Sclerotherapy plus octreotide versus sclerotherapy alone in the prevention of early rebleeding from esophageal varices: A randomized, double-blind, placebo-controlled, multicenter trial*1

Primignani, Massimo; Andreoni, B.; Carpinelli, Luca; Capria, A; G, Rocchi; Lorenzini, I.; Staudacher, C.; Beretta, Luigi; Motta, Roberta; R, de Franchis

doi:10.1016/0270-9139(95)90054-3

Cited by 57 publications

(6 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Therefore, octreotide has been evaluated for both the adjuvant medical treatment of acute variceal bleeding [5, 6, 7]and the prophylaxis of rebleeding [8]. However, negative clinical tirals [9, 10]clearly indicated the need for comparative hemodynamic studies with respect to the duration of action, the mode of application and the optimal dose. These studies are sparse [11, 12]and those which have found no or only predominantly short-term hemodynamic effects [13, 14]contradict the beneficial outcome in at least some clinical trials [5, 6, 7].…”

Section: Introductionmentioning

confidence: 99%

Effects of Different Octreotide Dosages on Splanchnic Hemodynamics and Glucagon in Healthy Volunteers

Sartipy

Brensing²,

Göke³

et al. 1999

Digestion

View full text Add to dashboard Cite

Aims: This study evaluated the dependence of portal and mesenteric blood flow and plasma glucagon levels on octreotide dosage and its mode of application. Methods: Two groups of 10 individuals each received octreotide either subcutaneously (placebo, 100 and 200 µg) or intravenously (100-µg bolus i.v., 25 and 100 µg/h) in a double-blind, random order. Using Doppler ultrasound, we examined portal and mesenteric blood flow and measured plasma glucagon levels at regular intervals within a 4-hour period under fasting conditions. Results: Contrary to placebo, octreotide caused a decrease in portal blood flow (PVF) and in superior mesenteric artery blood flow (SMAF) together with an increase in the mesenteric pulsatility index (PI). The same total dose of 100 µg octreotide caused a similar PVF response, averaged over 4 h, given either subcutaneously (–28.0 ± 4.8%), intravenously (–29.4 ± 4.3%) or as a continuous infusion (–29.3 ± 4.6%). As concerns intravenous infusions, 100 µg/h was more effective than 25 µg/h (–37.8 ± 6.2 vs. –29.3 ± 4.6%). The PVF reduction remained constant during intravenous infusion, whereas glucagon levels decreased progressively over the entire observation time. Conclusions: The decrease in PVF is dependent on the octreotide dose. However, this is not constantly paralleled by a decrease in plasma glucagon concentration.

show abstract

Section: Introductionmentioning

confidence: 99%

Effects of Different Octreotide Dosages on Splanchnic Hemodynamics and Glucagon in Healthy Volunteers

Sartipy

Brensing²,

Göke³

et al. 1999

Digestion

View full text Add to dashboard Cite

show abstract

“…Primignani and colleagues 36 have recently reported that octreotide in doses of 100 µg given subcutaneously three times a day for 29 days doesn't prevent early rebleeding in cirrhotic patients treated with sclerotherapy after control of acute variceal bleeding. In contrast Besson and colleagues 13 found a significant beneficial effect of octreotide associated Abbreviation: BUN, blood urea nitrogen.…”

Section: Discussionmentioning

confidence: 99%

Octreotide compared with placebo in a treatment strategy for early rebleeding in cirrhosis. A double blind, randomized pragmatic trial

