BACKGROUND: Angina might persist or reoccur despite successful revascularisation with percutaneous coronary intervention (PCI) and antianginal therapy. Additionally, PCI in stable patients has not been shown to improve survival compared with optimal medical therapy. Trimetazidine is an antianginal agent that improves energy metabolism of the ischaemic myocardium and might improve outcomes and symptoms of patients who recently had a PCI. In this study, we aimed to assess the long-term potential benefits and safety of trimetazidine added to standard evidence-based medical treatment in patients who had a recent successful PCI. METHODS: We did a randomised, double-blind, placebo-controlled, event-driven trial of trimetazidine added to standard background therapy in patients who had undergone successful PCI at 365 centres in 27 countries across Europe, South America, Asia, and north Africa. Eligible patients were aged 21-85 years and had had either elective PCI for stable angina or urgent PCI for unstable angina or non-ST segment elevation myocardial infarction less than 30 days before randomisation. Patients were randomly assigned by an interactive web response system to oral trimetazidine 35 mg modified-release twice daily or matching placebo. Participants, study investigators, and all study staff were masked to treatment allocation. The primary efficacy endpoint was a composite of cardiac death; hospital admission for a cardiac event; recurrence or persistence of angina requiring an addition, switch, or increase of the dose of at least one antianginal drug; or recurrence or persistence of angina requiring a coronary angiography. Efficacy analyses were done according to the intention-to-treat principle. Safety was assessed in all patients who had at least one dose of study drug. This study is registered with the EU Clinical Trials Register (EudraCT 2010-022134-89). FINDINGS: From Sept 17, 2014, to June 15, 2016, 6007 patients were enrolled and randomly assigned to receive either trimetazidine (n=2998) or placebo (n=3009). After a median follow-up of 47·5 months (IQR 42·3-53·3), incidence of primary endpoint events was not significantly different between the trimetazidine group (700 [23·3%] patients) and the placebo group (714 [23·7%]; hazard ratio 0·98 [95% CI 0·88-1·09], p=0·73). When analysed individually, there were no significant differences in the incidence of the components of the primary endpoint between the treatment groups. Similar results were obtained when patients were categorised according to whether they had an elective or urgent PCI. 1219 (40·9%) of 2983 patients in the trimetazidine group and 1230 (41·1%) of 2990 patients in the placebo group had serious treatment-emergent adverse events. Frequencies of adverse events of interest were similar between the groups. INTERPRETATION: Our results show that the routine use of oral trimetazidine 35 mg twice daily over several years in patients receiving optimal medical therapy, after successful PCI, does not influence the recurrence of angina or the outcome; these findings should be taken into account when considering the place of trimetazidine in clinical practice. However, the long-term prescription of this treatment does not appear to be associated with any statistically significant safety concerns in the population studied. FUNDING: Servier.
- MeSH
- aplikace orální MeSH
- bezpečnost MeSH
- hospitalizace statistika a číselné údaje MeSH
- infarkt myokardu bez ST elevací terapie MeSH
- koronární angiografie metody statistika a číselné údaje MeSH
- koronární angioplastika metody trendy MeSH
- lidé středního věku MeSH
- lidé MeSH
- nestabilní angina pectoris terapie MeSH
- placeba aplikace a dávkování MeSH
- recidiva MeSH
- senioři MeSH
- smrt MeSH
- stabilní angina pectoris terapie MeSH
- studie případů a kontrol MeSH
- trimetazidin aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- vazodilatancia aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Asie MeSH
- Evropa MeSH
- Jižní Amerika MeSH
- severní Afrika MeSH
BACKGROUND: Serelaxin is a recombinant form of human relaxin-2, a vasodilator hormone that contributes to cardiovascular and renal adaptations during pregnancy. Previous studies have suggested that treatment with serelaxin may result in relief of symptoms and in better outcomes in patients with acute heart failure. METHODS: In this multicenter, double-blind, placebo-controlled, event-driven trial, we enrolled patients who were hospitalized for acute heart failure and had dyspnea, vascular congestion on chest radiography, increased plasma concentrations of natriuretic peptides, mild-to-moderate renal insufficiency, and a systolic blood pressure of at least 125 mm Hg, and we randomly assigned them within 16 hours after presentation to receive either a 48-hour intravenous infusion of serelaxin (30 μg per kilogram of body weight per day) or placebo, in addition to standard care. The two primary end points were death from cardiovascular causes at 180 days and worsening heart failure at 5 days. RESULTS: A total of 6545 patients were included in the intention-to-treat analysis. At day 180, death from cardiovascular causes had occurred in 285 of the 3274 patients (8.7%) in the serelaxin group and in 290 of the 3271 patients (8.9%) in the placebo group (hazard ratio, 0.98; 95% confidence interval [CI], 0.83 to 1.15; P = 0.77). At day 5, worsening heart failure had occurred in 227 patients (6.9%) in the serelaxin group and in 252 (7.7%) in the placebo group (hazard ratio, 0.89; 95% CI, 0.75 to 1.07; P = 0.19). There were no significant differences between the groups in the incidence of death from any cause at 180 days, the incidence of death from cardiovascular causes or rehospitalization for heart failure or renal failure at 180 days, or the length of the index hospital stay. The incidence of adverse events was similar in the two groups. CONCLUSIONS: In this trial involving patients who were hospitalized for acute heart failure, an infusion of serelaxin did not result in a lower incidence of death from cardiovascular causes at 180 days or worsening heart failure at 5 days than placebo. (Funded by Novartis Pharma; RELAX-AHF-2 ClinicalTrials.gov number, NCT01870778.).
