Published: 5 September 2019

Publications

Spotlight on vildagliptin

Prescriber Update 40(3): 45-46
September 2019

Vildagliptin (Galvus) was approved by Medsafe in October 2008. The combination product vildagliptin + metformin (Galvumet) was approved in May 2009. PHARMAC funded both of these medicines in October 2018.

What is vildagliptin?

Vildagliptin is a potent and selective dipeptidyl-peptidase-4 (DPP-4) inhibitor approved for the treatment of type 2 diabetes as an adjunct to diet and exercise^1–3.

In New Zealand, vildagliptin tablets can be used as monotherapy or in dual or triple combination treatment with other antidiabetic agents².

See the medicine data sheet for full prescribing information (the website URLs are listed below).

Considerations for use

Hepatotoxicity is the most significant risk of harm. Perform liver function tests before starting treatment, at 3-monthly intervals during the first year of treatment, and periodically thereafter^2,3. Stopping treatment in the event of a persistent increase in AST or ALT results in a return to normal levels.

Avoid using vildagliptin during pregnancy unless the expected benefits outweigh any potential risks^2,3.

Galvumet (vildagliptin + metformin) is contraindicated in patients with severe renal impairment, congestive heart failure and metabolic acidosis³.

Interactions

Vildagliptin is not metabolised by the cytochrome P 450 enzymes and has a low potential for drug-drug interactions^2,3. However, interactions with metformin should be checked when using the combination product Galvumet. Refer to the medicine data sheet for further information regarding interactions.

Adverse drug reactions

The most common adverse reactions identified from clinical trials were dizziness, headache, constipation and peripheral oedema².

As of 30 June 2019, the Centre for Adverse Reactions Monitoring (CARM) had received 15 reports where vildagliptin (alone or in combination with metformin) was the suspect medicine. These 15 reports describe 36 reactions, including hepatic reactions, oedema, cardiac disorders, mood disorders and gastrointestinal disorders.

Two reports described hepatic reactions:

• liver failure was reported in a patient with multiple co-morbidities (CARM ID: 130633)
• raised LFTs (liver function tests) were reported in another patient (CARM ID: 131133).

More information

See the medicine data sheet for full prescribing information, available on the Medsafe website.

• Galvus
• Galvumet.

See also ‘Vildagliptin: a new treatment for type 2 diabetes’, available on the bpac website.

References

1. bpac^NZ. 2018. Vildagliptin: a new treatment for type 2 diabetes. URL: https://bpac.org.nz/2018/docs/vildagliptin.pdf (accessed 25 June 2019).
2. Novartis New Zealand Limited. 2017. Galvus New Zealand Data Sheet January 2017. URL: www.medsafe.govt.nz/profs/Datasheet/g/galvustab.pdf (accessed 24 June 2019).
3. Novartis New Zealand Limited. 2018. Galvumet New Zealand Data Sheet August 2018. URL: www.medsafe.govt.nz/profs/Datasheet/g/galvusmettab.pdf (accessed 25 June 2019).