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A year of excitement and challenges
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Progress was made on a number of exciting new therapies in 2013.
First and foremost is the enthusiasm created by renal denervation for treatment-resistant hypertension. The SYMPLICITY HTN-1 and SYMPLICITY HTN-2 trials showed encouraging data for additional BP lowering and the ability to decrease doses and number of antihypertensive drugs. Follow-up reports presented at the European Society of Cardiology Congress suggest reduction of atrial fibrillation, left ventricular hypertrophy, metabolic syndrome and diabetes with renal denervation. The first US trial, SYMPLICITY HTN-3, completed enrollment (n=535) in May 2013 and results are expected early in 2014. By the end of 2013, SYMPLICITY HTN-4 was underway for patients with systolic BP >140 mmHg. At an August 2013 Duke Clinical Research Institute/FDA Think-Tank on Resistant Hypertension, more than a dozen new devices under investigation using various novel methodologies were presented, ranging from energy delivery methods including radiofrequency, ultrasound and radiation (brachytherapy) to adventitial renal denervation with ethanol and neurotropic agents (eg, guanethidine, vincristine, botox, magnetic nanoparticles) to mechanical and/or electrical implants for carotid baroreceptor modulation of sympathetic outflow. This is truly an exciting field to watch in 2014.
It is also encouraging to see progress in the cholesterol field with impressive results from early studies of PCSK9 inhibitors, which could provide an alternative to patients who are intolerant to statins and the small group with familial hypercholesterolemia.
Carl J. Pepine
Both renal denervation and PCSK9 inhibition could revise our thinking about how patients accept more complex therapy. Renal denervation is an invasive procedure and PCSK9 inhibitors require injections once every 2 to 4 weeks. Yet, patients screened for our studies seem to readily accept these therapies if they can reduce their pill burden. This could help with adherence/compliance issues.
There has also been encouraging progress in treatments for obesity and diabetes. The American Medical Association declared obesity a disease state, which could impact legislation in Washington, D.C., and the insurance companies. This should help get obese patients the treatments (dietary counseling, drugs, bariatric surgery) they need. Qsymia (Vivus) and Belviq (Eisai) were approved by the FDA in late 2012 and have turned out to be reasonably well tolerated and associated with a lot of weight loss in my patients. Canagliflozin (Invokana, Janssen) is an exciting first-in-class diabetes drug that was approved in 2013. It not only helps control hypertension and diabetes, but also causes weight loss. It could be a remarkable adjunctive tool for CVD prevention.
This past year also brought two new agents, riociguat (Adempas, Bayer) and macitentan (Opsumit, Actelion), to help build quite a portfolio for the treatment of patients with pulmonary hypertension.
Approval of the MitraClip (Abbott Vascular) provides us a percutaneous approach for mitral insufficiency or mitral regurgitation, which moves the field for nonsurgical treatment of valve disease forward.
New challenges posed in 2013 will continue to unfold in 2014. One concerns the new oral anticoagulant alternatives to prevent stroke in AF. We clearly need ways to get more AF patients taking anticoagulants for stroke prevention, but I fear that the situation has now reached a point where many physicians are confused trying to find the right drug for the right patient. These are exciting new agents, but how best to use them remains a challenge. Also, it seems that genetic testing for vitamin K antagonists and genetic and platelet function testing for P2Y12 inhibitors have not panned out. These results have dampened enthusiasm for the entry of “personalized medicine” in CVD. While the HPS2-THRIVE trial confirmed that niacin-related elevation of HDL is not really a benefit, it created a paradigm shift and the focus is now on the quality of the HDL rather than the quantity. Although the TOPCAT trial failed to prove its primary hypothesis, there were signals that aldosterone blockade could benefit some HFpHF patients by reducing HF hospitalizations. Unfortunately, there was marked regional variation that obscured the primary outcome results with important implications for inclusion of these regions in future NIH-funded trials.
As we look to 2014, it will be interesting to see what happens with the American College of Cardiology/American Heart Association clinical practice guidelines for prevention of CVD. It will require a number of years to see if it accomplishes its goal to get more patients taking statins. There may even be unintended consequences, such as patients stopping statins if they slightly lower their BP.
Disclosure: Pepine reports financial ties with Abbott, Actelion, Amarin, Amgen, Amorcyte, Angioblast/Mesoblast, AstraZeneca, Baxter Healthcare, Capricor, Catabasis, Cytori, Daiichi Sankyo, Eli Lilly, Esperion, Genentech, Gilead, GlaxoSmithKline, InfraReDx, Isis, Janssen, Medtronic, NeoStem, Regeneron, Sanofi, Servier and United Therapeutics.