Number of cases and odds ratios with 95% confidence intervals for all outcomes (sensitivity analysis – statistical testing conducted on cases and matched controls)_
| Outcome | Patients exposed to Medikinet® MR (N=1249), n (%) | Patients exposed to Concerta® (N=1528), n (%) | p value* | Adjusted p value* | OR (95% CI) |
|---|---|---|---|---|---|
| Essential hypertension | <5 | <5 | 0.66 | 1 | 1.625 (0.262–10.096) |
| Sudden death (cause unknown), cardiac arrest | 0 | <5 | - | - | - |
| Mental and behavioral disorders due to psychoactive substance use | 11 (0.88) | 29 (2.16) | 0.28 | 1 | 0.646 (0.305–1.369) |
| Cerebral arteritis | 0 | 0 | - | - | - |
| Priapism | 0 | 0 | - | - | - |
| Psychiatric disorders | 41 (3.28) | 33 (2.16) | 0.02 | 0.1386 | 1.864 (1.125–3.087) |
| Conduct disorder | 5 (0.40) | 10 (0.65) | 0.10 | 0.6972 | 0.372 (0.116–1.195) |
| Suicidal tendency, intentional self-harm | <5 | 11 (0.72) | 0.44 | 1 | 0.299 (0.035–2.521) |
| Tics | 23 (1.84) | 16 (1.05) | 0.73 | 1 | 1.158 (0.576–2.327) |
| Episodic and seizure disorders | 13 (1.04) | 8 (0.52) | 0.15 | 1 | 2.192 (0.835–5.753) |
| Anorexia | 0 | <5 | - | - | - |
| Non-organic sleep disorders | 0 | 0 | - | - | - |
Outcomes with ICD-10 codes
| Outcome | ICD-10 codes |
|---|---|
| Essential hypertension | I10 |
| Sudden death (cause unknown), cardiac arrest | R96, R99, I46 |
| Mental and behavioral disorders due to psychoactive substance use | F10-F19 |
| Cerebral arteritis | I67.7 |
| Priapism | N48.3 |
| Psychiatric disorders | |
| Schizophrenia, schizotypal and delusional disorders | F20-F29 |
| Mood (affective) disorders | F30-F39 |
| Neurotic, stress-related and somatoform disorders | F40-F48 |
| Behavioral syndromes associated with physiological disturbances and physical factors | F50-F59 |
| Conduct disorder | F91 |
| Suicidal tendency, intentional self-harm | X60-X84, EUW |
| Tics | F95 |
| Episodic and seizure disorders | G40-G47 |
| Anorexia | R63.0 |
| Non-organic sleep disorders | F51 |
Number of cases and odds ratios with 95% confidence intervals for all outcomes (main analysis – statistical testing conducted on cases and matched controls)_
| Outcome | Patients exposed to Medikinet® MR (N=1249), n (%) | Patients exposed to Concerta® (N=2455), n (%) | p value* | Adjusted p value* | OR (95% CI) |
|---|---|---|---|---|---|
| Essential hypertension | <5 | <5 | 0.68 | 1 | 1.5 (0.28–8.036) |
| Sudden death (cause unknown), cardiac arrest | 0 | <5 | - | - | - |
| Mental and behavioral disorders due to psychoactive substance use | 11 (0.88) | 53 (2.16) | 0.33 | 1 | 0.69 (0.343–1.389) |
| Cerebral arteritis | 0 | 0 | - | - | - |
| Priapism | 0 | 0 | - | - | - |
| Psychiatric disorders | |||||
| All patients | 41 (3.28) | 77 (3.14) | 0.59 | 1 | 1.134 (0.747–1.72) |
| 6–11 years | 14 (1.98) | 12 (1.91) | - | - | - |
| 12–17 years | 17 (4.87) | 33 (3.27) | - | - | - |
| ≥18 years | 10 (5.18) | 32 (3.93) | - | - | - |
| Conduct disorder | 5 (0.40) | 14 (0.57) | 0.30 | 1 | 0.491 (0.164–1.474) |
| Suicidal tendency, intentional self-harm | <5 | 11 (0.45) | 0.16 | 1 | 0.196 (0.024–1.631) |
| Tics | 23 (1.84) | 24 (0.98) | 0.87 | 1 | 1.071 (0.572–2.003) |
| Episodic and seizure disorders | 13 (1.04) | 15 (0.61) | 0.29 | 1 | 1.61 (0.709–3.654) |
| Anorexia | 0 | <5 | - | - | - |
| Non-organic sleep disorders | 0 | 0 | - | - | - |
Demographic characteristics of the study population_
| Patients exposed to Medikinet® MR (N=1249) | Patients exposed to Concerta® (N=2455) | |
|---|---|---|
| Sex, n (%) | ||
| Female | 347 (27.8) | 671 (27.3) |
| Male | 902 (72.2) | 1784 (72.7) |
| Age at index date, n (%) | ||
| 6–11 years | 707 (56.6) | 630 (25.7) |
| 12–17 years | 349 (27.9) | 1010 (41.1) |
| ≥18 years | 193 (15.5) | 815 (33.2) |