Results - Safety
Ramipril was well tolerated and the only adverse event worthy of note is an increase in the number of patients experiencing cough in the ramipril group. More patients in the ramipril group than in the placebo group stopped treatment because of cough (7.3 percent vs. 1.8 percent). There was only one serious adverse event that met the criteria for expedited reporting to regulatory authorities. This event was a ruptured esophagus (secondary to excessive coughing) and was in the ramipril group. The patient was hospitalized and underwent surgery. Symptoms abated and the patient was subsequently discharged without sequelae.