The effect of statins exposure during pregnancy on congenital anomalies and spontaneous abortions: A systematic review and meta-analysis
Objective: To assess the effect of statin exposure during pregnancy on congenital anomalies and spontaneous abortions.Data sources: Electronic databases were searched from inception to January 2022.Study Eligibility Criteria: Cohort studies and randomized controlled trials (RCTs) evaluate the effect...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-09-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.1003060/full |
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| author | Ayala Hirsch Natali Ternovsky Donna R. Zwas Donna R. Zwas Reut Rotem Offer Amir Bruria Hirsh Raccah Bruria Hirsh Raccah |
| author_facet | Ayala Hirsch Natali Ternovsky Donna R. Zwas Donna R. Zwas Reut Rotem Offer Amir Bruria Hirsh Raccah Bruria Hirsh Raccah |
| author_sort | Ayala Hirsch |
| collection | DOAJ |
| description | Objective: To assess the effect of statin exposure during pregnancy on congenital anomalies and spontaneous abortions.Data sources: Electronic databases were searched from inception to January 2022.Study Eligibility Criteria: Cohort studies and randomized controlled trials (RCTs) evaluate the effect of treatment with statins on congenital anomalies in general and cardiac malformations in particular. Studies evaluating spontaneous abortions were included as a secondary outcome.Study appraisal and synthesis methods: Pooled odds ratio was calculated using a random-effects model and meta-regression was utilized when applicable.Results: Twelve cohort studies and RCTs were included in the analysis. Pregnancy outcomes of 2,447 women that received statins during pregnancy were compared to 897,280 pregnant women who did not. Treatment with statins was not associated with a higher risk of overall congenital anomalies (Odd Ratio = 1.1, CI (0.9–1.3), p = 0.33, I2 = 0%). Yet, cardiac malformations were more prevalent among neonates born to statins users (OR = 1.4, CI (1.1–1.8), p = 0.02, I2 = 0%). The risk was higher when exposure occurred during the first trimester. This finding was statistically significant in cohort studies, but not in RCTs. Statin treatment was also associated with a higher rate of spontaneous abortions (OR = 1.5, CI (1.1–2.0), p = 0.005, I2 = 0%). In meta-regression analysis, no significant association between lipophilic statins and the rate of congenital anomalies was found.Conclusion: Overall, treatment with statins during pregnancy was not associated with an increased risk of congenital anomalies. A slight risk elevation for cardiac malformation and spontaneous abortions was seen in cohort studies but not in RCTs.Systematic Review Registration:clinicaltrials.gov, identifier [CRD42020165804 17/2/2020]The meta-analysis was presented online at 42nd annual meeting of SMFM. January 31-5 February 2022. |
| first_indexed | 2024-04-12T03:52:03Z |
| format | Article |
| id | doaj.art-82b1108c4e34416599927dcc81fd4b0e |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-12T03:52:03Z |
| publishDate | 2022-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-82b1108c4e34416599927dcc81fd4b0e2022-12-22T03:48:58ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-09-011310.3389/fphar.2022.10030601003060The effect of statins exposure during pregnancy on congenital anomalies and spontaneous abortions: A systematic review and meta-analysisAyala Hirsch0Natali Ternovsky1Donna R. Zwas2Donna R. Zwas3Reut Rotem4Offer Amir5Bruria Hirsh Raccah6Bruria Hirsh Raccah7Department of Obstetrics and Gynecology, Shaare Zedek Medical Center, Affiliated with the Hebrew University School of Medicine, Jerusalem, IsraelDivision of Clinical Pharmacy, Institute for Drug Research, School of Pharmacy, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, IsraelLinda Joy Pollin Cardiovascular Wellness Center for Women, Department of Cardiology, Hadassah University Hospital, Jerusalem, IsraelDepartment of Cardiology, Hadassah University Hospital, Jerusalem, IsraelDepartment of Obstetrics and Gynecology, Shaare Zedek Medical Center, Affiliated