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  • 1
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    Online Resource
    Single‐center experience with use of letermovir for treatment of CMV infection in stem cell transplant recipients
    Wiley ; 2021
    In:  Transplant Infectious Disease Vol. 23, No. 2 ( 2021-04)
    Details
    In: Transplant Infectious Disease, Wiley, Vol. 23, No. 2 ( 2021-04)
    Abstract: The approval of letermovir provided a new option for cytomegalovirus (CMV) prophylaxis in CMV seropositive allogeneic hematopoietic stem cell transplantation (allo‐HSCT) recipients. Data are limited on the use of letermovir for the treatment of CMV infection. We performed a single‐center retrospective review of allo‐HSCT recipients who received letermovir off‐label for treatment of CMV infection (CMV DNAemia and CMV disease) from November 2017 until November 2019. Fifteen patients were included, 14 of which received letermovir for treatment of CMV DNAemia. The median duration from transplant to CMV DNAemia was 41 days and median duration of letermovir therapy was 53 days (IQR, 43‐59). Median time to first undetectable CMV viral load from the start of letermovir was 16 days (IQR, 13‐21). No significant correlation was noted between the time to CMV DNA clearance and either CMV DNA at the time of starting letermovir ( r  = −.12, 95% CI: −0.63‐0.46; P  = .69) or CMV DNA peak ( r  = .04, 95% CI: −0.51‐0.58, P  = .87). Three patients had late reactivation of CMV after completion of letermovir (20%) after 87 days (IQR, 68‐103) of therapy cessation. Clinical failure or treatment intolerance occurred in two patients (14%). One patient failed to achieve an undetectable viral load. In another patient, letermovir was discontinued due to documented therapy‐related thrombocytopenia. Our analysis suggests that letermovir might have a potential role for the treatment of CMV infection in select patients with contraindication or intolerance to more validated therapies.
    Type of Medium: Online Resource
    ISSN: 1398-2273 , 1399-3062
    URL: Issue
    URL: Article
    DOI: 10.1111/tid.v23.2
    DOI: 10.1111/tid.13502
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2010983-0
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  • 2
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    Genome‐wide Association Study Identified Chromosome 8 Locus Associated with Medication‐Related Osteonecrosis of the Jaw
    Wiley ; 2021
    In:  Clinical Pharmacology & Therapeutics Vol. 110, No. 6 ( 2021-12), p. 1558-1569
    Details
    In: Clinical Pharmacology & Therapeutics, Wiley, Vol. 110, No. 6 ( 2021-12), p. 1558-1569
    Abstract: Medication‐related osteonecrosis of the jaw (MRONJ) is a rare but serious drug‐related adverse event. To identify pharmacogenomic markers of MRONJ associated with bisphosphonate therapy, we conducted a genomewide association study (GWAS) meta‐analysis followed by functional analysis of 5,008 individuals of European ancestry treated with bisphosphonates, which includes the largest number of MRONJ cases to date (444 cases and 4,564 controls). Discovery GWAS was performed in randomly selected 70% of the patients with cancer and replication GWAS was performed in the remaining 30% of the patients with cancer treated with intravenous bisphosphonates followed by meta‐analysis of all 3,639 patients with cancer. GWAS was also performed in 1,369 patients with osteoporosis treated with oral bisphosphonates. The lead single‐nucleotide polymorphism (SNP), rs2736308 on chromosome 8, was associated with an increased risk of MRONJ with an odds ratio (OR) of 2.71 and 95% confidence interval (CI) of 1.90–3.86 ( P  = 3.57*10 −8 ) in the meta‐analysis of patients with cancer. This SNP was validated in the MRONJ GWAS in patients with osteoporosis (OR: 2.82, 95% CI: 1.55–4.09, P  = 6.84*10 −4 ). The meta‐analysis combining patients with cancer and patients with osteoporosis yielded the same lead SNP rs2736308 on chromosome 8 as the top SNP (OR: 2.74, 95% CI: 2.09–3.39, P  = 9.65*10 −11 ). This locus is associated with regulation of the BLK , CTSB , and FDFT1 genes, which had been associated with bone mineral density. FDFT1 encodes a membrane‐associated enzyme, which is implicated in the bisphosphonate pathway. This study provides insights into the potential mechanism of MRONJ.
