Use of sertraline and agomelatine in hemodialysis patients: A case series report.

OBJECTIVE: Major depressive disorder (MDD) is one of the most common psychiatric issues in hemodialysis population. However, the research on proper diagnostic tools and its treatment is still insufficient. The study was performed to investigate the safety and effectiveness of sertraline and agomelatine in a group of hemodialysis patients. PATIENTS AND METHODS: 78 adult patients from one dialysis centre in Poland were included into the study. The Beck Depression Inventory II (BDI-II) was used to screen for depressive symptoms and was followed by the clinical interview with the psychiatrist. Nine patients diagnosed with major depressive disorder received antidepressant treatment with sertraline or agomelatine, according to the best clinical practice. The additional treatment with vortioxetine was used if the initial one was not effective. The time of observation was 24 weeks. The psychiatric follow up as well as the laboratory data were obtained during the course of observation. RESULTS: All patients receiving sertraline achieved remission of depressive symptoms. In patients receiving agomelatine no remission was observed despite dose augmentation. The side effects of antidepressants were mild and did not result in treatment discontinuation. No abnormalities in liver enzymes levels were observed. In five cases the significant decrease of haemoglobin level was noticed, with no cases of bleeding reported. CONCLUSION: In patients receiving sertraline the antidepressant effect was satisfactory. No remission of depressive symptoms was observed in patients taking agomelatine. The side effects of antidepressants were mild and transient. Further research on depression treatment in hemodialysis patients is needed, including newer medications.

Safety and Tolerability of mRNA COVID-19 Vaccines in Kidney Transplant Recipients.

BACKGROUND: COVID-19 mRNA vaccines have demonstrated excellent short-term safety in phase 3 trials. However, no kidney transplant recipients (KTR) were included. The aim of the study was to assess the safety and tolerability of COVID-19 mRNA vaccines in KTR. MATERIALS AND METHODS: A longitudinal controlled study was conducted in 300 KTR and 143 control patients (CRL) without chronic kidney disease who had received 2-dose vaccinations with the mRNA vaccine. Solicited local and systemic reactogenicity and unsolicited adverse events were assessed with a standardized questionnaire. The toxicity grading scales were derived from the FDA guidelines. RESULTS: KTR (62.7% men) with a median (interquartile range) age of 53 (41-63) and transplant vintage of 7.25 (3-13) years did not differ with respect to age and sex distribution from CRL. One hundred percent CRL and 83.3% KTR were vaccinated with BNT162b2 (BionTech/Pfizer); 16.7% KTR received mRNA-1273 (Moderna) vaccine. Any local reactions were present in 84.7% (first dose) and 65.3% (second dose) KTR vs 67.1% and 60.1% CRL within 7 days after the vaccination. Any systemic reactions were reported by 26.7% (first dose) and 20.9% (second dose) KTR vs 24.7 and 35.7% CRL. The most common systemic reactions in KTR were fatigue, headache and myalgia. No serious adverse events were observed. Many systemic reactions were observed less frequently in KTR than CRL. Younger KTR (<54 years) reported any local and any systemic reactions significantly more frequently than older patients. CONCLUSION: mRNA COVID-19 vaccines are safe and well-tolerated by KTR. The results may resolve patients' doubts and reduce their vaccine hesitancy.

Local and Systemic Immunity Are Impaired in End-Stage-Renal-Disease Patients Treated With Hemodialysis, Peritoneal Dialysis and Kidney Transplant Recipients Immunized With BNT162b2 Pfizer-BioNTech SARS-CoV-2 Vaccine.

