coronary heart disease
Beyond trials and looking to prevention. Notes from AHA 2011
Since the early trials of beta-blockers and thrombolysis, or “clot-busting” drugs, in cardiovascular disease, the American Heart Association Scientific Sessions and other international cardiology meetings have been dominated by highly-anticipated “late-breaking” or “hot trials” sessions. During these talks, thousands of conference attendees would clamour to hear the results of trials of new drugs reported for the first time. As well as being highly talked about, they greatly influence projections of how the drug will perform in the real market: akin to a stockmarket floor for pharma. Today new drug trials are still by the dozen, but difficult economic times, increased regulation of pharma and wider and quicker dissemination of results may be changing the role of these sessions.
Aside from the trials, three messages are coming through loud and clear from this year’s meeting in Orlando. First, although the best-attended sessions are still the trials of new interventions and drugs for the range of cardiovascular disease, the number of talks devoted to primary prevention and primordial prevention is growing. In other words, prevention of the development of disease and prevention of the development of risk factors of disease, respectively
Second, there is a shifting focus on risk factors as continuous exposures over the whole lifespan. For example, we have talked about “pack-years” of smoking for a long time, i.e. an individual’s lifetime exposure to cigarette smoke. Rather than looking at arbitrary cut-offs for risk factors such as hypertension or high cholesterol, it may make more sense to look at the burden of that risk factor over their lifespan, and in combination with other risk factors.
Third, in the aftermath of the September UN high-level meeting, there is an increasing recognition of the global health aspects of heart disease and stroke. In a session chaired by Professor Sir Magdi Yacoub, eminent cardiac surgeon and long-term activist for improved health services for heart disease in low-income countries, a researcher from Mozambique showed the huge disease burden how feasible screening for common heart diseases can be, even in rural settings.
All three of these changes are welcome and signal gradual, encouraging paradigm shifts among both researchers and health professionals to look at the bigger picture of prevention and population approaches to cardiovascular disease.
The growing global health inequality of new drugs and clinical trials
At the European Cardiology Congress in Paris this week, the news is that cardiovascular medicine is still producing tonnes of new research and there are therapeutic advances in all areas from atrial fibrillation and stroke to heart failure and heart attacks. For example, there are 3 new oral anticoagulants (blood-thinning drugs) which offer true alternatives to warfarin for the first time in 50 years. All these drugs have shown superiority in recent trials presented at this meeting- rivaroxaban in ROCKET-AF, apixaban in ARISTOTLE and dabigatran in the RE-LY trial.
Salim Yusuf, arguably one of the most prolific clinical triallists and lead investigator in two of those trials, also presented the results of a different type of study, published in the Lancet this week. The PURE study included over 150000 patients with known coronary heart disease from 17 countries and showed that even in high-income countries. The drug treatments that such patients should be taking are well-established and available very cheaply-aspirin, beta-blockers, ACE-inhibitors and statins. Depressingly, the proportion of patients globally taking these drugs is less than 50% even in rich countries. In Africa, 80% of eligible patients were taking no drugs at all. As Salim Yusuf said, treatment gaps like this in the HIV/AIDS epidemic led to human rights arguments for broadening of antiretroviral treatment and mobilisation of the global health community and governments.
The inequality was also visible at concurrent “Meet the Triallists” sessions. Delegates clamoured to get to the trial update for the ARISTOTLE trial of the novel anticoagulant, apixaban, but I was one of only 20-30 people who heard Salim Yusuf talk about the PURE trial. Global health cardiology is just not sexy enough yet, even in the wake of the UN high-level meeting in September.
You could argue what is the point of all these fancy new drugs if we are failing to get simple, cheap, proven therapies to the people who need them most, even in rich countries. The tsunami of cardiovascular disease hitting all countries is not going to be touched by all the new drugs currently being trialled. We have to get better at translation. More research funders and senior researchers need to lead new trials with global health impact if we are to have any chance of focusing on problems worth researching.