Page last updated: 2024-10-24

candesartan and Abnormalities, Drug-Induced

candesartan has been researched along with Abnormalities, Drug-Induced in 6 studies

candesartan: a nonpeptide angiotensin II receptor antagonist
candesartan : A benzimidazolecarboxylic acid that is 1H-benzimidazole-7-carboxylic acid substituted by an ethoxy group at position 2 and a ({2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl}methyl) group at position 1. It is a angiotensin receptor antagonist used for the treatment of hypertension.

Abnormalities, Drug-Induced: Congenital abnormalities caused by medicinal substances or drugs of abuse given to or taken by the mother, or to which she is inadvertently exposed during the manufacture of such substances. The concept excludes abnormalities resulting from exposure to non-medicinal chemicals in the environment.

Research Excerpts

ExcerptRelevanceReference
" We report the experience from DIRECT (DIabetic REtinopathy and Candesartan Trials), three placebo-controlled studies designed to examine the effects of an ARB, candesartan, on diabetic retinopathy."9.15Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials. ( Bilous, R; Chaturvedi, N; Fuller, JH; Hainer, JW; Jansson, SO; Klein, R; Malm, A; Orchard, T; Parving, HH; Porta, M; Sjølie, AK, 2011)
" We report the experience from DIRECT (DIabetic REtinopathy and Candesartan Trials), three placebo-controlled studies designed to examine the effects of an ARB, candesartan, on diabetic retinopathy."5.15Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials. ( Bilous, R; Chaturvedi, N; Fuller, JH; Hainer, JW; Jansson, SO; Klein, R; Malm, A; Orchard, T; Parving, HH; Porta, M; Sjølie, AK, 2011)
"A pregnant young woman with a severe migraine is prescribed candesartan, an angiotensin II type 1 receptor antagonist (AT II antagonists)."1.36Angiotensin II receptor antagonists against migraine in pregnancy: fatal outcome. ( Haaland, K, 2010)

Research

Studies (6)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's2 (33.33)29.6817
2010's4 (66.67)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Haaland, K1
Porta, M1
Hainer, JW1
Jansson, SO1
Malm, A1
Bilous, R1
Chaturvedi, N1
Fuller, JH1
Klein, R1
Orchard, T1
Parving, HH1
Sjølie, AK1
Hünseler, C1
Paneitz, A1
Friedrich, D1
Lindner, U1
Oberthuer, A1
Körber, F1
Schmitt, K1
Welzing, L1
Müller, A1
Herkenrath, P1
Hoppe, B1
Gortner, L1
Roth, B1
Kattner, E1
Schaible, T1
Schlaich, MP1
Cox, RM1
Anderson, JM1
Cox, P1
Hinsberger, A1
Wingen, AM1
Hoyer, PF1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients Without Retinopathy.[NCT00252733]Phase 35,238 participants (Actual)Interventional2001-06-30Completed
Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 2 Diabetic Patients With Retinopathy.[NCT00252694]Phase 34,717 participants (Actual)Interventional2001-08-31Completed
DIRECT: DIabetic Retinopathy Candesartan Trials. Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients With Retinopathy.[NCT00252720]Phase 31,850 participants (Actual)Interventional2001-08-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale.

Two steps were defined as either a 1-step change in each eye or as a 2-step change in one eye only. ETDRS is a scale with 11 steps (1-11, where a score of 1 represents no retinopathy and a score of 11 represents proliferative retinopathy). A generalized log-rank test was used to test difference between treatments. (NCT00252733)
Timeframe: From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.

InterventionParticipants (Number)
Candesartan178
Placebo217

Rate of Change in Urinary Albumin Excretion Rate (UAER).

An estimate of the slope from fitting a linear regression of log(UAER) over time for each patient. (NCT00252733)
Timeframe: From baseline to end of study, i.e. 5 years.

Interventionlog (µg/min)/year (Least Squares Mean)
Candesartan0.510
Placebo0.543

Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale

3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments. (NCT00252694)
Timeframe: From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.

InterventionParticipants (Number)
Candesartan161
Placebo182

Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale.

3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). (NCT00252694)
Timeframe: From baseline to end of study, i.e. 5 years.

InterventionParticipants (Number)
Candesartan180
Placebo136

Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).

Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs. (NCT00252694)
Timeframe: From baseline to end of study, i.e. 5 years.

InterventionParticipants (Number)
Candesartan192
Placebo193

Rate of Change in Urinary Albumin Excretion Rate (UAER).

An estimate of the slope from fitting a linear regression of log(UAER) over time (post-randomisation, yearly assessments) for each patient. (NCT00252694)
Timeframe: From Baseline to end of study, i.e. 5 years.

