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. 2021 May 28;118(21):357–362. doi: 10.3238/arztebl.m2021.0129

eTable 2. Overall cancer risk and liver cancer risk from use of potentially NDMA-contaminated valsartan drug products compared with uncontaminated valsartan, different lag times.

Hazard ratio [95% CI]* Sample size/cancer cases
Cancer overall: valsartan prescription
Lag time 6 months
 No exposure 1.00 (ref) 386 322/19 383
 Exposure 1.00 [0.99; 1.02] 443 442/26 375
Lag time 12 months (main analysis)
 No exposure 1.00 (ref) 371 688/17 504
 Exposure 1.00 [0.98; 1.02] 409 183/24 752
Lag time 24 months
 No exposure 1.00 (ref) 291 955/11 252
 Exposure 0.99 [0.97; 1.01] 371 555/16 966
Liver cancer: valsartan prescription
Lag time 6 months
 No exposure 1.00 (ref) 367 705/485
 Exposure 1.16 [1.04; 1.31] 418 219/774
Lag time 12 months (main analysis)
 No exposure 1.00 (ref) 354 628/444
 Exposure 1.16 [1.03; 1.31] 385 167/736
Lag time 24 months
 No exposure 1.00 (ref) 280 990/287
 Exposure 1.22 [1.05; 1.41] 355 115/526

* Lag time 1 year, fully adjusted for sex; age; polypharmacy (defined as prescription of five or more different drugs); prescription of low-dose acetylsalicylic acid (ASA), non-ASA non-steroidal anti-inflammatory drugs, 5α-reductase inhibitors, statins, spironolactone, glucocorticoids for systemic use, selective serotonin reuptake inhibitors, and hormone replacement therapy; the comorbidities diabetes, chronic obstructive pulmonary disease, congestive heart failure, and alcohol-related diseases; the Charlson comorbidity index (score); and prevalent valsartan use

95% CI, 95% confidence interval