Browsing by Author "Krievins, Dainis"

Now showing 1 - 9 of 9
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    Changes in Cognition, Depression and Quality of Life after Carotid Stenosis Treatment
    (2019) Pūcīte, Elīna; Krievina, Ildze; Miglāne, Evija; Erts, Renārs; Krievins, Dainis; Millers, Andrejs; Department of Neurology and Neurosurgery
    Background: Although several studies have evaluated the change of cognitive performance after severe carotid artery stenosis, the results still remain elusive. The objective of this study was to assess changes in cognitive function, depressive symptoms and Health Related Quality of Life (HRQoL) after carotid stenosis revascularisation and Best Medical Treatment (BMT). Methods: Study involved 213 patients with ≥70% carotid stenosis who underwent assessment of cognitive function using Montreal Cognitive Assessment scale (MoCA), depressive symptoms - using Patient Health Questionnaire-9 (PHQ-9) and HRQoL - using Medical Outcome Survey Short Form version 2 (SF-36v2). The assessment was performed before and at 6 and 12 months followup periods in patients who had Carotid Endarterectomy (CEA), Carotid Artery Stenting (CAS) or received BMT only. Results: Improvement in the total MoCA scores was observed after 6 and 12 months (p<0.001, Kendall's W=0.28) in the CEA group. In the CAS group - after 12 months (p=0.01, Kendall's W=0.261) whereas in the BMT group - no significant changes (p=0.295, Kendall's W=0.081) were observed. Reduction of depressive symptoms was not found in any of the study groups. Comparing mean SF-36v2 scores in the CEA group, there was no significant difference in any of 10 subscales. Likewise in the CAS group - no significant difference in 9 of 10 subscales (p=0.028, η2=0.343) was observed. Three subscales worsened in the BMT group during the 1-year follow-up period. Conclusion: Patients with severe carotid stenosis who underwent revascularisation enhanced their cognitive performance without exerting significant change of depressive symptoms. Preoperative HRQoL may be maintained for at least one year in the CEA group.
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    Characteristics of clinical trials in rare vs. common diseases : A register-based Latvian study
    (2018-04) Logviss, Konstantins; Krievins, Dainis; Purvina, Santa; Department of Pharmacology
    Background Conducting clinical studies in small populations may be very challenging; therefore quality of clinical evidence may differ between rare and non-rare disease therapies. Objective This register-based study aims to evaluate the characteristics of clinical trials in rare diseases conducted in Latvia and compare them with clinical trials in more common conditions. Methods The EU Clinical Trials Register (clinicaltrialsregister.eu) was used to identify interventional clinical trials related to rare diseases (n = 51) and to compose a control group of clinical trials in non-rare diseases (n = 102) for further comparison of the trial characteristics. Results We found no significant difference in the use of overall survival as a primary endpoint in clinical trials between rare and non-rare diseases (9.8% vs. 13.7%, respectively). However, clinical trials in rare diseases were less likely to be randomized controlled trials (62.7% vs. 83.3%). Rare and non-rare disease clinical trials varied in masking, with rare disease trials less likely to be double blind (45.1% vs. 63.7%). Active comparators were less frequently used in rare disease trials (36.4% vs. 58.8% of controlled trials). Clinical trials in rare diseases enrolled fewer participants than those in non-rare diseases: In Latvia (mean 18.3 vs. 40.2 subjects, respectively), in the European Economic Area (mean 181.0 vs. 626.9 subjects), and in the whole clinical trial (mean 335.8 vs. 1406.3 subjects). Although, we found no significant difference in trial duration between the groups (mean 38.3 vs. 36.4 months). Conclusions The current study confirms that clinical trials in rare diseases vary from those in non-rare conditions, with notable differences in enrollment, randomization, masking, and the use of active comparators. However, we found no significant difference in trial duration and the use of overall survival as a primary endpoint.
