Physician Views: Jardiance demonstrates a cardiovascular benefit – what impact on the oral diabetes market?

Marketing partners Eli Lilly and Boehringer Ingelheim confirmed last week that the SGLT-2 inhibitor Jardiance has become the first glucose-lowering agent to demonstrate cardiovascular risk reduction in a dedicated outcomes study.

Full results from the 7000-patient EMPA-REG OUTCOME study have yet to be presented, but Jardiance met its primary endpoint by demonstrating superiority in CV risk reduction when added to standard-of-care therapy. The primary endpoint was defined as time to first occurrence of either CV death, or non-fatal myocardial infarction or non-fatal stroke.

Consensus suggested that the study was more likely to fail than succeed. Partly as no other diabetes medication has been shown to demonstrate a CV benefit in such a setting and partly as the EMPA-REG OUTCOME study was half the size of the TECOS and SAVOR outcomes studies, which assessed Merck & Co.'s Januvia and AstraZeneca's Onglyza, respectively, for a similar benefit. Both products –DPP-4 inhibitors – failed to demonstrate a CV advantage.

The suggestion is that based on data from these three CV outcomes studies, there will likely be a shift in the competitive dynamic of the oral diabetes market (ViewPoints: Will 'holy grail' of cardiovascular benefit put Eli Lilly, Boehringer Ingelheim's Jardiance top of the class?).

A number of key questions remain, however; will the positive data for Jardiance be considered a class-effect applicable to other SGLT-2 inhibitors (it will be two years until data from the next CV outcomes study for an SGLT-2 inhibitor (Johnson & Johnson's Invokana) is presented) and what impact will any positive share gain have on the DPP-4 inhibitor class?

To better ascertain the short-to-medium term commercial impact of positive data from the EMPA-REG OUTCOME study, FirstWord is polling US and EU5-based endocrinologists with the following questions…

Will the study result/updated labelling for Jardiance (empagliflozin) to include superiority in CV risk reduction have a positive effect on your usage of the drug?

Will the study result/updated labelling for Jardiance (empagliflozin) to include superiority in CV risk reduction have a positive effect on your usage of the SGLT-2 inhibitor class?

How likely do you think it is that the CV risk reduction benefit demonstrated by Jardiance (empagliflozin) is broadly applicable to the SGLT-2 inhibitor class?

What negative impact would you expect the study result/updated labelling for Jardiance (empagliflozin) – to include superiority in CV risk reduction – to have on usage of the DPP-4 class?

Will the study result/updated labelling for Jardiance increase your future usage of the SGLT-2/DPP-4 fixed-dose combination Glyxambi (empagliflozin/linagliptin) at the expense of individual SGLT-2 and DPP-4 products? (note: EU respondents, we are aware the drug is yet to be approved in Europe)

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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