Cost-effectiveness of ambroxol in the treatment of Gaucher disease type 2.

Objective: Our aim was to compare the costs and efficacy of ambroxol in combination with imiglucerase with the costs and efficacy of imiglucerase only in the treatment of Gaucher disease type 2 (GD2) in the socio-economic settings of the Republic of Serbia, an upper-middle-income European economy. Methods: The perspective of the Serbian Republic Health Insurance Fund was chosen for this study, and the time horizon was 6 years. The main outcomes of the study were quality-adjusted life years gained with ambroxol + imiglucerase and comparator, and direct costs of treatment. The study was conducted through the generation and simulation of the Markov chain model. The model results were obtained after Monte Carlo microsimulation of a sample with 1,000 virtual patients. Results: Treatment with ambroxol in combination with imiglucerase was cost-effective when compared with imiglucerase only and was associated with positive values of net monetary benefit regardless of the onset of the disease. Such beneficial result for ambroxol and imiglucerase combination is primarily driven by the low cost of ambroxol and its considerable clinical effectiveness in slowing the progression of neural complications of GD2. Conclusion: If ambroxol and imiglucerase are used in combination for the treatment of GD2, it is more cost-effective than using imiglucerase alone.

Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure.

Serious hematological adverse drug reactions (HADRs) may lead to or prolong hospitalization and even cause death. The aim of this study was to determine the regulatory factors associated with HADRs caused by drugs that were authorized up to July 2023 by the European Medicines Agency (EMA) and to evaluate the frequency of HADRs. Using a cross-sectional approach, the type and frequency of HADRs were collected from the Summaries of Product Characteristics of Drugs Authorized by the EMA and analyzed within proprietary, nonproprietary, and biosimilar/biological frameworks. Multivariate statistical analysis was used to investigate the associations of generic status, biosimilar status, conditional approval, exceptional circumstances, accelerated assessment, orphan drug status, years on the market, administration route, and inclusion on the Essential Medicines List (EML) with HADRs. In total, 54.78% of proprietary drugs were associated with HADRs at any frequency, while anemia, leucopenia, and thrombocytopenia were observed in approximately 36% of the patients. The predictors of any HADR, anemia, and thrombocytopenia of any frequency are generic status, biosimilar status, and inclusion on the EML, while the only protective factor is the administration route. Biosimilars and their originator biologicals have similar frequencies of HADRs; the only exception is somatropin. Knowledge of the regulatory factors associated with HADRs could help clinicians address monitoring issues when new drugs are introduced for the treatment of patients.

Evaluation of quality of life in patients with schizophrenia: An inpatient social welfare institution-based cross-sectional study.

Schizophrenia is a chronic mental illness with a poor quality of life (QoL). The main aim of this study was to measure the QoL and factors that affect the QoL of patients with schizophrenia placed in a social welfare institution. This cross-sectional study included 287 patients with schizophrenia who were treated in a long-stay social care institution in which QoL was assessed using five different instruments: the World Health Organization Quality of Life scale, the EuroQoL Five-Dimension-Five-Level scale (including the visual analog scale), the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form, and the Brief Psychiatric Rating Scale. To determine the impact of patients' characteristics on score values, multiple linear regression using backward elimination was employed. Due to non-normality in the distribution of the dependent variables, a Box-Cox power transformation was applied to each dependent variable prior to conducting multiple linear regression analysis. Results revealed that patients with schizophrenia have lower QoL. Our study revealed that age, level of education, type of accommodation, type of pavilion, age of onset of the disease, number of prescribed antipsychotics, number of psychiatric comorbidities, duration of therapy, and the number of daily doses of antipsychotics are dominant contributors to the QoL in patients with schizophrenia who were treated in social welfare institution.

Impact of Emergency Situations on the Level of Fear and Anxiety in Oncology Patients During Radiotherapy in a Developing Country.

