Delving into the Latest Updates on Menadiol Sodium Diphosphate with Synapse

In the study by Lees et al, biol. efficacy was tested in 72/90 patients.Yet, the majority of these patients had dp-ucMGP levels <900 pmol/L at both timepoints, and were therefore defined as 900 pmol/L (figure 2 in the paper by Lees et al).Therefore, the biol. efficacy seems merely based on a small subgroup of patients with more severe vitamin K deficiency.This is a concern since dp-ucMGP was the only vitamin K status marker used and the efficacy of menadiol diphosphate to improve vascular vitamin K status had not been previously studied.Moreover, the efficacy of vitamin K supplementation in a population that was in majority vitamin Ksufficient may be questioned.

01 Oct 2021·American Journal of TransplantationQ1 · MEDICINE

The ViKTORIES trial: A randomized, double-blind, placebo-controlled trial of vitamin K supplementation to improve vascular health in kidney transplant recipients

Q1 · MEDICINE

Article

Author: Rutherford, Elaine ; Lees, Jennifer S ; Mangion, Kenneth ; Roditi, Giles H ; Witham, Miles D ; Rankin, Alastair J ; Zhu, Luke Y ; Jardine, Alan G ; Mark, Patrick B ; Panarelli, Maurizio ; Gillis, Keith A ; Chantler, Donna

Premature cardiovascular disease and death with a functioning graft are leading causes of death and graft loss, respectively, in kidney transplant recipients (KTRs). Vascular stiffness and calcification are markers of cardiovascular disease that are prevalent in KTR and associated with subclinical vitamin K deficiency. We performed a single-center, phase II, parallel-group, randomized, double-blind, placebo-controlled trial (ISRCTN22012044) to test whether vitamin K supplementation reduced vascular stiffness (MRI-based aortic distensibility) or calcification (coronary artery calcium score on computed tomography) in KTR over 1 year of treatment. The primary outcome was between-group difference in vascular stiffness (ascending aortic distensibility). KTRs were recruited between September 2017 and June 2018, and randomized 1:1 to vitamin K (menadiol diphosphate 5 mg; n = 45) or placebo (n = 45) thrice weekly. Baseline demographics, clinical history, and immunosuppression regimens were similar between groups. There was no impact of vitamin K on vascular stiffness (treatment effect -0.23 [95% CI -0.75 to 0.29] × 10^-3 mmHg^-1 ; p = .377), vascular calcification (treatment effect -141 [95% CI - 320 to 38] units; p = .124), nor any other outcome measure. In this heterogeneous cohort of prevalent KTR, vitamin K supplementation did not reduce vascular stiffness or calcification over 1 year. Improving vascular health in KTR is likely to require a multifaceted approach.

01 Jun 2021·Skin Health and Disease

Prevalence and treatment of vitamin K deficiency in paediatric patients with recessive dystrophic epidermolysis bullosa‐severe subtype

Article

Author: Martinez, A. ; Yerlett, N. ; Holsgrove, K. ; Petrof, G.

AbstractIntroductionPatients with recessive dystrophic epidermolysis bullosa‐severe subtype (RDEB‐S) are at risk of vitamin K deficiency, potentially causing abnormal clotting, excessive bleeding, poor bone metabolism and abnormal vascular calcification. This study quantifies vitamin K deficiency prevalence in this cohort and identifies potential risk‐factors to prevent deficiency.MethodsPatients with RDEB‐S who attended the EB service between 2014 and 2020 were included. Serum vitamin K and PIVKAII were measured as part of the usual nutritional blood screen. Dietetic and medical notes were reviewed to establish: antibiotic use, enteral feed intake and micronutrient supplementation.ResultsA total of 16/25 64% (10/16 female), of children aged 22–180 months, had serum vitamin K and PIVKAII analysed. Six of sixteen (37.5%) patients had vitamin K deficiency requiring supplementation. Two of six (33.3%) normalized serum vitamin K after 12 weeks supplementation with oral menadiol diphosphate. Four of six (66.6%) await retesting following supplementation. Six of six (100%) patients with vitamin K deficiency were not consuming a gastrostomy/sip feed. Nine of ten (90%) patients with sufficient vitamin K levels were consuming either; more than 200 ml prescribed sip feed or more than 400–800 ml gastrostomy feed daily (containing 5.9–11 µg/100 ml vitamin K). Patients who were consuming either more than 200 ml prescribed sip feed or more than 400–800 ml gastrostomy feed daily (containing 5.9–11 µg/100 ml vitamin K) were significantly less likely to suffer from vitamin K deficiency (0.08 odds ratio [(1/7)/(5/3)] with significance level p = 0.0342 [95% CI: 0.0074–0.8275]). Sixteen of sixteen (100%) received antibiotics (range 0–4 courses/year; median, 3; IQR, 3). Patients with the most frequent antibiotics (n = 4) had normal vitamin K and PIVKAII levels if they consumed a minimum of 200 ml prescribed sip feed or 400–800 ml gastrostomy feed daily. Sixteen of sixteen (100%) patients took a multivitamin/mineral supplement; none contained vitamin K.SummaryThe prevalence of vitamin K deficiency is 37.5% in this cohort. Patients whom were not consuming gastrostomy/sip feeds of at least 200 ml daily were at greatest risk of vitamin K deficiency. Patients on a micronutrient supplement remain at risk of vitamin K deficiency, as most contain no vitamin K. Prescribing a vitamin/mineral supplement that contains vitamin K is recommended. Twelve‐week supplementation of oral vitamin K (5 mg/day for 1–10 years and 10 mg/day for 12–17 years) adequately improved stores.

100 Deals associated with Menadiol Sodium Diphosphate

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KEGG	Wiki	ATC	Drug Bank
D04908	Menadiol Sodium Diphosphate	-	DB14650

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Biliary pain	Phase 2	CN	Wuxi Jialing Medicine Co., Ltd.	07 Sep 2011
Biliary pain	Phase 2	CN	Guangdong Aimin Pharmaceutical Co., Ltd.	07 Sep 2011
Cholelithiasis	Phase 2	CN	Wuxi Jialing Medicine Co., Ltd.	07 Sep 2011
Cholelithiasis	Phase 2	CN	Guangdong Aimin Pharmaceutical Co., Ltd.	07 Sep 2011
Hypoprothrombinemias	Phase 2	CN	Wuxi Jialing Medicine Co., Ltd.	07 Sep 2011
Hypoprothrombinemias	Phase 2	CN	Guangdong Aimin Pharmaceutical Co., Ltd.	07 Sep 2011
Biliary Fistula	Phase 1	CN	Guangdong Aimin Pharmaceutical Co., Ltd.	22 Sep 2012
Chronic diarrhea	Phase 1	CN	Guangdong Aimin Pharmaceutical Co., Ltd.	22 Sep 2012
Chronic diarrhea	Discovery	CN	Wuxi Jialing Medicine Co., Ltd.	22 Sep 2012