Patients who buy acetylsalicylic acid in Polish pharmacies — population characteristics and description of medical problem

Wstęp. Celem badania była charakterystyka pacjentów nabywających w ogólnodostępnych aptekach preparaty kwasu acetylosalicylowego (ASA) rekomendowanego w dawkach kardiologicznych, a także jej powiązanie z próbą stratyfikacji grup ryzyka tych osób. Materiał i metody. Wykorzystano wystandaryzowane ankiety w formie elektronicznej skierowane do pacjentów zgłaszających się do aptek. Wywiad przeprowadzali farmaceuci lub technicy farmaceutyczni. Wyniki. Badanie objęło 532 pacjentów, którzy kupili preparat ASA dla siebie. Większość z nich nie przybyła wcześniej incydentów sercowo-naczyniowych, zaś decyzja o rozpoczęciu leczenia stanowiła wynik rekomendacji profesjonalisty medycznego. Odsetek osób, które kierowały się reklamą mediach, był znacznie mniejszy i kształtował się na poziomie około 20%. Wnioski. Sugeruje się, że w kontekście stosowania preparatów ASA w dawkach kardiologicznych największe znaczenie nadal mają wskazania objęte profilaktyką pierwotną. Obserwacja ta implikuje konieczność wykonywania dodatkowych badań diagnostycznych w tej grupie pacjentów, jak również wskazuje na rolę lekarzy i farmaceutów w procesie monito­rowania farmakoterapii.Introduction. The aim of our study was to characterize patients in Poland who buy in pharmacies over-the-counter formulations of acetylsalicylic acid (ASA) in doses recommended by cardiologists as well as to attempt a risk stratification of this population. Material and methods. We used standardized electronic questionnaires addressed to patients coming to pharmacies. Patients were interviewed by pharmacists or pharmacy technicians. Results. The survey included 532 patients who bought ASA drug for themselves. Most of them have not previously had any cardiovascular events, and the decision to start ASA was the result of a medical professional’s recommendation. The percentage of people who were motivated by mass media advertising was much smaller, at approximately 20%. Conclusions. It is suggested that the most important indications for use of ASA in cardiologic doses are those concerning primary prevention. This observation warrants performing further diagnostic work-up, and points out to the role of physicians and pharmacists in therapy monitoring

Mild therapeutic hypothermia after out-of-hospital cardiac arrest: What does really matter?

Background: Mild therapeutic hypothermia (MTH) is a recommended treatment of comatose patients after out-of-hospital cardiac arrest (OHCA). The aim of the study was to examine determinants of clinical outcome in OHCA survivors treated with MTH and variables associated with MTH induction time.Methods: Presented herein is an analysis of combined results from a retrospective and a prospective observational study which included 90 OHCA survivors treated with MTH from January 2010 to March 2018. Multivariate regression analysis was performed to determine variables associated with poor neurologic outcome (Cerebral Performance Category 3–5), mortality, and prolonged induction time.Results: At hospital discharge, 59 (65.6%) patients were alive, of whom 36 (61%) had a good neurologic outcome. Older patients (odds ratio [OR] 1.07, 95% confidence interval [CI] 1.03–1.12) with lower Glasgow Coma Scale (GCS) (OR 0.49, 95% CI 0.30–0.80) were at higher risk of poor neurological outcome. The predictors of in-hospital death included: older age (OR 1.08, 95% CI 1.02–1.13), lower GCS score (OR 0.47, 95% CI 0.25–0.85), presence of cardiogenic shock (OR 3.43, 95% CI 1.11–10.53), and higher doses of adrenaline (OR 1.27, 95% CI 1.04–1.56). Longer induction was associated with shorter cardio-pulmonary resuscitation (CPR) (unstandardized coefficient –3.95, 95% CI –7.09 to –0.81) and lower lactate level (unstandardized coefficient –18.55, 95% CI –36.10 to –1.01).Conclusions: Unfavorable neurologic outcome in OHCA patients treated with MTH is associated with age and lower GCS score. Risk factors for in-hospital mortality include age, high-dose adrenaline administration, lower GCS score and presence of cardiogenic shock. CPR duration and lactate level were predictive of prolonged MTH induction time

