Physician Views: Jardiance hits the jackpot – re-evaluating future usage trends based on full cardiovascular outcomes data

When Eli Lilly and Boehringer Ingelheim announced a positive top-line result from the EMPA-REG OUTCOME study last month, we polled endocrinologists to assess what level of impact a cardiovascular (CV) benefit for the diabetes treatment Jardiance would have on their usage of the drug.

Feedback suggested healthy interest in using Jardiance – and other SGLT-2 inhibitors – more frequently based on the promise of this result (Physician Views Poll Results: Jardiance demonstrates a cardiovascular benefit – what impact on the oral diabetes market?).

However, full data from the study, which was presented at the European Association for the Study of Diabetes (EASD) on Thursday, has exceeded virtually all expectations.

Results were presented to applause at the EASD and sent Eli Lilly's share price up to a near 15-year high on Thursday.

Jardiance demonstrated a relative risk reduction (RRR) for the primary endpoint (MACE-3) of 14 percent; a result broadly in-line with expectations following top-line confirmation last month. Of the three components to the MACE-3 endpoint, however, there was an outsized benefit in terms of CV mortality (RRR of 38 percent), despite lower reductions in non-fatal heart attacks and non-fatal strokes. Furthermore, Jardiance did not demonstrate a reduction in hospitalisations from unstable angina, but did demonstrate a 35 percent reduction in hospitalisations for heart failure.

While there is some uncertainty regarding the mechanism driving these impressive data – one would expect, for example, a higher reduction in heart attacks and strokes if caused by a reduction in blood pressure – Jardiance's "strong showing on CV mortality makes for a very marketable claim," wrote Bernstein analyst Tim Anderson in a note to investors.

Furthermore, he suggests that Boehringer Ingelheim and Eli Lilly will likely seek to press home any advantage that indicates this is a benefit only seen with the SGLT-2 inhibitor class, and possibly only with Jardiance. Sales growth for the other prominent class of oral anti-diabetes therapies – the DPP-4 inhibitors – are likely to be adversely impacted by data from EMPA-REG OUTCOME, as Jardiance (and potentially other SGLT-2 inhibitors) is used earlier in the treatment paradigm, suggested analysts; some members of the expert panel discussing the data at EASD suggested it would now be very difficult for guideline committees to not consider use of the SGLT-2 class as first-line therapy.

In response to publication of full data from EMPA-REG OUTCOME, we are polling US and EU5-based endocrinologists with the following questions…

Full data from the EMPA-REG OUTCOME study has been published. The most striking findings include a 38 percent RRR in CV mortality and a 35 percent reduction in hospitalisations from heart failure in favour of Jardiance. Will updated labelling to reflect these benefits have a positive effect on your usage of the drug?

Have your expectations for broader use of Jardiance increased on the strength of full data from the EMPA-REG OUTCOME study versus top-line confirmation (in August) that the drug had demonstrated a CV benefit? (i.e. have full study data exceeded your expectations since the study was top-lined?)

Based on full data from EMPA-REG OUTCOME, how likely do you think it is that the CV benefits demonstrated by Jardiance represent a class-effect broadly applicable to the SGLT-2 inhibitor class?

Based on full data from EMPA-REG OUTCOME, what negative impact would you expect updated labelling for Jardiance – to include superiority in CV mortality – to have on usage of the DPP-4 inhibitor class?

Based on full data from EMPA-REG OUTCOME, do you expect the number of patients to be treated with Jardiance ahead of a DPP-4 inhibitor to increase over the next 12 months?

You will be able to read the results and analysis later this week.

Results and related analysis will be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions.

Note: FirstWord Polls are powered by MedePolls, a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialities and over 100 markets. To conduct this poll with a different audience, or an entirely different poll, contact us at info@firstwordpharma.com.

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