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Use of vasoactive/vasodilating drugs for systemic sclerosis (SSc)-related digital ulcers (DUs) in expert tertiary centres: results from the analysis of the observational real-life DeSScipher study.
Blagojevic, J, Abignano, G, Avouac, J, Cometi, L, Frerix, M, Bellando-Randone, S, Guiducci, S, Bruni, C, Huscher, D, Jaeger, VK, et al
Clinical rheumatology. 2020;(1):27-36
Abstract
INTRODUCTION DeSScipher is the first European multicentre study on management of systemic sclerosis (SSc), and its observational trial 1 (OT1) evaluated the efficacy of different drugs for digital ulcer (DU) prevention and healing. The aim of this study was to assess current use of vasoactive/vasodilating agents for SSc-related DU in the expert centres by analysing the baseline data of the DeSScipher OT1. METHOD Baseline characteristics of patients enrolled in the OT1 and data regarding DU were analysed. RESULTS The most commonly used drugs, in both patients with and without DU, were calcium channel blockers (CCBs) (71.6%), followed by intravenous iloprost (20.8%), endothelin receptor antagonists (ERAs) (20.4%) and phosphodiesterase 5 (PDE-5) inhibitors (16.5%). Of patients, 32.6% with DU and 12.8% without DU received two drugs (p < 0.001), while 11.5% with DU and 1.9% without DU were treated with a combination of three or more agents (p < 0.001). Sixty-five percent of the patients with recurrent DU were treated with bosentan and/or sildenafil. However, 64 out of 277 patients with current DU (23.1%) and 101 (23.6%) patients with recurrent DU were on CCBs alone. CONCLUSIONS Our study shows that CCBs are still the most commonly used agents for DU management in SSc. The proportion of patients on combination therapy was low, even in patients with recurrent DU: almost one out of four patients with current and recurrent DU was on CCBs alone. Prospective analysis is planned to investigate the efficacy of different drugs/drug combinations on DU healing and prevention. Key Points • The analysis of DeSScipher, the first European multicentre study on management of SSc, has shown that the most commonly used vasoactive/vasodilating drugs for DU were CCBs, followed by intravenous Iloprost, ERAs and PDE-5 inhibitors. • More than half of the patients with recurrent DU received bosentan and/or sildenafil. • However, the proportion of patients on combination therapy of more than one vasoactive/vasodilating drug was low and almost one out of four patients with current and recurrent DU was on CCBs alone.
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The Effectiveness of Trimetazidine Treatment in Patients with Stable Angina Pectoris of Various Durations: Results from the CHOICE-2 Study.
Glezer, M, ,
Advances in therapy. 2018;(7):1103-1113
Abstract
INTRODUCTION Trimetazidine (TMZ) has been shown to reduce angina symptoms and to increase exercise capacity in randomized clinical trials, but more extensive data would be useful to assess its effects in real-world clinical practice and in patients with different durations of disease. METHODS CHOICE-2 was a Russian, multicenter, 6-month, open-label, prospective observational study that assessed the effect of adding TMZ modified release 35 mg bid to antianginal treatment in a real-world setting. The present analysis of CHOICE-2 results explored the effects of adding TMZ to background antianginal therapies with regard to the duration of stable angina. RESULTS A total of 741 patients with known durations of disease were divided into four groups according to stable angina pectoris (AP) duration, ranging from less than 1 year to more than 9 years. Addition of TMZ led to a significant decrease in the frequency of angina attacks and in the use of short-acting nitrates in all groups. In patients with recently diagnosed angina (AP duration < 1 year), the average number of angina attacks per week decreased significantly from 3.75 ± 4.63 to 0.67 ± 1.51 and in those with advanced disease (AP duration > 9 years) from 5.63 ± 5.24 to 1.32 ± 2.07. Angina-free walking distance also improved significantly. Addition of TMZ also improved patient well-being. Results were achieved rapidly (within 2 weeks), were maintained over 6 months, and were obtained in all patient groups regardless of angina duration. CONCLUSION TMZ added to other antianginal therapies proved to be effective for reducing angina attacks and short-acting nitrate use, increasing angina-free walking distance, and improving patient well-being in a real-life setting, irrespective of angina duration, including patients with recently diagnosed angina. This provides an opportunity for intensification of treatment early on in the disease process, with the aim of decreasing angina burden and improving patient quality of life. FUNDING Servier. TRIAL REGISTRATION ISRCTN identifier ISRCTN65209863. Plain language summary available for this article.
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[Effectiveness of trimetazidine prolong in stable coronary artery disease. Multicenter, prospective, observational study, ONECAPS study].
