“Heart failure patients have many pills to take for their heart failure and for comorbidities such as diabetes and hypertension,” said principal investigator Dr Luis E. Rohde, of the Federal University of Rio Grande do Sul, Porto Alegre, Brazil. “Withdrawing one drug when it is no longer necessary should make it easier to take the ones that are needed.”
“Patients don’t like using diuretics because they feel they have to stay at home to use the bathroom and they get cramps,” he added. “Patients would welcome being able to stop this medication.”
Diuretics are commonly prescribed for symptom relief in patients with heart failure. The drugs get rid of the excess fluids (congestion) which cause shortness of breath, swollen legs, coughing, and weight gain. Once the symptoms have resolved, patients are maintained on a low dose due to concerns that symptoms may return. Observational research has shown that long-term diuretic use is associated with a worse prognosis.
The ReBIC-1 trial examined the safety and tolerability of withdrawing the diuretic furosemide in outpatients with stable chronic heart failure. The trial was conducted by the Brazilian Research Network in Heart Failure (ReBIC), which includes 11 tertiary care university hospitals in Brazil.
Eligible criteria were: no or mild symptoms (defined as New York Heart Association functional class I to II), reduced left ventricular ejection fraction (45% or below), no heart failure-related hospital admission within the last six months, and receiving low-dose furosemide (40 to 80 mg per day) for at least six months.
A total of 188 patients were randomly allocated to maintain or withdraw furosemide. Patients in the withdrawal group received a placebo pill. Both patients and investigators were blinded to the treatment allocation. The trial had two coprimary outcomes: 1) patient reported dyspnoea using a visual analogue scale at four time points across 90 days; and 2) the proportion of patients maintained without additional diuretics during the 90-day follow-up (on top of the randomly allocated diuretic or placebo).
There was no difference between groups in the self-perception of dyspnoea during the 90-day follow-up period. Also, 72 patients (75.3%) in the withdrawal group and 78 patients (83.9%) in the maintenance group were free of furosemide reuse during follow-up (p=0.16).
Senior author Dr Andréia Biolo, of the Federal University of Rio Grande do Sul, who presented the results in Athens, said: “The results show that patients with stable heart failure who stop diuretics do not have more dyspnoea than those who continue taking the drug. Withdrawal also does not lead to increased reuse of diuretics – around 20% of patients in both groups needed a top-up, presumably for symptom relief.”
Dr Rohde said the findings indicate that diuretics can be safely discontinued in heart failure patients meeting the trial’s eligibility criteria. “Most patients we see in the heart failure outpatient clinic fulfil the trial criteria and could benefit from this strategy,” he said.
No extra follow-up is needed for patients who quit taking diuretics, noted Dr Biolo. “Patients can be followed-up in the usual way,” she said. “And, as we do now, patients should be educated to seek medical help if they become breathless, get oedema, or have sudden weight gain which indicates fluid retention.”
Source: European Society of Cardiology (ESC)
References and notes
1 The abstract ‘Furosemide Withdrawal in Stable Chronic Outpatients with Heart Failure: a Double-blind, Multicenter, Randomized Trial’ presented during the session Late breaking trial II - Chronic heart failure