 | |
| Combination of | |
|---|---|
| Sitagliptin | antidiabeticDPP-4 inhibitor |
| Simvastatin | hypolipidemicstatin |
| Clinical data | |
| Trade names | Juvisync |
| AHFS/Drugs.com | Consumer Drug Information |
| ATC code |
|
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| KEGG |
|
 N Y (what is this?) (verify) | |
Sitagliptin/simvastatin, sold under the brand nameJuvisync, is afixed-dose combinationanti-diabetic medication used to treattype 2 diabetes andhypercholesterolemia. It containssitagliptin andsimvastatin. Sitagliptin is adipeptidyl peptidase-4 inhibitor and simvastatin is anHMG-CoA reductase inhibitor.[1] These two disorders commonly occur in people at the same time, and have been typically treated with administration of these medications separately. The combination was approved in 2011, and sold under the brand name Juvisync byMerck. Juvisync was later removed from the market in 2013, due to business reasons.[2]
In 1991, Merck & Co'ssimvastatin was approved as an HMG-COA inhibitor to lower the levels of LDL cholesterol.[citation needed] In 2006, Merck & Co'ssitagliptin was approved by the FDA for treatment of diabetes mellitus type 2.[3]
Juvisync was the first product to combine a cholesterol lowering drug with a type 2 diabetes drug in the same tablet.[4]
Sitagliptin: Using male and female rats, a two-yearcarcinogenicity study was carried out with doses of 50, 150, and 500 mg/kg/day. The 500 mg/kg dose has exposure limits of 60 times what would be seen in the highest dose in humans. At this dose, liveradenoma/carcinoma was seen. Tumors were not seen from the smaller doses. Nomutagenic orclastogenic effects were seen from tests using several assays (CHO, rat, etc.). Fertility studies in rats showed noteratogenic effects.[5]
Simvastatin: No tumorigenic effect was seen in a 72-week carcinogenicity study using mice at the low dose levels. However, at the higher dose levels (eight and 16 times the human dose equivalent), liver carcinomas and adenomas, lung adenomas, and adenomas of theHarderian gland occurred. No mutagenic effects were seen in assays. Testicular atrophy was noted in dogs and rats at four and eight times the human exposure, respectively.[6]
It should not be used in patients withtype 1 diabetes,diabetic ketoacidosis,pancreatitis, Fredrickson types I and Vdyslipidemias, and severe renal impairment.[7]
Juvisync should not be used with: strongCYP3A4 inhibitors,cyclosporine,danazol,gemfibrozil, and otherfibrates.[8] Caution should be used and the patient should be monitored if they are taking the following:amiodarone,dronedarone,ranolazine,calcium channel blockers,niacin,digoxin,coumarin anticoagulants, andcolchicine.[9]
