Table 3. Risk of individual cancers owing to use of potentially NDMA-contaminated valsartan drug products compared with uncontaminated valsartan.
Exposure to NDMA-contaminated valsartan | Hazard ratio [95% CI]*1 | Sample size/ Cancer outcomes |
Outcome bladder cancer | ||
No exposure | 1.00 (ref) | 355 225/ 1041 |
Exposure | 1.02 [0.95; 1.11] | 385 922/ 1491 |
Outcome breast cancer | ||
No exposure | 1.00 (ref) | 208 262/ 1804 |
Exposure | 1.02 [0.96; 1.08] | 242 778/ 2736 |
Outcome colorectal cancer | ||
No exposure | 1.00 (ref) | 356 208/ 2024 |
Exposure | 0.99 [0.94; 1.05] | 387 297/ 2866 |
Outcome kidney cancer | ||
No exposure | 1.00 (ref) | 354 980/ 796 |
Exposure | 0.96 [0.87; 1.05) | 385 522/ 1091 |
Outcome lung cancer | ||
No exposure | 1.00 (ref) | 355 891/ 1707 |
Exposure | 0.97 [0.91; 1.03] | 386 710/ 2279 |
Outcome malignant melanoma | ||
No exposure | 1.00 (ref) | 354 934/ 750 |
Exposure | 0.94 [0.85; 1.03] | 385 414/ 983 |
Outcome pancreatic cancer | ||
No exposure | 1.00 (ref) | 354 897/ 713 |
Exposure | 0.93 [0.84; 1.02] | 385 398/ 967 |
Outcome prostate cancer | ||
No exposure | 1.00 (ref) | 149 514/ 1788 |
Exposure | 1.00 [0.94; 1.06] | 146 768/ 2379 |
Outcome uterine cancer | ||
No exposure | 1.00 (ref) | 206 944/ 486 |
Exposure | 1.08 [0.96; 1.21] | 240 801/ 759 |
*1 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