Background/Objectives: Propatyl nitrate is a coronary vasodilator with immediate and prolonged action, indicated in the treatment and prevention of acute angina pectoris episodes. Methods: This was an open, self-paire...Background/Objectives: Propatyl nitrate is a coronary vasodilator with immediate and prolonged action, indicated in the treatment and prevention of acute angina pectoris episodes. Methods: This was an open, self-paired comparative study performed at UNIFESO Medical School evaluating the clinical and laboratory results of treatment with propatyl nitrate in patients with chronic stable angina pectoris. Subjects received 10 mg of propatyl nitrate, at the dose of three sublingual tablets per day, to be taken at 8:00 A.M., 2:00 P.M., and 8:00 P.M. Subjects returned to the study center after 15 days of treatment for Visit 2 assessments, and at the end of the 30-day treatment period (Visit 3). Results: A total of 200 subjects were included in the study. There was a statistically significant reduction in blood pressure (p < 0.0001) and heart rate (p = 0.0001), but no change in respiratory rate (p = 0.23). Laboratory results did not vary throughout the treatment period. There was no significant change from pretreatment in the SAQ Physical Limitation scale (p = 0.7415). The Angina Stability, Angina Frequency, and Treatment Satisfaction, and Quality of Life scales showed a significant improvement from pretreatment (p < 0.0001). Adverse events were observed among 41 subjects at Visit 2 and 35 subjects at Visit 3. Conclusions: Propatyl nitrate was safe and effective in treating chronic stable angina pectoris over the course of the 30-day treatment period. Treatment with propatyl nitrate increased angina stability and reduced angina frequency while increasing treatment satisfaction and quality of life in the patient population evaluated.展开更多
In order to evaluate the safety and efficacy of Borago officinalis (900 mg borage oil capsules) in the treatment of patients presenting with cyclic mastalgia, 91 subjects were included in the study. Efficacy assessmen...In order to evaluate the safety and efficacy of Borago officinalis (900 mg borage oil capsules) in the treatment of patients presenting with cyclic mastalgia, 91 subjects were included in the study. Efficacy assessments were performed based on data obtained prior to the start of treatment (Pretreatment), and after each menstrual cycle (Assessment 2—following 45 days of treatment;and Assessment 3—at the end of the 90-day treatment period). Primary efficacy measures considered the results of the Mastalgia Questionnaire, including a 100 mm visual analog pain scale assessing mean, most intense mastalgia severity, and impact on work, sleep, and sexual activity. Safety and tolerability measures included any changes in vital signs and physical exam in relation to pretreatment, any changes in clinical laboratory exams in relation to pretreatment, and the occurrence of adverse events after the first dose of study medication. The VAS scores of the mean mastalgia and most severe mastalgia both showed statistically significant展开更多
文摘Background/Objectives: Propatyl nitrate is a coronary vasodilator with immediate and prolonged action, indicated in the treatment and prevention of acute angina pectoris episodes. Methods: This was an open, self-paired comparative study performed at UNIFESO Medical School evaluating the clinical and laboratory results of treatment with propatyl nitrate in patients with chronic stable angina pectoris. Subjects received 10 mg of propatyl nitrate, at the dose of three sublingual tablets per day, to be taken at 8:00 A.M., 2:00 P.M., and 8:00 P.M. Subjects returned to the study center after 15 days of treatment for Visit 2 assessments, and at the end of the 30-day treatment period (Visit 3). Results: A total of 200 subjects were included in the study. There was a statistically significant reduction in blood pressure (p < 0.0001) and heart rate (p = 0.0001), but no change in respiratory rate (p = 0.23). Laboratory results did not vary throughout the treatment period. There was no significant change from pretreatment in the SAQ Physical Limitation scale (p = 0.7415). The Angina Stability, Angina Frequency, and Treatment Satisfaction, and Quality of Life scales showed a significant improvement from pretreatment (p < 0.0001). Adverse events were observed among 41 subjects at Visit 2 and 35 subjects at Visit 3. Conclusions: Propatyl nitrate was safe and effective in treating chronic stable angina pectoris over the course of the 30-day treatment period. Treatment with propatyl nitrate increased angina stability and reduced angina frequency while increasing treatment satisfaction and quality of life in the patient population evaluated.
文摘In order to evaluate the safety and efficacy of Borago officinalis (900 mg borage oil capsules) in the treatment of patients presenting with cyclic mastalgia, 91 subjects were included in the study. Efficacy assessments were performed based on data obtained prior to the start of treatment (Pretreatment), and after each menstrual cycle (Assessment 2—following 45 days of treatment;and Assessment 3—at the end of the 90-day treatment period). Primary efficacy measures considered the results of the Mastalgia Questionnaire, including a 100 mm visual analog pain scale assessing mean, most intense mastalgia severity, and impact on work, sleep, and sexual activity. Safety and tolerability measures included any changes in vital signs and physical exam in relation to pretreatment, any changes in clinical laboratory exams in relation to pretreatment, and the occurrence of adverse events after the first dose of study medication. The VAS scores of the mean mastalgia and most severe mastalgia both showed statistically significant
