Association Between Statin Use and Daptomycin-related Musculoskeletal Adverse Events: A Mixed Approach Combining a Meta-analysis and a Disproportionality Analysis

Chuma, Masayuki; Nakamoto, Aki; Bando, Takashi; Niimura, Takahiro; Kondo, Yutaka; Hamano, Hirofumi; Okada, Naoto; Asada, Mizuho; Zamami, Yoshito; Takechi, Kenshi; Goda, Mitsuhiro; Miyata, Kôji; Yagi, Kenta; Yoshioka, Toshihiko; Izawa‐Ishizawa, Yuki; Yanagawa, Hiroaki; Tasaki, Yoshikazu; Ishizawa, Keisuke

doi:10.1093/cid/ciac128

Cited by 16 publications

(10 citation statements)

References 32 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Daptomycin-induced CPK elevation is considered to be dependent on trough concentration; therefore daptomycin at HDs should be used with caution. 18,40,41 In addition to trough concentration, other risk factors for daptomycin-induced CPK elevation include statins, antihistamines, obesity, history of rhabdomyolysis, baseline CPK levels and African American ancestry [42][43][44][45][46][47] ; however, their effect on safety was not evaluated in the present study.…”

Section: Discussionmentioning

confidence: 90%

Comparison of the efficacy and safety of standard‐ and high‐dose daptomycin: A systematic review and meta‐analysis

Samura

Takada

Hirose

et al. 2023

Brit J Clinical Pharma

View full text Add to dashboard Cite

Aims: Standard doses of daptomycin at 4 and 6 mg/kg were used for the treatment of skin and soft tissue for infections and bacteraemia, respectively. However, increased doses of daptomycin are recommended for complicated infections by Gram-positive organisms.Methods: A systematic review was conducted using 4 databases. We compared treatment success between standard-dose (SD, 4-6 mg/kg) and high-dose (HD, >6 mg/kg) daptomycin in patients with all-cause bacteraemia, complicated bacteraemia, infective endocarditis, osteomyelitis and foreign body/prosthetic infection as the primary outcome. We also compared the success between SD and HD2 (≥8 mg/kg) daptomycin treatments in patients with these diseases as the secondary outcome. The incidence of creatine phosphokinase (CPK) elevation was evaluated as safety.Results: In patients with complicated bacteraemia and infective endocarditis, the treatment success was significantly lower in the SD group than in the HD group (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.30-0.76 and OR 0.50, 95% CI 0.30-0.82) and HD2 group (OR 0.38, 95% CI 0.21-0.69 and OR 0.30, 95% CI 0.15-0.60), respectively. A significant difference was demonstrated only in the HD2 group in patients with bacteraemia, including simple infection. SD did not decrease the success rate for the treatment of osteomyelitis and foreign body/prosthetic infection. The incidence of elevated CPK was significantly lower in SD group than in HD group. Conclusion:SD daptomycin was associated with significantly lower treatment success than HD in patients with complicated bacteraemia/infective endocarditis.The CPK elevation should be considered in patients treated with high daptomycin doses.

show abstract

Section: Discussionmentioning

confidence: 90%

Comparison of the efficacy and safety of standard‐ and high‐dose daptomycin: A systematic review and meta‐analysis

Samura

Takada

Hirose

et al. 2023

Brit J Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…Disproportionality analysis is a data mining method now widely used in monitoring adverse drug reactions ( Chuma et al, 2022 ; Raschi et al, 2022 ). The Proportional Reporting Ratio (PRR) method, and Bayesian Confidence Propagation Neural Network method were utilized to detect safety signals for the drugs under study.…”

Section: Methodsmentioning

confidence: 99%

Comparing the difference of adverse events with HER2 inhibitors: a study of the FDA adverse event reporting system (FAERS)

Bao,

Chen,

Duan

et al. 2024

Front. Pharmacol.