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    IMPACT OF CAROTID ENDARTERECTOMY ON COGNITIVE PERFORMANCE AND DEPRESSIVE SYMPTOMS
    (Central Bohemia University, 2016) Pucite, Elina; Slisers, Marius; Miglane, Evija; Krievins, Dainis; Erts, Renars; Jurjans, Kristaps; Krievina, Ildze; Department of Neurology and Neurosurgery
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    Impact of orphan drugs on Latvian budget
    (2016-05-11) Logviss, Konstantins; Krievins, Dainis; Purvina, Santa; Department of Pharmacology
    Background: Number of orphan medicinal products on the market and number of rare disease patients, taking these usually expensive products, are increasing. As a result, budget impact of orphan drugs is growing. This factor, along with the cost-effectiveness of orphan drugs, is often considered in the reimbursement decisions, directly affecting accessibility of rare disease therapies. The current study aims to assess the budget impact of orphan drugs in Latvia. Methods: Our study covered a 5-year period, from 2010 to 2014. Impact of orphan drugs on Latvian budget was estimated from the National Health Service's perspective. It was calculated in absolute values and relative to total pharmaceutical market and total drug reimbursement budget. A literature review was performed for comparison with other European countries. Results: Orphan drug annual expenditure ranged between EUR 2.065 and 3.065 million, with total 5-year expenditure EUR 12.467 million. It constituted, on average, 0.84 % of total pharmaceutical market and 2.14 % of total drug reimbursement budget, respectively. Average annual per patient expenditures varied widely, from EUR 1 534 to EUR 580 952. The most costly treatment was enzyme replacement therapy (Elaprase) for MPS II. Glivec had the highest share (34 %) of the total orphan drug expenditure. Oncological drugs represented more than a half of the total orphan drug expenditure, followed by drugs for metabolic and endocrine conditions and medicines for cardiopulmonary diseases. Three indications: Ph+ CML, MPS II, and PAH accounted for nearly 90 % of the total orphan drug expenditure. Conclusions: Budget impact of orphan drugs in Latvia is very small. It increased slightly over a period of five years, due to the slight increase in the number of patients and the number of orphan drugs reimbursed. Current Latvian drug reimbursement system is not sufficient for most orphan drugs.
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    Influence of severe carotid stenosis on cognition, depressive symptoms and quality of life
    (2017) Pucite, Elina; Krievina, Ildze; Miglane, Evija; Erts, Renars; Krievins, Dainis; Department of Neurology and Neurosurgery
    Background: Carotid artery disease is not just a causal risk factor of ischemic stroke, but may predispose patients to depressive symptoms and low health related quality of life (HRQoL). Objectives: The objectives of the present study were to assess the association between severe carotid artery stenosis (CAS) and cognitive impairment, frequency of depressive symptoms and status of HRQoL. Methods: Cross - sectional study involved 55 patients with severe CAS and 54 patients with lower extremity peripheral artery disease (PAD). Cognitive impairment was assessed using Montreal Cognitive Assessment Scale (MoCA), depressive symptoms - PHQ-9 scale. HRQoL was measured using Medical Outcome Survey Short Form version 2 (SF-36v2). Results: Median MoCA score 24 [23;26] was significantly lower in patients with severe CAS than in patients with PAD - 26 [25-28],(p=0.005; effect size r=0.3). There was no statistically significant difference of median PHQ-9 scores the in CAS group (median PHQ-9 score 4.0 [5]) and in the PAD group (median PHQ-9 score 5.5 [7]), (p=0.08, effect size r=0.18). Mean SF-36v2 scores were similar in CAS and PAD groups except for bodily pain (p=0.001, Cohen's d value = 0.77) and vitality (p=0.02, Cohen's d value = 0.49). Conclusion: In summary, our findings indicate that severe CAS could play a role in cognitive decline. Further studies should be conducted using larger patient cohorts without ischemic brain lesions and with balanced vascular risk profiles to investigate impact of CAS on cognition. There was no association between severe CAS and depressive symptoms in the present study. As patients with severe CAS did not exhibit physical symptoms, HRQoL was better for those patients than for patients with lower extremity PAD.
