Analysis of treatment efficacy and safety with leflunomide according to patients’ age and rheumatoid arthritis duration

Celem artykułu jest ocena skuteczności i bezpieczeństwa terapii leflunomidem w zależności od wieku chorych oraz czasu trwania reumatoidalnego zapalenia stawów (RZS). Bezpieczeństwo terapii leflunomidem przeanalizowano w grupie 261 pacjentów, porównując liczbę działań niepożądanych będących przyczyną przerwania terapii oraz liczbę działań niepożądanych leku niebędących przyczyną odstawienia leku, w zależności od wieku chorych, a także czasu trwania reumatoidalnego zapalenia stawów. W trakcie 6-miesięcznej obserwacji leczenie przerwało 27 pacjentów. Skuteczność terapii leflunomidem analizowano w grupie pozostałych 234 pacjentów na podstawie różnicy wartości wskaźnika DAS 28, ocenianego przed rozpoczęciem leczenia i po sześciu miesiącach terapii w zależności od wieku pacjentów. Wyniki potwierdziły skuteczność terapii leflunomidem we wszystkich grupach wiekowych chorych. Nie stwierdzono statystycznie istotnych różnic w skuteczności terapii w zależności od wieku pacjentów. Działania niepożądane leflunomidu wystąpiły u 47 chorych (18,8%), a u 23 (8,8%) były przyczyną przerwania terapii. Nie stwierdzono różnic statystycznie istotnych w występowaniu działań niepożądanych w zależności od wieku pacjentów oraz czasu trwania choroby podstawowej.Aim of the study: Evaluation of safety and therapeutic effectiveness of leflunomide according to age of the patients and duration of rheumatoid arthritis. Methods: Leflunomide therapy safety was analyzed in a group of 261 patients based on number of adverse effects responsible for treatment interruption and according to adverse effects number that allowed for continuing therapy. During six-month observation 27 patients interrupted therapy and in the group of remaining 234 persons leflunomide therapy efficacy was evaluated according to DAS-28 score. Results: Efficacy of leflunomide therapy was confirmed in every group according to patients age and no significant differences were observed between groups of patients with different age. Adverse leflunomide effects occurred in 47 (18.8%) patients and were the cause of therapy interruption in 23 (8.8%) cases. No significant differences in adverse leflunomide effects were observed to depend on patients age or rheumatoid arthritis period. Conclusions: (1) Patients’ age and period of rheumatoid arthritis do not influence leflunomide therapy safety. (2) Efficacy of leflunomide was confirmed in each group of patients. (3) Patients’ age does not influence leflunomide therapy outcome

Mechanical thrombectomy in acute stroke – Five years of experience in Poland

Objectives Mechanical thrombectomy (MT) is not reimbursed by the Polish public health system. We present a description of 5 years of experience with MT in acute stroke in Comprehensive Stroke Centers (CSCs) in Poland. Methods and results We retrospectively analyzed the results of a structured questionnaire from 23 out of 25 identified CSCs and 22 data sets that include 61 clinical, radiological and outcome measures. Results Most of the CSCs (74%) were founded at University Hospitals and most (65.2%) work round the clock. In 78.3% of them, the working teams are composed of neurologists and neuro-radiologists. All CSCs perform CT and angio-CT before MT. In total 586 patients were subjected to MT and data from 531 of them were analyzed. Mean time laps from stroke onset to groin puncture was 250±99min. 90.3% of the studied patients had MT within 6h from stroke onset; 59.3% of them were treated with IV rt-PA prior to MT; 15.1% had IA rt-PA during MT and 4.7% – emergent stenting of a large vessel. M1 of MCA was occluded in 47.8% of cases. The Solitaire device was used in 53% of cases. Successful recanalization (TICI2b–TICI3) was achieved in 64.6% of cases and 53.4% of patients did not experience hemorrhagic transformation. Clinical improvement on discharge was noticed in 53.7% of cases, futile recanalization – in 30.7%, mRS of 0–2 – in 31.4% and mRS of 6 in 22% of cases. Conclusion Our results can help harmonize standards for MT in Poland according to international guidelines

Ocena siły i wytrzymałości mięśni tułowia pacjentów z zespołem dolnego odcinka kręgosłupa

Introduction: In this study, strength and endurance of the trunk muscles were assessed in patients with spondyloarthrosis of the lower spine. Material and methods: 52 women and 49 men with low back pain syndrome (LBPS) were enrolled into the study. The muscle strength of the flexors and extensors of the trunk was determined by calculation of the maximum (MT) and relative torque (RT) during an isometric contraction. Evaluation of endurance of the extensors used calculation of the regression coefficient of the strength reduction during the testing of maximum strength capability. The obtained results were compared to results obtained in healthy persons. Moreover, the relation of those parameters to age, body-mass index – BMI (describing somatic habitus) and the Oswestry Disability Index – ODI (describing pain intensity during activities of daily living) was assessed. Separate analyses were conducted for the groups of males and females.Results: Based on the conducted study and the performed analyses, it can be stated that in patients with chronic low back pain syndrome there is a marked reduction in trunk muscle strength as compared to healthy persons. For females, the reduction ranged from 45% (flexors) to 48% (extensors) for absolute maximum torque values, while for relative values (RT) – from 51% (flexors) to 56% (extensors). In men, the strength reduction of abdominal and back muscles was smaller and was approximately 40% (for MT and RT). Because of such differences in the strength of the back muscles and methodological reasons, endurance variables were not compared. Reduction in trunk muscle strength is primarily due to the pain syndrome and does not depend on patients’ age or habitus. Lower muscle strength can affect the intensity of spinal pain during every-day activities.Conclusions: Precise determination of strength and endurance of the trunk muscles and the appropriate selection of methods of their reinforcement should constitute one of the principal aims of rehabilitation treatment in patients with low back pain

