Systematic evaluation of the pre-eclampsia drugs, dietary supplements and biologicals pipeline using target product profiles

McDougall, Annie R A; Hastie, Roxanne; Goldstein, Maya; Tuttle, Andrew; Tong, Stephen; Ammerdorffer, Anne; Gülmezoglu, A. Metin; Vogel, Joshua P.

doi:10.1186/s12916-022-02582-z

Cited by 9 publications

(11 citation statements)

References 39 publications

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“…Many medications, dietary supplements, and herbal treatments have been investigated for the prevention and treatment of PE [ 242 , 243 ]. One systematic evaluation using target product profiles identified 153 candidates for PE.…”

Section: Identification Assessment and Management Of Women With Pcos ...mentioning

confidence: 99%

“…One systematic evaluation using target product profiles identified 153 candidates for PE. Of the 87 candidates in clinical development, 5 were classified as having high potential for the prevention of PE (esomeprazole, l-arginine, chloroquine, vitamin D, and metformin), and 4 as having medium potential for the prevention of PE (probiotic lactobacilli, dalteparin, selenium, and omega-3 fatty acid) [ 242 ]. Calcium supplementation has been shown to reduce the risk of PE in populations with low dietary calcium intake [ 243 ].…”

Section: Identification Assessment and Management Of Women With Pcos ...mentioning

confidence: 99%

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Reducing the Risk of Pre-Eclampsia in Women with Polycystic Ovary Syndrome Using a Combination of Pregnancy Screening, Lifestyle, and Medical Management Strategies

Parker,

O’Brien,

Yeoh

et al. 2024

JCM

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Polycystic ovary syndrome (PCOS) is a multisystem disorder that presents with a variety of phenotypes involving metabolic, endocrine, reproductive, and psychological symptoms and signs. Women with PCOS are at increased risk of pregnancy complications including implantation failure, miscarriage, gestational diabetes, fetal growth restriction, preterm labor, and pre-eclampsia (PE). This may be attributed to the presence of specific susceptibility features associated with PCOS before and during pregnancy, such as chronic systemic inflammation, insulin resistance (IR), and hyperandrogenism, all of which have been associated with an increased risk of pregnancy complications. Many of the features of PCOS are reversible following lifestyle interventions such as diet and exercise, and pregnant women following a healthy lifestyle have been found to have a lower risk of complications, including PE. This narrative synthesis summarizes the evidence investigating the risk of PE and the role of nutritional factors in women with PCOS. The findings suggest that the beneficial aspects of lifestyle management of PCOS, as recommended in the evidence-based international guidelines, extend to improved pregnancy outcomes. Identifying high-risk women with PCOS will allow targeted interventions, early-pregnancy screening, and increased surveillance for PE. Women with PCOS should be included in risk assessment algorithms for PE.

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Section: Identification Assessment and Management Of Women With Pcos ...mentioning

confidence: 99%

Section: Identification Assessment and Management Of Women With Pcos ...mentioning

confidence: 99%

Reducing the Risk of Pre-Eclampsia in Women with Polycystic Ovary Syndrome Using a Combination of Pregnancy Screening, Lifestyle, and Medical Management Strategies

Parker,

O’Brien,

Yeoh

et al. 2024

JCM

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“…Recognising the potential opportunity to improve obstetrical outcomes, a systematic framework has been developed recently to identify medications that should be considered for further trials and regulatory assessment. 72 Most of these compounds have been developed for other clinical indications and been repurposed for the prevention of pre-eclampsia. Consistent with aspirin, two of the candidate medications, metformin and pravastatin, act in part through the COX-2 mechanism.…”

Section: Other Medications That May Be Beneficialmentioning

confidence: 99%

“…A lack of approved medications vetted through regulatory processes reflects minimal investment in phase II–IV trials that examine maternal–child outcomes, in part because of the medico‐legal concerns of drug developers. Recognising the potential opportunity to improve obstetrical outcomes, a systematic framework has been developed recently to identify medications that should be considered for further trials and regulatory assessment 72 . Most of these compounds have been developed for other clinical indications and been repurposed for the prevention of pre‐eclampsia.…”