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    Multidisciplinary approach to treat ruptured abdominal aortic aneurysm into the vena cava
    (2020-12) Lacis, Aigars; Savlovskis, Janis; Kisis, Kaspars; Zellans, Edgars; Zarins, Christopher K.; Krievins, Dainis; Rīga Stradiņš University
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    Randomized, double-blind comparison of once-weekly dalbavancin versus twice-daily linezolid therapy for the treatment of complicated skin and skin structure infections
    (2005-11-15) Jauregui, Luis E.; Babazadeh, Simon; Seltzer, Elyse; Goldberg, Lisa; Krievins, Dainis; Frederick, Mark; Krause, David; Satilovs, Igors; Endzinas, Zilvinas; Breaux, Jeffrey; O'Riordan, William
    Background. Dalbavancin, a novel lipoglycopeptide with a pharmacokinetic profile that allows weekly dosing, is active against gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). The efficacy of dalbavancin for treatment of skin and skin structure infections (SSSIs) was demonstrated in a phase 2 study. Methods. In a phase 3 noninferiority study, patients with complicated SSSIs, including infections known or suspected to involve MRSA, were randomized (ratio, 2:1) in a double-blind manner to receive dalbavancin (1000 mg given intravenously on day 1 and 500 mg given intravenously on day 8) or linezolid (600 mg given intravenously or intravenously/orally every 12 h for 14 days). Efficacy was assessed by determining clinical and microbiological responses at the end of therapy and at the test-of-cure visit. Relapses were identified by additional follow-up ~1 month later. Results. MRSA was identified in 51% of patients from whom a pathogen was isolated at baseline. Dalbavancin and linezolid demonstrated comparable clinical efficacy in the clinically evaluable population at the test-of-cure visit (88.9% and 91.2% success, respectively). The rate of clinical success at the end of therapy was >90% in both arms. Less than 1.0% of patients in either treatment arm experienced relapse after the test-of-cure visit. Both treatments yielded successful microbiological response in excess of 85% among microbiologically evaluable patients at end of therapy and at the test-of-cure visit for all pathogens combined, for all S. aureus strains, and for MRSA. Gastrointestinal symptoms were among the most common adverse events in both arms. A higher proportion of patients in the linezolid arm reported adverse events that were judged by the investigator to be probably/possibly related to treatment (dalbavancin arm, 25.4% of subjects; linezolid arm, 32.2% of subjects). Conclusions. Two doses of dalbavancin (1000 mg given on day 1 followed by 500 mg given on day 8) were as well tolerated and as effective as linezolid given twice daily for 14 days for the treatment of patients with complicated SSSI, including those infected with MRSA.
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    Rare diseases and orphan drugs : Latvian story
    (2014-09-18) Logviss, Konstantins; Krievins, Dainis; Purvina, Santa; Department of Internal Diseases
    Background: Ten years have passed since Latvia became a Member State of the EU in 2004. As a result European regulations, including those related to rare diseases and orphan drugs, have been applied to Latvian legislative system. Orphan diseases have been recognized as a priority area for action in the public health system, though there are significant differences in the national healthcare services for rare diseases among the EU States. This study aims to determine situation in the field of rare diseases in Latvia and compare it with other European countries. Methods: We used the national plan for rare diseases, EUCERD reports, Orphanet data, Latvian and European regulations, publicly available data from the state agencies, and directly contacted drug manufacturers and wholesalers. Results: National plan for rare diseases was developed and approved in 2013. Although there are no official designated centers of expertise as well as no specific register for rare diseases. Newborns are screened for only two disorders: phenylketonuria and congenital hypothyroidism. Currently 34 orphan drugs are available on Latvian market. Three medicines (8.8%) are included in the reimbursement drug list, all indicated for Ph + CML. 15 drugs (44.1%) were reimbursed within the framework of individual reimbursement system, and five drugs (14.7%) were provided within the program of medicinal treatment of rare diseases in children. Conclusions: Majority of orphan drugs authorized in the EU are not available in Latvia, moreover those drugs that are available are often not accessible because they are insufficiently reimbursed. Besides, approval of the national plan might be an important step towards improving situation in the field of rare diseases.
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    Three-Year Patency Results following Endovascular Transvenous Femoropopliteal Bypass
    (2023-02-25) Rumba, Roberts; Krievins, Dainis; Savlovskis, Janis; Ezite, Natalija; Lacis, Aigars; Petrosina, Eva; Mouttet, Ludovic; Gardovskis, Janis; Zarins, Christopher K.; Rīga Stradiņš University; Statistics Unit
    Background and Objectives: Peripheral artery disease is one of the most common vascular pathologies. There is an ongoing debate among specialists on whether open or endovascular revascularization is preferred in cases of complex superficial femoral artery (SFA) lesions. The purpose of this study was to assess patency results of a relatively new transvenous endovascular bypass device. This could add to existing evidence and aid in comparison between open and endovascular bypass. Materials and Methods: Patients with complex TASC-C and D SFA lesions who had indications for revascularization were identified. Prospective analysis of stent graft patency from 54 transvenous femoropopliteal bypass procedures was performed. Patency was assessed by Duplex ultrasound every six months. Kaplan–Meier analysis was performed to assess primary, primary-assisted, and secondary patency of transvenous bypass. Results: Following endovascular transvenous femoropopliteal bypass, 3-year graft primary, primary-assisted, and secondary patency was 43.8%, 66.3%, and 73.9%, respectively. Conclusions: Transvenous endovascular femoropopliteal bypass is a viable option for selected patients who lack adequate saphenous vein or have comorbidities that increase the risk of open femoropopliteal bypass. Strict post-operative follow-up is necessary to improve patency rates.