Table 4.
Efficacy and safety results – randomised controlled trial summary
| Author, year | Serum sodium (pretreatment) | Serum sodium (post treatment) | Urine sodium (pretreatment) | Urine sodium (post treatment) | AEs (total) | AEs (individual) | SAEs (total) | Author conclusion | Comments |
|---|---|---|---|---|---|---|---|---|---|
| Alexander et al. 1991 24 |
On placebo: Mean of 131.4 mmol/l in third week Episodes of serum sodium <125 mmol/l, 13 of 110 measurements |
On DMC: Mean of 134.1 mmol/l in third week Episodes of serum sodium <125 mmol/l, 10 of 103 measurements |
NR | NR | 0 | 0 | 0 | No significant effect of DMC on serum sodium of in psychotic patients with polydipsia‐HN. | Patients not explicitly diagnosed with SIADH |
| Horattas et al. 1998 25 |
Pre‐operative: DMC mean: 138.9 mmol/l Placebo mean: 138.1 mmol/l |
Postoperative day 2: DMC mean: 138 mmol/l approx. Placebo mean: 135.5 mmol/l approx. |
NR | NR | Two patients discontinued |
Hypersensitivity (rash) leading to discontinuation: 1/30 GI upset leading to discontinuation: 1/30 Mild GI upset: 4/30 |
No specific SAEs reported, but 2 patients discontinued | Administration of DMC can inhibit vasopressin secretion following urgery | Postoperative length of stay was not affected by DMC |
AE, adverse event; DMC, demeclocycline; GI, gastrointestinal; HN, hyponatraemia; NR, not reported; SAE, serious adverse event; SIADH, symptom of inappropriate antidiuretic hormone secretion.