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.

Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial

Objective To assess the clinical effectiveness of acupoint application(AP)of Guan Xin Su He Pill(冠心苏合丸,GXSHP)for patients with chronic stable angina pectoris(CSAP).Methods This study was carried out in 3 local hospitals in Chengdu,China.After baseline evaluation,eligible patients were randomly assigned to the placebo application for acupoints(PAA)group or the herbal application for acupoints(HAA)group.Patients in the HAA group underwent AP with herbal powder,which was mainly GXSHP,and patients in the PAA group underwent AP with sham drugs.For each treatment session,unilateral acupoints including Neiguan(PC 6),Danzhong(RN 17),Xinshu(BL 15)and Jueyinshu(BL 14),were stimulated for both groups.AP was performed 3 times a week with a 2-day interval for 4 weeks.The primary outcome was the frequency of angina pectoris attacks per week,while the secondary outcomes included angina pain intensity measured by the Visual Analogue Scale(VAS),dose of rescue oral drugs(nitroglycerin),scores on the Seattle Angina Questionnaire(SAQ),Self-Rating Anxiety Scale scores(SAS)and Self-Rating Depression Scale scores(SDS).Clinical outcomes were measured at week 0,4 and 8.The safety of AP of GXSHP treatment for CSAP were assessed.Results A total of 121 patients were enrolled.Baseline characteristics were comparable across the 2 groups.After treatment,the angina attack numbers in the HAA group were significantly reduced from 11.00 to 4.81(P<0.05).While,for PAA group,the angina frequency was not significantly improved(baseline 10.55;post-treatment 11.05).The HAA group had significantly fewer angina attacks than the PAA group(P<0.05).Pain intensity measured by VAS in HAA group was significantly reduced from 4.06 to 3.02(P<0.05).While,for PAA group,the VAS was significantly increased(baseline 3.62;post-treatment 3.96;P<0.05).Clinical outcomes showed better improvement after treatment in the HAA group than in the PAA group in terms of oral administration of rescue drugs,SAS,SDS and SAQ scores(P<0.05).The adverse events were also reported.Conclusion AP of GXSHP is a safe and effective treatment for CSAP patients(Registration No.NCT02029118).

A Multicenter,Randomized,Double-blind Clinical Study on Wufuxinnaoqing Soft Capsule(五福心脑清胶囊) in Treatment of Chronic Stable Angina Patients with Blood Stasis Syndrome

Objective： To confirm the efficacy and safety of Wufuxinnaoqing Soft Capsule （五福心脑清胶囊, WSC） in the treatment of chronic stable angina （blood stasis syndrome）. Methods： A multicenter, randomized, double-blind, placebo-controlled trial with superiority test was designed. A total of 240 patients with chronic stable angina （blood stasis syndrome） from multiple centers were randomly and equally assigned to the treatment group and the control group. Based on standard treatment of Western medicine, the treatment group was given WSC, while the control group was given WSC mimetic, both for 12 weeks. Observed indicators included the efficacy in angina, the efficacy in Chinese medicine syndrome, the withdrawal or reduce rate of nitroglycerin and routine safety indices. Results： After 12-week treatment, the significant effective rate and total effective rate of the treatment group were significantly better than those of the control group （23.5% vs. 9.2%, 64.7% vs. 30.8%）, respectively, with statistically significant difference （P〈0.01）. After 12-week treatment, the decreased points and the decreased rate of angina symptom score in the treatment group were better than in the control group （5.1±4.2 points vs. 2.8± 3.5 points, 44.9% ±37.2% vs. 25.4%±30.7%） respectively, with significant difference （P〈0.01）. After 12-week treatment, the significant effective rate and total effective rate of the treatment group were better than the control group （respectively, 30.3% vs. 15.0%, 67.2% vs. 45.0%, P〈0.01）. After 8- or 12-week treatment, the decreased points and the decreased rate of Chinese medicine syndrome score in the treatment group were better than the control group （P〈0.05 or P〈0.01）. After 12-week treatment, nitroglycerin withdrawal rate and the withdrawal or reduce rate in treatment group were better than the control group （P〈0.01）. On safety evaluation, the incidence of adverse events （7.563% vs. 7.500%） and the incidence of cardiovascular events （0.840% vs. 0.000%） in the treatment group were similar with the control group, and the difference was not statistically significant （P〉0.05）. Couch=SlOB： In treatment of chronic stable angina （blood stasis syndrome）, WSC can reduce angina attacks and consumption of nitroglycerin, decrease angina severity degree, effectively relieve the blood stasis syndromes, such as chest pain, chest tightness, palpitations, dark purple tongue and other symptoms. Besides, adverse events and cardiovascular adverse events in the treatment group and the control group showed no difference. All shows that the drug is safe and effective. [This study was registered in Chinese Clinical Trial Registry （ChiCTR）, with registration number： ChiCTR-TRC-14005158.]