Sitagliptin/Simvastatin: A first combination tablet to treat type 2 diabetes and hypercholesterolemia - A review of its characteristics

Vascular Health and Risk Management

Volumn 11, Issue , 2015, Pages 125-132

  Ramadan, Wijdan H ^a   Kabbara, Wissam K ^a  

^a LEBANESE AMERICAN UNIVERSITY   (Lebanon)

Author keywords

Diabetes mellitus; Hypercholesterolemia; Juvisync ; Simvastatin; Sitagliptin

Indexed keywords

AMIODARONE; ATORVASTATIN; CLARITHROMYCIN; CYCLOSPORIN; DANAZOL; DILTIAZEM; ERYTHROMYCIN; EXENDIN 4; EZETIMIBE; FLUINDOSTATIN; GEMFIBROZIL; GLIMEPIRIDE PLUS METFORMIN; GLIPIZIDE; INSULIN GLARGINE; ITRACONAZOLE; KETOCONAZOLE; METFORMIN; MEVINOLIN; NEFAZODONE; PLACEBO; POSACONAZOLE; PRAVASTATIN; ROSUVASTATIN; SIMVASTATIN; SIMVASTATIN PLUS SITAGLIPTIN; SITAGLIPTIN; SULFONYLUREA; TELITHROMYCIN; UNINDEXED DRUG; VERAPAMIL; BIOLOGICAL MARKER; CHOLESTEROL; DIPEPTIDYL PEPTIDASE IV INHIBITOR; DRUG COMBINATION; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; PYRAZINE DERIVATIVE; TRIAZOLE DERIVATIVE;

ABDOMINAL PAIN; ABNORMAL LABORATORY RESULT; ACUTE KIDNEY FAILURE; ACUTE PANCREATITIS; ADD ON THERAPY; BIOEQUIVALENCE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; CONSTIPATION; DIABETES MELLITUS; DRUG BIOAVAILABILITY; DRUG CONTRAINDICATION; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HYDROLYSIS; DRUG MEGADOSE; DRUG METABOLISM; DRUG SAFETY; DRUG STRUCTURE; ENZYME INHIBITION; EVENING DOSAGE; GLYCEMIC CONTROL; HEADACHE; HEART DEATH; HEART DISEASE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTRANSAMINASEMIA; HYPOGLYCEMIA; LOW DRUG DOSE; META ANALYSIS; METABOLIC SYNDROME X; MYALGIA; MYOPATHY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; REVIEW; RHABDOMYOLYSIS; RHINOPHARYNGITIS; SIDE EFFECT; SYSTEMATIC REVIEW; TIME TO MAXIMUM PLASMA CONCENTRATION; UPPER RESPIRATORY TRACT INFECTION; VENOUS THROMBOEMBOLISM; WEIGHT GAIN; BLOOD; CARDIOVASCULAR DISEASES; CHEMICALLY INDUCED; COMPLICATION; DIABETES MELLITUS, TYPE 2; DRUG COMBINATION; DRUG EFFECTS; GLUCOSE BLOOD LEVEL; METABOLISM; POLYPHARMACY; RISK FACTOR; TREATMENT OUTCOME;

BIOMARKERS; BLOOD GLUCOSE; CARDIOVASCULAR DISEASES; CHOLESTEROL; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DRUG COMBINATIONS; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPERCHOLESTEROLEMIA; HYPOGLYCEMIA; POLYPHARMACY; PYRAZINES; RISK FACTORS; SIMVASTATIN; SITAGLIPTIN PHOSPHATE; TREATMENT OUTCOME; TRIAZOLES; WEIGHT GAIN;

EID: 84923122812     PISSN: 11766344     EISSN: 11782048     Source Type: Journal    
DOI: 10.2147/VHRM.S79198     Document Type: Review

References (40)

