Digoxin is back in action: a cheap heart pill beats drugs that cost 5 euros

Dutch cardiologists have brought back an 18th-century medicine from semi-oblivion — low doses of digoxin have reduced the number of hospitalizations for heart failure by a quarter, and the course costs pennies. Three studies from Groningen have already been published in Nature Medicine and JAMA — and may force a reconsideration of international treatment protocols.

An old friend returns to the game

Digoxin, a substance from digitalis that doctors have been using for the heart since the end of the 18th century, has gradually faded into the background in recent decades, xrust states. Against the background of new treatment regimens, only about 15% of patients with chronic heart failure receive it today, although 25–30 years ago it was the mainstay of treatment. A team of cardiologists at the University Medical Center Groningen (UMCG) — Dirk Jan van Veldhuizen, Kevin Damman and Pieter van der Meer — decided to check whether the drug had been written off early. The results of three studies presented at the ESC Heart Failure congress in Barcelona suggest that it may have been cheated.

What the main study showed

The work is based on a randomized trial involving 1,000 patients from 43 medical centers in the Netherlands. Half took a low dose of digoxin in addition to standard therapy for an average of three years, the other half took a placebo. Deaths from cardiovascular causes and worsening heart failure were reduced by 19% in the digoxin group, but this figure alone did not reach statistical significance — the sample was not large enough to rule out chance.

Then the scientists combined their data with the results of two earlier studies in a meta-analysis — and here the effect became stable and statistically significant, even in patients who were already receiving the full set of four standard drugs. The most notable result was that the number of hospitalizations due to heart failure fell by an average of 25%. At the same time, low-dose digoxin turned out to be safe and easy to use.

Fifth place in the «fantastic four»

class=»notranslate»>__GTAG7__Modern basic therapy for heart failure is based on a combination of four drugs — in English-speaking cardiology it is called “Fantastic Four”. The question of whether digoxin could become the fifth mandatory component of this regimen has been discussed by cardiologists for a long time, but there has still been no convincing prospective randomized data. The three Groningen papers are the first serious attempt to close this gap.

You can’t quit abruptly: what drug withdrawal showed

class=»notranslate»>__GTAG5__A separate, third study followed about 600 of the 1,000 original participants who received either digoxin or a placebo. It turned out that patients who had to stop taking digoxin had significantly more problems in the first six weeks after stopping than those who did not take the drug initially: among 288 patients, 14 were hospitalized or died. This in itself does not directly prove the effectiveness of the drug, but the scale and synchronicity of the effect surprised even the authors of the work.

Why a small dose works better than a large dose

Previously, digoxin was often prescribed in high doses, causing the heart muscle to contract more strongly, but over time this strategy did not show itself to be the best: for a weakened heart, it is more profitable not to work through force, but to unload. At a low dose, the mechanism of action is different — the drug primarily suppresses the body’s compensatory reactions to heart failure, in particular, it reduces the level of stress hormones like adrenaline in the blood, and this is what, apparently, benefits the heart. Earlier observational data had already hinted that low doses worked better than high doses, but prospective confirmation was lacking—until the current study.

How much does it cost in Russia

In the Netherlands, the price of digoxin is estimated at less than 10 cents per day — compared to new heart failure drugs that cost several euros per day, the difference looks almost comical. In Russian pharmacies the picture is similar: a pack of 30 tablets of 0.25 mg costs from 33 to 53 rubles from domestic manufacturers — Tomsk and Usolsk chemical pharmaceutical plants — and the daily dose for chronic heart failure is usually a quarter to a half of a tablet. That is, therapy costs one or two rubles a day — amounts that have long been forgotten with modern cardiac drugs. Digoxin is sold strictly by prescription, and you should absolutely not adjust the dose yourself or start taking it without a doctor’s prescription: the drug has a narrow therapeutic window and a noticeable list of drug interactions.

Why cheap medicine is difficult to study

There is an unpleasant paradox: the cheaper the drug, the more difficult it is to find money for its study — pharmaceutical companies are not interested in sponsoring research on a drug that cannot make money. The current work was funded by the Dutch Hartstichting (similar to the heart fund) together with the ZonMw organization as part of the rational use of medicines program — a grant of 3 million euros. For heart failure, which in Russia, according to the EPOCHA-CHF study, affects about 7% of the population — almost 8 million people — the appearance of an inexpensive addition to standard therapy could have a quite tangible effect on the healthcare system if the results are confirmed in further trials and end up in clinical recommendations.

The authors of the studies are still cautious: they only say that the accumulated data may be enough to revise the guidelines for the treatment of heart failure. But the very fact that a drug that is more than two centuries old is still able to surprise cardiologists is already a good reason to take a closer look at it.

Sources :
sciencedaily.com
nature.com
jamanetwork.com

Xrust Digoxin is back in action: a cheap heart pill beats drugs that cost 5 euros