Myopathy with DPP-4 inhibitors and statins in the real world: investigating the likelihood of drug–drug interactions through the FDA adverse event reporting system

Antonazzo, Ippazio Cosimo; Poluzzi, Elisabetta; Forcesi, Emanuele; Salvo, Francesco; Pariente, Alexandre; Marchesini, Giulio; Ponti, Fabrizio De; Raschi, Emanuel

doi:10.1007/s00592-019-01378-7

Cited by 22 publications

(14 citation statements)

References 39 publications

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“…Since the aim of our study is to detect the possible occurrence of MAEs in patients exposed to PCSK9 inhibitors alone and further, compare the reports of PCSK9 inhibitors together with statins with the condition where they are prescribed alone; the target population is categorized into three groups [ 20 ]: reports of patients prescribed PCSK9 inhibitors and without statins; reports of patients prescribed statins and without PCSK9 inhibitors; reports of patients simultaneously prescribed PCSK9 inhibitors and statins. The reference group is composed of reports exposed to neither PCSK9 inhibitors nor statins.…”

Section: Methodsmentioning

confidence: 99%

“…So, we downloaded the data from the FAERS website from October 2015 to June 2021. The following reasons explain why the FAERS attracts our attention: collection of millions of spontaneous adverse events reports; public and easy access to raw data obtained in a format suitable for external researchers or consumers to look to signal detection of adverse drug events; published previous studies demonstrating great accuracy in detecting safety signals, especially for DDIs, and monitoring uncommon adverse events [20][21][22].…”

Section: Methodsmentioning

confidence: 99%

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Musculoskeletal Adverse Events Associated with PCSK9 Inhibitors: Disproportionality Analysis of the FDA Adverse Event Reporting System

Ding

Chen

Yang

et al. 2022

Cardiovascular Therapeutics

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Background. Some studies suggest that potential safety issues about PCSK9 inhibitors have not been sufficiently explored in clinical trials, including musculoskeletal adverse events (MAEs). Objective. To examine the association between use of PCSK9 inhibitors with and without concurrent statins and risk of MAEs. Patients and Methods. FDA Adverse Event Reporting System (FAERS) dataset of PCSK9 inhibitors and statins from October 2015 to June 2021 was queried. The reporting odds ratio (ROR) with relevant 95% confidence interval (95% CI) was calculated as the index of disproportionality. Outcome of MAEs of different PCSK9 inhibitors regimens was also investigated. Results. 3,185 cases of PCSK9 inhibitor-associated MAEs were recorded. PCSK9 inhibitor class alone demonstrated a strong link to MAEs (ROR 5.92; 95% CI 5.70-6.15), and evolocumab was associated with more reports of MAEs than alirocumab. Concomitant use with statins leaded to an increased occurrence of MAEs (ROR 32.15 (25.55-40.46)), and the risk differed among different statins. The PCSK9 inhibitors were safer than statins in terms of hospitalization rate and death rate (15.64% vs. 36.83%; 0.72% vs. 3.53%). Conclusions. This pharmacovigilance investigation suggests that PCSK9 inhibitors are associated with MAEs. The risk significantly increases when combined with statins. Increased laboratory and clinical monitoring are required to timely diagnose and manage MAEs.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Musculoskeletal Adverse Events Associated with PCSK9 Inhibitors: Disproportionality Analysis of the FDA Adverse Event Reporting System

Ding

Chen

Yang

et al. 2022

Cardiovascular Therapeutics

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“…On the other hand, the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database collects voluntary AE reports of post-marketed drugs submitted by manufacturers, healthcare professionals, and consumers from United States and non-US countries. Compared to other international databases for spontaneous AE reporting, FAERS has several distinctive characteristics, including the heterogeneous catchment area (to broaden the generalization of findings), the public access to raw data that can be downloaded in a format suitable for customized analysis ( Antonazzo et al, 2020 ). Data mining from the FAERS pharmacovigilance source can be utilized to evaluate drug safety, such as identifying rare or new AEs ( Meng et al, 2021 ) and quantitatively detecting drug-drug interactions (DDIs) ( Oshima et al, 2018 ; Antonazzo et al, 2020 ).…”

