Several major pharmaceutical companies reported additional results and data on their heart drugs at the European Society of Cardiology's annual conference in Barcelona.
Merck & Co. Inc.'s results from its phase 3 REVEAL trial of about 30,449 patients showed that its investigational cholesterol drug anacetrapib cut the risk of heart attacks and death in patients by 9%.
However, the blood protein inhibitor missed its key secondary endpoint due to a lack of observed benefit on presumed ischemic stroke, which results from an obstruction in a blood vessel carrying blood to the brain. A substudy linked prolonged dosing of the drug with fat accumulation, although the safety impact of that is uncertain.
Merck is reviewing the trial results and will consider seeking regulatory approval for anacetrapib. Anacetrapib belongs to the class of drugs called cholesteryl ester transfer protein, or CETP, inhibitors, which has struggled to show noticeable benefits against heart attacks.
Credit Suisse's Vamil Divan believes the clinical significance of a 9% relative risk reduction from a study of more than 30,000 patients is limited. He said in an Aug. 29 note that he believes there is no viable path forward for anacetrapib to be used in a broad population of patients.
"CETP inhibitors may still have a role in patients with certain genetic predispositions or potentially in patients who cannot tolerate statins, but, from a [Merck] perspective, this would mean doing significantly more work for a potentially limited commercial opportunity," Divan said.
Novartis drug effective for heart disease, lung cancer
The ESC meeting also featured additional data from the Cantos study involving Novartis AG's anti-inflammatory drug ACZ885, or canakinumab, which showed that the drug could reduce the risk of not only heart disease but also lung cancer. The Cantos study met its primary endpoint in June, but detailed data was unveiled only at the conference.
The trial comprised patients who had previously had a heart attack and suffered from inflammatory atherosclerosis. Atherosclerosis is hardening and narrowing of the arteries.
Patients on one of three doses of canakinumab, combined with the current standard of care including therapy to reduce cholesterol, were 15% less likely to suffer another major cardiac event compared with those on placebo.
Canakinumab is already approved as Ilaris for rare autoimmune conditions.
Results from a phase 3 Compass study of Johnson & Johnson and Bayer AG's blood-thinning drug Xarelto, or rivaroxaban, showed that the drug in combination with aspirin can reduce cardiovascular risks by 24% in patients with stable coronary or peripheral artery disease versus aspirin alone.
The regimen reduced the risk of a stroke by 42% in the trial, while the risk of death related to heart disease was down by 22%.
In an Aug. 27 note, Barclays' Geoff Meacham said the risk of the composite net-clinical-benefit outcome was lower with Xarelto plus aspirin than with aspirin alone, which he believes should support Johnson & Johnson and Bayer's plans to expand Xarelto into a significantly larger pool of stable coronary or peripheral artery disease patient population.
Bristol-Myers Squibb Co. and Pfizer Inc.'s Eliquis reduces the risk of stroke compared with the old heart drug warfarin, according to data presented at the conference.
The study involved patients who had not previously received blood thinners with a common heart arrhythmia called atrial fibrillation scheduled for elective cardioversion, a medical procedure that restores a normal heart rhythm. Patients treated with Eliquis had fewer strokes and similar bleeding to those receiving usual care.
Diabetes drug cuts heart risk
New findings presented at the meeting showed Novo Nordisk A/S' Victoza reduces the risk of major cardiovascular events in people with type 2 diabetes at high cardiovascular risk compared to placebo.
Victoza reduced the risk of major cardiovascular events by 16% in people who had already experienced a heart attack or stroke when the trial started. Similarly, a nonsignificant 11% risk reduction was achieved with treatment in people who had not experienced a prior heart attack or stroke.
Statins' harms tied to genetic makeup
A common genetic variant may play an important role in the odds of suffering aches and pains in people who take statins, new research suggests.
Researchers have found that a genetic variant of the LILRB5 gene, which helps the immune system repair and regenerate, predisposes people to developing muscle aches, regardless of whether they are taking statins. They also found that there is a genetic subgroup of people who have a higher risk of statins-induced muscle pains.
According to the study, people taking statins to lower their cholesterol levels sometimes complain of muscle aches and pains and therefore stop taking their medication believing it is causing their symptoms. This puts them at higher risk of developing diseases of the heart and blood vessels.
In a study of more than 111,912 Scottish statin users, researchers found that risk of statin intolerance doubled when patients carried two identical copies of the LILRB5 gene.
A meta-analysis of three other studies showed that patients with two copies of the common form of the gene were 1.3 times more likely to suffer from adverse effects linked to statin intolerance, compared to those without identical copies.
Coffee and chocolate strengthen the heart
A study also discussed the most commonly consumed drug in the world: caffeine.
People who drink coffee regularly are less likely to die of any causes than those who do not drink it, according to the research.
The study stated that middle-aged Mediterranean patients who drank at least four cups of coffee each day had a 64% lower risk of death than those who never or almost never drank it. The prospect of death declined another 22% for every two additional cups per day.
Dark chocolate enriched with extra virgin olive oil is associated with an improved cardiovascular risk profile, according to a study by the University of Pisa in Italy.
The study tested the association between consumption of dark chocolate enriched with extra virgin olive oil with the progression of hardening and narrowing of the arteries in healthy people with cardiovascular risk factors.
Olive oil-enriched chocolate was associated with significantly increased high-density lipoprotein cholesterol, also known as good cholesterol, and decreased blood pressure.