TY - JOUR
T1 - Myobloc® (rimabotulinumtoxinB) in the treatment of adult sialorrhea
AU - Isaacson, Stuart
AU - Ondo, William
AU - Lew, Mark
AU - Dashtipour, Khashayar
AU - Chary, Dilip
AU - Clinch, Thomas
AU - Pagan, Fernando
PY - 2018/12/1
Y1 - 2018/12/1
N2 - Introduction: Sialorrhea (drooling) can cause significant morbidity, including impaired oral hygiene, perioral irritation, embarrassment, swallowing impairment, and increased risk of aspiration, in several neurologic disorders. Local injections of botulinum toxin-B (BoNT-B) into the parotid and submandibular glands reduce saliva production. Methods: This double-blind, placebo-controlled (DBPC) study with open-label (OL) extension determined the efficacy, safety, and tolerability of repeat injections of BoNT-B for the treatment of sialorrhea. In the DBPC phase, adult subjects with Parkinson's disease, amyotrophic lateral sclerosis, medication-induced stroke, and other disorders were randomized (1:1:1) to receive MYOBLOC (rimabotulinumtoxinB) 2500 U vs 3500 U vs placebo. During the OL phase, all subjects received 3500 U during the first OL treatment cycle; dose adjustments were permitted in OL cycles 2 to 4 (injection interval, 11 to 15 weeks). Co-primary outcomes were change from baseline to week 4 in unstimulated salivary flow rate (USFR) and Clinical Global Impression of Change (CGI-C). Results: Of the 187 enrolled subjects, 176 completed the DBPC, 170 entered OL treatment, and 128 completed the OL phase up to 1 year. Treatment with rimabotulinumtoxinB in the DBPC study significantly reduced USFR at week 4 versus placebo (mean treatment effect, ‒0.30 for both doses vs placebo; P
AB - Introduction: Sialorrhea (drooling) can cause significant morbidity, including impaired oral hygiene, perioral irritation, embarrassment, swallowing impairment, and increased risk of aspiration, in several neurologic disorders. Local injections of botulinum toxin-B (BoNT-B) into the parotid and submandibular glands reduce saliva production. Methods: This double-blind, placebo-controlled (DBPC) study with open-label (OL) extension determined the efficacy, safety, and tolerability of repeat injections of BoNT-B for the treatment of sialorrhea. In the DBPC phase, adult subjects with Parkinson's disease, amyotrophic lateral sclerosis, medication-induced stroke, and other disorders were randomized (1:1:1) to receive MYOBLOC (rimabotulinumtoxinB) 2500 U vs 3500 U vs placebo. During the OL phase, all subjects received 3500 U during the first OL treatment cycle; dose adjustments were permitted in OL cycles 2 to 4 (injection interval, 11 to 15 weeks). Co-primary outcomes were change from baseline to week 4 in unstimulated salivary flow rate (USFR) and Clinical Global Impression of Change (CGI-C). Results: Of the 187 enrolled subjects, 176 completed the DBPC, 170 entered OL treatment, and 128 completed the OL phase up to 1 year. Treatment with rimabotulinumtoxinB in the DBPC study significantly reduced USFR at week 4 versus placebo (mean treatment effect, ‒0.30 for both doses vs placebo; P
UR - https://www.sciencedirect.com/science/article/pii/S0041010118308365
UR - https://www.mendeley.com/catalogue/4e210191-6298-3ac5-aa9e-4da963ffa935/
U2 - 10.1016/J.TOXICON.2018.11.115
DO - 10.1016/J.TOXICON.2018.11.115
M3 - Meeting abstract
VL - 156
SP - S47-S48
JO - Toxicon
JF - Toxicon
ER -