    Type of Medium: Online Resource
    ISSN: 0009-9236 , 1532-6535
    URL: Issue
    URL: Article
    DOI: 10.1002/cpt.v110.6
    DOI: 10.1002/cpt.2397
    RVK:
    XA 36900
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2040184-X
    SSG: 15,3
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  • 3
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    Review of Opioid Pharmacogenetics and Considerations for Pain Management
    Wiley ; 2017
    In:  Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy Vol. 37, No. 9 ( 2017-09), p. 1105-1121
    Details
    In: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, Wiley, Vol. 37, No. 9 ( 2017-09), p. 1105-1121
    Abstract: Opioid analgesics are the standards of care for the treatment of moderate to severe nociceptive pain, particularly in the setting of cancer and surgery. Their analgesic properties mainly emanate from stimulation of the μ receptors, which are encoded by the OPRM1 gene. Hepatic metabolism represents the major route of elimination, which, for some opioids, namely codeine and tramadol, is necessary for their bioactivation into more potent analgesics. The highly polymorphic nature of the genes coding for phase I and phase II enzymes (pharmacokinetics genes) that are involved in the metabolism and bioactivation of opioids suggests a potential interindividual variation in their disposition and, most likely, response. In fact, such an association has been substantiated in several pharmacokinetic studies described in this review, in which drug exposure and/or metabolism differed significantly based on the presence of polymorphisms in these pharmacokinetics genes. Furthermore, in some studies, the observed variability in drug exposure translated into differences in the incidence of opioid‐related adverse effects, particularly nausea, vomiting, constipation, and respiratory depression. Although the influence of polymorphisms in pharmacokinetics genes, as well as pharmacodynamics genes ( OPRM1 and COMT ) on response to opioids has been a subject of intense research, the results have been somehow conflicting, with some evidence insinuating for a potential role for OPRM1 . The Clinical Pharmacogenetics Implementation Consortium guidelines provide CYP2D6 ‐guided therapeutic recommendations to individualize treatment with tramadol and codeine. However, implementation guidelines for other opioids, which are more commonly used in real‐world settings for pain management, are currently lacking. Hence, further studies are warranted to bridge this gap in our knowledge base and ultimately ascertain the role of pharmacogenetic markers as predictors of response to opioid analgesics.
    Type of Medium: Online Resource
    ISSN: 0277-0008 , 1875-9114
    URL: Issue
    URL: Article
    DOI: 10.1002/phar.2017.37.issue-9
    DOI: 10.1002/phar.1986
    Language: English
    Publisher: Wiley
    Publication Date: 2017
    detail.hit.zdb_id: 2061167-5
    SSG: 15,3
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  • 4
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    Optimization of Voriconazole Therapy for the Treatment of Invasive Fungal Infections in Adults
    Wiley ; 2018
    In:  Clinical Pharmacology & Therapeutics Vol. 104, No. 5 ( 2018-11), p. 957-965
    Details
    In: Clinical Pharmacology & Therapeutics, Wiley, Vol. 104, No. 5 ( 2018-11), p. 957-965
    Abstract: Therapeutic concentrations of voriconazole in invasive fungal infections (IFIs) are ensured using a drug monitoring approach, which relies on attainment of steady‐state pharmacokinetics. For voriconazole, time to reach steady state can vary from 5–7 days, not optimal for critically ill patients. We developed a population pharmacokinetic/pharmacodynamic model‐based approach to predict doses that can maximize the net benefit (probability of efficacy‐probability of adverse events) and ensure therapeutic concentrations, early on during treatment. The label‐recommended 200 mg voriconazole dose resulted in attainment of targeted concentrations in ≥80% patients in the case of Candida spp . infections, as compared to only 40–50% patients, with net benefit ranging from 5.8–61.8%, in the case of Aspergillus spp . infections. Voriconazole doses of 300–600 mg were found to maximize the net benefit up to 51–66.7%, depending on the clinical phenotype (due to CYP2C19 status and pantoprazole use) of the patient and type of Aspergillus infection.