Section: Potential Therapeutic Treatments For the Great Obstetrical S...mentioning

confidence: 99%

The great obstetrical syndromes and the placenta

Hoffman

2023

BJOG

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Although historically pre‐eclampsia, preterm birth, abruption, fetal growth restriction and stillbirth have been viewed as clinically distinct entities, a growing body of literature has demonstrated that the placenta and its development is the root cause of many cases of these conditions. This has led to the term ‘the great obstetrical syndromes’ being coined to reflect this common origin. Although these conditions mostly manifest in the second half of pregnancy, a failure to complete deep placentation (the transition from histiotrophic placentation to haemochorial placenta at 10–18 weeks of gestation via a second wave of extravillous trophoblast invasion), is understood to be key to the pathogenesis of the great obstetrical syndromes. While the reasons that the placenta fails to achieve deep placentation remain active areas of investigation, maternal inflammation and thrombosis have been clearly implicated. From a clinical standpoint these mechanisms provide a biological explanation of how low‐dose aspirin, which affects the COX‐1 receptor (thrombosis) and the COX‐2 receptor (inflammation), prevents not just pre‐eclampsia but all the components of the great obstetrical syndromes if initiated early in pregnancy. The optimal dose of low‐dose aspirin that is maximally effective in pregnancy remains a question open for further research. Additionally, other candidate medications have been identified that may also prevent pre‐eclampsia, and further study of them may offer therapeutic options beyond low‐dose aspirin. Interestingly, three of the eight identified compounds (hydroxychloroquine, metformin and pravastatin) are known to decrease inflammation.

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“…That is, assessment of device capability against TPP criteria can help identify those devices that best meet pre-specified clinical and operational needs, or the most promising candidates for further development. A TPP-based matching approach has been used previously to identify high-potential candidates for new obstetric medicines [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

Portable digital devices for paediatric height and length measurement: A scoping review and target product profile matching analysis

Soller,

Huang,

Horiuchi

et al. 2023

PLoS ONE

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Background Routine anthropometry of children, including length/height measurement, is an essential component of paediatric clinical assessments. UNICEF has called for the accelerated development of novel, digital height/length measurement devices to improve child nutrition and growth surveillance programs. This scoping review aimed to identify all digital, portable height/length measurement devices in the literature or otherwise available internationally. We also assessed identified devices against the UNICEF Target Product Profile (TPP) to identify those of highest potential for clinical and public health use. Method We searched four databases (Medline, Embase, CINAHL and Global Health) and the grey literature between 1st January 1992 and 2nd February 2023. We looked for studies or reports on portable, digital devices for height or length measurement in children up to 18 years old. Citations were screened independently by two reviewers, with data extraction and quality assessment performed in duplicate and disagreements resolved. Devices were evaluated and scored against the 34 criteria of the UNICEF TPP. Results Twenty studies describing twelve height/length measurement devices were identified, most of which used prospective validation designs. Additional devices were found in the grey literature, but these did not report key performance data so were not included. Across the twelve devices, only 10 of 34 UNICEF criteria on average could be fully assessed. Six met UNICEF’s ideal accuracy standard and one device met the minimum accuracy standard. The Leica DistoD2 device scored highest (41%), followed by Autoanthro in a controlled environment (33%) and GLM30 (32%). These devices may be high potential for further assessment and development, though further research is required. Conclusion While 12 portable, digital devices exist for child height/length measurement, insufficient data are available to fully assess whether they meet the industry’s needs. Although some devices show promise, further research is needed to test the validity of these devices in varying contexts, and continued development and commercialization will be important to improve reliability and precision of these devices for widespread use.

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Systematic evaluation of the pre-eclampsia drugs, dietary supplements and biologicals pipeline using target product profiles

Cited by 9 publications

References 39 publications

Reducing the Risk of Pre-Eclampsia in Women with Polycystic Ovary Syndrome Using a Combination of Pregnancy Screening, Lifestyle, and Medical Management Strategies

Reducing the Risk of Pre-Eclampsia in Women with Polycystic Ovary Syndrome Using a Combination of Pregnancy Screening, Lifestyle, and Medical Management Strategies

The great obstetrical syndromes and the placenta

Portable digital devices for paediatric height and length measurement: A scoping review and target product profile matching analysis

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