European Society of Cardiology 2013: Key study highlights.
Analysis of key data presented at the world's leading cardiology conference
By Victoria Hudson, Senior Analyst
18 September 2013
I am the senior analyst for Datamonitor Healthcare’s cardiovascular and metabolic team, and cover everything from acut...
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Over 4,000 new studies – including 67 Hot Line trials showcasing the latest results from clinical trials, registries, and basic and translational science – were presented at this year’s European Society of Cardiology’s Annual Congress (ESC 2013) in Amsterdam from 31 August to 4 September. Datamonitor Healthcare identified the following key highlights from the congress:
Lixiana is expected to struggle in the wider venous thromboembolism indication, despite strong Phase III data
The first Phase III data released for Daiichi Sankyo’s novel oral anticoagulant showed that Lixiana (edoxaban) demonstrated superior safety and non-inferior efficacy versus warfarin in venous thromboembolism. While the drug’s safety data are impressive, generally slow uptake of the novel oral anticoagulants and the drug’s anticipated fourth-to-market status will limit future sales in the indication. However, Lixiana demonstrated promising efficacy data in a high-risk subset of patients, suggesting there may be a role for the therapy in this patient group. Datamonitor Healthcare believes that a similar safety and efficacy advantage will need to be demonstrated in the larger indication of stroke prevention in atrial fibrillation as the drug is expected to face similar barriers to uptake. The results of the ENGAGE-AF trial are expected to be released in November 2013.
- SAVOR-TIMI 53/EXAMINE:
Both Onglyza and Nesina are expected to struggle to differentiate themselves in the DPP-IV class in type 2 diabetes with neutral cardiovascular outcome trial results
With both Onglyza (saxagliptin; Bristol-Myers Squibb/AstraZeneca) in the SAVOR-TIMI 53 trial and Nesina (alogliptin; Takeda) in the EXAMINE trial demonstrating no increase in adverse cardiovascular events, physicians will be reassured over the safety of these therapies. However, the results did not demonstrate reductions in cardiovascular events, which would have differentiated Onglyza or Nesina within the largely homogenous dipeptidyl peptidase-IV (DPP-IV) inhibitor drug class. Despite two DPP-IV therapies demonstrating neutral results in cardiovascular outcome trials, the overall impact of the drug class on cardiovascular events remains to be seen.
The failure of RVX-208 to significantly regress atherosclerosis versus placebo is disappointing in light of the uncertainty surrounding HDL-targeted therapies
With previous clinical trials of high-density lipoprotein (HDL)-targeted therapies also failing to show a reduction in cardiovascular risk on top of statin therapy, the debate over the best method to increase HDL and which HDL subfraction to target continues. As a result, in a symposium on HDL biology, physicians at ESC 2013 were recommended to focus drug treatment on low-density lipoprotein cholesterol (LDL-C) and to treat low HDL levels with lifestyle interventions. The debate over HDL-targeted therapies will impact on the late-stage current dyslipidemia pipeline, with two novel drug classes, the CETP and PCSK9 inhibitors, expected to compete for patients requiring the reduction of residual risk on top of statin therapy. The results of the therapies’ Phase III cardiovascular outcomes trial will help to determine whether the CETP inhibitors’ strategy of raising HDL is warranted or if the PCSK9 inhibitor class, which lowers LDL-C, will benefit from the renewed focus on LDL-C.
Despite strong safety data in VTE Lixiana will struggle as the anticipated fourth-to-market novel oral anticoagulant
At the first Hot Line session of ESC 2013 on 1 September, Daiichi Sankyo released the first Phase III data for its novel oral anticoagulant, Lixiana (edoxaban), in any indication. In the Hokusai-VTE trial, which studied the drug’s effect in venous thromboembolism (VTE), the factor Xa inhibitor demonstrated superior safety (clinically relevant bleeding: 8.5% Lixiana, 10.3% warfarin; p=0.004 for superiority) and non-inferior efficacy (recurrent symptomatic VTE: 3.2% Lixiana, 3.5% warfarin; p<0.001 for non-inferiority) versus warfarin in 8,292 patients with either acute symptomatic deep vein thrombosis, pulmonary embolism, or both (Hokusai-VTE investigators, 2013).
Despite Lixiana’s demonstrating impressive safety data versus warfarin in the trial, Datamonitor Healthcare still expects the drug to struggle in an increasingly saturated market as it is anticipated to launch as the fourth-to-market novel oral anticoagulant and third-to-market oral factor Xa inhibitor in VTE (see table below). With Bayer’s and Johnson & Johnson’s once-daily factor Xa inhibitor Xarelto (rivaroxaban) already marketed, and Bristol-Myers Squibb/Pfizer’s twice-daily pipeline factor Xa Eliquis (apixaban) also demonstrating superior safety and non-inferior efficacy in the AMPLIFY trial (Agnelli et al., 2013), Lixiana will struggle to compete in the wider indication….
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Posted in Cardiovascular. Tagged to anticoagulant, assure, cardiology, clinical trial, DPP-IV, ESC 2013, European Society of Cardiology, hokusai, Lixiana, Nesina, Onglyza, RVX-208, savor-timi 53, warfarin