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Table 3 Data used to compute limits and reference values for the risk of coeliac disease following antihypertensive treatment

From: Computing limits on medicine risks based on collections of individual case reports

Drug N xy R * N x R N x E Reference risk
Amlodipine 26 23,272 8.1 million 361 events in 991,184 users
Atenolol 12 18,166 3.7 million 181 events in 452,985 users
Hydrochlorothiazide 20 17,786 7.4 million 294 events in 913,563 users
Losartan 9 7,232 3.5 million 174 events in 440,583 users
Olmesartan 31 5,243 1.2 million 40 events in 151,461 users
Valsartan 12 11,603 2.3 million 118 events in 290,305 users
  1. *Reports with MedDRA preferred term ’Coeliac disease’.
  2. This estimate is the actual number of users in the Mini-Sentinel cohort scaled up according to the number of eligible patients and the total number of US citizens.
  3. The reference values were obtained from a Mini-Sentinel report [18], and the limits were computed based on US reports in VigiBase. All risks refer to the US population between 1st January 2007 and 31st December 2011.