Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled diabetic retinopathy candesartan trials

Porta, Massimo; Hainer, James W.; Jansson, S-O; Malm, Anders; Bilous, Rudy; Chaturvedi, Nish; Fuller, John; Klein, Ron; Orchard, Trevor J.; Parving, Hans‐Henrik; Sjølie, A. K.

doi:10.1007/s00125-010-2040-1

Cited by 42 publications

(23 citation statements)

References 14 publications

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“…Six articles were excluded from the analysis because the listed cases were not described in detail [76][77][78][79][80][81] ; however, these reports were further explored for the description of the prevalence and general aspects of fetal RAS-blockade syndrome (see the online-only Data Supplement Expanded Results section with Figure S2) and the analysis of the prevalence of major congenital malformations.…”

Section: Search Resultsmentioning

confidence: 99%

“…76,[79][80][81] It is worthy of mention that the congenital malformations that occur following in utero exposure to a blocker of the RAS may result either directly from the drug as well as from the underlying maternal illness. It is well-recognized, for example, that pregestational diabetes mellitus is associated with a 2-to 3-fold increase in risk of malformations.…”

Section: Bullo Et Al Fetal Renin-angiotensin System Blockade Syndromementioning

confidence: 99%

See 1 more Smart Citation

Pregnancy Outcome Following Exposure to Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor Antagonists

Bullo

Tschumi²,

Bucher³

et al. 2012

Hypertension

273

150

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Abstract-The objective was to analyze the outcome following prenatal exposure to angiotensin-converting enzyme inhibitors (ACE-Is) or angiotensin receptor antagonists (ARBs). For this purpose, a systematic review of published case reports and case series dealing with intrauterine exposure to ACE-Is or to ARBs using Medline as the source of data was performed. The publications retained for analysis included patients who were described individually, revealing, at minimum, the gestational age, substance used, period of medication intake, and the outcome. In total, 72 reports were included; 37 articles (118 well-documented cases) described the prenatal exposure to ACE-Is; and 35 articles (68 cases) described the prenatal exposure to ARBs. Overall, 52% of the newborns exposed to ACE-Is and 13% of the newborns exposed to ARBs did not exhibit any complications (PϽ0.0001). Neonatal complications were more frequent following exposure to ARBs and included renal failure, oligohydramnios, death, arterial hypotension, intrauterine growth retardation, respiratory distress syndrome, pulmonary hypoplasia, hypocalvaria, limb defects, persistent patent ductus arteriosus, or cerebral complications. The long-term outcome is described as positive in only 50% of the exposed children. Fetopathy caused by exposure to ACE-Is or ARBs has relevant neonatal and long-term complications. The outcome is poorer following exposure to ARBs. We propose the term "fetal renin-angiotensin system blockade syndrome" to describe the related clinical findings. Thirty years after the first description of ACE-I fetopathy, relevant complications are, at present, regularly described, indicating that the awareness of the deleterious effect of prenatal exposure to drugs inhibiting the renin-angiotensin system should be improved. A n undamaged renin-angiotensin system (RAS) is a prerequisite for normal prenatal renal development. Loss of function mutations in the genes encoding the RAS present with a disturbed renal development, characterized by reduced fetal diuresis, leading to oligohydramnios and, occasionally, skull-ossification defects. At birth, blood pressure is low, and death occurs in most cases.1 This clinical scenario resembles the findings, first reported by Guignard et al 2 and Duminy et al 3 in 1981, in infants exposed during pregnancy to drugs that block the RAS. This condition, which occurs following maternal treatment with either angiotensinconverting enzyme inhibitors (ACE-Is) or angiotensin receptor antagonists (ARBs), is usually termed fetal reninangiotensin system blockade syndrome (fetal RAS-blockade syndrome). Some data also indicate a possible association between the use of these drugs during the first trimester of pregnancy and congenital malformations.Because the adverse effects of drugs that block the RAS in the unborn child have been described only in single-case reports or in small case series, we performed a formal systematic analysis of the literature that addresses the intrauterine exposure to ACE-Is or ARBs. Our purposes in con...

