We Can Dramatically Improve Treatment for Congestive Heart Failure with Poor Pumping Function (HFrEF) and Save Money
Yesterday, I wrote on spironolactone as the fourth drug for high blood pressure and how it is dramatically underused. There is much more to it. Not only does spironolactone lower the blood pressure, but it is a disease modifying drug for one of the main consequences of high blood pressure—congestive heart failure with poor pumping function (heart failure reduced ejection fraction-HFrEF). High pressure itself causes heart enlargement, but angiotensin II and aldosterone contribute to this process by stimulating scar tissue formation and causing the pumping cells in the heart to die. Aldosterone levels in the blood are elevated in proportion to the severity of the heart failure. High aldosterone levels cause low potassium and magnesium which may stop the heart causing sudden death. Most patients with heart failure receive aggressive treatment with fluid pills which further increase aldosterone levels.
Spironolactone blocks the effect of aldosterone and inhibits pumping cell death in a dose dependent manner. It also inhibits scar formation in the heart. Pumping cell death and scar formation are the key processes that cause HFrEF. Spironolactone and eplerenone interfere with the core biology that causes heart failure. Spironolactone reduces death and hospitalization by about one third in this type of heart failure for $4 a month. Despite this very strong evidence and inclusion in heart failure guidelines only 15-29% of patients with HFrEF are taking spironolactone or eplerenone in the outpatient setting. Twenty-one thousand Americans are dying a year because they don’t receive a disease modifying, life-saving drug that costs $4 a month.
These medications are not for everyone. Spironolactone and eplerenone should not be used if the creatinine is over 2.5 or the potassium level is over 5. If you are worried about potassium increases or reduced kidney function, begin with spironolactone 12.5 mg every other day. You can always give more medication, but it is hard to get it back once taken. Watch the potassium and kidney function carefully. You are not giving this medication as a fluid pill. Small doses interfere with the molecular biology that causes disease. Give what you can without causing high potassium or serious decreases in kidney function. Small decreases may occur and are often temporary.
There is a new medication for heart failure called Entresto. It costs over $600 a month. That is $7200 a year. Entresto saw sales jump 41% at constant currencies to $2.6 billion in the first nine months of 2021. The clinical trial that led to billions of dollars in sales is called Paradigm-HF. Just over half of the patients in Paradigm-HF trial were on spironolactone or eplerenone when the Entresto trial started for HFrEF. The trial examined the impact of Entresto on death and hospitalization. Death was reduced by 16% and hospitalization by 20%. The impact would have been much less if treatment with spironolactone or eplerenone were maximized
My post yesterday generated this comment from Dr H. Robert Silverstein FACC. “To me the reviews of PARADIGM-HF were overly optimistic and a case of cardiological mass hysteria. The study compared a new drug combination of a potent ARB + a neprilysin inhibitor to an old fashioned and seldom used ACE I , Vasotec = enalapril = 2 drugs to 1! There should have been a comparison of an insurmountable/potent and generic ARB like telmisartan …..in adequate doses coupled with …..epleronone (Inspra) or spironolactone, again in adequate (!) doses. These are less expensive generics already on the market. Doing so would compare 2 powerhouses to 2 powerhouses. My bet is there would be very little difference except in a markedly decreased cost using the latter.” I agree. New trials of cardiometabolic medications should be done against maximized optimal medical therapy. In HFrEF, that would be lisinopril, carvedilol, and spironolactone—all in adequate doses.
There is another new development that impacts this discussion. There is a new class of drugs for type 2 diabetes called the SGLT2 inhibitors. Empagliflozin or Jardiance is a good example. Dr. Milton Packer is a cardiologist who is a leading scientist in heart failure treatment who said: “There is compelling evidence that ….. (SGLT2) inhibitors exert cardioprotective and renoprotective (kidney protection) effects that are far greater than expected based on their effects on glycemia or glycosuria (sugar levels). In large-scale randomized controlled trials, SGLT2 inhibitors reduce the risk of hospitalizations for heart failure by ∼30% and often decrease the risk of cardiovascular death. This benefit is particularly striking in patients who have the most marked impairment of systolic function prior to treatment. (the sickest patients) In parallel, SGLT2 inhibitors also reduce the risk of end-stage renal events (kidney failure), including the occurrence of renal death and the need for dialysis or renal transplantation by ∼30%. This benefit is seen even when glomerular filtration rates (kidney function) are sufficiently low to abolish the glycosuric (losing sugar in the urine)effect of these drugs.” A medication developed for diabetes has a greater impact on heart failure than Entresto whether the patient is diabetic or not and it slows down kidney damage. Dr Packer sums it up this way: “it is now critical for physicians to reconceptualize SGLT2 inhibitors as organ-protective agents rather than glucose-lowering drugs.” Empagliflozin produces this effect by switching on AMPK. Empagliflozin also costs almost $600 a month.
Poorly controlled high blood pressure causes most heart failure. Only 44% of Americans have their pressure controlled to 140/90 or less. We need to do much better with blood pressure control. Spironolactone and eplerenone are critical elements of the protocol to lower blood pressure. If we increased blood pressure control to 90% and used these medications, the number of Americans with heart failure would drop like a rock. That is the best way to deal with heart failure. Like Jardiance, lisinopril, losartan, spironolactone, and eplerenone interfere with the biology that causes heart failure and kidney failure. When treating hypertension, they protect every organ as an added benefit. If HFrEF develops, use lisinopril, carvedilol, and spironolactone in adequate doses. You can provide that for $12 a month. If those fail, add empagliflozin. Aggressively managing blood pressure and heart failure early with OMT produces much better heart failure outcomes at lower cost.
We all have a stake in this topic. Twenty percent of us will develop heart failure in our lifetime. Many of us will die from it. Heart failure generates one third of Medicare costs. We can deliver OMT in the most remote areas. Get in touch if you want to bring this benefit to your community. wbestermann@congruityhealth.com
We Can Dramatically Improve Treatment for Congestive Heart Failure with Poor Pumping Function (HFrEF) and Save Money
Multifunction Cardiogram Technology can objectively, cost-effectively, and non-invasively measure and monitor the functional improvement as result of this type of treatments in near real time 24/7/365! We can really help!
Excellent narratives! Thank you, Bill!