Fundus EDucation: Analysing the utility of an online education tool in improving the diagnostic accuracy of non-mydriatic fundus photography image interpretation amongst Emergency Doctors and Medical Students

Start Date19 Jul 2021

Sponsor / Collaborator

The University of New South Wales

CTR20180976

/ CompletedNot Applicable

阿折地平片（16mg）在中国健康受试者中空腹和餐后人体生物等效性试验

[Translation] Bioequivalence study of azelnidipine tablets (16 mg) in Chinese healthy subjects after fasting and feeding

按有关生物等效性试验的规定，选择Daiichi Sankyo Co., Ltd.生产的阿折地平片（商品名：Calblock®，规格：16mg/片）为参比制剂，对合肥英太制药有限公司生产的阿折地平片进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收程度和吸收速度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹及餐后给药条件下的生物等效性。

[Translation]

According to the relevant provisions of bioequivalence tests, Azelnidipine Tablets (trade name: Calblock®, specification: 16 mg/tablet) produced by Daiichi Sankyo Co., Ltd. were selected as the reference preparation, and a human bioequivalence test of Azelnidipine Tablets produced by Hefei Yingtai Pharmaceutical Co., Ltd. was carried out on fasting and fed administration to compare whether the differences in the absorption degree and absorption rate of the drug in the test preparation were within an acceptable range with those of the reference preparation, and to compare the bioequivalence of the two preparations under fasting and fed administration conditions.

Start Date25 Jul 2018

Sponsor / Collaborator

Hefei Yingtai Pharmaceutical Co Ltd.

NCT02808026

/ CompletedPhase 3

A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Patients With Severe Hypertension (Grade III)

To examine antihypertensive effect and safety of administration of CS-3150 in patients with severe hypertension (Grade III).

Start Date01 Jun 2016

Sponsor / Collaborator

Daiichi Sankyo Co., Ltd.

100 Clinical Results associated with Hypertension, severe

100 Translational Medicine associated with Hypertension, severe

0 Patents (Medical) associated with Hypertension, severe

159

Literatures (Medical) associated with Hypertension, severe

15 Jan 2025·The Journal of Maternal-Fetal & Neonatal Medicine

Race/ethnicity differences in response to acute antihypertensive treatment of peripartum severe hypertension

Article

Author: Kilpatrick, Sarah J. ; Pon, Fay F. ; Greene, Naomi H.

BACKGROUNDHypertensive disorders of pregnancy increase maternal morbidity, mortality, and long-term risk for cardiovascular disease. The rising incidence of chronic hypertension and preeclampsia disproportionately affects people of color. There is a paucity of published data examining differences in the effectiveness of acute antihypertensive agents between pregnant patients of different races/ethnicities. We aimed to determine if the effectiveness of acute antihypertensive agents for peripartum severe hypertension differs by race/ethnicity.METHODSA retrospective cohort study of patients with severe peripartum hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 110 mm Hg confirmed within 15 min) to determine whether the effectiveness of blood pressure control using nationally recommended medications (hydralazine, labetalol, nifedipine) differed by race/ethnicity. The primary outcome was reduction and maintenance of blood pressure to target ranges (140-150/90-100 mm Hg or below) for ≥4 h in each race/ethnicity group. Statistical tests included χ², Fisher's exact, analysis of variance, and multivariable logistic regression.RESULTSOf 729 patients receiving treatment for severe peripartum hypertension, all medications were effective (overall 86.4% efficacy) at controlling blood pressure. Labetalol was the most effective medication in White patients (93.0 vs. 74.7% for nifedipine and 86.5% for hydralazine, p < .001). No overall differences in medication effectiveness were found in Black, Asian, or LatinX patients. Black and Asian patients were more likely to experience >1 hypertensive episode [51.0 and 49.0%, respectively vs. 35.4% (White) and 40.0% (LatinX), p = .008].CONCLUSIONCurrently recommended therapies for severe peripartum hypertension are effective in controlling blood pressure for ≥4 h in patients of all race/ethnic groups. Labetalol was the most effective medication in White patients with no overall differences in medication effectiveness in Black, Asian, or LatinX patients.

