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Reflections on the Lack of Consideration of Ethnic Ancestry to Stratify Clozapine Dosing
Jose de Leon(Jose de Leon ) 대한신경정신의학회 2023 PSYCHIATRY INVESTIGATION Vol.20 No.3
This review article argues against trusting standard clozapine references, including the US package insert, because they do not include advances in the sciences of pharmacokinetics and pharmacovigilance and ignore the effects of ethnic ancestry on therapeutic dosing. The minimum therapeutic dose leading to the minimum therapeutic concentration of 350 ng/mL in serum/plasma can be used to compare individuals/groups with treatment-resistant schizophrenia. The US clozapine package insert recommends targeting doses of 300-450 mg/day and, subsequently, increments of up to 100 mg with a maximum dose of 900 mg/day. Ethnic ancestry is defined by DNA ancestry group. Asians (people with ancestry ranging from Pakistan to Japan) and Indigenous Americans are similar in clozapine dosing; their average clozapine minimum therapeutic dose ranged from 166 mg/day (female non-smokers) to 270 mg/day (male smokers). For those with European ancestry, average clozapine minimum therapeutic doses ranged from 236 mg/day (female non-smokers) to 368 mg/day (male smokers). Based on limited studies, Black (African sub-Saharan ancestry) patients may be treated with typical US doses (300-600 mg/day), assuming no poor metabolism (PM) status. Ancestry’s impact on clozapine lethality in four countries is discussed (two countries with highly homogenous populations, Denmark and Japan, and two countries with increasingly heterogenous populations due to immigration, Australia and the UK). An international guideline with 104 authors from 50 countries/regions was recently published, providing 6 personalized clozapine titration schedules for adult inpatients (3 ancestry groups and PM/non-PM schedules) and recommending c-reactive protein monitoring at baseline and weekly for 4 weeks.
Leon-Hernandez, Saul Renan,Padilla, Eleazar Lara,Algara, Alfredo Cortes,Rodriguez, Noemi Cardenas,Sanchez, Esau Floriano,Cruz, Jaime Lopez,Barradas, Cesar Miguel Mejia,Bandala, Cindy Asian Pacific Journal of Cancer Prevention 2014 Asian Pacific journal of cancer prevention Vol.15 No.14
Background: An association between alcohol/tobacco use and risk of metastasis in breast cancer has been clearly shown. Materials and Methods: The present study explored, in 48 samples of tissue from mammary ductal carcinoma (taken from Mexican women with an average age of $58.2{\pm}10.9$ years), the association of risk of metastasis with the status of hormonal receptors and the c-erbB2 protein (by immunohistochemistry) as well as clinical, histopathological and sociodemographic factors. Results: Of 48 patients, 41.6% (20/48) presented with metastasis, 43.8% were positive for the estrogen receptor (RE+), 31.3% for the progesterone receptor (RP+) and 47.7% for c-erbB2 (c-erbB2+). The following combinations were found: RE+/RP+/c-erbB2+ 8.3%, RE+/RP+ 22.9%, RE+/RP- 20.8%, RE-/RP+ 8.3%, RE-/RP-/c-erbB2- 22.9% and RE-/RP- 47.8%. There were 12 patients who used alcohol/tobacco, of which 91.6% did not present metastasis and 81.9% were RE-/RP-. Compared to the RE-/RP-/c-erbB2+, the RE+/RP+/c-erbB2+ group had a 15-fold greater risk for metastasis (95%CI, 0.9-228.8, p=0.05). The carriers of the double negative hormonal receptors had a 4.7 fold greater probability of being (or having been) smokers or drinkers (95%CI, 1.0-20.4, p = 0.03). Conclusions: There was a clear protective effect of using alcohol and/or tobacco, in the cases included in the present study of mammary ductal carcinoma, associated with double negative hormonal receptors. However, this association could be due to a protective factor not measured (Neyman bias) or to a bias inherent in the rate of hospitalization (Berkson fallacy). This question should be explored in a broad prospective longitudinal study.
Mechanical properties of whey protein/Na alginate gel microparticles
Leon, A.M.,Medina, W.T.,Park, D.J.,Aguilera, J.M. Applied Science Publishers 2016 Journal of food engineering Vol.188 No.-
<P>A proportion of the fast-growing elderly population needs special foods which are soft to chew and easily swallowed. Gel microparticles, GMP, (e.g., less than 100 mu m in size) are an alternative as texture modifiers in liquid and pureed foods, and may be used as carriers of needed flavors and nutrients. GMP (sizes < 40 mu m) were fabricated from whey protein isolate (WPI)/sodium alginate (NaAlg) mixtures by size reduction of bulk gels made by the cold-gelation method. A cell test based on back extrusion was designed to evaluate the mechanical properties of a GMP paste and image analysis techniques implemented to resolve the size of GMP. A good correlation (R-2 = 0.89) was obtained between the stress (at 60% strain) of bulk gels and that of GMP. Compression stress at 30% strain depended on the concentrations of WPI and NaAlg and a maximum was observed at intermediate values. Through Principal Component Analysis gels with low and high sodium alginate contents were clearly explaining 93% of the variability. The ample range of mechanical properties of GMP suggest that they may be used to design or modify the texture of soft foods. (C) 2016 Elsevier Ltd. All rights reserved.</P>
Building a Peace Regime in Korea: An American View
Leon V. Sigal 통일연구원 2006 International journal of korean unification studie Vol.15 No.1
Mutual deterrence makes the risk of deliberate aggression on the Korean Peninsula quite low, but the very steps that both sides have taken to deter pre-meditated war have increased the risk of inadvertent war. For a peace treaty to be militarily meaningful, the force postures and war plans on both sides that pose an excessive risk of pre-emptive war have to be altered. That will require mutual and reciprocal, though not necessarily identical steps by both sides to defuse the volatile standoff at the DMZ. That is a demanding task, and one that is unlikely to succeed without fostering a conducive political environment first. One way to foster that environment is a series of peace agreements, as distinct from a peace treaty, that establishes a new three.way peace mechanism and develops some politically useful, though militarily less meaningful, confidencebuilding measures. Such peace agreements, in which the United States is a signatory, are a way to give the DPRK a form of diplomatic recognition, thereby facilitating a resolution of the current nuclear crisis. The September 19, 2006 joint statement gives impetus to this effort when it says “the directly related parties will negotiate a permanent peace regime on the Korean Peninsula at an appropriate separate forum.” Mutual deterrence makes the risk of deliberate aggression on the Korean Peninsula quite low, but the very steps that both sides have taken to deter pre-meditated war have increased the risk of inadvertent war. For a peace treaty to be militarily meaningful, the force postures and war plans on both sides that pose an excessive risk of pre-emptive war have to be altered. That will require mutual and reciprocal, though not necessarily identical steps by both sides to defuse the volatile standoff at the DMZ. That is a demanding task, and one that is unlikely to succeed without fostering a conducive political environment first. One way to foster that environment is a series of peace agreements, as distinct from a peace treaty, that establishes a new three.way peace mechanism and develops some politically useful, though militarily less meaningful, confidencebuilding measures. Such peace agreements, in which the United States is a signatory, are a way to give the DPRK a form of diplomatic recognition, thereby facilitating a resolution of the current nuclear crisis. The September 19, 2006 joint statement gives impetus to this effort when it says “the directly related parties will negotiate a permanent peace regime on the Korean Peninsula at an appropriate separate forum.”