OBJECTIVE: To analyze the level of fear and anxiety related to radiotherapy in oncology patients treated before and during the COVID-19 pandemic, as well as to examine whether the advancement of radiotherapy centers leads to any reduction in the patient's fear in emergency situations. METHODS: Two cross-sectional studies were conducted in two time frames (2016 and 2022) based on the analysis of the intensity of anxiety and fear of radiotherapy in oncology patients with assistance. A questionnaire for assessing fear of radiotherapy in oncology patients and Zung's and Beck's self-reported anxiety scales were used. The first part of the research integrated all data of research interest obtained from patients treated with radiotherapy during 2016, and the second cross-sectional study included all patients treated in 2022 during the COVID-19 pandemic. The study was prepared according to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist. RESULTS: The first cross-sectional study had 154 participants who had been treated with radiotherapy, while in the second study, there were 159 patients. Patients treated in 2022 show significantly higher levels of fear and anxiety. External beam radiotherapy and brachytherapy simultaneously used in both studies increased the level of fear and anxiety. CONCLUSION:  The conducted research showed exceptional differences in the intensity of fear and anxiety in patients treated with radiotherapy in different health situations, as was the case during the COVID-19 pandemic, with a significant impact on the stability of the health system and the challenges to providing standard services.

Risk Factors for Potential Drug-Drug Interactions in Patients on Chronic Peritoneal Dialysis.

INTRODUCTION: The prevalence of potential drug-drug interactions (pDDIs) is becoming a major safety concern, as it has been previously linked to a significant number of adverse drug events and could have serious consequences for patients, including death. This is especially relevant for patients with chronic renal failure, as they are particularly vulnerable to drug-drug interactions. The aim of this study is to evaluate the prevalence and associated factors of pDDIs in patients receiving chronic peritoneal dialysis. METHODS: An observational, cross-sectional study was conducted on consecutive peritoneal dialysis patients attending four tertiary-care hospitals for regular monthly examination. The primary outcome was the number of pDDIs identified using Lexicomp. Potential predictors were determined using multiple linear regression. RESULTS: Total number of patients included in the study was 140. The results showed that pDDIs were highly prevalent, especially in patients who use antiarrhythmics (p=0.001), have diabetes mellitus (p=0.001), recently started peritoneal dialysis (p=0.003) or have higher number of prescribed drugs (p<0.001). Number of prescribed drugs (p<0.001) remained a significant predictor of high-risk pDDIs in addition to the female gender (p=0.043). CONCULSION: In conclusion, clinicians should be particularly cautious when prescribing multiple medications to high-risk patients, such as peritoneal dialysis patients, to mitigate the risk of drug-drug interactions and associated adverse health outcomes.

Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies in Migraine: Focus on Drug Interactions.

Calcitonin gene-related peptide neurotransmission was the target for recent development of monoclonal antibodies that effectively prevent attacks of both episodic and chronic migraine. The aim of this narrative review was to offer deeper insight into drug-drug, drug-food and drug-disease interactions of monoclonal antibodies approved for prevention of migraine attacks. For this narrative review, relevant literature was searched for in MEDLINE and Google Scholar databases, covering the 1966-2023 and 2006-2023 periods, respectively. The ClinicalTrials.gov database was also searched for relevant clinical studies whose results had not been published previously in medical journals, covering 2000-2023. Monoclonal antibodies (erenumab, fremanezumab, galcanezumab and eptinezumab) augment prophylactic action of gepants and onabotulinumtoxin A and somewhat increase efficacy of triptans used to abort migraine attacks; however, their adverse reactions may also be augmented. Pharmacokinetic interactions and interactions in general with drugs used for other indications except migraine are negligible, as are drug-food interactions. However, monoclonal antibodies may worsen diseases with already weakened CGRP neurotransmission, Raynaud phenomenon and constipation. Monoclonal antibodies used for prevention of migraine do not engage in significant pharmacokinetic interactions with other drugs; however, they do engage in pharmacodynamic interactions with other anti-migraine drugs, additively augmenting their prophylactic action, but also increasing frequency and severity of adverse reactions, which are a consequence of the CGRP neurotransmission interruption.

Anti-calcitonin Gene-Related Peptide Monoclonal Antibodies in Migraine: Focus on Clinical Pharmacokinetics.

The calcitonin gene-related peptide transmission was the target for recent development of drugs that effectively prevent attacks of both episodic and chronic migraine. The aim of this narrative review was to offer deeper insight into pharmacokinetics of monoclonal antibodies approved for prevention of migraine attacks. For this narrative review, relevant literature was searched for in MEDLINE and Google Scholar databases, covering periods 1966-2023 and 2006-2023, respectively. The ClinicalTrials.gov database was also searched for relevant clinical studies whose results had not been published previously in medical journals, covering the period 2000-2023. The monoclonal antibodies from this group are distributed mainly in the plasma and part of the extracellular space; they are neither metabolized in the liver nor excreted via the kidneys. The elimination of galcanezumab, eptinezumab and fremanezumab takes place only by a non-specific linear process via the reticuloendothelial system in the liver, while erenumab is eliminated by a non-specific process and by a specific, saturable process because of binding to receptors located on the cell membrane. Since the elimination processes do not have a large capacity, the half-life is about 2 weeks for erenumab and about 4 weeks for other monoclonal antibodies. Variability in the pharmacokinetics of these monoclonal antibodies is small in different subpopulations, and body weight is the only parameter to consider when choosing the dose of these drugs.

