| Autor: |
Wo, J M, Ejskjaer, N, Hellström, P M, Malik, Aneeka, Pezzullo, J C, Shaughnessy, L, Charlton, P, Kosutic, G, McCallum, R W |
| Jazyk: |
angličtina |
| Rok vydání: |
2011 |
| Zdroj: |
Wo, J M, Ejskjaer, N, Hellström, P M, Malik, A, Pezzullo, J C, Shaughnessy, L, Charlton, P, Kosutic, G & McCallum, R W 2011, ' Randomised clinical trial: ghrelin agonist TZP-101 relieves gastroparesis associated with severe nausea and vomiting-randomised clinical study subset data ', Alimentary Pharmacology and Therapeutics, vol. 33, no. 6, pp. 679 . https://doi.org/10.1111/j.1365-2036.2010.04567.x |
| Popis: |
Background Limited therapeutic options exist for severe gastroparesis, where severe nausea and vomiting can lead to weight loss, dehydration and malnutrition due to inadequate caloric and fluid intake. TZP-101 (ulimorelin) is a ghrelin receptor agonist that accelerates gastric emptying and improves upper gastrointestinal symptoms in diabetic patients with gastroparesis. Aim To assess effects of TZP-101 in diabetic gastroparesis patients with severe nausea/vomiting and baseline severity scores of ≥3.5 (range: 0-5) on the Gastroparesis Cardinal Symptom Index (GCSI) Nausea/Vomiting subscale. Methods Patients were hospitalised and received four single daily 30-min infusions of one of six TZP-101 doses (range 20-600 μg/kg) or placebo. Efficacy was assessed by symptom improvement. Results At baseline, 23 patients had a mean severity score for GCSI Nausea/Vomiting of 4.45 ± 0.44. Statistically significant improvements over placebo occurred in the 80 μg/kg group for end of treatment changes from baseline in GCSI Nausea/Vomiting subscale (reduction in score of -3.82 ± 0.76, P = 0.011) and the GCSI Total score (-3.14 ± 0.78, P = 0.016) and were maintained at the 30-day follow-up assessment (-2.02 ± 1.63, P = 0.073 and -1.99 ± 1.33, P = 0.032 respectively). The proportion of days with vomiting was reduced significantly (P = 0.05) in the 80 μg/kg group (mean of 1.2 days of vomiting for four treatment days) compared with placebo (mean of 3.2 days of vomiting across 4 treatment days). Conclusions TZP-101 substantially reduced the frequency and severity of nausea and vomiting as well as overall gastroparesis symptoms. The results are consistent with gastrointestinal motility effects of TZP-101, supporting further investigation of TZP-101 in the management of severe gastroparesis. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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