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Sitagliptin (JanuviaŽ)
P&T review: is recommended for formulary inclusion. It is FDA approved for
patients 18 years of age and older for the following:
o
Monotherapy: Adjunct to diet and
exercise to improve glycemic control in patients with type 2 diabetes mellitus
o
Combination Therapy: In patients
with type 2 diabetes mellitus to improve glycemic control in combination with
metformin or a thiazolidinedione when the single agent alone, with diet and
exercise, does not provide adequate glycemic control
§
Advantages include:
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limited or no weight gain/loss
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low rates of hypoglycemia when
compared to placebo
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few drug interactions
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possible regeneration of pancreatic
beta cells
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once daily oral dose
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few gastrointestinal side effects
as opposed to the GLP-1 analogues, and few adverse side effects (sore throat,
upper respiratory infection, and headache)
§
Disadvantages include:
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modest decreases in A1C when
compared to other anti-diabetic agents
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dosage adjustments for renal
impairment
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high cost
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lack of long term safety data on
immune modulating effects
o
DDP-4 is widely distributed in
numerous tissues and T-cells, B-cells, and natural killer cells.
§
Long term effects on immune system
are unknown. DPP-4 inhibitors have been shown to inhibit T-cell activity in
vitro at high concentration; but unlikely to achieve these levels in-vivo.
DPP-4 cleaves hormones, neuropeptides, and chemokines. DPP-4 inhibitors prolong
the action of hormone YY, neuropeptides (substance P), and macrophage-derived
chemokines. Potential adverse effects include increased BP, inflammation, and
allergic reactions.
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Pharmacy monitoring
o
Dosing adjustment for renal
dysfunction.
o
Doses greater than 100 mg per day
are not recommended as additional improvement in blood glucose is not provided.
Pharmacokinetics are not effected by BMI.
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Dosing adjustment for renal dysfunction |
|
Creatinine Clearance (ml/min) |
Greater Than 50 |
30-50 |
Less than 30 including hemodialysis or
peritoneal dialysis |
|
Daily Dose |
100 mg |
50 mg |
25 mg |
|
BSR Patient Cost Per Day |
|
Januvia |
Metformin
(Generic) |
Glipizide
(Generic) |
Rosiglitazone (Avandia) |
Pioglitazone
(Actos) |
|
25-100 mg daily
$4.58 |
500 mg TID
$0.30 |
5-20 mg Daily
$0.03-$0.09 |
4-8 mg Daily
$2.65-$4.90 |
15-45 mg Daily
$3.10-$5.38 |

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