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Multifactorial effects of vildagliptin added to ongoing metformin therapy in patients with type 2 diabetes mellitus

BACKGROUNDnTo assess the efficacy of a vildagliptin and metformin combination therapy to a metformin monotherapy in type 2 diabetes mellitus patients.nnnMETHODSnSixty-one patients with diabetes inadequately controlled by a metformin monotherapy were randomized to treatment with a combination therapy of vildagliptin 100mg and a metformin versus metformin monotherapy. This was a 12-week randomized parallel group study. During the study we assessed parameters of glycemic and lipid metabolism as well as the treatment effects on the release of proinflammatory and antiinflammatory cytokines.nnnRESULTSnCompared with baseline values we observed a significant improvement of glycaemic parameters such as HbA1c, FPG, PPG, FPI, HOMA-IR and HOMA-β index as well as decrease of TCh, TG and LDL and an increase of HDL with the greatest extent of vildagliptin plus a low-dose metformin therapy group. A metformin combination therapy significantly decreased such inflamation parameters as hs-CRP, ox-LDL, TNF-α and IL-1β levels relative to monotherapies. All treatments were well tolerated and there was no incidence of hypoglycaemia.nnnCONCLUSIONSnVildagliptin added to an ongoing metformin therapy allows to achieve better metabolic control parameters in comparison with a metformin monotherapy and the combination treatment is well tolerated and has a low risk of serious adverse effects.

Progesterone therapy in women with epilepsy

BACKGROUNDnProgesterone with its anti-seizure effect plays a role in the pathophysiology of catamenial epilepsy which affects 31-60% of epileptic women. In this study, an attempt to treat women suffering from catamenial epilepsy with progesterone, as an adjuvant drug, was made.nnnMETHODSnThe treatment was given to 36 women aged 20-40 years (mean age: 30.75±6.05) with seizures in the entire second half of the menstrual cycle, who were found to have low serum levels of progesterone on days 22, 27, 28 of the cycle in comparison with a control group of healthy women. The patients were administered progesterone in a daily dose of 50 mg on days 16-25 of each cycle. The serum levels of antiepileptic drugs were assayed. The period of progesterone therapy ranged from 3 to 45 months (17.7 on average).nnnRESULTSnThree patients were free of secondary generalized seizures, and one--of simple partial seizures. A decline in the frequency of primary and secondary generalized seizures by 20-96% (55.9% on average) was accomplished in 18 patients (primary generalized by 20-96%--54.7% on average, and secondarily generalized by 38-85%--59% on average). A decline in the frequency of complex partial seizures by 38-87% (63.1% on average) was achieved in 15 women. In 1 patient, the frequency of myoclonic seizures decreased by 46%. There was no improvement in 5 women (3 patients with generalized, 1 with complex partial and 1 with simple partial seizures). An exacerbation of seizure frequency occurred in 5 patients. Adverse effects were not found in any of the subjects. The average concentrations of antiepileptic drugs during hormonal therapy were in the therapeutic range.nnnCONCLUSIONnProgesterone combined with antiepileptic therapy was well tolerated and resulted in a significant reduction of seizure frequency in majority of patients with catamenial epilepsy.

The impact of anemia on the course and short-term prognosis in patients with first ever ischemic stroke

BACKGROUNDnAnemia is the risk factor for cerebrovascular events. The aim of this study was to evaluate the prevalence of anemia among patients with first-ever stroke and its impact on neurological state in the acute phase of the disease and the degree of disability in short-term follow-up.nnnPATIENTS AND METHODSnThe prospective study included 107 patients aged 72.81 ± 11.12 with the first-ever stroke. Each patient underwent CT of the head and blood tests, including Hb concentration on the first day of hospitalization. We have analyzed the neurological state on the first day of stroke by NIHSS and the functional status on the 14th day after the onset of stroke by mRankin scale in patients with and without anemia. Patients with anemia were additionally divided according to Hb level (less or over 11g/dl).nnnRESULTSnPatients with Hb≤ 11g/dl significantly more often achieved a score of 4-5 points on mRankin scale on the 14th day of stroke compared to patients with anemia and Hb>11g/dl. Independent predictors of a worse functional status on the 14th day of stroke in patients with anemia include the neurological state on the 1st day and the hemispheric location of stroke; an independent predictor of death was the neurological state on the 1st day of onset.nnnCONCLUSIONnMild anemia did not influence significantly the neurological condition in acute phase of stroke but worsened the functional status in subacute phase of stroke. The neurological state on the first day of stroke and the hemispheric location of cerebral ischemia are independent factors of poor prognosis in patients with anemia in short-term follow-up.

Efficacy and safety of mitoxantrone use in primary and secondary progressive multiple sclerosis - study site experience based on the therapy of 104 patients.

ABSTRACT Mitoxantrone (MX) is used in patients with primary and secondary progressive as well as relapsing–remitting type of multiple sclerosis (PPMS, SPMS, RRMS). The objective of our project was to evaluate the efficacy and safety of MX use in patients with PPMS and SPMS. Methods: The retrospective study included 104 patients (mean age 54.2 ± 9.0), with PPMS (13.46%) and SPMS (86.54%) treated with MX. During single cycle of the MX therapy a dose of 12 mg/m2 of body surface area was administered and next cycles every three months up to a total dose of 140 mg/m2 were realized. Results: The course of the therapy was completed by 95 patients (91.34%) including 73 patients who received a scheduled whole dose. The average cumulative dose per patient was 75.2 mg/m2. Thirty-two patients reported nausea after MX administration, 20 revealed increase in the incidence of infection and 19 patients hair loss. Twenty-two patients discontinued therapy (seven patients because of the progress of disability). Independent risk factors for deterioration were: age and the form of PPMS (RR 1.56 [95% CI: 1.17–2.07] and RR 2.8 [95% CI: 1.08–7.21], respectively). Five patients revealed a asymptomatic decrease in EF value <50% or 10% in relation to the previous test. Conclusions: MX therapy enables us to stabilize the disease without causing any significant side effects in most patients with progressive disease as compared to patients with primary progressive disease with a comparable safety profile. Larger benefits of MX therapy are associated with the patients with secondary progressive disease.