Interventionlog (µg/min)/1000 year (Least Squares Mean)
Candesartan656
Placebo718

Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale

Retinopathy progression was defined as the first occurrence of at least a 3-step increase in the ETDRS severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments. (NCT00252720)
Timeframe: From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.

InterventionParticipants (Number)
Candesartan127
Placebo124

Number of Participants With a Regression of Diabetic Retinopathy.

Regression of diabetic retinopathy was defined as at least a 3 step improvement or a persistent 2-step improvement (confirmed in 2 consecutive photography sets) in the Early Treatment of Diabetic Retinopathy Study (ETDRS) severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). (NCT00252720)
Timeframe: From baseline to the end of the study, i.e., 5 years

InterventionParticipants (Number)
Candesartan140
Placebo139

Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).

Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs. (NCT00252720)
Timeframe: From baseline to end of study, i.e. 5 years.

InterventionParticipants (Number)
Candesartan110
Placebo107

Rate of Change in Urinary Albumin Excretion Rate (UAER).

An estimate of the slope from fitting a linear regression of log (UAER) over time (post-randimisation, yearly assessments) for each patient (NCT00252720)
Timeframe: From baseline to end of study, i.e. 5 years.

Interventionlog (µg/min)/year (Least Squares Mean)
Candesartan0.569
Placebo0.642

Trials

1 trial available for candesartan and Abnormalities, Drug-Induced

ArticleYear
Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials.
    Diabetologia, 2011, Volume: 54, Issue:6

    Topics: Abnormalities, Drug-Induced; Adolescent; Adult; Angiotensin Receptor Antagonists; Benzimidazoles; Bi

2011
Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials.
    Diabetologia, 2011, Volume: 54, Issue:6

    Topics: Abnormalities, Drug-Induced; Adolescent; Adult; Angiotensin Receptor Antagonists; Benzimidazoles; Bi

2011
Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials.
    Diabetologia, 2011, Volume: 54, Issue:6

    Topics: Abnormalities, Drug-Induced; Adolescent; Adult; Angiotensin Receptor Antagonists; Benzimidazoles; Bi

2011
Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials.
    Diabetologia, 2011, Volume: 54, Issue:6

    Topics: Abnormalities, Drug-Induced; Adolescent; Adult; Angiotensin Receptor Antagonists; Benzimidazoles; Bi

2011
Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials.
    Diabetologia, 2011, Volume: 54, Issue:6

    Topics: Abnormalities, Drug-Induced; Adolescent; Adult; Angiotensin Receptor Antagonists; Benzimidazoles; Bi

2011
Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials.
    Diabetologia, 2011, Volume: 54, Issue:6

    Topics: Abnormalities, Drug-Induced; Adolescent; Adult; Angiotensin Receptor Antagonists; Benzimidazoles; Bi

2011
Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials.
    Diabetologia, 2011, Volume: 54, Issue:6

    Topics: Abnormalities, Drug-Induced; Adolescent; Adult; Angiotensin Receptor Antagonists; Benzimidazoles; Bi

2011
Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials.
    Diabetologia, 2011, Volume: 54, Issue:6

    Topics: Abnormalities, Drug-Induced; Adolescent; Adult; Angiotensin Receptor Antagonists; Benzimidazoles; Bi

2011
Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials.
    Diabetologia, 2011, Volume: 54, Issue:6

    Topics: Abnormalities, Drug-Induced; Adolescent; Adult; Angiotensin Receptor Antagonists; Benzimidazoles; Bi

2011

Other Studies

5 other studies available for candesartan and Abnormalities, Drug-Induced

ArticleYear
Angiotensin II receptor antagonists against migraine in pregnancy: fatal outcome.
    The journal of headache and pain, 2010, Volume: 11, Issue:2

    Topics: Abnormalities, Drug-Induced; Adult; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting

2010
Angiotensin II receptor blocker induced fetopathy: 7 cases.
    Klinische Padiatrie, 2011, Volume: 223, Issue:1

    Topics: Abnormalities, Drug-Induced; Adult; Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents

2011
Angiotensin receptor blockade in diabetic women of childbearing potential: an acceptable risk?
    Diabetologia, 2011, Volume: 54, Issue:6

    Topics: Abnormalities, Drug-Induced; Angiotensin Receptor Antagonists; Benzimidazoles; Biphenyl Compounds; D

2011
Defective embryogenesis with angiotensin II receptor antagonists in pregnancy.
    BJOG : an international journal of obstetrics and gynaecology, 2003, Volume: 110, Issue:11

    Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Adult; Angiotensin Receptor Antagonists; Antih

2003
Angiotensin-II-receptor inhibitors in pregnancy.
    Lancet (London, England), 2001, May-19, Volume: 357, Issue:9268

    Topics: Abnormalities, Drug-Induced; Acute Kidney Injury; Adult; Antihypertensive Agents; Benzimidazoles; Bi

2001