et al. 1998

View full text Add to dashboard Cite

␤-Blockers and sclerotherapy prevent long-term upper digestive rebleeding in cirrhosis but they seem ineffective for early rebleeding. We compared octreotide with a placebo for the prevention of early rebleeding in cirrhotic patients. After control of acute upper digestive bleeding, 262 consecutive cirrhotic patients were randomized to octreotide 100 g subcutaneously three times a day for 15 days (n ‫؍‬ 131) or to the placebo (n ‫؍‬ 131), in a double blind pragmatic trial in which ␤-blockers and/or sclerotherapy were allowed together with the experimental treatment. Separate randomization and analysis were performed according to whether patients were eligible for ␤-blockers and/or sclerotherapy (101 placebo, 97 octreotide) or not (30 placebo, 34 octreotide). Rebleeding within 15 days was the primary measure of treatment efficacy; 6-week rebleeding rate was also assessed as a secondary measure. Fifteen-day cumulative proportions of patients rebleeding were 28% in the placebo group and 24% in the octreotide group (P ‫؍‬ .40); corresponding figures among the 198 patients eligible to ␤-blockers and/or sclerotherapy were 26% and 16% (P ‫؍‬ .05) and among the 64 not eligible for these treatments 33% and 49% (P ‫؍‬ .29). Among patients eligible to ␤-blockers and/or sclerotherapy, a significant reduction of rebleeding episodes (35 vs. 18, P ‫؍‬ .03), blood transfusions (75 vs. 50, P ‫؍‬ .04), and days of stay in hospital (1,544 vs. 1,190, P ‫؍‬ .0001) was also found in the octreotide group: this beneficial effect was confirmed 6 weeks after randomization. Following upper digestive bleeding in cirrhosis, almost 50% of patients rebleed and 30% die within 6 weeks.

show abstract

“…Although 15-day cumulative proportions of Octreotide in the Long-Term Prevention of Rebleeding (table 5) patients with rebleeding did not differ between the two groups, analysis of the subgroup of patients eligible to sclerotherapy and/or -blockers showed a significant reThree studies evaluated extended use of octreotide with the primary end-point of preventing rebleeding. In duction of rebleeding episodes (35 vs. 18, p>0.03), blood transfusions (75 vs. 50, p>0.04), and days of stay in the first study, Primignani et al [57] randomized 58 patients, 24 h after variceal bleeding had stopped to receive hospital (1,544 vs. 1,190, p>0.0001) in the octreotide group, compared to the placebo group. The multivariate 100 g of octreotide subcutaneously 3 times a day, or an identical placebo, up to day 29.…”

Section: Endoscopic Therapy Plus Somatostatin Ormentioning

confidence: 99%

Somatostatin or Octreotide in Acute Variceal Bleeding

Hadengue¹

1999

Digestion

View full text Add to dashboard Cite

In patients with cirrhosis, somatostatin or octreotide administration is followed by a transient decrease in the hepatic venous pressure gradient and azygos blood flow. Although no clear-cut changes in variceal pressure are observed and the exact mechanisms of acute hemodynamic changes induced by somatostatin or its derivatives are still unknown, this provided the rationale for its use in patients with variceal hemorrhage. The only known sustained hemodynamic effect of octreotide is to prevent increases in hepatic venous gradient or azygos blood flow in response to food intake. Somatostatin infusion can be as effective as sclerotherapy in the initial control of bleeding esophageal varices in patients with cirrhosis and is associated with fewer complications. Octreotide also seems to be as effective as endoscopic therapy in the control of acute variceal bleeding, although larger studies should be performed before its efficacy and safety profile can be fully evaluated. The combination of somatostatin or long-acting analogues to endoscopic therapy has recently been delineated as one of the most promising approaches in these patients. Early somatostatin administration with repeat boluses, starting several hours before sclerotherapy is combined, eases the endoscopic procedure and reduces bleeding control failure rate. Although two studies also showed that octreotide, when started at the time of sclerotherapy or variceal banding, also improves bleeding control, a conclusion on octreotide use in these patients is premature. Optimal administration schedules and doses of somatostatin or octreotide are still unknown. The safety of octreotide in patients with variceal bleeding, which has recently been challenged, should be assessed in larger trials. Recent data suggesting that octreotide combination to β-blockers or sclerotherapy may represent a useful approach for long-term prevention of rebleeding in these patients will have to be confirmed.

show abstract

Sclerotherapy plus octreotide versus sclerotherapy alone in the prevention of early rebleeding from esophageal varices: A randomized, double-blind, placebo-controlled, multicenter trial*1

Cited by 57 publications

References 21 publications

Effects of Different Octreotide Dosages on Splanchnic Hemodynamics and Glucagon in Healthy Volunteers

Effects of Different Octreotide Dosages on Splanchnic Hemodynamics and Glucagon in Healthy Volunteers

Octreotide compared with placebo in a treatment strategy for early rebleeding in cirrhosis. A double blind, randomized pragmatic trial

Somatostatin or Octreotide in Acute Variceal Bleeding

Contact Info

Product

Resources

About