Cross-sectional study of medical advertisements in a national general medical journal: evidence, cost, and safe use of advertised versus comparative drugs

Boesen, Kim; Simonsen, Anders Lykkemark; Jørgensen, Karsten Juhl; Gøtzsche, Peter C.

doi:10.1186/s41073-021-00111-9

Table 5 Post-marketing studies ongoing at three year follow-up after advertising (Dec 2018)

From: Cross-sectional study of medical advertisements in a national general medical journal: evidence, cost, and safe use of advertised versus comparative drugs

Drug	Study ID	Requested	Clinical question
*Advertised drugs*
Aripiprazole IM	EUPAS21056	EMA	Specific harms (extrapyramidal symptoms)
Canagliflozin	EUPAS27670	EMA	Specific harm (lower limb amputations)
Canagliflozin	NDA 204042 commitment no. 1	FDA	Specific harm (ketoacidosis)
Canagliflozin	NDA 204042 commitment no. 3	FDA	Specific harm (various conditions)
Fluticasone propionate / formoterol	EUPAS3702^a	MHRA	Benefits and harms
Lisdexamfetamin	EUPAS20546	EMA	Specific harm (cardiovascular events)
Rivaroxaban	EUPAS11299, EUPAS9895, EUPAS11141, and EUPAS11145	EMA	Specific harms (bleeding events and liver disease)
Tiotropium / olodaterol	EUPAS14273	Japan	Long-term benefits and harms
Tiotropium / olodaterol	EUPAS21574	EMA	Specific harms (cardiovascular)
Tiotropium / olodaterol	EUPAS14956	South Korea	Benefits and harms
Umeclidinium/ vilanterol	EUPAS9868	Japan	Benefits and harms
Umeclidinium/ vilanterol	EUPAS11397	South Korea	Benefits and harms
Vortioxetine	NDA 204447 commitment no. 6	FDA	Benefits and harms
Vortioxetine	EUPAS19199	EMA	Clinical use and several specific harms
*Comparator drugs*
Duloxetine	EUPAS20253^b	United States	Specific harms (maternal and fetal harms)
Duloxetine	NDA 21427 commitment no. 2	FDA	Specific harms (maternal and fetal harms)
Methylphenidate	EUPAS4551^c	EMA	Harms
Methylphenidate	EUPAS3985^c	EMA	Long-term harms
Umeclidinium	EUPAS14947	South Korea	Benefits and harms
Umeclidinium	EUPAS10224	Japan	Benefits and hams
*Advertised drugs and comparator drugs*
Aclidinium and aclidinium/ formoterol	EUPAS6559	EMA	Clinical use
Aclidinium and aclidinium/ formoterol	EUPAS13616	EMA	Specific harms (cardiovascular and mortality)
Dabigatran and rivaroxaban, versus warfarin	EUPAS13017	France	Benefits and harms
Olodaterol and olodaterol/tiotropium	EUPAS21574	EMA	Specific harms (cardiovascular events)
Umeclidinium and umeclidinium/ vilanterol	EUPAS10316	EMA	Specific harms (cardiovascular and cerebrovascular events)

EMA European Medicines Agency; FDA US Food and Drug Administration; IM Intramuscular. ^aThe study was scheduled to report data in 2015, but data had not been submitted. ^bThis study may likely be the same. ^cThe two methylphenidate studies were planned to finish in 2014 and 2015, but they were listed as ongoing since data had not been reported on the website

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ISSN: 2058-8615

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