    Type of Medium: Online Resource
    ISSN: 0009-9236 , 1532-6535
    URL: Issue
    URL: Article
    DOI: 10.1002/cpt.2018.104.issue-5
    DOI: 10.1002/cpt.1012
    RVK:
    XA 36900
    Language: English
    Publisher: Wiley
    Publication Date: 2018
    detail.hit.zdb_id: 2040184-X
    SSG: 15,3
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  • 5
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    Online Resource
    Osteonecrosis of the Jaw in the United States Food and Drug Administration's Adverse Event Reporting System (FAERS)
    Wiley ; 2016
    In:  Journal of Bone and Mineral Research Vol. 31, No. 2 ( 2016-02), p. 336-340
    Details
    In: Journal of Bone and Mineral Research, Wiley, Vol. 31, No. 2 ( 2016-02), p. 336-340
    Abstract: Osteonecrosis of the jaw (ONJ) is a serious adverse drug event that was initially reported with intravenous bisphosphonates (BPs) and more recently with other classes of drugs such as receptor activator of NF‐κB ligand (RANKL) inhibitor, antiangiogenic agents, and mammalian target of rapamycin (m‐TOR) inhibitors. The purpose of this study is to analyze the ONJ cases and the associated drugs in the US Food and Drug Administration's adverse event reporting system (FAERS). The FAERS database was queried for the adverse drug events reported from the first quarter of 2010 to the first quarter of 2014. The reporting odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for each queried drug. A total of 17,119 unique ONJ cases were identified. In the overall analysis, the drugs with the highest reporting ORs were BPs: pamidronate (OR = 498.9), zoledronate (OR = 171.7), and alendronate (OR = 63.6), whereas denosumab had lower ORs than all the BPs except for etidronate. The antiangiogenic and m‐TOR inhibitors had the lowest ORs. In cancer patients who were treated for prevention of skeletal‐related events (SREs), the reporting ORs for zoledronate and denosumab were 125.2 and 4.9, respectively. In patients with osteoporosis, the ORs were 1.1 (1.0–1.18) for zoledronate and 0.63 (0.56–0.70) for denosumab, respectively. Our analysis of the FAERS database showed that the intravenous BPs were associated with the highest risk for ONJ, RANKL inhibitor was associated with risk comparable to BPs used for osteoporosis such as etidronate, and the antiangiogenic agents and m‐TOR inhibitors were associated with the lowest risk for ONJ. The high risk for ONJ with zoledronate and denosumab was mainly observed in those who were treated for prevention of SREs, whereas there was limited evidence for such risk in those who were treated for osteoporosis. © 2015 American Society for Bone and Mineral Research.
    Type of Medium: Online Resource
    ISSN: 0884-0431 , 1523-4681
    URL: Issue
    URL: Article
    DOI: 10.1002/jbmr.v31.2
    DOI: 10.1002/jbmr.2693
    RVK:
    XA 52230
    Language: English
    Publisher: Wiley
    Publication Date: 2016
    detail.hit.zdb_id: 2008867-X
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  • 6
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    Online Resource
    SIRT1/HERC4 Locus Associated With Bisphosphonate‐Induced Osteonecrosis of the Jaw: An Exome‐Wide Association Analysis
    Wiley ; 2018
    In:  Journal of Bone and Mineral Research Vol. 33, No. 1 ( 2018-01), p. 91-98
    Details
    In: Journal of Bone and Mineral Research, Wiley, Vol. 33, No. 1 ( 2018-01), p. 91-98
    Abstract: Osteonecrosis of the jaw (ONJ) is a rare, but serious drug side effect, mainly associated with the use of intravenous (iv) bisphosphonates (BPs). The purpose of this study was to identify genetic variants associated with ONJ in patients of European ancestry treated with iv BPs using whole‐exome sequencing (WES). The WES phase 1 included 44 multiple myeloma patients (22 ONJ cases and 22 controls) and WES phase 2 included 17 ONJ patients with solid tumors. Multivariable logistic regression analysis was performed to estimate the odds ratios (ORs) and 95% confidence intervals (CI), adjusting for age, sex, and principal components for ancestry. Meta‐analysis of WES phase 1 and 2 was performed to estimate the combined ORs. In silico analyses were then performed to identify expression quantitative loci (eQTL) single‐nucleotide polymorphisms (SNPs) that are in high linkage disequilibrium (LD) with the top SNPs. The associations of the potentially functional SNPs were replicated and validated in an independent case‐control study of 48 patients of European ancestry treated with iv BPs (19 ONJ cases and 29 controls). The top SNPs in the exome‐wide association meta‐analysis were two SNPs on chromosome 10: SIRT1 SNP rs7896005 and HERC4 SNP rs3758392 with identical OR of 0.07 (0.01–0.46; p  = 3.83 × 10 −5 ). In the in silico functional analyses, two promoter region SNPs (rs7894483 and rs3758391) were identified to be in high LD with the index SNPs and are eQTLs for SIRT1 gene in whole blood in the GTEx database. The ORs were 0.30 (0.10–0.88), 0.26 (0.12–0.55), and 0.26 (0.12–0.55) for the WES top SNP rs7896005 and two promoter SNPs rs7894483 and rs3758391, respectively, in the replication sample. In summary, we identified the SIRT1/HERC4 locus on chromosome 10 to be associated with iv BP‐induced ONJ and two promoter SNPs that might be the potential genetic markers for this association. © 2017 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals Inc.