A New Scale for Rating Oral Health-Related Quality of Life in Denture Wearers.

PURPOSE: When carrying out prosthetic rehabilitation of edentulous and partially edentulous patients, great attention is paid to the personal attitude of the patients, their satisfaction with oral health and psychosocial interaction due to tooth loss, as well as the treatment of the resulting disorders. This attention has led to the development of various instruments for examining the quality of life related to oral health. The aim of this study was to develop and validate a reliable instrument in the Serbian language suitable for measuring oral health-related quality of life in patients who have been rehabilitated with complete or partial dentures. Мaterials and Methods: The study was unicentric and cross-sectional, and assessed the reliability and validity of a newly developed instrument for measuring the oral health-related quality of life in denture wearers (OHRQoL-DW). It was conducted on a sample of 200 adults from Serbia, wearers of various types of dentures, with a mean age 66.9 ± 10.3 years and male/female ratio of 86/114 (43%/57%). RESULTS: The definitive version of the OHRQoL-DW scale with 28 items showed very good reliability, with Cronbach's alpha = 0.938. Good temporal stability of the questionnaire was demonstrated, and satisfactory results were obtained for divergent and convergent validity tests. Exploratory factorial analysis revealed four domains of oral health-related quality of life in denture wearers: physical, psychosocial, environmental and aesthetic. CONCLUSIONS: The OHRQoL-DW scale is a reliable and valid generic instrument for measuring the oral health-related quality of life in patients wearing dentures, which is one of the most important outcomes of oral health in prosthetic treatment.

Factors affecting the healing of decubital lesions in patients wearing newly made dentures.

Background/purpose: Decubital lesions or traumatic ulcers caused by dentures usually appear one or two day(s) after new dentures placement due to mismatch of the microrelief of the tissue and the microrelief of the gingival surface of the prosthesis. The study aimed to analyze factors that could influence the healing of ulcers during a one-week period after the placement of new partial and complete dentures. Materials and methods: The prospective cohort study included 60 patients with new denture-induced traumatic ulcers. Traumatic ulcers were treated with denture adjustment, or combination of adjustment with 0.2% or 0.3% hyaluronic acid gels respectively for seven days. Healing of ulcers were observed through measurement of perimeter, area, maximum and minimum diameters on digital photographs. Multivariate logistic regression was used to predict other factors that could affect healing process. Results: Perimeter, area, maximum and minimum diameters of denture-related ulcers were significant decreased after application of gels on the fifth and seventh day. The fifth day ulcers were not healed if dentures were only adjusted, while healed lesion was 40% for the other two groups. On the seventh day, the percent of healed lesion in the group with dentures adjustment was 20%, while it was increased to 75% healed lesions for combination of denture adjustment and hyaluronic acid gels. Anticoagulant/anti-aggregation drugs also had positive impact on ulcer healing; antihypertensives that included diuretics slowed ulcer healing, other monitored factors in the study did not show a significant impact. Conclusion: Hyaluronic acid in combination with the dentures adjustment for seven days leads to higher healing rate, and reduction in size of ulcers that did not heal until this time point.

Predictors of gastrointestinal complaints in patients on metformin therapy.

Although being very effective in the treatment of diabetes and a few other conditions, metformin (MTF) cannot be tolerated by many patients due to gastrointestinal (GI) complaints. A number of risk factors for intolerance were identified, but many are still controversial or uninvestigated. The aim of this study was to further investigate possible risk factors for the occurrence of GI complaints in patients on MTF therapy. A cross-sectional design was used for this multicentric study on adult patients visiting 50 community pharmacies in Montenegro. The patients were surveyed by semi-structured questionnaire after a service of a pharmacist was delivered, and their drugs dispensed. Uni- and multi-variate regression methods were used for processing the data. In total 330 patients participated in the study. A higher body mass index (OR = 1.113, p = 0.003), living at a higher altitude (OR = 1.725, p = 0.000), anaemia (OR = 4.221, p = 0.008), and intestinal infection in the last 3 months (OR = 2.801, p = 0.006) increased the risk of GI complaints in patients on MTF therapy, while the use of statins was protective (OR = 0.204, p = 0.016). Each case of MTF intolerance should be carefully investigated for risk and protective factors, which could be potentially eliminated or augmented, respectively, and MTF withdrawal avoided.