[Relapsing polychondritis--a challenge for modern diagnostics and treatment]

Relapsing polychondritis is a rare autoimmune disease, which is due to sporadic occurrence, unexplained etiology and wide range of symptoms resulting in the difficulties in diagnosis. Recurrent inflammation leads to destruction of cartilaginous tissues, such as ear, nasal septum, larynx, trachea and bronchi, peripheral joints and vertebral structures. Blood vessels, the central nervous system, eyes, and the urinary tract can be involved as well. Clinical course of relapsing polychondritis is often modified by co-existing systemic diseases and remains misdiagnosed. In case of inappropriate or delayed treatment, serious and life-thretening complications may develop. In this article we present the most characteristic clinical features of the disease, differential diagnosis, focusing on current approaches to treatment

Mechanical thrombectomy in acute stroke : five years of experience in Poland

Objectives: Mechanical thrombectomy (MT) is not reimbursed by the Polish public health system. We present a description of 5 years of experience with MT in acute stroke in Comprehensive Stroke Centers (CSCs) in Poland. Methods and results: We retrospectively analyzed the results of a structured questionnaire from 23 out of 25 identified CSCs and 22 data sets that include 61 clinical, radiological and outcome measures. Results: Most of the CSCs (74%) were founded at University Hospitals and most (65.2%) work round the clock. In 78.3% of them, the working teams are composed of neurologists and neuro-radiologists. All CSCs perform CT and angio-CT before MT. In total 586 patients were subjected to MT and data from 531 of them were analyzed. Mean time laps from stroke onset to groin puncture was 250 99 min. 90.3% of the studied patients had MT within 6 h from stroke onset; 59.3% of them were treated with IV rt-PA prior to MT; 15.1% had IA rt-PA during MT and 4.7% - emergent stenting of a large vessel. M1 of MCA was occluded in 47.8% of cases. The Solitaire device was used in 53% of cases. Successful recanalization (TICI2b–TICI3) was achieved in 64.6% of cases and 53.4% of patients did not experience hemorrhagic transformation. Clinical improvement on discharge was noticed in 53.7% of cases, futile recanalization - in 30.7%, mRS of 0–2 - in 31.4% and mRS of 6 in 22% of cases. Conclusion: Our results can help harmonize standards for MT in Poland according to international guideline

Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI) : a phase 3, placebo-controlled, randomised trial

Background: Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor. Methods: The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) was a phase 3 randomised, double-blinded, placebo-controlled trial, done in 1315 sites in 42 countries. Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria: a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery. Eligible patients were randomly assigned (1:1) to either ticagrelor or placebo, by use of an interactive voice-response or web-response system. The THEMIS-PCI trial comprised a prespecified subgroup of patients with previous PCI. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population). Findings: Between Feb 17, 2014, and May 24, 2016, 11 154 patients (58% of the overall THEMIS trial) with a history of previous PCI were enrolled in the THEMIS-PCI trial. Median follow-up was 3·3 years (IQR 2·8–3·8). In the previous PCI group, fewer patients receiving ticagrelor had a primary efficacy outcome event than in the placebo group (404 [7·3%] of 5558 vs 480 [8·6%] of 5596; HR 0·85 [95% CI 0·74–0·97], p=0·013). The same effect was not observed in patients without PCI (p=0·76, p interaction=0·16). The proportion of patients with cardiovascular death was similar in both treatment groups (174 [3·1%] with ticagrelor vs 183 (3·3%) with placebo; HR 0·96 [95% CI 0·78–1·18], p=0·68), as well as all-cause death (282 [5·1%] vs 323 [5·8%]; 0·88 [0·75–1·03], p=0·11). TIMI major bleeding occurred in 111 (2·0%) of 5536 patients receiving ticagrelor and 62 (1·1%) of 5564 patients receiving placebo (HR 2·03 [95% CI 1·48–2·76], p<0·0001), and fatal bleeding in 6 (0·1%) of 5536 patients with ticagrelor and 6 (0·1%) of 5564 with placebo (1·13 [0·36–3·50], p=0·83). Intracranial haemorrhage occurred in 33 (0·6%) and 31 (0·6%) patients (1·21 [0·74–1·97], p=0·45). Ticagrelor improved net clinical benefit: 519/5558 (9·3%) versus 617/5596 (11·0%), HR=0·85, 95% CI 0·75–0·95, p=0·005, in contrast to patients without PCI where it did not, p interaction=0·012. Benefit was present irrespective of time from most recent PCI. Interpretation: In patients with diabetes, stable coronary artery disease, and previous PCI, ticagrelor added to aspirin reduced cardiovascular death, myocardial infarction, and stroke, although with increased major bleeding. In that large, easily identified population, ticagrelor provided a favourable net clinical benefit (more than in patients without history of PCI). This effect shows that long-term therapy with ticagrelor in addition to aspirin should be considered in patients with diabetes and a history of PCI who have tolerated antiplatelet therapy, have high ischaemic risk, and low bleeding risk