Drug-induced pancreatitis: study of 38 patients. / Pancreatitis inducidas por fármacos: estudio de 38 pacientes.

INTRODUCTION: Acute pancreatitis (AP) is an inflammatory disease with multiple etiologies, and the emergence of complications. Between 0.1-5% of cases are attributed to drugs. The absence of specific characteristics complicates the diagnosis and treatment of drug-induced AP. Reviewing patients admitted with the diagnosis of drug-induced AP can provide information and improve its management. PATIENTS AND METHODS: This is a descriptive, observational, and retrospective study. All patients admitted to the Hospital Universitari de Bellvitge between June 2007 and March 2023 with suspected drug-induced AP were included. The data were obtained from the hospital pharmacovigilance program database. RESULTS: Thirty-eight patients with suspected drug-induced AP were identified, representing 0.62% of all adverse drug reactions (n=6.085). Of these, 65.8% (n=25) had a single suspected drug. The median latency period for the onset of adverse drug reactions was 160.5 days (IQR: 18-582 days), and the median hospital stay was 5 days (IQR: 3-7 days). Fifty-nine suspected drugs were identified, involving 26 active principles. Azathioprine and atorvastatin were the most frequent, with 9 cases each (15.2%), followed by enalapril with 8 cases (13.6%). Drug etiology was assessed in 23 cases (60.5%), and the suspected drug was discontinued in all cases. There was one fatal case documented (2.63%). CONCLUSION: This study can contribute to better understanding of drug-induced pancreatitis episodes. We propose a diagnostic algorithm that includes the assessment of the drug as a possible cause.

Efficacy and safety clinical trial with efavirenz in patients diagnosed with adult Niemann-pick type C with cognitive impairment.

BACKGROUND: Niemann-Pick disease Type C (NPC) is a genetic, incurable, neurodegenerative disorder. This orphan disease is most frequently caused by mutations in the NPC1 protein, resulting in intralysossomal cholesterol accumulation. NPC1 is found in neuronal cell bodies, axon terminals and synaptosomes, suggesting it plays a role in lysosomal degradation pathway and in synaptic transmission. Neuronal function is especially vulnerable to NPC1 deficiency and synaptic changes seem a key element in disease development. Currently, Miglustat (Zavesca®) is the only approved treatment for NPC. However, preclinical evidence showed that low-dose Efavirenz reverted synaptic defects through pharmacological activation of the enzyme CYP46. METHODS: This is a single-center, phase II clinical trial to evaluate the efficacy and safety of Efavirenz in addition to standard of care in patients diagnosed with adult or late juvenile-onset NPC with cognitive impairment. All enrolled patients will be treated orally with 25 mg/d of Efavirenz for 52 weeks (1 year). Secondary objectives include evaluating clinical (neurological and neuropsychological questionnaires) and biological (imaging and biochemical biomarkers) parameters. DISCUSSION: NPC is still an unmet medical need. Although different therapeutic approaches are under study, this is the first clinical trial (to the best of our knowledge) studying the effects of Efavirenz in adult- and late-juvenile-onset NPC. Despite the small sample size and the single-arm design, we expect the results to show Efavirenz's capacity of activating the CYP46 enzyme to compensate for NPC1 deficiency and correct synaptic changes, therefore compensating cognitive and psychiatric changes in these patients. This study may provide direct benefit to enrolled patients in terms of slowing down the disease progression.

Suspected adverse events following immunization against SARS-CoV2 in a university hospital in 2021: Observational study.

AIM: Vaccination against SARS-CoV2 has been proposed as a fundamental element for the control of the pandemic. This study aimed to describe the suspected adverse reactions (ADR) reported by vaccinated hospital workers. METHODS: A descriptive study of suspected ADR was conducted between January and March 2021. The suspected ADR were identified using a specifically designed electronic form and spontaneous reporting. Data were also collected regarding the characteristics of the professionals, vaccine administered, severity, and outcome of ADR. RESULTS: 8169 professionals received 2 doses of SARS-CoV2 vaccine (6672 Comirnaty® and 1497 Spikevax®) and 894 reports of suspected ADR were reported (762 for Comirnaty® and 132 for Spikevax®), resulting in a cumulative ADR incidence of 10.94% (95%CI: 10.27-11.62). The majority of ADR were reported only after the second dose, 497 (56.2%), while 211 (23.6%) were reported only after the first dose and 186 (21%) after both doses. The symptoms were mostly mild, did not require medical assistance, and disappeared within approximately 3 days. One hundred and seventeen professionals had a history of COVID-19 infection. These studies reported, statistically significant, more suspected ADR after the first dose (42.7%) than those with no history of COVID-19 (20.7%). Among professionals, more ADR occurred after the first dose with the Spikevax® vaccine (41.6%) than with the Comirnaty® vaccine (20.5%). CONCLUSION: The majority of suspected ADR reported were described in the summary of product characteristics (SmPC). Professionals with a history of COVID-19 reported more suspected ADR after the first dose than did those without a history.