Vaccination against COVID-19 in patients with end-stage renal disease (ESRD) on replacement therapy and kidney transplant recipients (KTRs) is particularly important due to the high mortality rate. Here, we tested the local and systemic immunity to the novel Pfizer BioNTech (BNT162b2) messenger RNA (mRNA) in ESRD, KTR patients, and healthy individuals (150 subjects). The ESRD group was divided into: hemodialysis (HD) and peritoneal dialysis (PD). We investigated the local and systemic immunity based on anti-N (nucleoprotein) and anti-S (spike1/2) Immunoglobulin A (IgA) and Immunoglobulin G (IgG) antibodies, respectively. Additionally, we performed an Interferon gamma (IFN-γ) release test Interferon-gamma release assay (IGRA) to monitor the cellular component of vaccine response. The control group had the highest level of anti-S IgG antibodies (153/2,080 binding antibody units (BAU)/ml) among all analyzed patients after the 1st and 2nd dose, respectively. The HD group (48/926 BAU/ml) had a diminished antibody level compared to PD (93/1,607 BAU/ml). Moreover, the seroconversion rate after the 1st dose was lower in HD than PD (56% vs. 86%). KTRs had extremely low seroconversion (33%). IgA-mediated immunity was the most effective in the control group, while other patients had diminished IgA production. We observed a lower percentage of vaccine responders based on the IFN-γ level in all research participants (100% vs. 85% in control, 100% vs. 80% in PD, 97% vs. 64% in HD). 63% of seropositive KTRs had a positive IGRA, while 28% of seronegative patients produced IFN-γ. Collectively, PD patients had the strongest response among ESRD patients. Two doses of the Pfizer vaccine are ineffective, especially in HD and KTRs. A closer investigation of ESRD and KTRs is required to set the COVID-19 vaccine clinical guidance. Clinical Trial Registration Number: www.ClinicalTrials.gov, identifier: NCT04 905 862.

Waning Humoral Response after COVID-19 mRNA Vaccination in Maintenance Dialysis Patients and Recovery after a Complementary Third Dose.

The aim of this study was to analyze the waning of anti-spike (S) antibodies after mRNA vaccination against COVID-19 in maintenance dialysis patients, and to assess the safety and effectiveness of the complementary third dose. This was a prospective, longitudinal study in which we analyzed the kinetics of antibodies up to six months after a two-dose vaccination (first protocol) in infection-naïve dialysis patients (IN-Ds), previously infected dialysis patients (PI-Ds) and subjects without chronic kidney disease (the controls), as well as their humoral response to the third dose of the same mRNA vaccine (second protocol). The respective reduction in antibody titer after 3 and 6 months by 82.9% and 93.03% in IN-Ds (n = 109), 73.4% and 93.36% in PI-Ds (n = 32) and 75.5% and 88.8% in the controls (n = 20) was demonstrated. Consequently, a protective antibody titer above 141 BAU/mL was found in only 47.7% and 23.8% of IN-Ds after 3 and 6 months, respectively. After the third vaccine dose, a significant increase in antibody titer was observed in all groups, with increases by a factor of ×51.6 in IN-Ds, ×30.1 in the controls and ×8.4 in PI-Ds. The median antibody titer after the third dose differed significantly between groups, and was the highest in PI-Ds: PI-Ds, 9090 (3300−15,000) BAU/mL; the controls, 6945 (2130−11,800); IN-Ds, 3715 (1470−7325) (p < 0.001). In conclusion, we observed similar degrees of antibody waning in all patients. After 3 months, over half of the infection-naïve dialysis patients had a very low antibody titer, and almost twenty percent of them had no antibodies at all. The humoral response to the third dose was very good, raising their titer of antibodies to a higher level than those in the general population who have received the primary two-dose scheme. The results support the administration of a complementary third dose of the mRNA vaccine for dialysis patients as soon as possible.

Predictors of Humoral Response to mRNA COVID19 Vaccines in Kidney Transplant Recipients: A Longitudinal Study-The COViNEPH Project.

BACKGROUND: The efficacy of SARS-CoV-2 vaccination among kidney transplant recipients (KTR) is low. The main goal of this study was to analyze factors that may influence the humoral response to vaccination. METHODS: We analyzed the titer magnitude of IgG antibodies directed against spike (S)-SARS-CoV-2 antigen after the second dose of the mRNA vaccine in 142 infection naïve KTR (83 men, i.e., 58.4%) with a median age (IQR) of 54 (41-63), and 36 respective controls without chronic kidney disease. mRNA-1273 or BNT162b2 were applied in 26% and 74% of KTR, respectively. RESULTS: S-specific immune response (seroconversion) was seen in 73 (51.41%) of KTR, and in all controls 36 (100%). Independent predictors of no response were elder age, shorter transplantation vintage, and a more than two-drug immunosuppressive protocol. In subgroup analyses, the seroconversion rate was highest among KTR without MMF/MPS treatment (70%), treated with no more than two immunosuppressants (69.2%), treated without corticosteroid (66.7%), younger patients aged <54 years (63.2%), and those vaccinated with the mRNA-1273 vaccine (62.16%). The independent predictors of higher S-antibody titer among responders were younger age, treatment with no more than two immunosuppressants, and the mRNA-1273 vaccination. CONCLUSIONS: Our study confirmed a low rate of seroconversion after vaccination with the mRNA vaccine in KTR. The major modifiable determinants of humoral response were the composition of the immunosuppressive protocol, as well as the type of vaccine. The latter could be taken into consideration when initial vaccination as well as booster vaccination is considered in KTR.

