Efficacy, Safety, and Pharmacokinetics of Candesartan Cilexetil in Hypertensive Children Aged 6 to 17 Years

Trachtman, Howard; Hainer, James W.; Sugg, Jennifer; Teng, Renli; Sorof, Jonathan M.; Radcliffe, Jerilynn; Walle, Johan Vande; Szabo, Laszio; Tulassay, Tivadar; Túri, Sándor; Márová, Eva; Jurko, A; Horáková, M; Achtel, Robert A.; Barcia, John; Batisky, Donald L.; Brophy, Patrick D.; Falkner, Bonita; Flynn, Joseph T.; Jenkins, Randall; Kusnoor, Vijay; Miller, Kenneth M.; Paredes, Ana; Restaino, Irene; Sherbotie, Joseph R.; Zilleruelo, Gastón; Chiang, Myra; Assadi, Farahnak; Nagaraj, Shashi; Sullivan, Janice E.; Aigbe, M.; Portman, Ronald J.; Mak, Robert H.; Moritz, Michael L.; Williams, Robert L.; Kupferman, Juan C.; Neufeld, Naomi D.; Stewart, Jeremy; Hanevold, Coral; Hazan, L.; Blummer, Jeffery; Henshaw, Melissa Howard; Headley, David M.; Primack, William A.; Feldenberg, L. Richard

doi:10.1111/j.1751-7176.2008.00022.x

Cited by 72 publications

(80 citation statements)

References 27 publications

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“…However, it differs by age with subjects $65 years exhibiting a 50 and 80% higher C max and AUC, respectively, than younger subjects (Hübner et al, 1997), but this difference does not result in a need for dose adjustments. Children experience a greater exposure upon oral administration of the same dose compared with adults, but the overall pharmacokinetic profiles within a range of 1-17 years were similar to those found in adults (Trachtman et al, 2008;Schaefer et al, 2010).…”

Section: E Age Sex and Ethnicitymentioning

confidence: 64%

A Systematic Comparison of the Properties of Clinically Used Angiotensin II Type 1 Receptor Antagonists

et al. 2013

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Section: E Age Sex and Ethnicitymentioning

confidence: 64%

A Systematic Comparison of the Properties of Clinically Used Angiotensin II Type 1 Receptor Antagonists

et al. 2013

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“…In phase 2, participants were re-randomized to continuing verum or to placebo for 2 weeks. One trial with 240 patients [18] had a similar design but had a primary placebo group in phase 1. All four RCTs had an open-label phase after phase 2 up to 52 weeks of duration for the purpose of gaining safety data.…”

Section: Study Characteristicsmentioning

confidence: 98%

“…The quality of randomization was unclear in two trials [16,19], and allocation concealment was unclear in one [16]. Participants and investigators were blinded in five trials [13,[16][17][18]20], whereas one study was open label [19]. Between 0% and 10% of patients were lost to follow-up.…”

Section: Study Qualitymentioning

confidence: 99%

“…Between 0% and 10% of patients were lost to follow-up. Three trials analyzed only the available data [16,17,19], and three used intention to treat analysis [13,18,20] with the last observation carried forward. In one trial [19], the two treatment groups were different: baseline albumin/creatinine level in the verum group was 41% higher than in the control group.…”

Section: Study Qualitymentioning

confidence: 99%

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Efficacy and safety of angiotensin II receptor type 1 antagonists in children and adolescents

et al. 2009

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Our purpose was to evaluate the effects of angiotensin II receptor type 1 antagonists (ARAs) in children and adolescents with hypertension or/and several kinds of nephropathies on blood pressure (BP) and proteinuria and to evaluate related safety issues. Data sources were Medline, Embase, The Cochrane Library, BIOSIS Previews, contact with investigators and manufacturers, personal bibliography of the lead author, and manual searches. We selected randomized controlled trials (RCTs), uncontrolled trials, and case series investigating ARAs in children and adolescents, as well as case reports about adverse events and the embryotoxic effects of ARAs in children. In four RCTs with 698 individuals, mean systolic blood pressure (BP) decreased by 10.5 mmHg [95% confidence interval (CI) 9.8-11.2] and mean diastolic BP by 6.4 mmHg (95% CI 5.8-7.0). Proteinuria decreased by 30-64% (range) in two RCTs and four case series. Safety data were comparable with adult safety data. ARAs can be considered effective and safe in lowering BP and proteinuria in the pediatric age group. The correlation between the surrogate parameters BP and proteinuria with clinical endpoints is documented to a large degree. The evidence is based on RCTs and also on lower evidence levels, such as case series. In some conditions, RCTs in children are not feasible. Registers could provide more evidence in the future.

