Assessment of Acute Episodes in Chronic Stable Angina: A Clinical-Laboratory Approach to the Use of the Coronary Vasodilator Propatyl Nitrate

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.

Impact of Low Back Pain on Quality of Life: Assessment by Patient Functionality Questionnaire and Treatment Results Using a Combination of Diclofenac plus B Vitamins or Diclofenac Monotherapy

Objective: To analyze the Patient Functionality Questionnaire (PFQ) scores of the patients treated with either Diclofenac + B vitamins (Group DB) or Diclofenac monotherapy (Group D) in order to better understand the impact of the combination of diclofenac with vitamins B1, B6, and B12 on quality of life. Research Design/Methods: We performed a post-hoc analysis of tabulated data generated during the DOLOR study (Diclofenac plus B vitamins versus diclofenac monotherapy in lumbago: the DOLOR study), using the software GraphPad Prism 5 for Windows, v5.04. The absolute number or percentage of “True”/“False” respondents for each questionnaire item at each study visit, together with the absolute number and percentage of subjects with no change, improvement, or worsening of each PFQ item at each study visit, within and between treatment groups were arranged on contingency tables and analyzed with the Chi-squared or Fisher’s Exact test. Results: At pretreatment there were no statistically significant differences between treatment groups (p > 0.05 for all items). At Visit 2 in both treatment groups, there were statistically significant improvements in individual question responses in each of the 12 items of the questionnaire (p < 0.05 for all items). At Visit 2, comparing the distribution of patients in each treatment group with “improvement”, “no change”, or “worsening”, there was a statistically significant superiority among subjects of group DB in response to items 1, 6, 8, and 10. At Visit 3, both groups had statistically significant (p < 0.001) improvements in each individual item of the PFQ in relation to pretreatment values. The distribution of subjects in each treatment group presenting with “improvement”, “no change”, or “worsening” at Visit 3 varied significantly in favor of group DB in the responses to item 4. At Visit 4, the subjects remaining in treatment in both groups showed statistically significant improvement in PFQ responses in relation to pretreatment values (p < 0.05). The distribution of subjects in each treatment group presenting with “improvement” or “no change” at Visit 4 varied significantly in favor of group D in the responses to items 5, 8, and 12. Conclusion: Improvement in overall PFQ scores was observed in both treatment groups, though the specific items of the questionnaire of the subjects in group DB at Visit 2 showed greater improvement in areas related to sleep quality, mobility, ability to wash and dry, ability to walk distances, and posture comfort. These results serve to corroborate the previously published data, which indicates a benefit of combining the B vitamins with diclofenac in the treatment of patients with low back pain, yielding shorter treatment time to resolution of the lumbago in the treated patients.

Clinical Assessment of Treatment Outcomes Following Borago officinalis Extract Therapy in Patients Presenting with Cyclical Mastalgia

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