Long-term outcomes in refractory status epilepticus.

INTRODUCTION: Refractory status epilepticus (RSE) is a diagnosis that can be made when tonic-clonic status epilepticus (SE) and focal SE cannot be stopped by at least two anti-seizure medications after 30 and 60 minutes, respectively, from the time of commencement. It could result in mortality, loss of functionality, neurological deficiency, and other serious short- and long-term effects. AREAS COVERED: This narrative review covers original clinical studies of any design and case series investigating long-term outcomes of RSE recorded after at least a year from the SE onset. EXPERT OPINION: The future of a patient with RSE rests mostly on the long-term effects of this severe pathological condition, which may be accompanied with systemic complications like hyperthermia, hyperkalemia, acidosis, and/or stress cardiomyopathy. Younger patients with less severe RSE of shorter duration, particularly of the convulsive kind, are reported to have better long-term outcomes. Previous studies on the factors influencing the long-term outcomes of RSE, however, did not link the outcomes to treatment options for the condition. Such circumstances currently prevent making any definitive recommendations on the treatment of RSE until future research with adequate statistical power is completed.

Bioequivalence of Different Formulations of Zonisamide Oral Suspensions: A Short Review.

To satisfy the needs of pediatric and other patients with focal onset seizures who cannot swallow solid dosage forms of zonisamide, an oral liquid form of this drug is necessary in clinical practice. Although there are two oral suspensions of zonisamide with marketing authorization (MA), there are issues of availability and high cost which limit their use and inspire extemporaneous compounding. Extemporaneously compounded oral suspensions of zonisamide are prepared according to different formulas and vary in stability; therefore it is essential to test this characteristic. Bioequivalence of extemporaneously compounded oral suspensions has never been tested, and the efficacy and safety of zonisamide oral suspensions have generally not been demonstrated in clinical trials. As a narrow therapeutic window drug, zonisamide requires precision in dosing, which could be achieved only with dosage forms with established bioavailability, efficacy, and safety. In order to avoid underdosing and toxicity with zonisamide oral suspensions and utilize their full therapeutic potential, it is necessary to perform bioequivalence studies with each variation of extemporaneously compounded oral suspension and also clinical trials with both commercial and extemporaneous oral suspensions of zonisamide.

Factors associated with gastrointestinal dysmotility in critically ill patients.

Critical illness may disrupt nutritional, protective, immune, and endocrine functions of the gastrointestinal tract, leading to a state of gastrointestinal dysmotility. We aimed to identify factors associated with the occurrence of gastrointestinal dysmotility in critically ill patients. A cross-sectional retrospective study was conducted, using patient files as a source of data. The study included 185 critically ill patients treated in the intensive care unit of the University Clinical Center, Kragujevac, Serbia, from January 1, 2016, to January 1, 2022. Significant risk factors associated with some form of gastrointestinal dysmotility were acute kidney injury (with paralytic ileus, nausea, vomiting, and constipation), recent abdominal surgery (with ileus, nausea, vomiting, and constipation), mechanical ventilation (with ileus, and nausea), age (with ileus and constipation), and use of certain medication such as opioids (with ileus, gastro-esophageal reflux, nausea, vomiting, and constipation), antidepressants (with ileus, nausea, and vomiting), and antidiabetics (with ileus). On the other hand, Charlson comorbidity index had divergent effects, depending on the form of gastrointestinal dysmotility: it increased the risk of gastro-esophageal reflux but protected against ileus, nausea, and vomiting. In clonclusion, recognition of factors associated with gastrointestinal dysmotility should initiate preventative measures and, thus, accelerate the recovery of critically ill.

Results of the trycort: Cohort study of add-on antihypertensives for treatment of resistant hypertension.