The influence of metoclopramide on pharmacokinetics and pharmacodynamics of ticagrelor in patients with unstable angina pectoris receiving concomitant treatment with morphine — a protocol of a randomized trial

Introduction. Nowadays, due to the “morphine effect”, the screening of methods that provide quick and effective platelet inhibition with oral P2Y12 inhibitors administrated simultaneously with morphine in patients with acute coronary syndromes are extensively investigated by numerous scientists. Metoclopramide, which stimulates the motility of gastrointestinal tract, may become a potential method of overcoming the negative morphine effect. The present study was designed to demonstrate the influence of metoclopramide administration on the pharmacokinetic and pharmacodynamic profile of ticagrelor between patients with unstable angina pectoris treated with morphine and crushed ticagrelor. Methods/design. A study was designed as a phase IV, single-centre, randomized, investigator-initiated, parallel-group, open-label, interventional trial. Patients will be randomized in a 1:1 manner into two arms: 1) patients treated with a combination of crushed ticagrelor and morphine and 2) patients treated with a combination of crushed ticagrelor followed by morphine and metoclopramide. Blood sample collection will be scheduled directly before the administration of ticagrelor loading dose and 15, 30, 45, 60, 120, 180, 240, and 360 minutes after the loading dose. Pharmacokinetic and pharmacodynamic assessment of ticagrelor and its active metabolite will be evaluated in all pre-defined time points. Discussion. The current study is, to our knowledge, the first one to provide data on the influence of metoclopramide in patients with acute coronary syndromes, who received intravenous opioid analgesia. It is expected to contribute to the development of contemporary knowledge on the treatment of patients presenting with acute coronary syndromes, and should enable clinicians to implement strategies of quick platelet inhibition

Optymalizacja postępowania w nagłym pozaszpitalnym zatrzymaniu krążenia w przebiegu ostrego zawału serca — opis przypadku i przegląd piśmiennictwa

Pozaszpitalne zatrzymanie krążenia (OHCA) pozostaje obarczone bardzo dużą śmiertelnością. Najczęstszą przyczyną OHCA jest choroba wieńcowa. W pracy przedstawiono przypadek 55-letniego mężczyzny z ostrym zawałem serca ściany dolno-bocznej z uniesieniem odcinka ST powikłanym OHCA i wstrząsem kardiogennym. U pacjenta zachowanie reguł łańcucha przetrwania (natychmiastowe powiadomienie zespołu Ratownictwa Medycznego, podjęcie przez świadków zdarzenia czynności reanimacyjnych, wczesna defibrylacja, stabilizacja układu krążenia poprzez niezwłoczne leczenie reperfuzyjne z całkowitą rewaskularyzacją oraz leczenie neuroprotekcyjne z użyciem łagodnej hipotermii terapeutycznej wraz z nowoczesną, multidyscyplinarną opieką nad chorym) zaowocowało powrotem do normalnego życia. (Folia Cardiologica Excerpta 2011; 6, 4: 270–276

Comparison of temperature measurements in esophagus and urinary bladder in comatose patients after cardiac arrest undergoing mild therapeutic hypothermia

Background: Mild therapeutic hypothermia (MTH) is a recommended method of treatment for comatose out-of-hospital cardiac arrest (OHCA) survivors. However, the proper site of temperature measurement in MTH is still not defined. The aim of this study was to compare temperature measurements in the esophagus and urinary bladder in comatose post-OHCA patients treated with MTH.Methods: This temperature comparison protocol was a part of a prospective, observational, multicenter cohort study. The study population included 36 unconscious patients after resuscitation for OHCA. The patient’s core temperature was independently measured every hour during MTH in the urinary bladder and in the esophagus.Results: The mean temperature was lower in the esophagus (differences during induction phase: 1.04 ± 0.92°C, p < 0.0001; stabilization phase: 0.54 ± 0.39°C, p < 0.0001; rewarming phase: 0.40 ± 0.47°C, p < 0.0001). Nevertheless, a strong correlation between both sites was found (R2 = 0.83, p < 0.001). The decrease in temperature observed in the esophagus during the induction phase was faster when compared with the urinary bladder (1.09 ± 0.71°C/h vs. 0.83 ± 0.41°C/h; p = 0.002). As a consequence, time to reach temperature < 34.0°C was longer when temperature was measured in the urinary bladder (the difference between medians of the time 1.0 [0–1.5] h, p < 0.001).Conclusions: Urinary bladder temperature measurements may lag behind temperature changes measured in the esophagus. Monitoring temperature simultaneously in the esophagus and in the urinary bladder is an accessible and reliable combination, although esophageal measurements seem to better reflect the dynamics of temperature changes, thus it seems to be more appropriate for MTH control. ClinicalTrials.gov Identifier: NCT0261193

