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Treatment of Stable Angina Pectoris With Ivabradine in Everyday Practice: A Pan-Hellenic, Prospective, Noninterventional Study.

ABSTRACT: In coronary artery disease (CAD), medical treatment is the main clinical strategy for controlling ischemia and angina symptoms while restoring a satisfactory level of usual activities and improving quality of life (QOL). This study's purpose was to evaluate in CAD patients the antianginal efficacy of 4-month treatment with ivabradine plus a β-blocker and to record patient compliance and the effect of treatment on QOL.In this noninterventional study, 2403 patients with chronic stable angina were prospectively studied from 245 private cardiology offices. Data were recorded at baseline and at 1 and 4 months after inclusion. Patient quality of life was assessed using the EuroQol 5 dimensions (EQ-5D) questionnaire.From baseline to study completion, mean heart rate decreased from 81.5 ± 9.7 bpm to 63.9 ± 6.0 bpm (P <-0.001), mean number of anginal attacks decreased from 2.0 ± 2.0 times/wk to 0.2 ± 0.6 times/wk (P < 0.001) and nitroglycerin consumption decreased from 1.4 ± 2.0 times/wk to 0.1 ± 0.4 times/wk (P < 0.001). The percentage of patients with Canadian Cardiovascular Society angina class I increased from approximately 38% (baseline) to 84% (study completion; P < 0.001). The reduction in anginal attacks, nitroglycerin consumption, and angina score was correlated with reduction in heart rate (P < 0.001). The mean EQ-5D visual analogue scale index increased by 16.1 points (P < 0.001), and compliance with treatment was high throughout the trial (96%).Ivabradine administration on top of optimal individualized dose of β-blockers is associated with decreased anginal events and with improvement of QOL in CAD patients.

SUBMITTER: Zarifis J

PROVIDER: S-EPMC4738471 | biostudies-other | 2015 Dec

REPOSITORIES: biostudies-other

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Project description:IntroductionPrevious reviews indicate that the effect of acupuncture on stable angina pectoris (SAP) remains controversial. The results of trials published in the past 5?years may possibly change this situation, but an updated systematic review is not available. We therefore designed this study to systematically assess the efficacy and safety of acupuncture for treating SAP.Methods and analysisNine online databases will be searched without language or publication status restrictions from their inception to September 2017. Randomised controlled trials that include patients with stable angina receiving acupuncture therapy versus a control group will be deemed eligible. The selection of studies, data extraction and risk of bias assessment will be carried out by two independent reviewers. Data synthesis will be performed using RevMan V.5.3 software with either a fixed effects model or random effects model, depending on the heterogeneity test. Evidence quality will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation system. The efficacy-effectiveness spectrum for each included trial will be rated using the Rating of Included Trials on the Efficacy-effectiveness Spectrum tool. Outcomes of interest include the improvement of weekly angina attacks and reduction of nitroglycerin medication use after receiving acupuncture treatment, the incidence of cardiovascular events, heart rate variability, pain intensity measured on a visual analogue scale, total workload and exercise duration at peak exercise, safety and adverse events. A meta-analysis will be conducted if no considerable heterogeneity is detected. The results will be presented as risk ratios with 95% CIs for dichotomous data and weighted mean differences or standardised mean differences with 95% CIs for continuous data.Ethics and disseminationThis systematic review will not involve private information from individuals or endanger their rights, and therefore does not necessarily require ethical approval. The results may be published in a peer-reviewed journal or disseminated in relevant conferences.Trial registration numberCRD42015016201.

Project description:BACKGROUND:Patients with coronary heart disease (CHD) angina pectoris are in critical condition, which can cause sudden death, myocardial infarction, and other adverse events, and bring serious burden to families and society. Timely treatment should be given to improve the condition. Western medicine treatment of angina pectoris failed to meet the demand of angina symptom control. OBJECTIVE:It is hoped that the research method with higher evidential value will be adopted to compare the short-term, medium-term, and long-term effects of Chinese patent medicine combined with conventional western medicine and conventional western medicine alone in the treatment of CHD angina pectoris, so as to tap the clinical efficacy advantages of traditional Chinese medicine (TCM) and provide reliable data support for its clinical application. METHODS:A prospective cohort study was conducted among patients with CHD angina pectoris who were treated with oral Chinese patent medicine and conventional western medicine. The patients were divided into exposed group and nonexposed group according to whether or not the patients with CHD angina pectoris were treated with Chinese patent medicine. The exposed group was treated with TCM combined with conventional western medicine, while the nonexposed group was treated with conventional western medicine alone. Patients need to be hospitalized for 2 weeks as the introduction period and whether to enter the group is determined according to the treatment and medication conditions of the patients. The follow-up time points were 0th, 4th, 12th, 24th, and 48th weeks. The main events and secondary events were used as the evaluation criteria for clinical efficacy of CHD angina pectoris. In the experimental study, we will use strict indicators to detect standard operation procedure for multinomics and bacterial flora detection. CONCLUSION:This study will provide evidence for the clinical efficacy advantages of Chinese patent medicine and reliable support for its clinical application through test data.

Project description:IntroductionIn the prospective, open-label, non-interventional, multicenter RESPONSIfVE study, the effectiveness, response rates and tolerability of ivabradine with or without beta blocker (BB) were evaluated in patients with chronic stable angina pectoris (AP) in daily clinical practice.MethodsIn patients with AP, ivabradine was given twice daily in flexible doses for 4 months. Resting heart rate (HR), number of angina attacks, short-acting nitrate use, severity of symptoms [by Canadian Cardiovascular Society (CCS) score] and tolerability with or without existing BB therapy were documented and analyzed using descriptive statistical methods.ResultsIn total, 1250 patients with AP (mean age 66.0 ± 10.9 years, 59.6% male, 31.9% previous myocardial infarction) and an indication for ivabradine were included. Sixty-five percent of all patients received BB. Further concomitant standard medication included aspirin (74.2%), statins (69.3%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (84.2%), diuretics (40.0%), long-acting nitrates (15.7%), and calcium antagonists (21.4%). After 4 months of ivabradine treatment (mean daily dose 11.0 ± 2.7 mg), mean HR was reduced from 82.4 ± 11.8 beats per minute (bpm) to 67.1 ± 8.4 bpm. The average number of angina attacks/week decreased from 1.2 ± 1.9 to 0.1 ± 0.6 and the average use of short-acting nitrates/week from 1.5 ± 2.8 units to 0.2 ± 1.0 units. CCS classification of patients improved from 76% classified in CCS grades II or III and 24% in CCS grade I to 66% classified in CCS grade I and only 35% remaining in CCS grades II or III at study end. Response rate to ivabradine (defined as HR <70 bpm or HR reduction ≥10 bpm) reached 87%. HR reduction, symptomatic improvement and response rates were comparable in patients with or without BB. Adverse drug reactions were reported for 2.2% of patients.ConclusionIn this prospective study over a four-month period in clinical practice, ivabradine effectively reduced HR, angina attacks, and nitrate consumption in patients with AP with or without concomitant BB therapy. Ivabradine improved CCS scores and achieved a high treatment response rate with good general tolerability.FundingServier.Trial registrationControlled-trials.com identifier, ISRCTN73861224.

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Treatment of Stable Angina Pectoris With Ivabradine in Everyday Practice: A Pan-Hellenic, Prospective, Noninterventional Study.

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