou I, Tsigos C. Obesity in the elderly diabetic patient: is weight loss beneficial? No. Diabetes Care. 2009;32(Suppl 2):S403-S409.
7. Schwartz SL. Treatment of elderly patients with type 2 diabetes mellitus: a systematic review of the benefits and risks of dipeptidyl peptidase-4 inhibitors. Am J Geriatr Pharmacother. 2010;8:405-418.
8. Suh DC, Kim CM, Choi IS, Plauschinat CA. Comorbid conditions and glycemic control in elderly patients with type 2 diabetes mellitus, 1988 to 1994 to 1999 to 2004. J Am Geriatr Soc. 2008;56:484-492.
9. ® (saxagliptin). Princeton, NJ/Wilmington, DE, USA: Bristol-Myers Squibb/AstraZeneca Pharmaceuticals LP; 2011.
10. Charbonnel B, Cariou B. Pharmacological management of type 2 diabetes: the potential of incretin-based therapies. Diabetes Obes Metab. 2011;13:99-117.
11. DeFronzo RA, Hissa MN, Garber AJ, et al. The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin alone. Diabetes Care. 2009;32:1649-1655.
12. Hollander P, Li J, Allen E, Chen R; CV181-013 Investigators. Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione alone. J Clin Endocrinol Metab. 2009;94:4810-4819.
13. Chacra AR, Tan GH, Apanovitch A, Ravichandran S, List J, Chen R. Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: a randomised controlled trial. Int J Clin Pract. 2009;63:1395-1406.
14. Barnett AH, Charbonnel B, Donovan M, Fleming D. Effect of saxagliptin as add-on therapy in patients with poorly controlled type 2 diabetes on insulin alone or insulin combined with metformin. Curr Med Res Opin. 2012;28:513-523.
15. Chacra AR, Tan GH, Ravichandran S, List J, Chen R; CV181040 Investigators. Safety and efficacy of saxagliptin in combination with submaximal sulphonylurea versus up-titrated sulphonylurea over 76 weeks. Diab Vasc Dis Res. 2011;8:150-159.
16. Hollander PL, Li J, Frederich R, Allen E, Chen R; CV181040 Investigators. Safety and efficacy of saxagliptin added to thiazolidinedione over 76 weeks in patients with type 2 diabetes mellitus. Diab Vasc Dis Res. 2011;8:125-135.
17. Rosenstock J, Gross JL, Aguilar-Salinas C, et al. Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with type 2 diabetes. Diabet Med. 2013;30:1472-1476.
18. Doucet J, Chacra A, Maheux P, Lu J, Harris S, Rosenstock J. Efficacy and safety of saxagliptin in older patients with type 2 diabetes mellitus. Curr Med Res Opin. 2011;27:863-869.
19. Karyekar CS, Ravichandran S, Allen E, Fleming D, Frederich R. Tolerability and efficacy of glycemic control with saxagliptin in older patients (aged ≥65 years) with inadequately controlled type 2 diabetes mellitus. Clin Interv Aging. 2013;8:419-430.
20. DeFronzo RA, Hissa MN, Garber AJ, et al. The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin alone. Diabetes Care. 2009;32:1649-1655.
21. Schernthaner G, Barnett AH, Emser A, et al. Safety and tolerability of linagliptin: a pooled analysis of data from randomized controlled trials in 3,572 patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2012;14:470-478.
22. Hornick T, Aron DC. Managing diabetes in the elderly: go easy, individualize. Cleve Clin J Med. 2008;75:70-78.
23. American Diabetes Association. Standards of medical care in diabetes - 2012. Diabetes Care. 2012;35 (Suppl 1):S11-S63.
24. Barzilai N, Guo H, Mahoney EM, et al. Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin. 2011;27:1049-1058.
25. Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369:1317-1326.