View full text Add to dashboard Cite

Aim and background: This study attempted to identify similarities and differences in adverse events (AEs) between human epidermal growth factor receptor 2 (HER2) inhibitors, especially those related to hemorrhagic events and nervous system disorders.Methods: This study summarized the types, frequencies, and system organ classes (SOCs) of AEs of HER2 inhibitors. The US Food and Drug Administration Adverse Event Reporting System (FAERS) data from January 2004 through March 2022 was collected and analyzed. Disproportionality analyses were conducted to detect AEs signals for every HER2 inhibitor. The chi-square test, Wilcoxon test, and descriptive analysis were used to compare the differences of AEs for specific SOCs or drugs.Results: A total of 47,899 AE reports were obtained for eight HER2 inhibitors. Trastuzumab-related AEs were reported in the highest number and combination of regimens. In monotherapy, trastuzumab had the highest reported rate of cardiac disorders-related AEs (24.0%). However, small-molecule drugs exceeded other drugs in the reported rates of AEs related to gastrointestinal disorders, metabolism and nutrition disorders. The highest reported rates of respiratory disorders (47.3%) and hematologic disorders (22.4%) were associated with treatment with trastuzumab deruxtecan (T-DXd). Patients treated with trastuzumab emtansine (TDM-1) had the highest reported rate (7.28%) of hemorrhagic events, especially intracranial haemorrhage events. In addition, patients treated with TDM-1 with concomitant thrombocytopenia were likely to experience hemorrhagic events compared to other HER2 inhibitors (p < 0.001). The median time to onset of intracranial haemorrhage associated with trastuzumab (0.5 months) and TDM-1 (0.75 months) was short. However, there was no significant difference in median time to onset intracranial haemorrhage between patients in different age groups or with different outcomes. Disproportionality analysis results reveal that cerebral haemorrhage is a positive signal associated with T-DXd and TDM-1. In addition, tucatinib was the drug with the highest rate of reported nervous system disorders (31.38%). Memory impairment (83 cases) is a positive signal for tucatinib.Conclusion: The types and reporting rates of AEs associated with different HER2 inhibitors vary across multiple systems. In addition, hemorrhagic events concomitant with TDM-1 treatment and nervous system disorders concomitant with tucatinib treatment may be worthy of attention.

show abstract

“…However, statin use may result in serious but rare skeletal muscle‐related adverse drug reactions (ADRs), including statin‐associated muscle symptoms (SAMS), induced by mitochondrial dysfunction mechanisms. SAMS, especially myopathy, and rhabdomyolysis, were observed in 5%–10% and 0.01%–0.1% of those using statins, respectively [2].…”

Section: Introductionmentioning

confidence: 99%

Exploring signals of myopathy associated with statin and contraindicated comedications in the realworld

Park,

Lee,

Nam

et al. 2023

Fundamemntal Clinical Pharma

View full text Add to dashboard Cite

BackgroundUsing statins in combination with other drugs was reported to increase the risk of myopathy. However, there was a sparse number of studies on the incidence of adverse events (AEs) associated with the concomitant use of statin and contraindicated drugs in the real world.ObjectivesThis study aimed to identify the risk of concomitant use of statins with contraindicated drugs by exploring signals related to statin–drug interactions.MethodsWe performed a disproportionality analysis for drugs and AEs by applying the case/non‐case study using the KIDS‐KAERS database (KIDS‐KD), 2016–2020. A case was defined as an individual case safety reports (ICSRs) including “rhabdomyolysis/myopathy.” A non‐case was defined as an ICSR, including all other AEs. We applied Ω shrinkage measure model, chi‐square statics model, additive model, multiplicative model, and combination risk ratio model to detect signals of myopathy due to statin with concomitant drugs including antiviral agents, immunosuppressants, and antifungals.ResultsAmong 1 011 234 ICSRs, 2708 were cases, with 861 cases of statin monotherapy and 1248 of concomitant uses of statin. The adjusted reporting odds ratios were 3.27 (95% confidence interval [CI]: 3.11–3.43), 8.70 (95% CI: 8.04–9.40), and 1.83 (95% CI: 1.73–1.94), respectively. Several combinations of signals were detected through an additive model or multiplicative model.ConclusionSignals of an increased risk of myopathy associated with the use of statins with concomitant drugs, including contraindicated drugs, were confirmed in a real‐world setting.

show abstract

Association Between Statin Use and Daptomycin-related Musculoskeletal Adverse Events: A Mixed Approach Combining a Meta-analysis and a Disproportionality Analysis

Cited by 16 publications

References 32 publications

Comparison of the efficacy and safety of standard‐ and high‐dose daptomycin: A systematic review and meta‐analysis

Comparison of the efficacy and safety of standard‐ and high‐dose daptomycin: A systematic review and meta‐analysis

Comparing the difference of adverse events with HER2 inhibitors: a study of the FDA adverse event reporting system (FAERS)

Exploring signals of myopathy associated with statin and contraindicated comedications in the realworld

Contact Info

Product

Resources

About