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Photo courtesy of the
University of Utah
Health Sciences Center
Results of a phase 2 study suggest a saline nose spray may be as effective as 3 different medicated sprays for preventing epistaxis in patients with hemorrhagic telangiectasia (HHT).
The study was a comparison of bevacizumab, estriol, tranexamic acid, and saline.
The results showed no significant differences in the frequency or duration of epistaxis, and patients in all 4 groups reported improvements in Epistaxis Severity Scores (ESS).
“This research highlights that there could be a benefit even in the simplest of interventions,” said study author Kevin Whitehead, MD, of the University of Utah School of Medicine in Salt Lake City.
“No drug proved to be any better than the saline placebo, but the majority of patients improved over the course of treatment—even those using saline.”
Dr Whitehead and his colleagues reported these results in JAMA.
The study included 121 HHT patients who had experienced HHT-related epistaxis. They were randomized to twice-daily nose sprays with bevacizumab 1% (4 mg/day), estriol 0.1% (0.4 mg/day), tranexamic acid 10% (40 mg/day), or placebo (0.9% saline) for 12 weeks.
Safety
The investigators said nasal symptoms were the most common adverse events, and they occurred in all 4 treatment groups.
Gastrointestinal symptoms, including abdominal pain, nausea, and vomiting, were most common among patients receiving tranexamic acid.
There were no thrombotic complications, episodes of severe hypertension, serious drug-related adverse events, or deaths in any treatment group.
Efficacy
There was no significant difference in epistaxis frequency between the placebo group and the other treatment groups (P=0.97).
After 12 weeks of treatment, the median weekly number of bleeding episodes was 7.0 for patients in the bevacizumab group, 8.0 for the estriol group, 7.5 for the tranexamic acid group, and 8.0 for the placebo group. At baseline, the median weekly number of bleeding episodes was 10.0, 7.0, 7.8, and 7.0, respectively.
After 12 weeks of treatment, there was no significant difference in epistaxis duration between the placebo group and the other treatment groups (P=0.09).
The median duration of epistaxis per bleeding episode was 3.0 minutes for the bevacizumab group, 4.0 minutes for the estriol group, 6.2 minutes for the tranexamic acid group, and 5.0 minutes for the placebo group. (Bleeding duration was not recorded at baseline.)
After 12 weeks of treatment, there were no significant differences between the treatment groups when it came to hemoglobin levels (P=0.43), ferritin levels (P=0.10), treatment failure (P=0.08), the need for transfusion (P=0.42), or emergency department visits (P=0.72).
Patients in all 4 treatment groups experienced a significant decline in ESS from baseline to week 12 (P<0.001 for time effect).
The median ESS decreased from 5.71 to 3.74 in the placebo group, 5.16 to 3.54 in the bevacizumab group, 5.19 to 3.56 in the estriol group, and 5.43 to 4.06 in the tranexamic acid group. The investigators said the improvement in ESS was clinically significant.
However, the team also said they cannot completely rule out the possibility that symptoms may have improved because of a placebo effect.
What’s more, it could be that some of the drugs tested would work better if taken at a higher dose, or if applied as a gel or polymer that adheres better to the inside of the nasal cavity.
Nevertheless, the results from this trial were enough to convince Dr Whitehead and his colleagues to routinely recommend saline nasal spray to their patients with HHT.
“We stress the importance of hydration,” Dr Whitehead said. “We tell them that something as simple as a morning and night saline spray could offer them some benefit.” 
Photo courtesy of the
University of Utah
Health Sciences Center
Results of a phase 2 study suggest a saline nose spray may be as effective as 3 different medicated sprays for preventing epistaxis in patients with hemorrhagic telangiectasia (HHT).
The study was a comparison of bevacizumab, estriol, tranexamic acid, and saline.
The results showed no significant differences in the frequency or duration of epistaxis, and patients in all 4 groups reported improvements in Epistaxis Severity Scores (ESS).
“This research highlights that there could be a benefit even in the simplest of interventions,” said study author Kevin Whitehead, MD, of the University of Utah School of Medicine in Salt Lake City.
“No drug proved to be any better than the saline placebo, but the majority of patients improved over the course of treatment—even those using saline.”
Dr Whitehead and his colleagues reported these results in JAMA.
The study included 121 HHT patients who had experienced HHT-related epistaxis. They were randomized to twice-daily nose sprays with bevacizumab 1% (4 mg/day), estriol 0.1% (0.4 mg/day), tranexamic acid 10% (40 mg/day), or placebo (0.9% saline) for 12 weeks.
Safety
The investigators said nasal symptoms were the most common adverse events, and they occurred in all 4 treatment groups.
Gastrointestinal symptoms, including abdominal pain, nausea, and vomiting, were most common among patients receiving tranexamic acid.
There were no thrombotic complications, episodes of severe hypertension, serious drug-related adverse events, or deaths in any treatment group.
Efficacy
There was no significant difference in epistaxis frequency between the placebo group and the other treatment groups (P=0.97).
After 12 weeks of treatment, the median weekly number of bleeding episodes was 7.0 for patients in the bevacizumab group, 8.0 for the estriol group, 7.5 for the tranexamic acid group, and 8.0 for the placebo group. At baseline, the median weekly number of bleeding episodes was 10.0, 7.0, 7.8, and 7.0, respectively.