Diagnostic methods used in searching for markers of atrophy in patients with multiple sclerosis

Abstract The results of available studies on assessment of neurodegenerative lesions in multiple sclerosis (MS) patients using different approaches have not been conclusive. Currently, clinical assessment is the most commonly used (involving primarily mobility assessment), along with magnetic resonance imaging and electrophysiological testing. In this review we describe available clinical, neuroimaging, electrophysiological and laboratory tests used to assess the neurodegeneration in MS. Laboratory markers to determine the risk of disease, its conversion and prognosis in MS patients are being constantly sought. Cerebrospinal fluid (CSF) sample collection is invasive and constitutes a burden to a patient, so serum biomarkers are being investigated. Optimistic preliminary results of studies assessing neurofilament light chains (NFL) in serum of MS patients, encourage further research. The possibility to use such marker (or a group of markers) would significantly facilitate clinical decisions at the stage of diagnosis and treatment. Currently used treatments have limited efficacy and are associated with numerous adverse effects. Additional information from available clinical, imaging, electrophysiological or laboratory biomarker or a group of biomarkers, which predict the course and prognosis, will facilitate choosing optimal treatment and its escalation at the relevant stage. Conclusion: Using the diagnostic panel consisting of imaging, neurophysiology and serology testing along with clinical and neuropsychological assessment may improve the reliability of diagnostic instruments evaluating cerebral atrophy in MS patients.

Effect of comorbidities on the course of multiple sclerosis

OBJECTIVEnThe clinical condition of multiple sclerosis (MS) patients depends not only on the course of MS but also on their lifestyle and comorbidities. This study aimed to assess the effect of selected comorbidities, lifestyle-related factors and clinical data available at the time of MS diagnosis, on the disease activity and the disability progression in patients with relapsing-remitting multiple sclerosis (RRMS).nnnPATIENTS AND METHODSnBased on clinical relapses over a period of 12 months of observation and the results of MRI scans, 138 patients with RRMS were qualified into two groups: active or stable course of the disease. Patients from both groups were compared regarding the clinical data determined at diagnosis, comorbidities and lifestyle-related factors. Similar comparisons were carried out between patients with EDSSu202f<u202f3 vs, patients with EDSSu202f≥u202f3.nnnRESULTSnNo significant differences in comorbidities and lifestyle-related data between the stable and active group were detected. Arterial hypertension, hyperlipidemia, higher BMI values, older age and a lower education level, were found more frequently in patients with EDSSu202f≥u202f3. Oligoclonal bands, multifocal clinical manifestation as the first relapse, higher EDSS score and many T2 MRI lesions at the diagnosis were detected significantly more often in the active group. Motor or brainstem/cerebellum damage symptoms as the first relapse were observed more frequently in patients with EDSSu202f≥u202f3.nnnCONCLUSIONSnCardiovascular diseases may exacerbate disability progression in MS patients. Relapses and radiological activity do not depend on chronic comorbidities. Clinical data available at the diagnosis may be useful in forecasting a distant course of MS.

The impact of anemia on neurological and functional state in patients in acute stroke – preliminary report

W S T Ę P : Anemia jest czynnikiem ryzyka chorób sercowo-naczyniowych. Celem badania była ocena potencjalnego wpływu niedokrwistości na stan neurologiczny pacjentów w pierwszej dobie oraz funkcjonalny w 14 dobie od wystąpienia niedokrwiennego udaru mózgu. M A T E R IA Ł I M E T O D Y : Do prospektywnego badania włączono 109 pacjentów (w tym 53 kobiety) w wieku 72,8 ± 11,12 w pierwszej dobie pierwszego w życiu udaru mózgu. Porównano częstość wybranych chorób i parametrów biochemicznych, stan neurologiczny (wg NIHSS) w pierwszej oraz stan funkcjonowania (wg mRankin) w 14 dobie od wystąpienia udaru mózgu u pacjentów z anemią oraz prawidłowym stężeniem hemoglobiny. W Y N IK I : Anemię stwierdzono u 34 pacjentów (15 kobiet oraz 19 mężczyzn) oraz 8 pacjentów w wieku ≤ 65 r.ż. Częstość lekkiego i umiarkowanego/ciężkiego deficytu neurologicznego w pierwszej dobie nie różniła się znamiennie między pacjentami z anemią i bez anemii. Częstość stanu funkcjonalnego na poziomie 3–5 Rankin w 14 dobie oraz zgonu (do 14 dni od zachorowania) nie różniła się znamiennie między tymi pacjentami. Stan neurologiczny pacjentów z anemią w pierwszej dobie udaru mózgu okazał się niezależnym czynnikiem gorszego rokowania odnośnie do stanu funkcjonalnego w 14 dobie udaru mózgu oraz zgonu do 14 doby od zachorowania. W N IO S K I : Niedokrwistość występuje u ok. 1/3 pacjentów z ostrym niedokrwiennym udarem mózgu. Lekka oraz umiarkowana niedokrwistość nie wykazuje istotnego negatywnego wpływu na stan neurologiczny oraz funkcjonalny pacjentów w ostrym okresie udaru. Stan neurologiczny w pierwszej dobie udaru niedokrwiennego jest niezależnym czynnikiem złego rokowania w obserwacji krótkoterminowej u pacjentów z anemią.