    Type of Medium: Online Resource
    ISSN: 0884-0431 , 1523-4681
    URL: Issue
    URL: Article
    DOI: 10.1002/jbmr.v33.1
    DOI: 10.1002/jbmr.3285
    RVK:
    XA 52230
    Language: English
    Publisher: Wiley
    Publication Date: 2018
    detail.hit.zdb_id: 2008867-X
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  • 7
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    Implications of Polymorphisms in the BCKDK and GATA‐4 Gene Regions on Stable Warfarin Dose in African Americans
    Wiley ; 2021
    In:  Clinical and Translational Science Vol. 14, No. 2 ( 2021-03), p. 492-496
    Details
    In: Clinical and Translational Science, Wiley, Vol. 14, No. 2 ( 2021-03), p. 492-496
    Abstract: VKORC1 and CYP2C9 genotypes explain less variability in warfarin dose requirements in African Americans compared with Europeans. Variants in BCKDK and GATA‐ 4 gene regions, purported to regulate VKORC1 and CYP2C9 expression, have been shown to play an important role in warfarin dose requirements in Europeans and Asians, respectively. We sought to determine whether rs56314408 near BCKDK or GATA‐4 rs2645400 influence warfarin dose requirements in 200 African Americans. Unlike the strong linkage disequilibrium (LD) between rs56314408 and VKORC1 rs9923231 in Europeans, they were not in LD in African Americans. No associations were found on univariate analysis. On multivariable analysis, rs56314408 was associated ( P  = 0.027) with dose in a regression model excluding VKORC1 rs9923231, and GATA‐4 rs2645400 was associated ( P  = 0.032) with dose in a model excluding CYP2C ( CYP2C9*2 , *3 , *5 , *6 , *8 , and *11 , CYP2C rs12777823) variants. Neither variant contributed to dose in the model that included both VKORC1 rs9923231 and CYP2C variants. Our results do not support contributions of the studied variants to warfarin dose requirements in African Americans. However, they illustrate the value of studies in African descent populations, who have low LD in their genome, in teasing out genetic variation underlying drug response associations. They also emphasize the importance of confirming associations in persons of African ancestry.
    Type of Medium: Online Resource
    ISSN: 1752-8054 , 1752-8062
    URL: Issue
    URL: Article
    DOI: 10.1111/cts.v14.2
    DOI: 10.1111/cts.12939
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2433157-0
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  • 8
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    Evaluation of CYP 2C19 Genotype‐Guided Voriconazole Prophylaxis After Allogeneic Hematopoietic Cell Transplant
    Wiley ; 2020
    In:  Clinical Pharmacology & Therapeutics Vol. 107, No. 3 ( 2020-03), p. 571-579
    Details
    In: Clinical Pharmacology & Therapeutics, Wiley, Vol. 107, No. 3 ( 2020-03), p. 571-579
    Abstract: There is a high risk of voriconazole failure in those with subtherapeutic drug concentrations, which is more common in CYP 2C19 (cytochrome P450 2C19) rapid/ultrarapid metabolizers ( RMs / UM s). We evaluated CYP 2C19 genotype‐guided voriconazole dosing on drug concentrations and clinical outcomes in adult allogeneic hematopoietic cell transplant recipients. Poor ( PM s), intermediate ( IM s), and normal metabolizers ( NM s) received voriconazole 200 mg twice daily; RMs / UM s received 300 mg twice daily. Steady‐state trough concentrations were obtained after 5 days, targeting 1.0–5.5 mg/L. Of 89 evaluable patients, 29% had subtherapeutic concentrations compared with 50% in historical controls ( P   〈  0.001). Zero, 26%, 50%, and 16% of PM s, IM s, NM s, and RMs / UM s were subtherapeutic. Voriconazole success rate was 78% compared with 54% in historical controls ( P   〈  0.001). No patients experienced an invasive fungal infection ( IFI ). Genotype‐guided dosing resulted in $4,700 estimated per patient savings as compared with simulated controls. CYP 2C19 genotype‐guided voriconazole dosing reduced subtherapeutic drug concentrations and effectively prevented IFI s.
