In Pitt et al.'s "The Effect of Spironolactone on Morbidity and Mortality in Patients with Severe Heart Attacks," the researchers seek to answer the question of whether or not spirinolactone has a definitive effect on reducing heart failure rates in patients. Aldosterone is identified as one of the most important components of heart failure; as a result, aldosterone-receptor blockers are considered to be a potential treatment or therapy for those with severe heart failure.
In order to test the efficacy of spironolactone on those with moderate heart conditions and heart failure, a study was performed in which 822 patients were given regular treatment with spironolactone, while another 843 was given a placebo. The participants were all around the age of 65, 86% were white, and 3/4 of them were female. Most of them had class III heart disease as determined by the New York Heart Association, and the participants were fairly evenly split between the cause of their heart failure - ischemic and nonischemic. Both groups were given regular therapy consisting of loop diuretics, ACE inhibitors, aspirin, beta blockers and more, with the spironolactone being the only variant. With all of these varying criteria that are suited to the treatment the researchers are studying, their sample size is a good representation of who would benefit from this new treatment.
A number of factors required the researchers to stop treating some of the patients. Nineteen patients had to stop treatments because they needed to get heart transplants, two of them dying. Additional followup was performed on the patients who stopped treatment in order to see how their vitals were doing, though those findings were not included in the results.
The results were determined fairly early in the study, to the point where the trial was actually discontinued before its intended time. In the spironolactone group, 30% fewer people died over the trial period than those who engaged in the placebo group. The spironolactone group also experienced nearly 35% lower rates of hospitalization due to heart failure that was getting worse. Essentially, the effectiveness of spironolactone in reducing the symptoms of heart failure and its prevalence was made clear early and dramatically enough that the researchers stopped their trial.
The researchers concluded that spironolactone blocks aldosterone receptors to the point where, when combined with regular therapy, can lessen the chance of death and morbidity among those who are experiencing severe heart failure. Other findings included the fact that ACE inhibitors alone do not provide adequate blockage of aldosterone production; an additional element is needed, such as spironolactone, to suppress production of aldosterone. What's more, the proper dose of spironolactone being determined is a significant factor in the success of the reduction of morbidity and death among these patients who were at high risk for heart failure.
Works Cited
Pitt, Bertram, Zanna, Faeiz, Remme, Willem J., et al. "The Effect of Spironolactone on
Morbidity and Mortality in Patients with Severe Heart Failure." New England Journal of
Medicine vol. 341, no. 10, p. 709. 1999. Print.