- MeSH
- akutní nemoc MeSH
- dvojitá slepá metoda MeSH
- hospitalizace MeSH
- incidence MeSH
- intravenózní infuze MeSH
- kardiovaskulární nemoci mortalita MeSH
- krevní tlak účinky léků MeSH
- lidé MeSH
- progrese nemoci MeSH
- rekombinantní proteiny škodlivé účinky farmakologie terapeutické užití MeSH
- relaxin škodlivé účinky farmakologie terapeutické užití MeSH
- senioři MeSH
- srdeční selhání farmakoterapie mortalita patofyziologie MeSH
- terapie neúspěšná MeSH
- vazodilatancia škodlivé účinky terapeutické užití MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: About 30% of angina patients have persisting symptoms despite successful revascularization and antianginal therapy. Moreover, in stable patients, percutaneous coronary intervention (PCI) does not improve survival as compared with medical therapy alone. Trimetazidine, an antianginal agent devoid of hemodynamic effect, may help reducing symptoms and improving outcomes after PCI. The ATPCI study is investigating the efficacy and safety of adding trimetazidine to standard-of-care in angina patients who had a recent PCI. METHODS: ATPCI is a randomized, double-blind, parallel-group, placebo-controlled, event-driven study in patients with coronary artery disease having undergone PCI because of stable angina (elective PCI) or unstable angina/NSTEMI (urgent PCI). After PCI, patients were randomized to trimetazidine (35 mg bid) or placebo on top of standard-of-care including event prevention drugs and antianginal treatment. Patients will be followed for 2 to 4 years. The primary efficacy endpoint is a composite of cardiac death, hospitalization for a cardiac event and recurrence or persistence of angina. Safety events related to trimetazidine use will be monitored. RESULTS: Recruitment lasted from September 2014 to June 2016. A total of 6007 patients were enrolled (58% and 42% after elective and urgent PCI, respectively). Mean age was 61 years, 77% were males, and median durations of coronary artery disease were 1 and 5 months (if urgent or elective PCI, respectively). Almost all patients received drugs for event prevention and antianginal therapy at baseline. CONCLUSION: The ATPCI study will shed further light on the management of contemporary angina patients after PCI. Results are expected in 2019.
- MeSH
- angina pectoris farmakoterapie chirurgie MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- koronární angioplastika * MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- nemoci koronárních tepen chirurgie MeSH
- placeba terapeutické užití MeSH
- pooperační komplikace farmakoterapie MeSH
- recidiva MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- trimetazidin škodlivé účinky terapeutické užití MeSH
- vazodilatancia škodlivé účinky terapeutické užití MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
AIMS: The European Society of Cardiology Heart Failure Long-Term Registry (ESC-HF-LT-R) was set up with the aim of describing the clinical epidemiology and the 1-year outcomes of patients with heart failure (HF) with the added intention of comparing differences between participating countries. METHODS AND RESULTS: The ESC-HF-LT-R is a prospective, observational registry contributed to by 211 cardiology centres in 21 European and/or Mediterranean countries, all being member countries of the ESC. Between May 2011 and April 2013 it collected data on 12 440 patients, 40.5% of them hospitalized with acute HF (AHF) and 59.5% outpatients with chronic HF (CHF). The all-cause 1-year mortality rate was 23.6% for AHF and 6.4% for CHF. The combined endpoint of mortality or HF hospitalization within 1 year had a rate of 36% for AHF and 14.5% for CHF. All-cause mortality rates in the different regions ranged from 21.6% to 36.5% in patients with AHF, and from 6.9% to 15.6% in those with CHF. These differences in mortality between regions are thought reflect differences in the characteristics and/or management of these patients. CONCLUSION: The ESC-HF-LT-R shows that 1-year all-cause mortality of patients with AHF is still high while the mortality of CHF is lower. This registry provides the opportunity to evaluate the management and outcomes of patients with HF and identify areas for improvement.