Use of Sertraline in Hemodialysis Patients.

Depression and anxiety are the most common psychiatric disorders in end-stage renal disease (ESRD) patients treated with hemodialysis (HD) and may correlate with lower quality of life and increased mortality. Depression treatment in HD patients is still a challenge both for nephrologists and psychiatrists. The possible treatment of depressive disorders can be pharmacological and non-pharmacological. In our article, we focus on the use of sertraline, the medication which seems to be relatively safe and efficient in the abovementioned population, taking under consideration several limitations regarding the use of other selective serotonin reuptake inhibitors (SSRIs). In our paper, we discuss different aspects of sertraline use, taking into consideration possible benefits and side effects of drug administration like impact on QTc (corrected QT interval) prolongation, intradialytic hypotension (IDH), chronic kidney disease-associated pruritus (CKD-aP), bleeding, sexual functions, inflammation, or fracture risk. Before administering the medication, one should consider benefits and possible side effects, which are particularly significant in the treatment of ESRD patients; this could help to optimize clinical outcomes. Sertraline seems to be safe in the HD population when provided in proper doses. However, we still need more studies in this field since the ones performed so far were usually based on small samples and lacked placebo control.

[Haff disease - are we threatened with another epidemic?] / Choroba Zalewu Wislanego ­ czy grozi nam kolejna epidemia?

Haff disease is a group of symptoms caused by rhabdomyolysis following ingestion of some species of fish and crayfish. Pathophysiology remains unknown. Outbreaks of the Haff disease have been reported in many regions of the world. In this article we present the case of a 38-years-old patient, professional fisherman, suspected of suffering from Haff disease. He developed symptoms of diffuse myalgia, headache, chest pressure, brown-colored urine and elevated blood pressure. Predominant laboratory abnormalities were elevated serum creatine kinase and creatinine concentrations. During hospitalization the patient required the renal replacement therapy. As a result of applied procedures, clinical and laboratory improvement was achieved. The patient was discharged home in good general condition. The Haff disease should be included in the differential diagnosis of rhabdomyolysis. Detailed medical interview, especially questions about recently consumed food and occupational exposure, is crucial in making a proper diagnosis. Med Pr. 2021;72(5):605-10.

Safety and Tolerability of the BNT162b2 mRNA COVID-19 Vaccine in Dialyzed Patients. COViNEPH Project.

Background and Objectives: The Pfizer-BioNTech (BNT162b2) COVID-19 mRNA vaccine has demonstrated excellent efficacy and safety in phase 3 trials. However, no dialyzed patients were included, and therefore safety data for this patient group is lacking. The aim of the study was to assess the safety and tolerances of vaccinations with BNT162b2 performed in chronically dialyzed patients. Materials and Methods: We performed a prospective cohort study including a group of 190 dialyzed patients (65% male) at median age 68.0 (55-74) years. 169 (89.0%) patients were treated with hemodialysis and 21 (11.0%) with peritoneal dialysis. The control group consisted of 160 people (61% male) without chronic kidney disease at median age 63 (range 53-77) years. Both groups were vaccinated with BNT162b2 with a 21-day interval between the first and the second dose. Solicited local and systemic reactogenicity, unsolicited adverse events and antipyretic and pain medication use were assessed with a standardized questionnaire. The toxicity grading scales were derived from the FDA Center for Biologics Evaluation and Research guidelines. Results: 59.8% (dose 1), 61.4% (dose 2) and 15.9% (dose 1), 29.4% (dose 2) dialyzed patients reported at least one local and one systemic reaction respectively within seven days after the vaccination. Many local and systemic solicited reactions were observed less frequently in dialyzed patients than in the age and sex matched control group and much less frequently than reported in the pivotal study. They were mostly mild to moderate, short-lived, and more frequently reported in younger individuals and women. No related unsolicited adverse events were observed. Conclusions: We have shown here that BNT162b2, an mRNA vaccine from Pfizer-BioNTech against SARS-COV-2 is safe and well-tolerated by dialyzed patients. The results can be useful for the nephrological community to resolve patients' doubts and reduce their vaccine hesitancy.

