Abstract
A biphasic investigation conducted in 2 separate groups of patients (total number 124) hospitalized for a myocardial infarction is described. The objectives were to determine, during the immediate postinfarction period, the effect of sustained-action doses (80 mg, 2 times a day) of pentaerythritol tetranitrate on blood pressure, pulse rate, morbidity, and mortality; a randomized, double-blind, placebo-controlled method was used to determine the latter 2 effects. Multiple pre- and post-drug measurements failed to show that an 80-mg sustained-action dose of pentaerythritol tetranitrate caused sharp fluctuations in either blood pressure of pulse rate. A tabulation and analysis of major single and multiple complicating factors indicated that preinfarction disease related complications had little or no effect on mortality, regardless of whether they occurred singly or in various combinations. "Nondisease" related complications, when they occurred singly, did not seriously increase mortality either. Of all the various combinations of complications that occurred, those involving shock proved to be most lethal. A noteworthy finding was the statistically significant (Xc 2 = 4.4; P < 0.05 > 0.02), fewer number of patients in the pentaerythritol tetranitrate-treated group who developed shock following hospitalization. With the method of investigation employed, it could not be determined whether pentaerythritol tetranitrate was directly or indirectly responsible for this lower incidence of shock. Additional tabulations and analyses of the data for patients who was randomly assigned to each of the treatment groups indicated: that the severity of the acute illness, i.e., the clinical course, was less eventful in the survivors comprising the drug-treated group; that the differences between the mean number of days on which analgesics and oxygen were required were statistically significant, favoring the conclusion that the clinical course was smoother in the group of pentaerythritol tetranitrate-treated patients; that no statistical significance could be attached to the small difference between the groups in the mean number of days that it took for the patients'' pulse rate to return to preinfarction levels. The over-all mortality rate in the series of 50 patients who received a placebo in addition to regularly employed drug therapy was 22%; in the series of 50 patients receiving sustained-action doses (80 mg, 2 times a day) of pentaerythritol tetranitrate and regular drug therapy, the mortality rate was only 4%. Numberwise, these rates involved 11 and 2 patients, respectively; the difference between the number of nonsurvivors in each treatment group was statistically significant (Xc 2 = 5.7; P< 0.02 >0.01). The significance of the present findings is discussed and compared with those of others.