ADA 2019 – Farxiga strengthens kidney case for type 2 diabetes drugs

The cardiovascular benefits of the SGLT2 inhibitors are well known by now. But the case for using these drugs to prevent kidney problems in type 2 diabetics is building, with new data on Astrazeneca’s Farxiga presented the ADA meeting on Sunday. An analysis of Farxiga’s previously reported Declare-Timi cardiovascular outcomes study, described as both prespecified and exploratory, found a 47% reduction in a composite renal outcome. This was driven by improvements in estimated glomerular filtration rates rather than end-stage renal disease or death, but this might be expected in the broad population enrolled, said Elisabeth Björk, head of Astra’s cardiovascular, renal and metabolic division. In contrast, the Credence trial of Johnson & Johnson’s rival SGLT2 inhibitor Invokana recently showed a renal benefit in sicker patients. Astra hopes that its data could drive Farxiga uptake among primary care doctors, but the renal benefit is starting to look like another SGLT2 class effect. Asked about the prescribing impact of the Declare-Timi data, Ms Björk, replied: “I see no reason why [SGLT2s] shouldn’t be given as a first second-line therapy, after metformin.” All eyes will be on data next year from the Dapa-CKD trial of Farxiga in patients both with and without diabetes.

Renal outcomes data from Declare-Timi, NCT01730534
Endpoint Farxiga Placebo Stats
Renal-specific composite* 1.5% 2.8% HR 0.53, p<0·0001
     Reduction in EGFR decline 1.4% 2·6% HR 0.54, p<0·0001

     End-stage renal disease 

0.1% 0.2%

HR 0.31, p=0.013

     Renal death  0.1% 0.1% HR 0.60, p=0.32
Cardio-renal composite** 4.3% 5.6% HR 0.76, p<0·0001
*Comprises kidney function decline (sustained ≥40% decrease in estimated EGFR to <60ml/min), end-stage renal disease or renal death. **Comprises renal composite plus cardiovascular death, previously reported. Source: ADA, The Lancet Diabetes & Endocrinology, June 9, 2019.

Cardio-renal (A) and renal events (B) with Farxiga vs placebo

Source: The Lancet Diabetes & Endocrinology, June 9, 2019.

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