[New biochemical markers of ethyl alcohol abuse - new possibilities in clinical practice]. / Mozliwosci praktycznego zastosowania nowych wskazników biochemicznych naduzywania alkoholu etylowego.

Alcohol ranks as one of the leading behavioral threats to health and life in developed countries. Alcohol abuse triggers serious social and economic effects: it contributes to higher prevalence of work-related and road accidents, as well as absence from work. The diagnosis and treatment of alcoholism still remain very difficult. Hence, the use of objective biochemical markers of alcohol abuse may contribute to earlier detection, more effective therapy and reliable teetotalism control. The aim of this study is to present the sensitive and specific biomarkers of alcohol abuse available in Poland, with particular emphasis on the practical use possibilities. Such tests may be widely used, e.g., in driving license regranting cases involving drivers whose licenses were suspended for driving when intoxicated, for the early detection of persons abusing alcohol in employment-related health controls, for abstinence monitoring during withdrawal treatment, for detecting alcohol consumption in transplant settings, for assessing the prevalence of alcohol drinking in pregnancy, as well as in autopsical examinations. The standardization of biomarkers measurement methods is essential. Moreover, concomitant disorders may pose a significant problem in the proper outcome analysis. Despite these limitations, objective biochemical markers of ethyl alcohol abuse may become helpful tools in medical care. They can play a particular role in occupational medicine diagnostics, contributing to the higher level of safety on public roads and to worker safety. Med Pr. 2021;72(2):173-84.

Gastrointestinal Pathologies in Patients After Successful Renal Transplantation.

BACKGROUND: Kidney transplantation (KT) is the most desired and cost-effective modality of renal replacement therapy for patients with chronic kidney failure. KT protects the patient from complications that may develop during chronic dialysis. Unfortunately, evidence also suggests that KT patients are more prone to developing cancer than healthy persons. Many complications after renal transplantation can be prevented if they are detected early. The aim of this study was to evaluate the prevalence of gastrointestinal pathologies in patients after KT. METHODS: Adult patients after KT who are under the care of the Outpatient Department of Nephrology at the Medical University of Gdansk, Poland, received alarm symptom questionnaires and referral for testing for the presence of fecal occult blood. Then, in 58 selected patients (36 men and 22 women), endoscopic examination was performed. Mean age was 57.34 ± 10.1 (range, 35-83) years. RESULTS: Out of 940 patients after KT, resting under supervision of the Outpatient Department, 208 patients completed the questionnaire and 118 gave a stool sample for testing: 40 results were positive. After analyzing the questionnaires and stool results, 100 patients qualified for further investigation. The endoscopic examination had been performed so far in 58 patients and revealed gastritis and/or duodenitis in 49 patients, diverticular colon disease in 26, esophagitis in 8, colon polyps in 16, stomach polyps in 4, inflammatory bowel disease in 12, and cancers in 3. CONCLUSIONS: The preliminary results indicate that patients after KT have significant risk of gastrointestinal pathologies and require detailed diagnostic endoscopy.

Antipsychotic Medication Prescribing Trends in a Pediatric Population in Northern Poland 2008-2012.

OBJECTIVES: In recent years antipsychotics have been increasingly used in the population of children and adolescents. The objective of this article is to profile the use of antipsychotic medications in a pediatric population in Poland based on data from the Pomeranian region (Northern Poland). METHODS: The study was based on National Health Fund data about prescription drug reimbursement between 2008 and 2012. A patient database was created using ID to analyze specific patterns and information about individuals using antipsychotics. Percentage population indicators were calculated using official demographic reports. RESULTS: An increased number of overall prescriptions was observed since 2008, with a subsequent decline to its lowest number in 2012. The population with at least one antipsychotic-filled prescription per year has grown in the same time. The annual rate has increased from 0.26% to 0.31% of the general population between 0 and 17 years of age in the Pomeranian region. We observed an increasing number of females and the 0- to 4-year-old receiving antipsychotic prescriptions. The population share of prescribed first-generation antipsychotics exceeded the share of second-generation antipsychotics (SGAs). The use of SGAs increased from 38% to 44% of all prescriptions, during the observation period. The most frequently prescribed drugs were Risperidone (26.7%) and Chlorprothixene (21.7%). CONCLUSIONS: The study revealed that the prescribing patterns of antipsychotics increased in the Polish pediatric population and concerned more patients from the youngest group. The high prevalence of such early exposure to antipsychotics should focus more attention on drug safety in this population.