Although true treatment resistant hypertension is relatively rare (about 7.3% of all patients with hypertension), optimal control of blood pressure is not achieved in every other patient due to suboptimal treatment or nonadherence. The aim of this study was to compare effectiveness, safety and tolerability of various add-on treatment options in adult patients with treatment resistant hypertension The study was designed as multi-center, prospective observational cohort study, which compared effectiveness and safety of various add-on treatment options in adult patients with treatment resistant hypertension. Both office and home blood pressure measures were recorded at baseline and then every month for 6 visits. The study cohort was composed of 515 patients (268 females and 247 males), with average age of 64.7 ± 10.8 years. The patients were switched from initial add-on therapy to more effective ones at each study visit. The blood pressure measured both at office and home below 140/90 mm Hg was achieved in 80% of patients with add-on spironolactone, while 88% of patients taking this drug also achieved decrease of systolic blood pressure for more than 10 mm Hg from baseline, and diastolic blood pressure for more than 5 mm Hg from baseline. Effectiveness of centrally acting antihypertensives as add-on therapy was inferior, achieving the study endpoints in <70% of patients. Adverse drug reactions were reported in 9 patients (1.7%), none of them serious. Incidence rate of hyperkalemia with spironolactone was 0.44%, and gynecomastia was found in 1 patient (0.22%). In conclusion, the most effective and safe add-on therapy of resistant hypertension were spironolactone alone and combination of spironolactone and a centrally acting antihypertensive drug.

Factors affecting outcome in hospitalized patients treated according to recommendations from clinical pharmacologists.

OBJECTIVE: Although some of the positive effects of consulting a clinical pharmacologist when using complex treatment schedules have been demonstrated, the factors determining treatment outcomes are largely unknown. A main aim of this study was to identify and analyze the factors associated with the treatment outcomes in hospital patients in whom a therapeutic plan proposed by a clinical pharmacologist had been accepted and implemented. MATERIALS AND METHODS: The research was conducted as a retrospective cohort study on a random sample of 200 inpatients in the University Clinical Center Kragujevac, Serbia. The main outcome variables were i) in-hospital mortality, ii) inadequate clinical response to the therapy or pharmacological recommendations proposed by a clinical pharmacologist, iii) the total length of hospitalization, and iv) the length of hospitalization after consulting a clinical pharmacologist. The effect of putative predictors and confounders on the study outcomes were analyzed using multivariate regression models. RESULTS: Early integration of clinical pharmacologists in the course of patient treatment was associated with a reduction in the risk of a fatal outcome (OR = 1.146; 95% CI, 1.006 - 1.305; p = 0.040). Delay in consulting a clinical pharmacologist was associated with a longer overall length of patient hospitalization (B = 1.592; 95% CI, 1.100 - 2.084; p = 0.000). When the reasons for consulting a clinical pharmacologist involved the choice of drug or the occurrence of adverse drug reactions, the duration of hospitalization following the consultation was shorter by ~ 4 days (B = -4.337; 95% CI, -8.190 to -0.484; p = 0.028) and 12 days (B = -12.024; 95% CI, -19.108 to -4.940; p = 0.001), respectively. CONCLUSION: To achieve more favorable treatment outcomes in the case of difficult-to-treat hospital inpatients, clinical pharmacologists should be consulted early in the course of the disease, especially when the choice of drug is difficult, and the occurrence of adverse drug reactions is an important issue.

Population Pharmacokinetic Modeling to Inform Sertraline Dosing Optimization in Patients with Depression.

Sertraline is one of the most prescribed antidepressants, but its pharmacokinetic (PK) properties are still not completely characterized. Using nonlinear mixed-effects modeling, we examined factors influencing sertraline PK variability in outpatients with major depressive disorder. Blood samples from 53 male and female adults treated with sertraline orally were collected at a steady state. Various demographic and clinical covariates were tested by stepwise regression procedure. We found that sertraline clearance is significantly influenced by serum concentrations of its main metabolite N-desmethylsertraline, whereas clearance of N-desmethylsertraline is affected by both creatinine clearance and drug daily dose. These results were confirmed by the reduction of points dispersion in goodness-of-fit plots for their predicted versus measured concentrations and with bootstrapping analyses. This finding can serve to inform sertraline dosing optimization, especially when changes in kidney function occur in treated individuals, to prevent adverse drug reactions and maximize therapeutic benefits.

Systematic review of sodium-glucose cotransporter 2 inhibitors: a hopeful prospect in tackling heart failure-related events.