Mild therapeutic hypothermia after sudden cardiac arrest

Wysoką śmiertelność wśród pacjentów, u których osiągnięto powrót spontanicznego krążenia po jego zatrzymaniu, można przypisać różnym procesom patofizjologicznym. Działająca wielokierunkowo łagodna hipotermia terapeutyczna (MTH) jest — jak dotąd — jedyną terapią, w odniesieniu do której udowodniono, że zwiększa przeżywalność pacjentów po zatrzymaniu krążenia. Europejskie Towarzystwo Kardiologiczne w 2012 roku przyznało hipotermii terapeutycznej stosowanej po nagłym zatrzymaniu krążenia najwyższą klasę wskazań I/B. Hipotermia, ze względu na swój skomplikowany mechanizm, wywiera zarówno pożądane, jak i niepożądane działania na organizm. Sposób jej stosowania i monitorowania są nadal kwestią sporną. Celem niniejszej pracy było podsumowanie obecnej wiedzy na temat stosowania MTH po nagłym zatrzymaniu krążenia.High mortality among survivors of sudden cardiac arrest results from multiple pathophysiological pathways. Acting in different directions, mild therapeutic hypothermia (MTH) constitutes the only available treatment method that has been proven to increase the survival after sudden cardiac arrest, and has found its place in the European Society of Cardiology guidelines in 2012. Hypothermia, due to its complex mechanism, exerts both desirable and undesirable effects. Therefore the mode of its application and monitoring are still a matter of question. The aim of this paper is to summarize the current knowledge on MTH after sudden cardiac arrest

Współczesne diuretyki pętlowe

Pętlowe leki moczopędne należą do najsilniejszych diuretyków. Kliniczne efekty ich działania są wypadkową zarówno bezpoœredniego działania na nefron, jak i działania spazmolitycznego na mięśniówkę gładką naczyń żylnych. Diuretyki pętlowe wykorzystuje siê w leczeniu niewydolności serca, ciężkiej niewydolności nerek, nadciśnienia têtniczego, marskości wątroby, a także przy stosowaniu diurezy wymuszonej. W celu minimalizowania częstości występowania działań niepożądanych oraz zwiększenia efektywności terapii w aspekcie zarówno medycznym, jak i farmakoekonomicznym wskazane jest rozważenie powszechnego wdrożenia do leczenia nowych przedstawicieli pętlowych leków moczopędnych

ACS network-based implementation of therapeutic hypothermia for the treatment of comatose out-of-hospital cardiac arrest survivors improves clinical outcomes: the first European experience