- MeSH
- akutní nemoc MeSH
- ambulantní péče MeSH
- chronická nemoc MeSH
- hospitalizace MeSH
- kardiologie MeSH
- komorbidita MeSH
- lidé středního věku MeSH
- lidé MeSH
- mortalita * MeSH
- následné studie MeSH
- příčina smrti MeSH
- prospektivní studie MeSH
- registrace * MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- společnosti lékařské MeSH
- srdeční selhání krev epidemiologie patofyziologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- pozorovací studie MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Evropa epidemiologie MeSH
A meeting of European experts in cardiovascular (CV) disease and lipids was convened in Paris, France, on 10 November 2014 to discuss lipid profile, and in particular atherogenic dyslipidaemia (AD), and associated CV risk. Key points that were raised and discussed during the meeting are summarised in this paper, which also accounts for further discussion and agreement on these points by the group of experts. Elevated levels of low-density lipoprotein cholesterol (LDL-c) are commonly associated with a greater CV risk than low LDL-c levels, and are routinely managed with statins. However, even for patients controlled on statins and achieving low LDL-c levels, abnormal lipid profiles observed in some patients (i.e. elevated triglyceride levels, with/without low levels of high-density lipoprotein cholesterol [HDL-c]) have been linked to the presence of a residual CV risk. Therefore, it is recommended that both triglyceride and HDL-c levels be measured, to allow for the overall CV residual risk to be adequately managed. Favourable safety and clinical data support the combination of statins with other lipid-lowering agents, such as fenofibrate. Patients who have elevated triglyceride levels plus low levels of HDL-c are most likely to achieve clinical benefit from fenofibrate-statin combination therapy. In these patients with AD, achieving target non-HDL-c levels should be a key focus of CV risk management, and the use of non-HDL-c was advocated to provide a better measure of CV risk than LDL-c levels.
- MeSH
- ateroskleróza farmakoterapie MeSH
- diabetes mellitus 2. typu komplikace farmakoterapie MeSH
- dyslipidemie farmakoterapie MeSH
- fenofibrát terapeutické užití MeSH
- hypolipidemika terapeutické užití MeSH
- kardiovaskulární nemoci prevence a kontrola MeSH
- kombinovaná farmakoterapie MeSH
- lidé MeSH
- lipidy krev MeSH
- statiny terapeutické užití MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- konsensus - konference MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Evropa MeSH
- Paříž MeSH
- MeSH
- hrudní chirurgie organizace a řízení normy MeSH
- lidé MeSH
- revaskularizace myokardu metody normy MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- směrnice pro lékařskou praxi MeSH
- Geografické názvy
- Evropa MeSH
- MeSH
- amlodipin aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- blokátory kalciových kanálů aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- hypertenze diagnóza farmakoterapie prevence a kontrola MeSH
- inhibitory ACE aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- kardiovaskulární nemoci farmakoterapie komplikace prevence a kontrola MeSH
- kombinovaná farmakoterapie MeSH
- kongresy jako téma MeSH
- lidé MeSH
- medicína založená na důkazech trendy MeSH
- perindopril aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- směrnice pro lékařskou praxi jako téma normy MeSH
- společnosti lékařské MeSH
- Check Tag
- lidé MeSH
- Geografické názvy
- Česká republika MeSH
- MeSH
- amlodipin terapeutické užití MeSH
- blokátory kalciových kanálů terapeutické užití MeSH
- cévní endotel patologie účinky léků MeSH
- fixní kombinace léků MeSH
- hypertenze farmakoterapie komplikace MeSH
- inhibitory ACE terapeutické užití MeSH
- kardiovaskulární nemoci farmakoterapie komplikace prevence a kontrola MeSH
- krevní tlak MeSH
- lidé MeSH
- perindopril farmakokinetika terapeutické užití MeSH
- progrese nemoci MeSH
- Check Tag
- lidé MeSH
European heart journal supplements, ISSN 1520-765X vol. 11, suppl. E, August 2009
25 s. : il., tab. ; 28 cm
- MeSH
- amlodipin MeSH
- ateroskleróza MeSH
- blokátory kalciových kanálů MeSH
- diabetes mellitus MeSH
- hypertenze MeSH
- inhibitory ACE MeSH
- kardiovaskulární nemoci farmakoterapie prevence a kontrola MeSH
- kombinovaná farmakoterapie MeSH
- mikrocirkulace MeSH
- nemoci koronárních tepen MeSH
- perindopril MeSH
- Publikační typ
- sborníky MeSH
- Konspekt
- Patologie. Klinická medicína
- NLK Obory
- kardiologie
- angiologie
European heart journal supplements, ISSN 1520-765X vol. 11, suppl. F, December 2009
53 s. : il., tab. ; 28 cm
- MeSH
- inhibitory ACE MeSH
- kardiovaskulární nemoci farmakoterapie prevence a kontrola terapie MeSH
- kombinovaná farmakoterapie MeSH
- ramipril MeSH
- receptor typu 2 angiotensinu II - blokátory MeSH
- renin-angiotensin systém MeSH
- zohlednění rizika MeSH
- Publikační typ
- sborníky MeSH
- Konspekt
- Patologie. Klinická medicína
- NLK Obory
- kardiologie
- angiologie