In modern cardiology, sodium-glucose cotransporter 2 (SGLT2) inhibitors are critical components of heart failure (HF) treatment algorithms and exert their effects primarily by preventing glucose reabsorption and facilitating its urinary excretion. The objective was to systematically review randomized controlled trials (RCTs) assessing the effects of SGLT2 inhibitors, particularly canagliflozin, empagliflozin, dapagliflozin, ertugliflozin, sotagliflozin (dual SGLT inhibitor), and their use in HF. Systematic searches of PubMed/Medline, The Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov databases were performed. There were no restrictions imposed on the date and status of publication; however, there were restrictions on language for the searched studies. A total of 1139 records were identified in the bibliographic searches from both databases and the register of choice for this systematic review. Following duplicate removal, screening for titles and abstracts, and thorough assessment of full-text articles, 12 RCTs met the inclusion criteria. Altogether, 83 878 patients were included in this review. Among the included studies, two RCTs, with six respective reports, investigated canagliflozin, four RCTs with 13 derived reports investigated dapagliflozin, three RCTs with 12 separate reports studied the effects of empagliflozin, one RCT and its three respective reports assessed ertugliflozin's effects, and two RCTs with one added report investigated the dual inhibitor sotagliflozin. Pooled meta-analytic effects of SGLT2 inhibitors were as follows: on atrial fibrillation odds ratio (OR) = 0.83, 95% confidence interval (CI): 0.68-1.01, prediction interval (PI): 0.57-1.19; on HF hospitalization OR = 0.69, 95% CI: 0.60-0.78, PI: 0.60-0.78; on cardiovascular death OR = 0.82, 95% CI: 0.58-1.15, PI: 0.42-1.60; and on major adverse cardiovascular events OR = 0.90, 95% CI: 0.77-1.06, PI: 0.71-1.15. SGLT2 inhibitors significantly improve the quality of life in HF patients. Their beneficial effects on HF, especially in left ventricular dysfunction, have made their use possible irrespective of diabetes mellitus or atrial fibrillation status.

Economic analysis of cerliponase alfa for treatment of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2).

BACKGROUND: Cerliponase alfa is an orphan drug approved for the treatment of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2). AIM: Our goal was to assess the cost-effectiveness of cerliponase alfa in patients with CLN2 in the socioeconomic context of the Republic of Serbia in contrast to symptomatic therapy. METHOD: For this study, a forty-year horizon and the perspective of the Serbian Republic Health Insurance Fund were used. Quality-adjusted life years gained with cerliponase alfa and comparator, as well as direct treatment costs, were the study's key outcomes. The creation and simulation of a discrete-event simulation model served as the basis for the investigation. Monte Carlo microsimulation was performed on a sample of 1000 virtual patients. RESULTS: When compared to symptomatic therapy, cerliponase alfa treatment was not cost-effective and was linked to negative net monetary benefit regardless of when the illness signs started. CONCLUSION: Cerliponase alfa is not more economical than symptomatic therapy for the treatment of CLN2 when using typical pharmacoeconomic analysis. Cerliponase alfa has been shown to be effective but more has to be done to make it accessible to all CLN2 patients.

Predictors of Mortality in Early Neonatal Sepsis: A Single-Center Experience.

Background and Objectives: Early neonatal sepsis is associated with a significant mortality rate despite modern treatment strategies. Our aim was to identify risk factors contributing to the occurrence of death in newborns with early neonatal sepsis. Materials and Methods: We conducted a retrospective cross-sectional study that included newborns with early sepsis who received care in the intensive and semi-intensive care units at the Institute of Neonatology, Belgrade, Serbia. Newborns with early neonatal sepsis who died comprised the case group, whereas those who survived made up the control group. The diagnostic and therapeutic approach to the septic condition was carried out independently of this study, according to valid hospital protocols and current good practice guidelines. The influence of a large number of variables on the examined dichotomous outcome, as well as the mutual interaction of potential predictor variables, was examined by binary logistic regression. Results: The study included 133 pregnant women and 136 newborns with early neonatal sepsis, of which 51 (37.5%) died, while the remaining 85 newborns (62.5%) survived. Newborns who died had a statistically significantly lower birth weight compared to those who survived (882.8 ± 372.2 g vs. 1660.9 ± 721.1 g, p = 0.000). Additionally, compared to newborns who survived, among the deceased neonates there was a significantly higher proportion of extremely preterm newborns (74.5% vs. 22.4%, p = 0.000). The following risk factors for the occurrence of death in early neonatal sepsis were identified: low birth weight, sepsis caused by gram-negative bacteria, and the use of double-inotropic therapy and erythrocyte transfusion during the first week. Conclusions: Pediatricians should pay special attention to infants with early neonatal sepsis in whom any of the identified risk factors are present in order to prevent a fatal outcome.