For many years critics have bemoaned the absence of outcome studies for the many diabetes drugs used to lower blood glucose levels. Now, finally, two large trials with different drugs have been presented at the European Society of Cardiology meeting in Amsterdam and published simultaneously in The New England Journal of Medicine. The good news is that the drugs appear safe. Both trials turned up no evidence for the adverse cardiovascular events that some had feared. The bad news is that neither drug appeared to improve cardiovascular outcomes, though cardiovascular disease is the cause of death in most people with diabetes.
A total of 16,492 people with type 2 diabetes at high risk for a cardiovascular event were studied in SAVOR-TIMI 53. Participants were randomized to the DPP-4 inhibitor saxagliptin (Onglyza, Bristol-Myers Squibb and AstraZeneca) or placebo.
Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE)
In the EXAMINE trial, 5,380 people with a recent acute coronary syndrome (ACS) were randomized to alogliptin (Nesina, Takeda Pharmaceuticals) or placebo.
These trials represent the first round of FDA-mandated cardiovascular outcomes trials for diabetes drugs, a major result of the rosiglitazone controversy. In an accompanying perspective in NEJM, William Hiatt, Sanjay Kaul, and Robert Smith, all members of the FDA advisory committees that debated the fate of rosiglitazone, discuss the complicated recent history of diabetes drugs at the FDA.
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Although current guidelines strongly recommend that dual antiplatelet therapy be administered early in treating patients with non-ST-segment-elevation acute myocardial infarction (NSTEMI), it is unclear whether pretreatment is beneficial,especially with the newer, more potent and more rapidly acting antiplatelet agents prasugrel (Effient, Lilly) and ticagrelor (Brilinta, AstraZeneca). Now a large new study, ACCOAST, presented at the European Society of Cardiology in Amsterdam and published simultaneously in the New England Journal of Medicine, offers strong evidence that pretreatment with prasugrel should not be performed in this situation.
Near the end of the enrollment period, the trial was stopped prematurely on the advice of the independent data and safety monitoring committee because of an increase in major and life-threatening bleeding, but no reduction in cardiovascular events, among patients in the pretreatment group.
A total of 4033 patients scheduled for coronary angiography were randomized to receive pretreatment with prasugrel or no prasugrel. There were no significant differences in the primary endpoint, (death from CV causes, MI, stroke, urgent revascularization, or glycoprotein IIb/IIIa bailout at 7 days). However, TIMI major bleeding was significantly more common in the pretreatment group at 7 days. Similar findings were observed at 30 days.
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Top line results of a large phase 4 study with saxagliptin (Onglyza, Bristol-Myers Squibb and AstraZeneca) demonstrate that the drug is safe but has no cardiovascular benefits. AstraZeneca and Bristol-Myers Squibb today announced the top line results for the SAVOR-TIMI-53 Cardiovascular Outcomes Trial of Onglyza®. The full results are scheduled to presented at the annual meeting of the European Society of Cardiology in Amsterdam on September 2 by Deepak Bhatt.
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Use it or lose it. A UK politician is urging the National Health Service (NHS) to increase use of the antiplatelet drug ticagrelor (trade name Brilinta in the US, Brilique and Possia in the EU) in order to prevent the loss of British jobs.
Like nearly all the major pharmaceutical companies, AstraZeneca has been fighting a difficult cycle of patent expirations and unsuccessful new drugs, leading to repeated rounds of layoffs. But, according to the Manchester Evening News, the UK-based company, with the help of UK politicians, is seeking to turn lemons into lemonade. Science Minister David Willetts is lobbying the National Health Service (NHS) “to increase its use of an AstraZeneca heart medicine, amid mounting political concern about the drugs company’s commitment to British jobs.
The minister, according to the paper, “has urged health officials to accelerate the uptake of Brilique [ticagrelor], a blood thinner used to treat patients suffering from severe angina or heart attacks, which has sold poorly despite winning a green light from the NHS’s cost-effectiveness watchdog in 2011.
AstraZeneca said although it invests heavily in producing new drugs in this country, it’s difficult to persuade primary healthcare trusts to adopt new costly medicines.
The group added: “Despite this recommendation and the NHS target of reducing the mortality rate from cardiovascular disease, it is currently only routinely available to patients in some parts of England.
“We share the NHS and the Government’s objective of broadening patient access to innovative medicines and continue to engage in dialogue.”
Hat tip: Lisa Jarvis (@lisamjarvis) and Matthew Herper (@matthewherper)
The Medicines Company will collaborate with AstraZeneca to help sell Brilinta (ticagrelor), AstraZeneca’s struggling oral antiplatelet drug. The collaboration is the first stage of ”a global collaboration for acute ischemic heart disease compound” announced by the two companies today.
AstraZeneca will pay $15 million per year for The Medicines Company’s Brilinta-related sales activities, scheduled to begin in May. The two companies also plan to collaborate on two other drugs from The Medicines Company, Angiomax (bivalirudin), the direct thrombin inhibitor, and cangrelor, an acute intravenous antiplatelet agent. Details of these collaborations have not yet been established.
Like many other large pharmaceutical companies, AstraZeneca has been seeking new sources of revenue after the expiration of patents for many of its key drugs. Initial hopes that Brilinta would provide a much-needed boost to the company have so far not been realized. The Medicines Company has also sought to find a successor to Angiomax, which has been the company’s mainstay.
Click here to read the press release from AstraZeneca and The Medicines Company…