Cardiac Safety Signals Detected Only in Real-World Use: A Case Series of Three Recently Approved Agents
DOI:
https://doi.org/10.5281/zenodo.22649579Keywords:
Cardiac Safety Signals Detected Only in Real-World Use; Translational medicine; Evidence synthesis; Clinical implementation; Health services researchAbstract
Cardiac Safety Signals Detected Only in Real-World Use is an area of active development in translational medicine, with evidence
that has accumulated unevenly across its component questions. We review the current evidence base for cardiac safety signals
detected only in real-world use, spanning analytical, clinical, implementation, governance, and economic dimensions, focusing on
where practice has converged and where it continues to vary, and set out the practical considerations relevant to a service
considering its adoption. We conclude that selective, context-specific use is best supported by the evidence currently available,
rather than uniform adoption or avoidance
References
Alvez D, Dumitrescu A, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a systematic review". J Transl Med 8(2011): 80-86. DOI: 10.2196/48633
Brankovic K, Kowalczyk B, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a methodological appraisal". Clin Pharmacol Ther 10(2014): 91-98. DOI: 10.1371/journal.pone.0305949
Castellani R, Ristic C, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a multicentre analysis". Nat Rev Drug Discov 12(2017): 102-110. DOI: 10.1371/journal.pdig.0000514
Dumitrescu A, Andric D, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a prospective cohort study". Trials 14(2020): 113-122. DOI: 10.17219/acem/208596
Eriksdottir B, Brankovic E, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a randomised evaluation". Drug Discov Today 16(2023): 124-134. DOI: 10.7759/cureus.104086
Farkas I, Ionescu F, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a consensus statement". Clin Cancer Res 18(2011): 135-146. DOI: 10.1038/s41746-023-00852-5
Grabowski P, Petrescu G, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a retrospective analysis". BMJ Open 20(2014): 146-158. DOI: 10.1016/j.mayocpiqo.2022.09.004
Hendriksen W, Wojcik H, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a validation study". J Clin Epidemiol 22(2017): 157-170. DOI: 10.1177/08404704241291226
Ionescu F, Foscarini I, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a scoping review". Contemp Clin Trials 24(2020): 168-182. DOI: 10.1093/medlaw/fwad013
Jankowiak G, Grabowski J, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a health-economic analysis". Ther Innov Regul Sci 26(2023): 179-185. DOI: 10.2196/89834
Kowalczyk N, Novotna K, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a systematic review". Br J Clin Pharmacol 28(2011): 190-197. DOI: 10.1007/s10916-024-02104-9
Lindqvist U, Urbanek L, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a methodological appraisal". PLoS Med 30(2014): 201-209. DOI: 10.3389/fdgth.2026.1896184
Marchetti D, Doncheva M, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a multicentre analysis". Lancet 32(2017): 212-221. DOI: 10.3390/diagnostics15162117
Novotna E, Eriksdottir N, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a prospective cohort study". N Engl J Med 34(2020): 223-233. DOI: 10.4103/jrpp.jrpp_20_65
Ostrowski L, Lindqvist O, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a randomised evaluation". JAMA 36(2023): 234-245. DOI: 10.3389/fdgth.2026.1763884
Petrescu S, Szabo P, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a consensus statement". Nat Med 38(2011): 245-257. DOI: 10.2196/48297
Quintero B, Balogh Q, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a retrospective analysis". Cell Rep Med 40(2014): 256-269. DOI: 10.1007/s00330-025-12031-z
Ristic C, Castellani R, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a validation study". Clin Transl Sci 42(2017): 267-281. DOI: 10.3389/fdgth.2026.1699005
Szabo J, Jankowiak S, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a scoping review". Pharmacogenomics J 44(2020): 278-284. DOI: 10.3389/fdgth.2026.1834800
Tarasov Q, Quintero T, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a health-economic analysis". Regul Toxicol Pharmacol 46(2023): 289-296. DOI: 10.2196/69678
Urbanek Z, Zielinski U, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a systematic review". Drug Saf 8(2011): 300-308. DOI: 10.7759/cureus.46454
Vasquez A, Alvez V, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a methodological appraisal". Ann Intern Med 10(2014): 311-320. DOI: 10.1016/j.ssci.2025.107028
Wojcik H, Hendriksen W, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a multicentre analysis". BMC Med 12(2017): 322-332. DOI: 10.2196/48633
Zielinski O, Ostrowski Z, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a prospective cohort study". Sci Transl Med 14(2020): 333-344. DOI: 10.1371/journal.pone.0305949