1. Ismail-Beigi F. Glycemic management of type 2 diabetes mellitus. N Engl J Med. 2012;366:1319-1327.
2. Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009;32:193-203.
3. Handelsman Y, Mechanick JI, Blonde L, et al. American Association of Clinical Endocrinologists Medical Guidelines for the Clinical Practice for Developing a Diabetes Mellitus Comprehensive Care Plan: executive summary. Endocr Pract. 2011;17 Suppl 2:287-302.
4. Ismail-Beigi F, Graven T, Benerji MA, et al. Effect of intensive treatment of hyperglycemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomized trial. Lancet. 2010;376:419-430.
5. Holman RR, Paul SK, Bethel M, et al. 10-year follow up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;358:2545-2559.
6. Patel A, MacMahon S, Chalmers J, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358:2560-2572.
7. Nauck MA, Meininger G, Sheng D, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007;9:194-205.
8. Rosenstock J, Baron MA, Camisasca RP, et al. Efficacy and tolerability of initial combination therapy with vildagliptin and pioglitazone compared with component monotherapy in patients with type 2 diabetes. Diabetes Obes Metab. 2007;9:175-185.
9. American Diabetes Association. Standards of medical care in diabetes-2014. Diabetes Care. 2014;37 Suppl 1:S5-S13.
10. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the 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). JAMA. 2001;285:2486-2497.
11. Irons BK, Kroon LA. Lipid management with statins in type 2 diabetes mellitus. Ann Pharmacother. 2005;39:1714-1719.
12. Colhoun HM, Betteridge J, Durrington PN, et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicenter randomized placebo-controlled trial. Lancet. 2004;364:685-696.
13. Heart Protection Study Collaborative Group. Effects on 11-year mortality and morbidity of lowering LDL cholesterol with simvastatin for about 5 years in 20536 high-risk individuals: a randomized controlled trial. Lancet. 2011;378:2013-2020.
14. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomized placebo controlled trial. Lancet. 2003;361:2005-2016.
15. US Food and Drug Administration. FDA approves combination therapy Juvisync. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm274748.htm. Accessed January 5, 2015.
16. Juvisync [package insert]. Whitehouse Station, NJ, USA: Merck and Co Inc.; 2012.
17. Nathan D. Finding new treatments for diabetes-how many, how fast … how good? N Engl J Med. 2007;356:437-440.
18. Miller SA, St Onge EL. Sitagliptin: a dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes. Ann Pharmacother. 2006;40:1336-1343.
19. Merck and Co Inc. Juvisync: prescribing information. Available from: http://www.januvia.com/sitagliptin/januvia/hcp/juvisync/index.jsp. Accessed January 5, 2015.
20. Bergman AJ, Stevens C, Zhou Y, et al. Pharmacokinetic and pharmacodynamic properties of multiple oral doses of sitagliptin, a dipeptidyl peptidase-IV inhibitor: a double-blind, randomized, placebo-controlled study in healthy male volunteers. Clin Ther. 2006;28:55-72.
21. Bergman AJ, Cote J, Maes A, et al. Effect of sitagliptin on the pharmacokinetics of simvastatin. J Clin Pharmacol. 2009;49:483-488.
22. Hermansen K, Kipnes M, Fanurik D, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007;9:733-745.
23. Harashima SI, Ogura M, Tanaka D, et al. Sitagliptin add-on to low dosage sulphonylureas: efficacy and safety of combination therapy on glycemic control and insulin secretion capacity in type 2 diabetes. Int J Clin Pract. 2012;66:465-476.
24. Merck Provides Update on Combination Medicine JUVISYNC™ (sitagliptin and simvastatin) Tablets. Available from: http://www.mercknewsroom.com/news/company-statements/merck-provides-update-combination-medicine-juvisync-sitagliptin-and-simvastatin. Accessed January 5, 2014.
25. Aschner P, Chan J, Owens DR, et al. Insulin glargine versus sitagliptin in insulin-naive patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicenter, randomized open-label trial. Lancet. 2012;379:2262-2269.
26. Lindholm LH. Major benefits from cholesterol lowering in patients with diabetes. Lancet. 2012;361:2000-2001.
27. Wanner C, Krane V, Marz W, et al. Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med. 2005;353:238-248.
28. Keech A, Colquhoun D, Best J, et al. Secondary prevention of cardiovascular events with long-term pravastatin in patients with diabetes or impaired fasting glucose. Diabetes Care. 2003;26:2713-2721.
29. Law MR, Wald NJ, Rudnicka AR. Quantifying effect of statins on low density lipoprotein cholesterol, ischemic heart disease, and stroke: systematic review and meta-analysis. BMJ. 2003;326:1423-1427.
30. Zhou Z, Rahme E, Pilote L, et al. Are statins created equal? Evidence from randomized trials of pravastatin, simvastatin, and atorvastatin for cardiovascular disease prevention. Am Heart J. 2006;151:273-281.
31. Mills EJ, Wu P, Chong G, et al. Efficacy and safety of statin treatment for cardiovascular disease: a network meta-analysis of 170255 patients from 76 randomized trials. Q J Med. 2001;104:109-124.
32. Ridker PM, Pradhan A, MacFadyen JG, et al. Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. Lancet. 2012;380:565-571.
33. US Food and Drug Administration. Information for healthcare professionals-acute pancreatitis and sitagliptin (marketed as Januvia or Janumet). Available from: http://www.fda.gov/Drug/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHealthcareProfessionals/ucm183764.htm. Accessed January 5, 2015.
34. Engel SS, Williams-Herman DE, Golm GT, et al. Sitagliptin: review of preclinical and clinical data regarding incidence of pancreatitis. Int J Clin Pract. 2010;64:984-990.
35. Garc R, Chen W, Pendergrass M. Acute pancreatitis in type 2 diabetes treated with exenatide or sitagliptin: a retrospective observational pharmacy claims analysis. Diabetes Care. 2010;33:2349-2354.
36. Egan A, Colman E. Weighing the benefits of high-dose simvastatin against the risk of myopathy. N Engl J Med. 2011;365:285-287.
37. Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) Collaborative Group. Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12064 survivors of myocardial infarction: a double-blind randomised trial. Lancet. 2010;376:1658-1669.
38. Kao DP, Kohrt HE, Kugler J. Case report: renal failure and rhabdomyolysis associated with sitagliptin and simvastatin use. Diabet Med. 2008;25:1229-1230.
39. Ma T, Tien L, Fang CL, et al. Statins and new-onset diabetes: a retrospective longitudinal cohort study. Clin Ther. 2012;34:1977-1983.
40. [No authors listed]. Sitagliptan and simvastatin (Juvisync). Med Lett Drugs Ther. 2011;53:89.