Tomcsányi, J, Szakács, L
Orvosi hetilap. 2018;(38):1549-1555
Abstract
INTRODUCTION The effectiveness of the manegement of stable coronary artery disease among outpatients is not well known. AIM: The aim of the study was to evaluate the effect of daily once trimetazidine prolong 80 mg on the angina number and severity (Canadian Cardiovascular Society class). METHOD This multicenter, prospective, observational, 3-month clinical study included 2160 patients, but only 1701 patients completed the study. The patients' mean age was 68 years (17% under 60 years). The start of angina was 7.8 ± 6.7 years. Hypertension (93.4%) and hypercholesterolemia (81%) were very common. RESULTS The patients were well treated with beta-blocking agents (88%), calcium antagonists (49%), angiotensin-converting enzym inhibitors (90%) and statin (77%) but only 5% received ivabradine and 50.5% was treated with trimetazidine MR. The patients attended 3 visits (inclusion, 1 month, 3 month). During the 3-month period, the weekly angina number of all patients treated with trimetazidine prolong 80 mg decreased from 2.55 to 0.41 (p<0.0001). A favorable effect was observed in CCS grading: CCS I. from 40.37% to 66.81%, CCS II. from 49.89% to 30.59%, CCS III. from 9.17% to 2% and CCS IV. from 0.56% to 0%. The mean office measured blood pressure decreased from 137/83 mmHg to 130/80 mmHg and the heart rate from 74 bpm to 71 bpm. CONCLUSIONS In the real-life, in the stable coronary artery disease the angina remains despite the medical treatment. Once a day administered trimetazidine prolong 80 mg significantly reduced the weekly number of angina and the severity, too. These beneficial effects mediated not only by antiischemic effect but also by increased medication adherence. Orv Hetil. 2018; 159(38): 1549-1555.
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Impact of Trimetazidine Treatment on 5-year Clinical Outcomes in Patients with Significant Coronary Artery Spasm: A Propensity Score Matching Study.
Kim, YH, Her, AY, Rha, SW, Choi, BG, Choi, SY, Byun, JK, Mashaly, A, Park, Y, Jang, WY, Kim, W, et al
American journal of cardiovascular drugs : drugs, devices, and other interventions. 2018;(2):117-127
Abstract
OBJECTIVE We aimed to evaluate the additive benefit of trimetazidine with well-known antispasmodic agents such as calcium channel blockers and nitrate in patients with significant coronary artery spasm (CAS) as assessed by acetylcholine provocation test up to 5 years. METHODS A total 1727 patients with significant CAS were enrolled. They were divided into two groups: a trimetazidine group (trimetazidine, diltiazem, and nitrate, n = 695), and control group (diltiazem and nitrate, n = 473). After propensity score matching analysis, two matched groups (441 pairs, n = 882, C-statistic = 0.673) were generated. The individual and composite clinical end points [mortality, myocardial infarction (MI), revascularization, cerebrovascular accident (CVA), major adverse cardiac events (MACE), major adverse cardiac or cerebrovascular events (MACCE), and recurrent angina] were assessed up to 5 years for the two groups. RESULTS At 5 years, there were similar incidences of individual and composite hard endpoints including mortality, MI, revascularization, CVA, MACE, MACCE, and recurrent angina in the two groups. CONCLUSIONS Additional long-term (5-year) treatment with trimetazidine in combination with diltiazem and nitrate in patients with significant CAS was not associated with improved clinical outcomes compared with combination therapy with diltiazem and nitrate only (without trimetazidine).
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Additive value of nicorandil on ATP for further inducing hyperemia in patients with an intermediate coronary artery stenosis.
Kobayashi, Y, Okura, H, Neishi, Y, Higa, T, Kobayashi, Y, Uemura, S, Yoshida, K
Coronary artery disease. 2017;(2):104-109
Abstract
BACKGROUND The induction of hyperemia is of importance to precisely assess the functional significance of coronary artery lesions with fractional flow reserve (FFR). Adenosine or ATP alone is used widely in this setting; however, little is known about the additive value of nicorandil, which acts as a nitrate and a K-ATP channel opener, to induce further hyperemia. PATIENTS AND METHODS A total of 183 intermediate native coronary artery lesions from 112 patients were prospectively enrolled into this study. FFR was measured using a coronary pressure wire during an intravenous ATP infusion alone (150 mcg/kg/min) (FFRATP) and repeated after an adjunctive intracoronary nicorandil injection (2.0 mg) (FFRATP+Nico). RESULTS Physiologic measurements were completed without any severe adverse effects from ATP and nicorandil in all patients. FFRATP and FFRATP+Nico had a strong linear correlation (R=0.79, P<0.001). The FFR value became significantly lower with an adjunctive intracoronary nicorandil injection compared with ATP alone [FFRATP vs. FFRATP+Nico, 0.87 (interquartile range: 0.81-0.92) vs. 0.85 (0.79-0.90), P<0.001]. A total of 18 lesions out of 183 (9.8%) were reclassified after a nicorandil injection (12 from FFR>0.80 to ≤0.80 vs. six from FFR≤0.80 to >0.80, P=0.26). The adjunctive effect of nicorandil was accentuated with each increment of FFRATP strata (per 0.05 increase, P for trend<0.001), but with minimal effect around the borderline FFR zone. CONCLUSION An adjunctive intracoronary nicorandil injection is safe, but appears to have little effect in inducing further hyperemia. Therefore, its effect on the clinical scenario is limited.
