Onglyza approved for use in renal impairment

The licence for Onglyza (saxagliptin) has been extended to allow its use in patients with type II diabetes and moderate or severe renal impairment. Onglyza, a dipeptidyl peptidase 4 (DPP-4) inhibitor, is the first in its class to be licensed for use in this patient population.

Onglyza now an option in diabetes with renal impairment
Onglyza now an option in diabetes with renal impairment

No dosage adjustment is required for Onglyza in mild renal impairment; however, in moderate to severe impairment a reduced dose of 2.5mg once daily is recommended. Renal function should be monitored prior to initiation of therapy and periodically thereafter. A new 2.5mg tablet has been launched to facilitate dosing in moderate or severe renal impairment.

Caution is advised in patients with severe renal impairment and use in patients with end-stage renal disease (ESRD) requiring dialysis is not recommended.

Approval for the licence extension was based on the results of a 12-week randomised controlled study, which showed that saxagliptin 2.5mg is a well-tolerated treatment option for patients with inadequately controlled type II diabetes and renal impairment.

The 12-week study involved 170 adults with type II diabetes, HbA1c 7-11% and creatinine clearance <50ml/minute who were randomised to saxagliptin 2.5mg once daily or placebo. Significantly greater reductions in HbA1c from baseline to week 12 were observed in the saxagliptin group than in the placebo group (adjusted mean treatment difference -0.42% [p=0.007]).

Saxagliptin was generally well tolerated with a similar incidence of hypoglycaemia in the saxagliptin and placebo groups (20% vs 22.4%, respectively). The proportion of patients experiencing an adverse effect was greater among those with severe renal impairment or ESRD than among those with moderate impairment.

View Onglyza drug record

Further Information: AstraZeneca

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register
Already registered?
Sign in

More from MIMS

A woman wearing a white vest as a blue-gloved hand of a healthcare professional are seen injecting a vaccine.

'Nocebo' effect may cause two-thirds of COVID-19 vaccine reactions, study suggests

Two-thirds of adverse reactions reported with the COVID-19...

An elderly woman with one arm in a plaster cast sits resting both hands on her walker

Doctors urge NICE to reverse decision on new osteoporosis drug

More than NHS 100 clinicians have called on NICE to...

Drug shortages - live tracker

Use our constantly updated shortages tracker to check...

Image of both strengths of Seffalair Spiromax inhaler side by side.

New salmeterol/fluticasone dry powder inhaler for asthma

Seffalair Spiromax is the sixth dry powder salmeterol/fluticasone...