Incidence of elevated creatine phosphokinase between daptomycin alone and concomitant daptomycin and statins: A systematic review and meta‐analysis

Samura, Masaru; Takada, Keisuke; Hirose, Naoki; Kurata, Takenori; Nagumo, Fumio; Koshioka, Sakura; Ishii, Junichi; Uchida, Masaki; Inoue, Junki; Enoki, Yuki; Taguchi, Kazuaki; Tanikawa, Koji; Matsumoto, Kazuaki

doi:10.1111/bcp.15172

Cited by 7 publications

(3 citation statements)

References 62 publications

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“…A meta-analysis comparing the effects of daptomycin, a cyclic lipopeptide antibiotic, given alone or together with a statin, showed that the incidence of daptomycin-related rhabdomyolysis was significantly higher in patients taking a statin [ 34 ]. Similar results were reported in another meta-analysis [ 35 ]. It must be emphasised, however, that knowledge of the metabolism of concomitant drugs and possible interactions with statins always provides the opportunity to substitute the statin with another (usually a hydrophilic one that spares hepatic metabolism), reduce the statin dose (and/or concomitant therapy) and, depending on baseline cardiovascular risk, add a non-statin therapy that does not use the CYP P450 pathway and is very safe (ezetimibe, bempedoic acid and PCSK9-targeted therapy approach).…”

Section: Resultssupporting

confidence: 91%

Rhabdomyolysis or Severe Acute Hepatitis Associated with the Use of Red Yeast Rice Extracts: an Update from the Adverse Event Reporting Systems

Banach,

Norata

2023

Curr Atheroscler Rep

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Purpose of Review Elevated plasma levels of low-density lipoprotein cholesterol (LDL-C) are a major risk factor for atherosclerotic cardiovascular disease (ASCVD), and lowering LDL-C reduces the risk of cardiovascular adverse events. Among natural approaches known for their lipid-lowering properties, red yeast rice (RYR) has a cholesterol-lowering effect due to the presence of bioactive components (monacolins) that act by inhibiting the activity of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. In August 2018, the European Food Safety Authority (EFSA) concluded in its assessment of the use of RYR (further amended in June 2022) that monacolins from RYR raise significant safety concerns when used as a food supplement at a dose of 10 mg/day. In particular, individual cases of serious adverse effects of monacolins from RYR have been reported at intakes as low as 3 mg/day. The EFSA Panel pointed out several uncertainties regarding the available data. Recent Findings We conducted an in-depth and updated analysis of the serious adverse events, with a focus on rhabdomyolysis and acute hepatitis, associated with the consumption of RYR. An analysis of the Food and Drug Administration reporting systems revealed a very small number of cases of rhabdomyolysis or severe acute hepatitis associated with RYR use. In addition, only a few case reports of these serious adverse events associated with RYR use have been published. Summary Based on data from adverse event reporting systems and available case reports, the occurrence of rhabdomyolysis or severe acute hepatitis that could be associated with the use of RYR appears to be extremely rare compared to the occurrence with statins, which is rare to common.

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Section: Resultssupporting

confidence: 91%

Rhabdomyolysis or Severe Acute Hepatitis Associated with the Use of Red Yeast Rice Extracts: an Update from the Adverse Event Reporting Systems

Banach,

Norata

2023

Curr Atheroscler Rep

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“…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: 92%

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

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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.

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“…For instance, high levels of voriconazole induce hepatotoxicity, while toxicities associated with the prolonged use of ganciclovir include pancytopenia, neurotoxicity, and nephrotoxicity, all of them described as dose-independent effects [ 92 ]. In addition, a recent systematic review and meta-analysis concluded that daptomycin administration in OPAT patients under treatment with statins significantly increased the incidence of rhabdomyolysis caused by creatinine phosphokinase level elevation [ 93 ].…”

Section: Implementation Of An Opat Multidisciplinary Circuitmentioning

confidence: 99%

Successful Integration of Clinical Pharmacists in an OPAT Program: A Real-Life Multidisciplinary Circuit

et al. 2022

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Outpatient parenteral antimicrobial therapy (OPAT) programs encompass a range of healthcare processes aiming to treat infections at home, with the preferential use of the intravenous route. Although several barriers arise during the implementation of OPAT circuits, recent cumulative data have supported the effectiveness of these programs, demonstrating their application in a safe and cost-effective manner. Given that OPAT is evolving towards treating patients with higher complexity, a multidisciplinary team including physicians, pharmacists, and nursing staff should lead the program. The professionals involved require previous experience in infectious diseases treatment as well as in outpatient healthcare and self-administration. As we describe here, clinical pharmacists exert a key role in OPAT multidisciplinary teams. Their intervention is essential to optimize antimicrobial prescriptions through their participation in stewardship programs as well as to closely follow patients from a pharmacotherapeutic perspective. Moreover, pharmacists provide specialized counseling on antimicrobial treatment technical compounding. In fact, OPAT elaboration in sterile environments and pharmacy department clean rooms increases OPAT stability and safety, enhancing the quality of the program. In summary, building multidisciplinary teams with the involvement of clinical pharmacists improves the management of home-treated infections, promoting a safe self-administration and increasing OPAT patients’ quality of life.

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Incidence of elevated creatine phosphokinase between daptomycin alone and concomitant daptomycin and statins: A systematic review and meta‐analysis

Cited by 7 publications

References 62 publications

Rhabdomyolysis or Severe Acute Hepatitis Associated with the Use of Red Yeast Rice Extracts: an Update from the Adverse Event Reporting Systems

Rhabdomyolysis or Severe Acute Hepatitis Associated with the Use of Red Yeast Rice Extracts: an Update from the Adverse Event Reporting Systems

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

Successful Integration of Clinical Pharmacists in an OPAT Program: A Real-Life Multidisciplinary Circuit

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