PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database

Mauro, Gabriella di; Zinzi, Alessia; Scavone, Cristina; Mascolo, Annamaria; Gaio, Mario; Sportiello, Liberata; Ferrajolo, Carmen; Rafaniello, Concetta; Rossi, Francesco; Capuano, Annalisa

doi:10.1007/s40264-020-01021-3

Cited by 29 publications

(30 citation statements)

References 74 publications

(82 reference statements)

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“…The 94.31% of ICSRs were reported by HCPs in accordance with other studies [ 27 , 28 , 29 , 30 , 31 ]. In most ICSRs was reported one suspected drug and no concomitant drugs.…”

Section: Discussionsupporting

confidence: 90%

The Reporting Frequency of Ketoacidosis Events with Dapagliflozin from the European Spontaneous Reporting System: The DAPA-KETO Study

et al. 2022

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Dapagliflozin was associated with an increased risk of diabetic ketoacidosis that has led to the European withdrawal of the authorization for the type 1 diabetes. However, it is still used for the treatment of type 2 diabetes. Therefore, we aim to evaluate the occurrence of dapagliflozin-induced ketoacidosis events by using the European spontaneous reporting system. The reporting odds ratios (ROR) were computed to assess the reporting frequency of ketoacidosis events for dapagliflozin compared to Dipeptidyl peptidase-4 (DPP-4) inhibitors, insulins, or all other Sodium-glucose cotransporter-2 (SGLT-2) inhibitors. A total of 2406 cases with dapagliflozin reported at least one event of ketoacidosis. The three most reported events were: diabetic ketoacidosis (1412; 55.39%), ketoacidosis (476; 18.67%), and euglycaemic diabetic ketoacidosis (296; 11.61%). Dapagliflozin was associated with the higher reporting frequency of ketoacidosis events compared to DPP-4 inhibitors (ROR 12.07, 95%CI 11.67–13.81) or insulins (ROR 7.59, 95%CI 7.13–7.89). A lower reporting frequency was instead observed compared to other SGLT2 inhibitors (ROR 0.91, 95%CI 0.87–0.96). Considering the higher reporting frequency of ketoacidosis observed with dapagliflozin then DPP-4 inhibitors or insulins, attention should be given to patients treated with this drug.

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“…The 94.31% of ICSRs were reported by HCPs in accordance with other studies [ 27 , 28 , 29 , 30 , 31 ]. In most ICSRs was reported one suspected drug and no concomitant drugs.…”

Section: Discussionsupporting

confidence: 90%

The Reporting Frequency of Ketoacidosis Events with Dapagliflozin from the European Spontaneous Reporting System: The DAPA-KETO Study

et al. 2022

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“…The ADR was considered as serious if it resulted in “death”, is “life-threatening”, requires “hospitalization” or “prolonged existing hospitalization”, result in significant “disabilities” and/or is a “congenital anomaly/birth defect” [ 26 ]. The outcome of the ADR was classified based on the recovery pattern.…”

Section: Methodsmentioning

confidence: 99%

Comparative Study of Adverse Drug Reactions Associated with Filgrastim and Pegfilgrastim Using the EudraVigilance Database

