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2015: A year of important advances; challenges ahead
The Cardiology Today Editorial Board reflects on major developments in cardiology and what may change practice in the future.
In the past year, we have seen many new contributions to the field of cardiology, particularly in those important areas that are summarized in our annual Top 10 stories of the year (see image below): hypertension, hypercholesterolemia, HF and atrial fibrillation. It is particularly appropriate that our Editorial Board chose these areas, which are very highly prevalent. We have had tremendous good fortune to have investigators pursue these important areas, that may seem trite and/or mundane to some but are the real keys to reducing our population’s health burdens.
The SPRINT trial
Finally, we have the highest level of evidence that, in older people particularly, lower BP targets are better than the traditional 140/90-mm Hg BP target. The results of SPRINT came in the wake of the recent decision from a majority of the panel convened for the JNC8 that a target even higher than the traditional target would be better in this population. Given the prevalence of hypertension worldwide, the results of the NIH-sponsored SPRINT trial are extraordinarily important and have the potential to benefit a huge number of people, more than anything on the Top 10 Stories of 2015 list. This will definitely impact practice guidelines in the future.
However, there are still several areas for future investigation. Some key populations were not well represented in SPRINT. For example, the largest group in the U.S. with hypertension is the cohort comprised of older women; women, in general and older women, in particular, were not adequately represented in SPRINT. Also, important are patients with diabetes. Many patients included in SPRINT, although not classified as diabetic by the arbitrary definition of a blood glucose 126 mg/dL, had fasting blood glucose levels 100 mg/dL and < 126 mg/dL, or “prediabetes.” We clearly have to focus more attention on better management of BP in these prediabetic patients. These are just a few examples that demand more studies in these particular cohorts of our population.
The PCSK9 inhibitors
The new PCSK9 inhibitors offer tremendous opportunities for patients with familial hypercholesterolemia who are statin intolerant. In the past year, two new agents were approved: alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen).
These recently approved inhibitors are humanized monoclonal antibodies that specifically target PCSK9 and require subcutaneous injection every 2 to 4 weeks. They are very effective with 50% to 70% further reduction in LDL and, in my opinion, are likely to cause a change in guidelines for treatment of hypercholesterolemia. Furthermore, their success is driving the field for the development of other approaches to inhibit PCSK9 that may be longer lasting and more cost-effective.
Diabetes drugs and CV effects
I am very impressed by the new class of diabetes drugs called SGLT2 inhibitors. Specifically, in the EMPA-REG OUTCOME study, empagliflozin (Jardiance, Boehringer Ingelheim) was associated with decreased risk for HF hospitalization as well as CV death and other important adverse outcomes. Within a year and a half, the curves for the placebo and empagliflozin-treated groups representing the cumulative incidence of the primary outcome (CV death, nonfatal MI or nonfatal stroke) as well as those that summarized CV deaths, all-cause death and HF hospitalization separated impressively. In my opinion, it is really amazing for a diabetes drug to have that kind of an effect on important outcomes like HF and mortality. This is the first diabetes drug to show this type of an impact.
The hope is that we will see this with the entire class of SGLT2 inhibitors.
Other developments of interest
Major depressive disorder and CVDs: In 2015, the American Heart Association released a scientific statement acknowledging that major depressive disorder and bipolar disorder in adolescents are moderate-risk conditions associated with accelerated atherosclerosis and early CVD. We, as a medical community, have to start focusing more on the risks associated with mental health disorders. A genome-wide association study published in Translational Psychiatry in 2015 looked at all the genes associated with schizophrenia. It shares a lot of genes that are also associated with microvascular dysfunction. They concluded that schizophrenia is possibly an adult vascular-ischemic and post-ischemic repair disorder — the cerebral analog of microvascular angina. More research in this area is clearly warranted.
Hormone replacement therapy: We are still in a hormone-replacement therapy quagmire, as far as I’m concerned, more so now with widespread use of testosterone and the newer estrogen therapies. The question is will we will have to conduct another Women’s Health Initiative (WHI) study with the newer synthetic estrogens and delivery methods in women and also for the androgens in men.
Leadless pacemakers: Recent data have demonstrated encouraging outcomes with leadless pacemakers in development. The promise of a leadless pacemaker is certainly something on the horizon that we are all watching for, and, if combined with a subcutaneous defibrillator would be of major significance.
Regenerative medicine for CVD: Trials are currently ongoing with the NIH CV Cell Therapy network using a combination of c-kit cells and mesenchymal cells. We continue to hope for a breakthrough in this area of regenerative medicine research that will affect the treatment of patients with HF or other end-stage CVDs like peripheral artery disease.
- Reference:
- Moises HW, et al. Transl Psychiatry. 2015;doi:10.1038/tp.2015.103.
- For more information:
- Carl J. Pepine, MD, MACC, is Chief Medical Editor of Cardiology Today and Eminent Scholar Emeritus and professor in the division of cardiovascular medicine at University of Florida, Gainesville. He can be reached at Cardiology Today, 6900 Grove Road, Thorofare, NJ 08086; email: cardiology@healio.com.
Disclosure: Pepine reports receiving a grant from Sanofi for ODYSSEY OUTCOMES.