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“…In contrast, candesartan failed to achieve the primary objective of detecting a significant slope for reduction in BP in pediatric patients because, in part, the highest doses tested did not produce additional BP lowering. 12 BP was also monitored during a placebo withdrawal period wherein one-half of the patients continued to receive OM. For cohort A, patients who had switched to placebo demonstrated …”

Section: Discussionmentioning

confidence: 99%

A Double-Blind, Dose-Response Study of the Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescents with Hypertension

et al. 2010

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Abstract-The current study investigated the efficacy and safety of olmesartan medoxomil in children with hypertension, defined as systolic blood pressure measured at or above the 95th percentile (90th percentile for patients with diabetes, glomerular kidney disease, or family history of hypertension) for age, gender, and height while off any antihypertensive medication. The active treatment phase was conducted in 2 periods, with 2 cohorts in each period (cohort A, 62% white; cohort B, 100% Black). In period 1, patients stratified by weight received low-dose (2.5 or 5 mg) or high-dose (20 or 40 mg) olmesartan medoxomil daily for 3 weeks. In period 2, patients maintained their olmesartan medoxomil dose or initiated placebo washout for an additional 2 weeks. Period 1 efficacy results showed a dose-dependent, statistically significant reduction in seated trough systolic and diastolic blood pressure for both cohorts, with mean blood pressure reductions numerically smaller in cohort B than in cohort A. The olmesartan medoxomil dose response remained statistically significant when adjusted for body weight. In period 2, blood pressure control decreased in those patients switching to placebo, whereas patients continuing to receive olmesartan medoxomil therapy maintained consistent blood pressure reduction. Adverse events were generally mild and unrelated to study medication. Olmesartan medoxomil was safe and efficacious in children with hypertension, resulting in significant blood pressure reductions. Key Words: adolescent Ⅲ angiotensin receptor blocker Ⅲ children Ⅲ hypertension Ⅲ olmesartan medoxomil Ⅲ safety H ypertension is an increasingly recognized disease in children and adolescents, yet it often remains undiagnosed and untreated. 1-4 Contributory factors include genetic background and increased childhood obesity, with a longterm health risk of potentially devastating consequences, including target organ damage. 2,3 The genetic component of hypertension is exemplified by a comparatively greater rise in blood pressure (BP) through adolescence for children of parents with hypertension compared with those of parents with normotension. 5 Considering the long-term impact of hypertension on quality of life, morbidity, and mortality, controlling BP to recommended levels is imperative in children. A major consequence of untreated pediatric hypertension is the development of left ventricular hypertrophy, which has been reported in more than 40% of children with hypertension. 6 However, the current management of pediatric hypertension is inadequate. As recently highlighted by the Chronic Kidney Disease in Children study, 37% of children with chronic kidney disease were diagnosed with elevated BP, and yet 39% of these were not receiving antihypertensive medication. 4 The goal of treatment in pediatric hypertension is to reduce BP below the 95th percentile for age, gender, and height or below the 90th percentile for those patients with comorbidity. 1 Lifestyle modifications, including a lowsodium diet, increased exercise, and ...

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Efficacy, Safety, and Pharmacokinetics of Candesartan Cilexetil in Hypertensive Children Aged 6 to 17 Years

Cited by 72 publications

References 27 publications

A Systematic Comparison of the Properties of Clinically Used Angiotensin II Type 1 Receptor Antagonists

A Systematic Comparison of the Properties of Clinically Used Angiotensin II Type 1 Receptor Antagonists

Efficacy and safety of angiotensin II receptor type 1 antagonists in children and adolescents

A Double-Blind, Dose-Response Study of the Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescents with Hypertension

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