After 12 weeks of treatment, there was no significant difference in epistaxis duration between the placebo group and the other treatment groups (P=0.09).
The median duration of epistaxis per bleeding episode was 3.0 minutes for the bevacizumab group, 4.0 minutes for the estriol group, 6.2 minutes for the tranexamic acid group, and 5.0 minutes for the placebo group. (Bleeding duration was not recorded at baseline.)
After 12 weeks of treatment, there were no significant differences between the treatment groups when it came to hemoglobin levels (P=0.43), ferritin levels (P=0.10), treatment failure (P=0.08), the need for transfusion (P=0.42), or emergency department visits (P=0.72).
Patients in all 4 treatment groups experienced a significant decline in ESS from baseline to week 12 (P<0.001 for time effect).
The median ESS decreased from 5.71 to 3.74 in the placebo group, 5.16 to 3.54 in the bevacizumab group, 5.19 to 3.56 in the estriol group, and 5.43 to 4.06 in the tranexamic acid group. The investigators said the improvement in ESS was clinically significant.
However, the team also said they cannot completely rule out the possibility that symptoms may have improved because of a placebo effect.
What’s more, it could be that some of the drugs tested would work better if taken at a higher dose, or if applied as a gel or polymer that adheres better to the inside of the nasal cavity.
Nevertheless, the results from this trial were enough to convince Dr Whitehead and his colleagues to routinely recommend saline nasal spray to their patients with HHT.
“We stress the importance of hydration,” Dr Whitehead said. “We tell them that something as simple as a morning and night saline spray could offer them some benefit.”
Photo courtesy of the
University of Utah
Health Sciences Center
Results of a phase 2 study suggest a saline nose spray may be as effective as 3 different medicated sprays for preventing epistaxis in patients with hemorrhagic telangiectasia (HHT).
The study was a comparison of bevacizumab, estriol, tranexamic acid, and saline.
The results showed no significant differences in the frequency or duration of epistaxis, and patients in all 4 groups reported improvements in Epistaxis Severity Scores (ESS).
“This research highlights that there could be a benefit even in the simplest of interventions,” said study author Kevin Whitehead, MD, of the University of Utah School of Medicine in Salt Lake City.
“No drug proved to be any better than the saline placebo, but the majority of patients improved over the course of treatment—even those using saline.”
Dr Whitehead and his colleagues reported these results in JAMA.
The study included 121 HHT patients who had experienced HHT-related epistaxis. They were randomized to twice-daily nose sprays with bevacizumab 1% (4 mg/day), estriol 0.1% (0.4 mg/day), tranexamic acid 10% (40 mg/day), or placebo (0.9% saline) for 12 weeks.
Safety
The investigators said nasal symptoms were the most common adverse events, and they occurred in all 4 treatment groups.
Gastrointestinal symptoms, including abdominal pain, nausea, and vomiting, were most common among patients receiving tranexamic acid.
There were no thrombotic complications, episodes of severe hypertension, serious drug-related adverse events, or deaths in any treatment group.
Efficacy
There was no significant difference in epistaxis frequency between the placebo group and the other treatment groups (P=0.97).
After 12 weeks of treatment, the median weekly number of bleeding episodes was 7.0 for patients in the bevacizumab group, 8.0 for the estriol group, 7.5 for the tranexamic acid group, and 8.0 for the placebo group. At baseline, the median weekly number of bleeding episodes was 10.0, 7.0, 7.8, and 7.0, respectively.
After 12 weeks of treatment, there was no significant difference in epistaxis duration between the placebo group and the other treatment groups (P=0.09).
The median duration of epistaxis per bleeding episode was 3.0 minutes for the bevacizumab group, 4.0 minutes for the estriol group, 6.2 minutes for the tranexamic acid group, and 5.0 minutes for the placebo group. (Bleeding duration was not recorded at baseline.)
After 12 weeks of treatment, there were no significant differences between the treatment groups when it came to hemoglobin levels (P=0.43), ferritin levels (P=0.10), treatment failure (P=0.08), the need for transfusion (P=0.42), or emergency department visits (P=0.72).
Patients in all 4 treatment groups experienced a significant decline in ESS from baseline to week 12 (P<0.001 for time effect).
The median ESS decreased from 5.71 to 3.74 in the placebo group, 5.16 to 3.54 in the bevacizumab group, 5.19 to 3.56 in the estriol group, and 5.43 to 4.06 in the tranexamic acid group. The investigators said the improvement in ESS was clinically significant.
However, the team also said they cannot completely rule out the possibility that symptoms may have improved because of a placebo effect.
What’s more, it could be that some of the drugs tested would work better if taken at a higher dose, or if applied as a gel or polymer that adheres better to the inside of the nasal cavity.
Nevertheless, the results from this trial were enough to convince Dr Whitehead and his colleagues to routinely recommend saline nasal spray to their patients with HHT.
“We stress the importance of hydration,” Dr Whitehead said. “We tell them that something as simple as a morning and night saline spray could offer them some benefit.”