    Type of Medium: Online Resource
    ISSN: 0009-9236 , 1532-6535
    URL: Issue
    URL: Article
    DOI: 10.1002/cpt.v107.3
    DOI: 10.1002/cpt.1642
    RVK:
    XA 36900
    Language: English
    Publisher: Wiley
    Publication Date: 2020
    detail.hit.zdb_id: 2040184-X
    SSG: 15,3
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  • 9
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    Examination of Metoprolol Pharmacokinetics and Pharmacodynamics Across CYP2D6 Genotype‐Derived Activity Scores
    Wiley ; 2020
    In:  CPT: Pharmacometrics & Systems Pharmacology Vol. 9, No. 12 ( 2020-12), p. 678-685
    Details
    In: CPT: Pharmacometrics & Systems Pharmacology, Wiley, Vol. 9, No. 12 ( 2020-12), p. 678-685
    Abstract: Recent CYP2D6 phenotype standardization efforts by CYP2D6 activity score (AS) are based on limited pharmacokinetic (PK) and pharmacodynamic (PD) data. Using data from two independent clinical trials of metoprolol, we compared metoprolol PK and PD across CYP2D6 AS with the goal of determining whether the PK and PD data support the new phenotype classification. S‐metoprolol apparent oral clearance (CLo), adjusted for clinical factors, was correlated with CYP2D6 AS ( P   〈  0.001). The natural log of CLo was lower with an AS of 1 (7.6 ± 0.4 mL/minute) vs. 2–2.25 (8.3 ± 0.6 mL/minute; P  = 0.012), similar between an AS of 1 and 1.25–1.5 (7.8 ± 0.5 mL/minute; P  = 0.702), and lower with an AS of 1.25–1.5 vs. 2–2.25 ( P =  0.03). There was also a greater reduction in heart rate with metoprolol among study participants with AS of 1 (−10.8 ± 5.5) vs. 2–2.25 (−7.1 ± 5.6; P  〈  0.001) and no significant difference between those with an AS of 1 and 1.25–1.5 (−9.2 ± 4.7; P =  0.095). These data highlight linear trends among CYP2D6 AS and metoprolol PK and PD, but inconsistencies with the phenotypes assigned by AS based on the current standards. Overall, this case study with metoprolol suggests that utilizing CYP2D6 AS, instead of collapsing AS into phenotype categories, may be the most precise approach for utilizing CYP2D6 pharmacogenomics in clinical practice.
    Type of Medium: Online Resource
    ISSN: 2163-8306 , 2163-8306
    URL: Issue
    URL: Article
    DOI: 10.1002/psp4.v9.12
    DOI: 10.1002/psp4.12563
    Language: English
    Publisher: Wiley
    Publication Date: 2020
    detail.hit.zdb_id: 2697010-7
    SSG: 15,3
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  • 10
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    Daratumumab, pomalidomide and dexamethasone combination therapy in daratumumab and/or pomalidomide refractory multiple myeloma
    Wiley ; 2019
    In:  British Journal of Haematology Vol. 186, No. 1 ( 2019-07), p. 140-144
    Details
    In: British Journal of Haematology, Wiley, Vol. 186, No. 1 ( 2019-07), p. 140-144
    Type of Medium: Online Resource
    ISSN: 0007-1048 , 1365-2141
    URL: Issue
    URL: Article
    DOI: 10.1111/bjh.2019.186.issue-1
    DOI: 10.1111/bjh.15716
    RVK:
    XA 34100
    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 1475751-5
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