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Section: Search Resultsmentioning

confidence: 99%

Section: Bullo Et Al Fetal Renin-angiotensin System Blockade Syndromementioning

confidence: 99%

Pregnancy Outcome Following Exposure to Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor Antagonists

Bullo

Tschumi²,

Bucher³

et al. 2012

Hypertension

273

150

View full text Add to dashboard Cite

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“…The only congenital malformation reported was a ventricular septal defect in the placebo group. The DIRECT experience indicates that exposure to a relatively high dosage of candesartan cilexetil, 32 mg/day, for up to 8 weeks into the first trimester of pregnancy may not result in a higher rate of malformations than placebo in normotensive normoalbuminuric women with type 1 diabetes 31,32,41…”

Section: Comparative Safety and Tolerabilitymentioning

confidence: 99%

Differential clinical profile of candesartan compared to other angiotensin receptor blockers

Cernes

Mashavi²,

Zimlichman³

2011

VHRM

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The advantages of blood pressure (BP) control on the risks of heart failure and stroke are well established. The renin-angiotensin system plays an important role in volume homeostasis and BP regulation and is a target for several groups of antihypertensive drugs. Angiotensin II receptor blockers represent a major class of antihypertensive compounds. Candesartan cilexetil is an angiotensin II type 1 (AT[1]) receptor antagonist (angiotensin receptor blocker [ARB]) that inhibits the actions of angiotensin II on the renin-angiotensin-aldosterone system. Oral candesartan 8–32 mg once daily is recommended for the treatment of adult patients with hypertension. Clinical trials have demonstrated that candesartan cilexetil is an effective agent in reducing the risk of cardiovascular mortality, stroke, heart failure, arterial stiffness, renal failure, retinopathy, and migraine in different populations of adult patients including patients with coexisting type 2 diabetes, metabolic syndrome, or kidney impairment. Clinical evidence confirmed that candesartan cilexetil provides better antihypertensive efficacy than losartan and is at least as effective as telmisartan and valsartan. Candesartan cilexetil, one of the current market leaders in BP treatment, is a highly selective compound with high potency, a long duration of action, and a tolerability profile similar to placebo. The most important and recent data from clinical trials regarding candesartan cilexetil will be reviewed in this article.

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“…The American Diabetes Association, the European Society of Hypertension and the Japanese Society of Hypertension recommend the use of angiotensin‐converting enzyme inhibitors or angiotensin receptor blockers (ARBs) as a first choice for type 2 diabetes patients with hypertension3, 4, 5. These drugs decrease not only the risk of macroangiopathy6, 7, 8, but also other diabetic complications9, 10, 11, 12, 13. Furthermore, these drugs also delay the onset of diabetes14, 15, 16.…”

Section: Introductionmentioning

confidence: 99%

Switching from low‐dose thiazide diuretics to sodium–glucose cotransporter 2 inhibitor improves various metabolic parameters without affecting blood pressure in patients with type 2 diabetes and hypertension

Kimura

Sanada

Shimoda

et al. 2017

J of Diabetes Invest

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Aims/IntroductionSodium–glucose cotransporter 2 (SGLT2) inhibitors function to increase urinary glucose excretion and improve glycemic control in individuals with type 2 diabetes mellitus. SGLT2 inhibitors, as well as diuretics, increase urinary volume, which leads to the reduction of blood pressure. The aim of the present study was to compare the effects of SGLT2 inhibitor and thiazide diuretic on blood pressure, metabolic parameters and body mass composition.Materials and MethodsA total of 31 participants were enrolled in the present study. We switched from thiazide diuretics to an SGLT2 inhibitor, ipragliflozin, in participants with type 2 diabetes and hypertension whose blood pressure was controlled with thiazide diuretics. Three months after the switch, we evaluated the effects of such switching on blood pressure, various metabolic parameters and body mass composition.ResultsThere was no significant difference in blood pressure from baseline to 3 months later. However, glycated hemoglobin, fasting plasma glucose and uric acid were significantly decreased after the switch. Body mass index and visceral fat area were also significantly reduced after the switch. Furthermore, urinary albumin excretion was also significantly decreased after the switch.ConclusionsSwitching from thiazide diuretic to an SGLT2 inhibitor, ipragliflozin, markedly improved various metabolic parameters and body mass composition without affecting blood pressure in participants with type 2 diabetes and hypertension.

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Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled diabetic retinopathy candesartan trials

Abstract: The study was funded jointly by AstraZeneca and Takeda.

Cited by 42 publications

References 14 publications

Pregnancy Outcome Following Exposure to Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor Antagonists

Pregnancy Outcome Following Exposure to Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor Antagonists

Differential clinical profile of candesartan compared to other angiotensin receptor blockers

Switching from low‐dose thiazide diuretics to sodium–glucose cotransporter 2 inhibitor improves various metabolic parameters without affecting blood pressure in patients with type 2 diabetes and hypertension

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