Table 4.
Adverse Events at 12 Months.*
| Adverse Event | Medical Therapy (N = 43) | Gastric Bypass (N = 50) | Sleeve Gastrectomy (N = 49) |
|---|---|---|---|
| no. of patients (%) | |||
|
Serious adverse event | |||
| Requiring hospitalization | 4 (9) | 11 (22) | 4 (8) |
| Intravenous treatment for dehydration | 0 | 4 (8) | 2 (4) |
| Reoperation | 0 | 3 (6) | 1 (2) |
| Transfusion | 0 | 1 (2) | 1 (2) |
| Hemoglobin decrease ≥5 g/dl | 0 | 1 (2) | 0 |
| Gastrointestinal leak | 0 | 0 | 1 (2) |
| Transient renal insufficiency | 0 | 1 (2) | 0 |
| Cholelithiasis | 0 | 1 (2) | 0 |
| Arrhythmia or palpitations | 2 (5) | 0 | 1 (2) |
| Pleural effusion | 0 | 0 | 1 (2) |
| Ketoacidosis | 0 | 1 (2) | 0 |
| Wound infection | 0 | 1 (2) | 0 |
| Cellulitis | 1 (2) | 0 | 0 |
| Pneumonia | 0 | 2 (4) | 0 |
| Kidney stone | 1 (2) | 0 | 0 |
| Hernia | 0 | 1 (2) | 0 |
|
Other adverse event | |||
| Hypoglycemic episode† | 35 (81) | 28 (56) | 39 (80) |
| Anemia‡ | 3 (7) | 6 (12) | 6 (12) |
| Hypokalemia | 1 (2) | 2 (4) | 2 (4) |
| Anastomotic ulcer | 0 | 4 (8) | 0 |
| Excessive weight gain§ | 3 (7) | 0 | 0 |
*
Patients may have had more than one event. Seven patients in the medical-therapy group withdrew immediately after randomization. One patient in the sleeve-gastrectomy group had anemia before withdrawing from the study before surgery.
†
Hypoglycemic episodes were self-reported. Patients were classified according to whether they reported at least one episode of hypoglycemia during the follow-up period.
‡
Anemia was defined as a hemoglobin level of less than 11.5 g per deciliter for women and less than 13.0 g per deciliter for men.
§
Excessive weight gain was defined as an increase of more than 5% over the baseline value.