Electrophysiological study for comparing the effect of biological activity between type A botulinum toxins in rat gastrocnemius muscle

Kim, Chang Sung; Ws, Jang; Ip, Son; Sh, Nam; Yi, Kim; Park, KY; Kim, BJ; Mn, Kim

doi:10.1177/0960327113479044

Cited by 14 publications

(11 citation statements)

References 19 publications

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“…In a similar study, CMAP measurements were used to quantitatively assess the biological activity of BoNT‐A . Kim and colleagues also used the rat‐CMAP test to compare the paralytic effect induced by ONA and PRA on the rat tibialis anterior muscle by the split‐body method . Compared with Mstn +/+ mice, inhibition of nerve conduction lasted longer.…”

Section: Discussionmentioning

confidence: 99%

“…Prabotulinumtoxina is manufactured by a new method of producing high‐purity BoNT‐A, precipitating the BoNT‐A with acid and purifying the BoNT‐A by anion exchange chromatography, yielding a purity of 98% or higher . PRA showed comparable safety and efficacy to onabotulinumtoxinA (ONA) in a study using a rat model as well as in a clinical study of patients with glabellar frown lines . Other studies have shown that PRA improves post‐stroke upper limb spasticity and reduces masseter muscle hypertrophy …”

Section: Introductionmentioning

confidence: 95%

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A comparison study of prabotulinumtoxinA vs onabotulinumtoxinA in myostatin‐deficient mice with muscle hypertrophy

Bak

Choi

Lee

et al. 2018

Basic Clin Pharma Tox

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Botulinum toxin A (BoNT-A) is used clinically for various muscle disorders and acts by preventing the release of the neurotransmitter acetylcholine into the synapse space. Here, we compared the efficacy of prabotulinumtoxinA (PRA) and onabotulinumtoxinA (ONA) for the reduction in hypertrophy in myostatin-deficient (Mstn −/− ) mice. Two different BoNT-A products (2.5, 10 and 25 U/kg) were injected to paralyse the hindlimb for 2 months, after which sciatic nerve conduction study, 3D micro-CT, haematoxylin and eosin (H&E) and dystrophin staining were conducted. Administration of BoNT-A products induced denervation-mediated atrophy and alleviated muscle hypertrophy generated in Mstn −/− mice. The present study revealed that each BoNT-A regulates skeletal muscle size, myofibre number and myofibre diameter in Mstn −/− mice. The potential applicability of BoNT-A for the treatment of rare muscle hypertrophic diseases was demonstrated. Compared with ONA, PRA had a comparable ability to act in the local area.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 95%

A comparison study of prabotulinumtoxinA vs onabotulinumtoxinA in myostatin‐deficient mice with muscle hypertrophy

Bak

Choi

Lee

et al. 2018

Basic Clin Pharma Tox

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“…1 Recently, the use of this agent has rapidly expanded in the field of aesthetic medicine. 5 Also in the comparative toxicology study, DWP450 showed two times higher safety than that of OBoNT (DWP450 NOAEL was 60 U/kg of female SD rat and OBoNT was 30 U/kg of female SD rat). [2][3][4] DWP450 (Daewoong Pharmaceutical, Seoul, Korea), a new BoNT-A formulation, was introduced recently.…”

Section: Introductionmentioning

confidence: 94%

“…In a previous in vivo study, we demonstrated that DWP450 produces an effect similar to that of OBoNT using a split-body electrophysiological protocol in a rat model. 5 Also in the comparative toxicology study, DWP450 showed two times higher safety than that of OBoNT (DWP450 NOAEL was 60 U/kg of female SD rat and OBoNT was 30 U/kg of female SD rat). As there has been no information about the clinical efficacy or safety of DWP450, we performed a multicenter, randomized, double-blinded, active-controlled trial to compare DWP450 and OBoNT in the treatment of glabellar lines.…”

Section: Introductionmentioning

confidence: 94%

Comparative trial of a novel botulinum neurotoxin type A versus onabotulinumtoxinA in the treatment of glabellar lines: A multicenter, randomized, double‐blind, active‐controlled study

Won

Kim

et al. 2014

Int J Dermatology

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A novel botulinum neurotoxin type A (DWP450; Daewoong Pharmaceutical, Seoul, Korea) has recently been introduced for the treatment of facial wrinkles. The efficacy of this agent has previously been demonstrated in an in vivo study using an electrophysiological protocol in a rat model. To compare the efficacy and safety of DWP450 with onabotulinumtoxinA (OBoNT) for use in the treatment of glabellar lines, we performed a multicenter, double-blind, randomized, active-controlled trial comparing DWP450 and OBoNT (Allergan Inc., Irvine, CA, USA). A total of 268 subjects with moderate to severe glabellar lines were randomized at a 1:1 ratio. Each patient received treatment with 20 U of study medication. Maximum frown responder rates at week 4 were measured to analyze the primary efficacy endpoint. To evaluate secondary efficacy endpoints, response rates were measured at weeks 8, 12, and 16, at maximum frown and rest. Specifically, responder rates at both maximum frown and at rest were assessed based on clinical photography. Subject degree of satisfaction and self-assessed rate of response were also measured. Adverse events (AEs) were documented to evaluate safety. Responder rate by physician-rating severity at maximal contraction at week 4 was 93.89% in the DWP450 group and 88.64% in OBoNT group. As the lower limit of the 97.5% one-sided confidence interval (-1.53%) surpassed the -15% threshold, we determined that DWP450 was not inferior to OBoNT. For the secondary efficacy endpoint analyses, no significant differences were observed between the two groups for any variable at any point in time. The incidences of AEs were similar for the two groups. Most of AEs were considered mild. DWP450 and OBoNT were comparable in efficacy and safety in the treatment of glabellar lines.

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“…In vivo, PRA has shown to have pharmacological similarities and comparable electrophysiological effects with ONA. Study in animal showed that it also has a higher safety profile than ONA . Several clinical studies comparing the efficacy and safety of PRA and ONA had been conducted, including for the treatment of glabellar lines and for limb spasticity in stroke patients.…”

Section: Introductionmentioning

confidence: 99%

A pilot study comparing the efficacy of two formulations of botulinum toxin type A for muscular calves contouring

Wanitphakdeedecha

Ungaksornpairote

Kaewkes

et al. 2018

J of Cosmetic Dermatology

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Electrophysiological study for comparing the effect of biological activity between type A botulinum toxins in rat gastrocnemius muscle

Cited by 14 publications

References 19 publications

A comparison study of prabotulinumtoxinA vs onabotulinumtoxinA in myostatin‐deficient mice with muscle hypertrophy

A comparison study of prabotulinumtoxinA vs onabotulinumtoxinA in myostatin‐deficient mice with muscle hypertrophy

Comparative trial of a novel botulinum neurotoxin type A versus onabotulinumtoxinA in the treatment of glabellar lines: A multicenter, randomized, double‐blind, active‐controlled study

A pilot study comparing the efficacy of two formulations of botulinum toxin type A for muscular calves contouring

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