Trial reportDiabetologia2011
Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials.
Trial report in Diabetologia, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 2 Diabetic Patients With Retinopathy.
DIRECT: DIabetic Retinopathy Candesartan Trials. Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients With Retinopathy.
Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients Without Retinopathy.
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.
- Adverse pregnancy outcomes associated with first-trimester exposure to angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers: A systematic review and meta-analysis.Pharmacology research & perspectives · 2020Pooled it
- Different insulin types and regimens for pregnant women with pre-existing diabetes.The Cochrane database of systematic reviews · 2017Pooled it
- Trial
- Exploring various novel diagnostic and therapeutic approaches in treating diabetic retinopathy.Inflammopharmacology · 2023Review
- Candesartan Does Not Activate PPARγ and Its Target Genes in Early Gestation Trophoblasts.International journal of molecular sciences · 2022Article
- Hypertension in pregnancy: Pathophysiology and treatment.SAGE open medicine · 2019Review
- 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.Journal of diabetes investigation · 2018Article
- Management of Type 1 Diabetes in Pregnancy.Current diabetes reports · 2016Review
- Diabetic Nephropathy in Women With Preexisting Diabetes: From Pregnancy Planning to Breastfeeding.Current diabetes reports · 2016Review
- Outcomes of 83 fetuses exposed to angiotensin receptor blockers during the second or third trimesters: a literature review.Hypertension research : official journal of the Japanese Society of Hypertension · 2015Review
- The relevance of the Renin-Angiotensin system in the development of drugs to combat preeclampsia.International journal of endocrinology · 2015Review
- Fetal renin-angiotensin-system blockade syndrome: renal lesions.Pediatric nephrology (Berlin, Germany) · 2014Article
- Should women with diabetic nephropathy considering pregnancy continue ACE inhibitor or angiotensin II receptor blocker therapy until pregnancy is confirmed?Diabetologia · 2014Article
- Managing type 1 diabetes mellitus in pregnancy--from planning to breastfeeding.Nature reviews. Endocrinology · 2012Review
- Differential clinical profile of candesartan compared to other angiotensin receptor blockers.Vascular health and risk management · 2011Review
- South African medicinal plants displaying angiotensin-converting enzyme inhibition: Potential use in the management of preeclampsia.Journal of Ayurveda and integrative medicineReview
Corrections and comments
- Commented on by
Authors and funding
12 authors at 8 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aims/hypothesisThe teratogenic consequences of angiotensin-converting enzyme inhibitors angiotensin receptor blockers (ARBs) during the second and third trimesters of pregnancy are well described. However, the consequences of exposure during the first trimester are unclear, especially in diabetes. 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.
methodsOver 4 years or longer, 178 normotensive women with type 1 diabetes (86 randomised to candesartan, 32 mg once daily, and 92 assigned to placebo) became pregnant (total of 208 pregnancies).
resultsMore than half of patients were exposed to candesartan or placebo prior to or in early pregnancy, but all discontinued it at an estimated 8 weeks from the last menstrual period. Full-term pregnancies (51 vs 50), premature deliveries (21 vs 27), spontaneous miscarriages (12 vs 15), elective terminations (15 vs 14) and other outcomes (1 vs 2) were similar in the candesartan and placebo groups. There were two stillbirths and two 'sick babies' in the candesartan group, and one stillbirth, eight 'sick babies' and one cardiac malformation in the placebo group. CONCLUSIONS/
interpretationThe risk for fetal consequences of ARBs in type 1 diabetes may not be high if exposure is clearly limited to the first trimester. Long-term studies in fertile women can be conducted with ARBs during pregnancy, provided investigators diligently stop their administration upon planning or detection of pregnancy.
trial registrationClinicalTrials.gov DIRECT-Prevent 1 NCT00252733; DIRECT-Protect 1 NCT00252720; DIRECT-Protect 2 NCT00252694.
fundingThe study was funded jointly by AstraZeneca and Takeda.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.