In a first for both the medical and scientific communities, a drug has proven to help prevent heart attacks by slowing down inflammation - a novel way of approaching the condition than lowering blood cholesterol. Safety concerns tied to a higher rate of serious infection could also temper interest.
Drugs called NSAIDs, such as ibuprofen, fight inflammation and pain, but they can raise heart risks, which may seem confusing in light of this study. There was also a reduction in the incidence of lung cancer in patients who received the drug, however the effect depended on the dose patients received.
Novartis focused on patients who had a prior heart attack and inflammatory atherosclerosis, screened using a biomarker known as C-reactive protein (CRP).
They were followed for up to five-and-a-half years.
Scientists found the recipients of the canakinumab had a 15 percent reduced risk of heart attack, stroke or a heart-related death compared to patients who had only received statins.
The study tested it in 10,000 heart attack survivors with low cholesterol but high CRP.
One bright point in the data was that the drug produced a significantly higher benefit in a particular subgroup of patients.
A huge drug study has just discovered a major new way to lower the risk of heart attacks, an important finding in the battle against the No. 1 killer of Americans.
The Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS) (NCT01327846) is a randomized, double-blind, placebo-controlled, event-driven Phase III study created to evaluate the efficacy, safety and tolerability of quarterly subcutaneous injections of ACZ885 (also known as canakinumab) in combination with standard of care in the prevention of recurrent cardiovascular (CV) events among 10,061 people with a prior myocardial infarction (MI) and with a high-sensitivity C-reactive protein (hsCRP) level of =2mg/L.
With canakinumab, Novartis faces a challenging decision.
Canakinumab is already approved for use in the United States as a drug to fight rare diseases, and is marketed under the brand name Ilaris. In contrast to canakinumab, low-dose methotrexate is a generic, cheap drug commonly used to treat rheumatoid arthritis. Yet, repricing could complicate marketing the drug for its rare disease indications. Canakinumab appears to have caught many doctors by surprise in the way it works to prevent heart attacks.
Novartis noted canakinumab's benefit was even greater in a sub-group of patients who quickly responded to the drug after one injection. In the case of cancer, a Scotsman named Sir Alexander Haddow introduced the idea in the early 1970s, suggesting that inflammation-a core process of wound healing-could go badly wrong, leading to tumor development in some cases. Study after study after study after study has shown it to be effective at lowering the risk for-get this-heart disease and cancer.
Canakinumab inhibits an inflammatory cytokine called interluekin-1 beta (IL-1ß) that is thought to play a role in cancer progression and metastases.
But analysts were underwhelmed by the CANTOS results, particularly in the context of the side effects reported during the study.
Narasimhan said the company plans to initiate a new Phase III trial based on its early findings to see how the drug does in the lung cancer setting.