Background: There is a paucity of data regarding clinical outcomes associated with the integration of a mild therapeutic hypothermia (MTH) protocol into a regional network dedicated to treatment of patients with acute coronary syndromes (ACS). Additionally, a recent report suggests that the neurological benefits of MTH therapy in interventionally managed ACS patients resuscitated from out-of-hospital cardiac arrest (OHCA) may be potentially offset by the catastrophic occurrence of stent thrombosis. The goal of this study was to share our experience with the implementation of an MTH program using a previously established ACS network in consecutive comatose OHCA survivors undergoing interventional management due to an initial diagnosis of ACS and to assess the clinical effectiveness and safety of MTH. Methods: We conducted a retrospective historically controlled single centre study. Hospital survival with a favourable neurological outcome (Cerebral Performance Category of 1 or 2) and all-cause in-hospital mortality were the primary and secondary efficacy end points, respectively. Occurrence of definite stent thrombosis was the primary safety end point while the development of pneumonia, presence of positive blood cultures, occurrence of probable stent thrombosis, any bleeding complications, need for red blood cell transfusion and presence of rhythm and conductions disorders during hospitalisation constituted secondary safety end points. Results: Comatose OHCA survivors (n = 32) were referred to our Department based on ECG recording transmissions and/ or phone consultations or admitted from the Emergency Department. Compared with controls (n = 33), they were significantly more likely to be discharged from hospital with a favourable neurological outcome (59 vs. 27%; p < 0.05; number needed to treat [NNT] = 3.11) and experienced lower all-cause in-hospital mortality (13 vs. 55%; p < 0.05; NNT = 2.38). Rates of all safety end points were similar in patients treated with and without MTH. Conclusions: Our study indicates that a regional system of care for OHCA survivors may be successfully implemented based on an ACS network, leading to an improvement in neurological status and to a reduction of in-hospitalmortality in patients treated with MTH, without any excess of complications. However, our findings should be verified in large, prospective trials

Mild therapeutic hypothermia for patients with acute coronary syndrome and cardiac arrest treated with percutaneous coronary intervention (UNICORN). The design and rationale for the prospective, observational, multicenter study

Introduction. Cardiac arrest constitutes the most frequent reason for sudden death in developed countries. Out-of-hospital cardiac arrest (OHCA) survivors are at high risk of death or neurologic deficits. The existing data regarding effectiveness and safety of mild therapeutic hypothermia (MTH) for treatment of OHCA survivors are inconsistent and ambiguous. Moreover, a uniform protocol of treatment by means of MTH is lacking. Methods. The UNICORN study is a phase IV, prospective, international, multi-centre, observational study designed to assess the effectiveness of MTH in patients after OHCA with shockable rhythm presenting with acute coronary syndrome (ACS). The trial is expected to include up to 500 patients. Depending on the availability of MTH in each study centre, besides the routine treatment of ACS in OHCA survivors, patients will either undergo MTH according to a uniform protocol or will not undergo MTH (250 patients per group). The primary end-point of the study is all cause mortality at 180 days after enrolment. Secondary end-points include: neurological outcome at discharge, stent thrombosis at 30 days, bleeding according to the BARC criteria, infectious complications at 180 days, and rhythm and conduction disorders at 180 days. Ethics and dissemination. The study received approval from the Local Ethics Committee to conduct the study (Komisja Bioetyczna Uniwersytetu Mikołaja Kopernika w Toruniu przy Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy; study approval reference number KB 615/2015). The study results will be disseminated through conference presentations and publications in peer-reviewed journals. Trial registration. ClinicalTrials.gov identifier: NCT02611934 (18 November 2015).

Early administration of LEvosimendan in Patients witH decompensAted chroNic hearT failure (ELEPHANT) study. Rationale and protocol of the study

Dobutamine and levosimendan are both indicated for inotropic support in acute decompensated heart failure (HF). The study aimed to assess the impact of early administration of levosimendan (first iv therapeutic approach) versus dobutamine (first iv therapeutic approach) on in-hospital treatment expenses and clinical outcomes in patients with decompensated chronic HF. The ELEPHANT study was designed as a phase III, multicentre, randomized 1:1, double-blind, active-controlled trial that will include patients admitted to the hospital due to HF decompensation. Co-primary endpoints were defined as total in-hospital expenses/survivor and duration of hospitalization/survivor. Secondary efficacy endpoints: on the last day of hospitalization: occurrence of treatment side effects, body weight change during hospitalization, BNP change during hospitalization, in-hospital mortality, additional levosimendan administration due to the ineffectiveness of the initial treatment. Patients will be randomized 1:1 to the active group receiving continuous infusion 24 h of levosimendan 0.1 μg/kg/min or to the control group receiving continuous infusion 24 h of dobutamine 3 μg/kg/min. After the enrolment of 20 patients, results analysis will be performed (pilot phase — single centre). Based on this analysis conducted according to the intention-to-treat principle, the final population size will be defined. The multicentre phase of the study will be initiated after the pilot phase