with the Hebrew University School of Medicine, Jerusalem, IsraelDepartment of Cardiology, Hadassah University Hospital, Jerusalem, IsraelDivision of Clinical Pharmacy, Institute for Drug Research, School of Pharmacy, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, IsraelDepartment of Cardiology, Hadassah University Hospital, Jerusalem, IsraelObjective: To assess the effect of statin exposure during pregnancy on congenital anomalies and spontaneous abortions.Data sources: Electronic databases were searched from inception to January 2022.Study Eligibility Criteria: Cohort studies and randomized controlled trials (RCTs) evaluate the effect of treatment with statins on congenital anomalies in general and cardiac malformations in particular. Studies evaluating spontaneous abortions were included as a secondary outcome.Study appraisal and synthesis methods: Pooled odds ratio was calculated using a random-effects model and meta-regression was utilized when applicable.Results: Twelve cohort studies and RCTs were included in the analysis. Pregnancy outcomes of 2,447 women that received statins during pregnancy were compared to 897,280 pregnant women who did not. Treatment with statins was not associated with a higher risk of overall congenital anomalies (Odd Ratio = 1.1, CI (0.9–1.3), p = 0.33, I2 = 0%). Yet, cardiac malformations were more prevalent among neonates born to statins users (OR = 1.4, CI (1.1–1.8), p = 0.02, I2 = 0%). The risk was higher when exposure occurred during the first trimester. This finding was statistically significant in cohort studies, but not in RCTs. Statin treatment was also associated with a higher rate of spontaneous abortions (OR = 1.5, CI (1.1–2.0), p = 0.005, I2 = 0%). In meta-regression analysis, no significant association between lipophilic statins and the rate of congenital anomalies was found.Conclusion: Overall, treatment with statins during pregnancy was not associated with an increased risk of congenital anomalies. A slight risk elevation for cardiac malformation and spontaneous abortions was seen in cohort studies but not in RCTs.Systematic Review Registration:clinicaltrials.gov, identifier [CRD42020165804 17/2/2020]The meta-analysis was presented online at 42nd annual meeting of SMFM. January 31-5 February 2022.https://www.frontiersin.org/articles/10.3389/fphar.2022.1003060/fullstatinshydroxymethylglutaryl-coenzyme a (HMG-CoA) reductase inhibitorscongenital anomaliescardiac anomaliesspontaneous abortion |
| spellingShingle | Ayala Hirsch Natali Ternovsky Donna R. Zwas Donna R. Zwas Reut Rotem Offer Amir Bruria Hirsh Raccah Bruria Hirsh Raccah The effect of statins exposure during pregnancy on congenital anomalies and spontaneous abortions: A systematic review and meta-analysis Frontiers in Pharmacology statins hydroxymethylglutaryl-coenzyme a (HMG-CoA) reductase inhibitors congenital anomalies cardiac anomalies spontaneous abortion |
| title | The effect of statins exposure during pregnancy on congenital anomalies and spontaneous abortions: A systematic review and meta-analysis |
| title_full | The effect of statins exposure during pregnancy on congenital anomalies and spontaneous abortions: A systematic review and meta-analysis |
| title_fullStr | The effect of statins exposure during pregnancy on congenital anomalies and spontaneous abortions: A systematic review and meta-analysis |
| title_full_unstemmed | The effect of statins exposure during pregnancy on congenital anomalies and spontaneous abortions: A systematic review and meta-analysis |
| title_short | The effect of statins exposure during pregnancy on congenital anomalies and spontaneous abortions: A systematic review and meta-analysis |
| title_sort | effect of statins exposure during pregnancy on congenital anomalies and spontaneous abortions a systematic review and meta analysis |
| topic | statins hydroxymethylglutaryl-coenzyme a (HMG-CoA) reductase inhibitors congenital anomalies cardiac anomalies spontaneous abortion |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.1003060/full |
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