01 Jan 2025·American Journal of Perinatology

Factors Associated with Refractory Severe Hypertension in Patients with Preeclampsia

Article

Author: Rastegar, Aref ; Francis, Matilda ; Nehme, Lea ; Gupta, Neha ; Vishnia, Maya ; Kawakita, Tetsuya ; Flicker, Kari ; Gilgannon, Lauren ; Wright, Madeleine ; Siva, Rohini Kousalya ; King, Kenyone S. ; Saade, George ; Sibai, Baha M. ; Long, Danielle

Objective This study aimed to identify factors associated with refractory severe hypertension that does not resolve after an initial dose of antihypertensive medication in patients with preeclampsia. Study Design This was a retrospective study of all pregnant and postpartum individuals with a diagnosis of preeclampsia, superimposed preeclampsia, HELLP (hemolysis, elevated liver enzymes, low platelet) syndrome, or eclampsia who delivered at 22 weeks or greater at a single academic institution from 2010 to 2020. Inclusion criteria were patients with preeclampsia who developed severe hypertension (systolic pressure ≥160 mm Hg or diastolic pressure ≥110 mm Hg) and received antihypertensive medications for acute severe hypertension. We defined refractory severe hypertension as a systolic blood pressure of ≥160 mm Hg or a diastolic blood pressure of ≥110 mm Hg that did not improve after receiving the initial treatment. To evaluate for factors associated with refractory severe hypertension, we developed multivariable modified Poisson regression using all variables with p-value <0.1 on bivariable analysis and calculated adjusted relative risks (aRRs) with 95% confidence intervals (95% CIs). Results Of 850, 386 (45.4%) had refractory severe hypertension and 464 (54.6%) responded to the initial antihypertensive medications. Factors associated with refractory severe hypertension included higher body mass index (BMI), chronic hypertension, and higher systolic pressure. Every 5 kg/m2 increase in BMI was associated with a 7% increased risk of refractory severe hypertension (aRR = 1.07; 95% CI: 1.02–1.12). Every 10 mm Hg increase in systolic blood pressure was associated with a 10% increased risk of refractory severe hypertension (aRR = 1.10; 95% CI: 1.04–1.17). Chronic hypertension was associated with a 25% increased risk of refractory severe hypertension (aRR = 1.25; 95% CI: 1.01–1.56) in the diastolic pressure model. Conclusion Refractory severe hypertension was associated with elevated BMI, chronic hypertension, and higher systolic blood pressure. Key Points

01 Dec 2024·Pregnancy Hypertension

The association between first trimester blood pressure, blood pressure trajectory, mid-pregnancy blood pressure drop and maternal and fetal outcomes: A systematic review and meta-analysis

Review

Author: Moes, Shinta L ; Bekker, Mireille N ; Depmann, Martine ; Lely, A Titia ; van de Kam, Lieke

BACKGROUNDHypertensive disorders of pregnancy occur in 5-10 % of pregnancies and are associated with an increased risk of adverse perinatal outcomes.OBJECTIVESThis review investigates the association between first trimester blood pressure (BP), mid-pregnancy BP drop, and BP-trajectories during pregnancy and adverse perinatal outcomes, exploring the fit of prediction and prevention.SEARCH STRATEGYObservational studies published before September 2023, reporting on desired determinants of BP and outcomes (preeclampsia (PE), severe hypertension, small for gestational age (SGA), fetal growth restriction (FGR)) were identified in MEDLINE, Embase and Cochrane.DATA COLLECTION AND ANALYSISData were collected in Excel. Results were analysed per BP-determinant. Meta analysis was performed for first trimester BP.MAIN RESULTSTen studies met selection criteria. A great variety of cut-off values were used for BP categorization. Pooled analysis of 6 studies showed that women with borderline or hypertensive first trimester BP had a higher risk of PE compared to normotensive BP, OR 3.23 (95 % CI 1.99-5.26) and 7.86 (95 % CI 1.28-48.31), respectively. Additionally, first trimester hypertension correlated with a higher risk of SGA neonate (pooled OR of 1.87 (95 % CI 1.17-2.99)) compared to normotension or borderline hypertension. Throughout pregnancy, prehypertension, hypertension, elevated and high stable trajectories increased PE risk. High-stable trajectory increased SGA neonate risk.CONCLUSIONSThe findings suggest that women with borderline and hypertensive BP in the first trimester are at increased risk for PE and SGA. However, standardization of cut-off values and BP measurement is necessary to estimate outcome risks more accurately.

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