Table 1.
Treatment-Emergent Gastrointestinal Complaints Associated With Study Drug and/or Narcotic Agents.a
| Teduglutide 0.05 mg/kg/d (n = 77), No. (%) |
Placebo (n = 59), No. (%) |
|||||
|---|---|---|---|---|---|---|
| Adverse Event | All Teduglutide (n = 77) | Narcoticsb (n = 32) | No Narcotics (n = 45) | All Placebo (n = 59) | Narcoticsb (n = 20) | No Narcotics (n = 39) |
| Abdominal pain | 29 (38) | 18 (56) | 11 (24) | 16 (27) | 9 (45) | 7 (18) |
| Nausea | 19 (25) | 16 (50) | 3 (7) | 12 (20) | 6 (30) | 6 (15) |
| Abdominal distension | 15 (19) | 9 (28) | 6 (13) | 1 (2) | 0 (0) | 1 (3) |
| Vomiting | 9 (12) | 7 (22) | 2 (4) | 6 (10) | 3 (15) | 3 (8) |
Pooled data for patients who received ≥1 dose of double-blind study drug (teduglutide 0.05 mg/kg/d or matching placebo) in NCT00081458 (EudraCT, 2004-000438-35) or STEPS (ClinicalTrials.gov, NCT00798967; EudraCT, 2008-006193-15) studies; abdominal complaints based on Medical Dictionary for Regulatory Activities terms.
Concomitant narcotic agents (eg, opium alkaloids and derivatives, opioid analgesics, or other opioids) in the teduglutide and placebo groups, respectively, included, in order of frequency the following: codeine (n = 14, 18%; n = 4, 7%), tramadol (7, 9%; 1, 2%), hydromorphone (5, 7%; 1, 2%), morphine (3, 4%; 3, 5%), oxycodone/acetaminophen (3, 4%; 2, 3%), codeine/paracetamol (Panadeine) (3, 4%; 1, 2%), hydrocodone/acetaminophen (Vicodin) (2, 3%; 1, 2%), dextropropoxyphene hydrochloride/paracetamol (Di-Gesic) (2, 3%; 0, 0%), oxycodone (1, 1%; 4, 7%), galenic/paracetamol/codeine (1, 1%; 1, 2%), acetaminophen/codeine (Procet) (1, 1%; 1, 2%), acetaminophen/propoxyphene (Propacet) (1, 1%; 1, 2%), dextromethorphan hydrobromide/guaifenesin (Tussin DM) (1, 1%; 1, 2%), dextropropoxyphene hydrochloride/acetaminophen (Aporex) (1, 1%; 0, 0%), sulfamethoxazole trimethoprim (Bactrizol) (1, 1%; 0, 0%), dextromethorphan (1, 1%; 0, 0%), fentanyl (1, 1%; 0, 0%), acetaminophen/salicylamide (Frenadol) (1, 1%; 0, 0%), paracetamol/dihydrocodeine tartrate (Remedeine) (1, 1%; 0, 0%), tramadol/acetaminophen (Ultracet) (1, 1%; 0, 0%), hydrocodone bitartrate/guaifenesin (Codiclear) (0, 0%; 1, 2%), hydrocodone (0, 0%; 1, 2%), methadone (0, 0%; 1, 2%), nicomorphine (0, 0%; 1, 2%), oxycodone/acetaminophen (Oxycocet) (0, 0%; 1, 2%), and noscapine/promethazine (Tussisedal) (0, 0%; 1, 2%). Patients may have received >1 narcotic agent.