Rastogi

Kalaiselvan

Jardan

et al. 2022

Biology

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The primary prophylaxis with filgrastim (FIL) and pegfilgrastim (PEG-F) is recommended to decrease the severity of chemotherapy-induced neutropenia (CIN). The commonly reported adverse drug reactions (ADRs) with FIL and PEG-F is bone pain. ADRs pertaining to FIL and PEG-F were extracted from the European EudraVigilance (EV) database. The Individual Case Safety Reports (ICSRs) obtained from EV database that reported FIL and PEG-F as the suspected drug were analyzed. Registered ADRs (from the groups “General disorders and administration site conditions”, “Blood and lymphatic system disorders”, “Musculoskeletal and connective tissue disorders” and “Investigations”) for FIL and PEG-F were collected from EV database from 2007 to 5 June 2021. The reporting odds ratio (ROR) was used to calculate ICSRs with most common ADRs related to FIL and PEG-F. A total of 17,403 ICSRs described the incidence of most common ADRs of FIL and PEG-F. The commonly reported ADRs for both drugs were pyrexia, bone pain, back pain, neutropenia and febrile neutropenia. The odds ratio of ICSRs belonging to the System Organ Class (SOC) “Investigations” (ROR 1.01 (CI 0.93–1.10)) revealed no significant difference in FIL and PEG-F. However, for the SOCs (General disorders and administration site conditions” and “Musculoskeletal and connective tissue disorders” ((ROR 1.14 (CI 1.06–1.21); ROR 1.21 (CI 1.18–1.32), respectively), an increased reporting probability with PEG-F was found. The authors reported a lower reporting probability for the SOC “Blood and lymphatic system disorders” for FIL versus PEG-F (ROR 0.75 (CI 0.70–0.80)). Our results have demonstrated that the occurrence of bone pain was similar with FIL and PEG-F. For the incidence of pyrexia and back pain, PEG-F was associated with a higher reporting probability as compared to FIL. However, the incidence of neutropenia and febrile neutropenia was higher in FIL compared to PEG-F. Further evaluation of data from real life is needed.

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“…), suspected medications, codified by ATC classification, indication of use, dosage, and concomitant/interacting medications can be retrieved as a line listing and/or ICSR form. These data are publicly available for transparency through the EMA website ( (accessed on 12 December 2020)) and have been previously described as a valid system for safety surveillance studies [ 39 , 40 , 41 ].…”

Section: Methodsmentioning

confidence: 99%

Cardiac Events Potentially Associated to Remdesivir: An Analysis from the European Spontaneous Adverse Event Reporting System

et al. 2021

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Remdesivir was recommended for hospitalized patients with COVID-19. As already reported in the Summary of Product Characteristics, most of remdesivir’s safety concerns are hepatoxicity and nephrotoxicity related. However, some cases have raised concerns regarding the potential cardiac events associated with remdesivir; therefore, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency requested to investigate all available data. Therefore, we analyzed all Individual Case Safety Reports (ICSRs) collected in the EudraVigilance database focusing on cardiac adverse events. From April to December 2020, 1375 ICSRs related to remdesivir were retrieved from EudraVigilance, of which 863 (62.8%) were related to male and (43.3%) adult patients. A total of 82.2% of all AEs (N = 2604) was serious and one third of the total ICSRs (N = 416, 30.3%) had a fatal outcome. The most frequently reported events referred to hepatic/hepatobiliary disorders (19.4%,), renal and urinary disorders (11.1%) and cardiac events (8.4%). Among 221 cardiac ICSRs, 69 reported fatal outcomes. Other drugs for cardiovascular disorders were reported as suspected/concomitant together with remdesivir in 166 ICSRs (75.1%), 62 of which were fatal. Moreover, the mean time to overall cardiac event was 3.3 days (±2.2). Finally, disproportionality analysis showed a two-fold increased risk of reporting a cardiac adverse event associated with remdesivir compared to both hydroxychloroquine and azithromycin. This study showed that remdesivir could be associated to risk of cardiac events, suggesting a potential safety signal which has not been completely evaluated yet. Further studies are needed to confirm these findings.

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PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database

Cited by 29 publications

References 74 publications

The Reporting Frequency of Ketoacidosis Events with Dapagliflozin from the European Spontaneous Reporting System: The DAPA-KETO Study

The Reporting Frequency of Ketoacidosis Events with Dapagliflozin from the European Spontaneous Reporting System: The DAPA-KETO Study

Comparative Study of Adverse Drug Reactions Associated with Filgrastim and Pegfilgrastim Using the EudraVigilance Database

Cardiac Events Potentially Associated to Remdesivir: An Analysis from the European Spontaneous Adverse Event Reporting System

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