alogliptin

alogliptin

(al-oh-glip-tin) ,

Nisena

(trade name)

Classification

Therapeutic: antidiabetics
Pharmacologic: dipeptidyl peptidase4 ddp4 inhibitors
Pregnancy Category: B

Indications

Adjunct with diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Action

Acts as a competitive inhibitor of dipeptidyl peptidase-4 (DDP-4) which slows the inactivation of incretin hormones, thereby increasing their concentrations and reducing fasting and postprandial glucose concentrations.

Therapeutic effects

Improved control of blood glucose.

Pharmacokinetics

Absorption: Completely absorbed following oral administration (100%).
Distribution: Well distributed into tissues.
Metabolism and Excretion: Not extensively metabolized, 76% excreted unchanged in urine.
Half-life: 21 hr.

Time/action profile (inhibition of DDP-4)

ROUTEONSETPEAK†DURATION
POunknown1–2 hr24 hr
†Multiple dosing.

Contraindications/Precautions

Contraindicated in: Type 1 diabetes;Diabetic ketoacidosis;Previous severe hypersensitivity reactions.
Use Cautiously in: Liver disease; Geriatric: Elderly patients may have ↑ sensitivity to effects; Lactation: Use cautiously; Obstetric: Use during pregnancy only if clearly needed; Pediatric: Safe and effective use has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • headache

Gastrointestinal

  • hepatotoxicity (life-threatening)
  • pancreatitis (life-threatening)
  • ↑ liver enzymes

Miscellaneous

  • hypersensitivity reactions including anaphylaxis, angioedema, severe cutaneous reactions including stevens-johnson syndrome

Interactions

Drug-Drug interaction

↑ risk of hypoglycemia with sulfonylureas and insulin, dose adjustments may be necessary

Route/Dosage

Oral (Adults) 25 mg once daily.

Renal Impairment

Oral (Adults) CCr ≥30 mL/min–<60 mL/min—12.5 once daily; CCr <30 mL/min–6.25 once daily.

Availability

Tablets: 6.25 mg, 12.5 mg, 25 mg
In combination with: metformin (Kazano), pioglitazone (Oseni).

Nursing implications

Nursing assessment

  • Observe for signs and symptoms of hypoglycemic reactions (abdominal pain, sweating, hunger, weakness, dizziness, headache, tremor, tachycardia, anxiety).
  • Monitor for signs of pancreatitis (nausea, vomiting, anorexia, persistent severe abdominal pain, sometimes radiating to the back) during therapy. If pancreatitis occurs, discontinue alogliptin and monitor serum and urine amylase, amylase/creatinine clearance ratio, electrolytes, serum calcium, glucose, and lipase.
  • Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
  • Lab Test Considerations: Monitor hemoglobin A1C prior to and periodically during therapy.
    • Monitor renal function prior to and periodically during therapy.

Potential Nursing Diagnoses

Imbalanced nutrition: more than body requirements (Indications)
Noncompliance (Patient/Family Teaching)

Implementation

  • Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
  • Oral: May be administered without regard to food.

Patient/Family Teaching

  • Instruct patient to take alogliptin as directed. Take missed doses as soon as remembered, unless it is almost time for next dose; do not double doses. Advise patient to read Medication Guide before starting and with each Rx refill in case of changes.
  • Explain to patient that alogliptin helps control hyperglycemia but does not cure diabetes. Therapy is usually long term.
  • Instruct patient not to share this medication with others, even if they have the same symptoms; it may harm them.
  • Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hyperglycemic or hypoglycemic episodes.
  • Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water, and notify health care professional.
  • Instruct patient in proper testing of blood glucose and urine ketones. These tests should be monitored closely during periods of stress or illness and health care professional notified if significant changes occur.
  • Advise patient to stop taking alogliptin and notify health care professional promptly if symptoms of hypersensitivity reactions (rash; hives; swelling of face, lips, tongue, and throat; difficulty in breathing or swallowing) or pancreatitis occur.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Improved hemoglobin A1C, fasting plasma glucose and 2-hr post-prandial glucose levels.
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References in periodicals archive ?
A 2018 review noted that cardiovascular outcome trials for alogliptin (Nesina), saxagliptin (Onglyza), and sitagliptin (Januvia) showed noninferiority but failed to demonstrate any superiority, compared with placebo in patients with type 2 diabetes mellitus and high cardiovascular risk (Circ Res.
On the other hand, the DPP-4 inhibitors saxagliptin (Onglyza[R]), alogliptin (Nesina[R]) and sitagliptin (Januvia[R]) appear to be CVD-neutral or possibly associated with increased likelihood of heart failure.
His previous experience includes serving as vice president, chemistry at Global Blood Therapeutics; director of chemistry at Takeda San Diego; and project leader for the DPP4 program at Syrrx, which resulted in the discovery of alogliptin, a drug now marketed for the treatment of type 2 diabetes.
All 9 completed trials demonstrated the CV safety of the DPP-4i (alogliptin, saxagliptin, sitagliptin), GLP-1RA (exenatide once-weekly, liraglutide, lixisenatide, semaglutide), or SGLT-2i (canagliflozin, empagliflozin) to be noninferior to placebo as part of standard care.
Petr Jarolim, M.D., Ph.D., from Brigham and Women's Hospital in Boston, and colleagues examined the prognostic implications of changes in NT-proBNP concentration in patients with type 2 diabetes and ischemic heart disease enrolled in the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care trial.
Combining a dipeptidyl peptidase 4 inhibitor, alogliptin, with pioglitazone improves glycaemic control, lipid profiles and [beta] cell function in db/db mice.
There has been some breakthrough in the management and treatment of this diabetes such as the use of glimepiride, acarbose, alogliptin, canagliflozin, glipizide, glimepiride, empagliflozin, dapagliflozin, colesevelam and sometimes a combination of medication.
DPP-4 inhibitors, saxagliptin, sitagliptin, vildagliptin, alogliptin, and linagliptin, increase physiological levels of the incretin hormones [87].
Alogliptin a member of dipeptidyl peptidase-4 inhibitors is a recent drug developed in 2010 by Takeda Pharmaceutical Company [2, 7], which is used for the treatment of Type 2 diabetes, and it potentiates the effect of incretin hormones through inhibition of their degradation by the dipeptidyl peptidase-4 enzyme [2, 4].
Furthermore, dipeptidyl peptidase-4 (DPP-4) inhibitors seem to exert neutral effects on CVD risk as shown for alogliptin in the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) trial [14] and for sitagliptin in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) [15].
Several components of this class, including vildagliptin, sitagliptin, saxagliptin, alogliptin, and linagliptin, have already been approved for this indication by the US Food and Drug Administration or by the European Medicines Agency; others are awaiting for approval or still in development.
Saxagliptin, sitagliptin, linagliptin vildagliptin, alogliptin, and linagliptin (either as a single agent product or a combination product) are the dipeptidyl peptidase 4 inhibitors available in Australia.