More data supports Jardiance lead in cardiovascular battle

Boehringer Ingelheim and Lilly’s Jardiance began a revolution late last year, becoming the first drug able to claim it could cut deaths due to heart attacks and strokes in diabetes patients.

Now the companies have produced a further analysis of the landmark EMPA-REG OUTCOME trial, in adults with type 2 disease, showing the protective effect occurred in patients with established cardiovascular disease, independent of blood sugar control at the start of the trial.

The analysis adds to the body of evidence supporting Jardiance, which last year generated sales of just over $200 million after a launch in late 2014. The FDA approved this landmark indication to reduce cardiovascular death at the end of last year and sales are expected to grow as a result.

Data published at the European Association for the Study of Diabetes conference showed in all four blood sugar level groups at study start (A1C levels of < 7.0% , 7.0% to < 8.0%, 8.0% to < 9.0% and ≥9.0%), patients receiving Jardiance demonstrated a reduction in the risk of cardiovascular death compared with placebo.

This was consistent with the risk reduction seen in the overall trial population and seen irrespective of whether blood sugar control was improved following introduction of the study treatment, according to the analysis.

Additional post-hoc analyses showed that when Jardiance was added to metformin or sulfonylurea, the reduction of cardiovascular death compared with placebo was consistent with the overall trial population.

These analyses also showed the proportion of patients with hypoglycaemic side effects were similar between the placebo and Jardiance groups in the EMPA-REG OUTCOME trial – another important factor as doctors are keen to minimise risk of dangerous “hypos” when prescribing diabetes drugs.

Jardiance is the only drug with an approved label showing the dual effect of treating diabetes and reducing cardiovascular risks.

This was based on main findings of EMPA-REG showing over a median of 3.1 years, Jardiance significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14% versus placebo. Risk of cardiovascular death was reduced by 38%, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.

Novo Nordisk’s Victoza, from the different GLP-1 class has shown a cardioprotective effect, and is likely to get this included on its US label after winning backing from a panel of FDA advisers in June.

Although Janssen’s Invokana (canagliflozin) protects against heart problems it also carries a boxed warning over an increased risk of leg or foot amputations that emerged in FDA-mandated cardiovascular safety trials earlier this year.