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Real-world Evidence for the Antianginal Efficacy of Trimetazidine from the Russian Observational CHOICE-2 Study.
Glezer, M, ,
Advances in therapy. 2017;(4):915-924
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Abstract
INTRODUCTION The guidelines recommend a beta-blocker or calcium channel blocker as the first-line medication for angina, supplemented by other agents for additional symptoms. One such agent is trimetazidine (TMZ), which has been shown to reduce the frequency of anginal episodes and improve exercise performance without affecting haemodynamic parameters. However, extensive real-world evidence for its efficacy in combination with first-line therapies has been lacking. METHODS The aim of this large-scale, Russian, multicentre, 6-month, open-label, prospective observational study was to assess the effect of adding TMZ modified release 35 mg bid to background antianginal therapy in the real-world clinical setting. RESULTS The study included 896 patients: 54% women, aged 29-90 years (42.6% >65 years), 63% with class II angina, and receiving beta-blockers alone or in combination (93%). Add-on TMZ reduced angina frequency and short-acting nitrate use within 2 weeks (both p < 0.0001) regardless of background therapy and maintained this effect over 6 months. It increased the proportion of patients with class I angina sixfold while decreasing that of class 3 angina almost fourfold. It also improved walking distance and well-being at 6 months (both p < 0.0001). Treatment was well tolerated. CONCLUSION Add-on TMZ is a safe and rapidly effective treatment for reducing angina attacks and nitrate use in the real-world clinical setting. It also increases exercise capacity and well-being. These effects are observed within 2 weeks and persist for at least 6 months.
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Long-term effects of beraprost sodium on arteriosclerosis obliterans: a single-center retrospective study of Japanese patients.
Arai, T
Advances in therapy. 2013;(5):528-40
Abstract
INTRODUCTION Arteriosclerosis obliterans (ASO) causes ischemic symptoms of the lower limbs, reducing quality of life (QOL), and has a poor prognosis. Early diagnosis and treatment are necessary. In this study, the effects of long-term administration of beraprost sodium (beraprost) to treat ASO were investigated. METHODS One hundred and eighty eight patients treated with beraprost for ≥1 year were retrospectively identified. Outcomes were lower limb ischemic symptoms, carotid intima/media thickness (IMT), and cardiovascular events. Patients reported visual analog scale scores for major symptoms at baseline and after 3, 6, and 12 months of treatment. RESULTS Overall, 188 patients (mean age 70.8 ± 10.15 years, Fontaine classification: grade I 14.4%, grade II 85.6%) treated with beraprost for 2.4-10.7 years (mean 6.5 years) were included in this study. Administration of beraprost significantly reduced patient-reported severity of lower limb ischemic symptoms in all patients at 12 months, including those with diabetes, hypertension, or dyslipidemia. IMT decreased from 1.09 ± 0.09 mm at baseline to 1.04 ± 0.11 mm at 12 months (P < 0.001). Decreases in IMT were similar in patients with diabetes, hypertension, or dyslipidemia. Overall, 26 (13.8%) events occurred during a mean follow-up of 6.5 years, including 23 cardiovascular events (unstable angina in three patients, myocardial infarction in six patients, cerebral infarction in eight patients, and transient cerebral ischemic attack in six patients) and non-cardiovascular death in three patients. Beraprost at 120 μg/day significantly reduced the risk of ischemic symptoms compared with <120 μg/day (adjusted hazard ratio: 0.17; 95% confidence interval: 0.06, 0.45; P < 0.001). No severe adverse events or adverse events requiring dose reductions/discontinuation occurred during long-term administration of beraprost. CONCLUSION Beraprost reduced lower limb ischemic symptoms, IMT, and the incidence of cardiovascular events in patients with ASO.