Section: Introductionmentioning

confidence: 99%

Peripheral Neuropathy During Concomitant Administration of Proteasome Inhibitors and Factor Xa Inhibitors: Identifying the Likelihood of Drug-Drug Interactions

et al. 2022

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Backgrounds: Proteasome inhibitors (PI) cause toxic peripheral neuropathy (PN), which is one of the dose-limiting adverse events of these treatments. Recent preclinical studies find that factor Xa inhibitor (FXaI), rivaroxaban, promotes PN in animals receiving oxaliplatin. Cancer patients can receive combined therapy of PI and FXaI. This study aimed to identify and characterize the interaction signals for the concomitant use of PI and FXaI resulting in PN.Methods: Reports from the United States FDA Adverse Event Reporting System (FAERS) were extracted from the first quarter of 2004 to the first quarter of 2020 for analysis. The Standardized Medical Dictionary for Regulatory Activities (MedDRA) query was used to identify PN cases. We conducted an initial disproportionality investigation to detect PN adverse event signals associated with the combined use of PI and FXaI by estimating a reporting odds ratio (ROR) with a 95% confidence interval (CI). The adjusted RORs were then analyzed by logistic regression analysis (adjusting for age, gender, and reporting year), and additive/multiplicative models were performed to further confirm the findings. Additionally, subset data analysis was performed on the basis of a single drug of PI and FXaI.Results: A total of 159,317 adverse event reports (including 2,822 PN reports) were included. The combined use of PI and FXaI was associated with a higher reporting of PN (RORadj = 7.890, 95%CI, 5.321–11.698). The result remained significant based on additive/multiplicative methods. The observed association was consistent in the analysis restricted to all specific PI agents (bortezomib and ixazomib) and FXaI (rivaroxaban), except apixaban.Conclusion: Analysis of FAERS data identified reporting associations of PN in the combined use of PI and FXaI, suggesting the need for more robust preclinical and clinical studies to elucidate the relationship.

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“…In the recent past, analysis of the spontaneous reporting systems (SRSs) has attracted considerable interest among clinicians for the accurate and timely characterization of drug-and vaccine-related risks occurring in the real world, where comorbidities and polypharmacotherapy exist. By offering a global epidemiological perspective, these pharmacovigilance studies have been pursued to test the hypothesis of potential associations, including refusing the likelihood of interactions [3,16,17], especially for rare, unexpected, and delayed AEs, such as MP.…”

Section: Introductionmentioning

confidence: 99%

Influenza Vaccination and Myo-Pericarditis in Patients Receiving Immune Checkpoint Inhibitors: Investigating the Likelihood of Interaction through the Vaccine Adverse Event Reporting System and VigiBase

et al. 2021

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Background: Evidence on whether the influenza vaccine could exacerbate immune-related adverse events, including myopericarditis (MP), in patients treated with immune checkpoint inhibitors (ICIs), is still conflicting. We explored this issue through a global real-world approach. Methods: We queried the Vaccine Adverse Event Reporting System (VAERS) and VigiBase to retrieve cases of MP in which the influenza vaccine and ICIs were recorded as suspect and were concomitantly reported. For the included cases, causality assessment and Drug Interaction Probability Scale (DIPS) algorithms were applied. Results: There were 191 and 399 reports of MP with the influenza vaccine that were retrieved (VAERS and VigiBase, respectively). No case of MP reporting the concomitant use of ICIs and the influenza vaccine was found in VAERS, while three cases of myocarditis were retrieved in VigiBase. All of the cases were unclassifiable for a causality assessment because of the lack of data concerning latency. According to the DIPS, one report was categorized as possible and two as doubtful. Conclusion: The paucity of cases coupled with the doubtful causality assessment make the potential interaction between influenza vaccines and ICIs in cancer patients negligible from clinical and epidemiological standpoints. These findings support the cardiovascular safety of the influenza vaccination, which remains strongly recommended in cancer patients, especially in the current COVID-19 era.

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Myopathy with DPP-4 inhibitors and statins in the real world: investigating the likelihood of drug–drug interactions through the FDA adverse event reporting system

Cited by 22 publications

References 39 publications

Musculoskeletal Adverse Events Associated with PCSK9 Inhibitors: Disproportionality Analysis of the FDA Adverse Event Reporting System

Musculoskeletal Adverse Events Associated with PCSK9 Inhibitors: Disproportionality Analysis of the FDA Adverse Event Reporting System

Peripheral Neuropathy During Concomitant Administration of Proteasome Inhibitors and Factor Xa Inhibitors: Identifying the Likelihood of Drug-Drug Interactions

Influenza Vaccination and Myo-Pericarditis in Patients Receiving Immune Checkpoint Inhibitors: Investigating the Likelihood of Interaction through the Vaccine Adverse Event Reporting System and VigiBase

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