Andric V, Vasquez A, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a randomised evaluation". J Transl Med 16(2023): 344-356. DOI: 10.1371/journal.pdig.0000514
Balogh E, Emmerich B, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a consensus statement". Clin Pharmacol Ther 18(2011): 355-368. DOI: 10.17219/acem/208596
Chiriac F, Farkas C, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a retrospective analysis". Nat Rev Drug Discov 20(2014): 366-380. DOI: 10.7759/cureus.104086
Doncheva M, Marchetti D, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a validation study". Trials 22(2017): 377-383. DOI: 10.1038/s41746-023-00852-5
Emmerich T, Tarasov E, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a scoping review". Drug Discov Today 24(2020): 388-395. DOI: 10.1016/j.mayocpiqo.2022.09.004
Foscarini C, Chiriac F, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a health-economic analysis". Clin Cancer Res 26(2023): 399-407. DOI: 10.1177/08404704241291226
Alvez D, Dumitrescu A, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a systematic review". BMJ Open 28(2011): 410-419. DOI: 10.1093/medlaw/fwad013
Brankovic K, Kowalczyk B, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a methodological appraisal". J Clin Epidemiol 30(2014): 421-431. DOI: 10.2196/89834
Castellani R, Ristic C, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a multicentre analysis". Contemp Clin Trials 32(2017): 432-443. DOI: 10.1007/s10916-024-02104-9
Dumitrescu A, Andric D, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a prospective cohort study". Ther Innov Regul Sci 34(2020): 443-455. DOI: 10.3389/fdgth.2026.1896184
Eriksdottir B, Brankovic E, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a randomised evaluation". Br J Clin Pharmacol 36(2023): 454-467. DOI: 10.3390/diagnostics15162117
Farkas I, Ionescu F, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a consensus statement". PLoS Med 38(2011): 465-479. DOI: 10.4103/jrpp.jrpp_20_65
Grabowski P, Petrescu G, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a retrospective analysis". Lancet 40(2014): 476-482. DOI: 10.3389/fdgth.2026.1763884
Hendriksen W, Wojcik H, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a validation study". N Engl J Med 42(2017): 487-494. DOI: 10.2196/48297
Ionescu F, Foscarini I, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a scoping review". JAMA 44(2020): 498-506. DOI: 10.1007/s00330-025-12031-z
Jankowiak G, Grabowski J, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a health-economic analysis". Nat Med 46(2023): 509-518. DOI: 10.3389/fdgth.2026.1699005
Kowalczyk N, Novotna K, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a systematic review". Cell Rep Med 8(2011): 520-530. DOI: 10.3389/fdgth.2026.1834800
Lindqvist U, Urbanek L, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a methodological appraisal". Clin Transl Sci 10(2014): 531-542. DOI: 10.2196/69678
Marchetti D, Doncheva M, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a multicentre analysis". Pharmacogenomics J 12(2017): 542-554. DOI: 10.7759/cureus.46454
Novotna E, Eriksdottir N, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a prospective cohort study". Regul Toxicol Pharmacol 14(2020): 553-566. DOI: 10.1016/j.ssci.2025.107028
Ostrowski L, Lindqvist O, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a randomised evaluation". Drug Saf 16(2023): 564-578. DOI: 10.2196/48633
Petrescu S, Szabo P, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a consensus statement". Ann Intern Med 18(2011): 575-581. DOI: 10.1371/journal.pone.0305949
Quintero B, Balogh Q, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a retrospective analysis". BMC Med 20(2014): 586-593. DOI: 10.1371/journal.pdig.0000514
Ristic C, Castellani R, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a validation study". Sci Transl Med 22(2017): 597-605. DOI: 10.17219/acem/208596
Szabo J, Jankowiak S, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a scoping review". J Transl Med 24(2020): 608-617. DOI: 10.7759/cureus.104086
Tarasov Q, Quintero T, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a health-economic analysis". Clin Pharmacol Ther 26(2023): 619-629. DOI: 10.1038/s41746-023-00852-5
Urbanek Z, Zielinski U, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a systematic review". Nat Rev Drug Discov 28(2011): 630-641. DOI: 10.1016/j.mayocpiqo.2022.09.004
Vasquez A, Alvez V, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a methodological appraisal". Trials 30(2014): 641-653. DOI: 10.1177/08404704241291226
Wojcik H, Hendriksen W, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a multicentre analysis". Drug Discov Today 32(2017): 652-665. DOI: 10.1093/medlaw/fwad013
Zielinski O, Ostrowski Z, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a prospective cohort study". Clin Cancer Res 34(2020): 663-677. DOI: 10.2196/89834
Andric V, Vasquez A, et al. "Cardiac Safety Signals Detected Only in Real-World Use: a randomised evaluation". BMJ Open 36(2023): 674-680. DOI: 10.1007/s10916-024-02104-9
