The Efficacy and Safety of 6% Gabapentin Topical ... · The Efficacy and Safety of 6% Gabapentin...
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The Efficacy and Safety of 6% Gabapentin Topical Formulation in The Treatment of Pruritus in Adult
Filipino Hemodialysis Patients: A Randomized, Double-Blind, Placebo-Controlled Study
TERESE MONETTE O. AQUINO, M.D., Karla Angela P. Cuenca-Luchnagco, MD, DPDS, Elizabeth V. Sanchez, MD, FPDS, Vermen M. Verallo-Rowell, MD, FPDS
SKIN & CANCER FOUNDATION, INC.PASIG CITY, PHILIPPINES
March 3, 2019
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TERESEMONETTEO.AQUINO,M.D.
S039 Residents and Fellows Symposium
DISCLOSURESI do not have any relevant relationships with the industry.
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PRURITUS• Unpleasant sensation of the skin
• Multidimensional phenomenon
• Primary/secondary skin condition
• Chronic Kidney Disease –Associated Pruritus (CKD-AP)
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30-50%Prevalence of CKD-AP
CHRONIC KIDNEY DISEASE – ASSOCIATED PRURITUS
Pisoni RL, Wikstrom B, Elder SJ, Akizawa T, Asano Y, Keen ML, et al. Pruritus in haemodialysis patients: International results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2006;21(12):3495-505. doi: 10.1093/ndt/gfl461. PubMed PMID: 16968725.
Poor quality of life
Poor sleep
Depression
Mortality
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BACKGROUND OF THE STUDYMECHANISMS OF PRURITUS
XEROSIS
Reduction of eccrine glands
Atrophy of sebaceous glands
Use of diuretics
IMMUNE SYSTEM
DERANGEMENT
Pro-inflammatory state
↑Peptides↑Proteases↑Cytokines
↑Kinins↑Prostanoids
METABOLIC
Altered calcium metabolism
Increases pruritogeniccytokines
NEUROPATHIC
Neuropathy &Central
sensitization to itch
Conveyed via nerve C-fibers (similar
with pain)
OPIOIDERGICSYSTEM
Increase in opioidergic tone
Opioid receptor antagonist
alleviates pruritus
Fallahzadeh MK, Roozbeh J, Geramizadeh B, Namazi MR. Interleukin-2 serum levels are elevated in patients with uremic pruritus: a novel finding with practical implications. Nephrology, dialysis,transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2011;26(10):3338-44. doi: 10.1093/ndt/gfr053. PubMed PMID: 21372257.Narita I, Alchi B, Omori K, Sato F, Ajiro J, Saga D, et al. Etiology and prognostic significance of severe uremic pruritus in chronic hemodialysis patients. Kidney international. 2006;69(9):1626-32.doi: 10.1038/sj.ki.5000251. PubMed PMID: 16672924.
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BACKGROUND OF THE STUDY
GABAPENTIN
XGABA
GLUTAMATE
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• Neuropathic pain• Oral form have shown to decrease
intensity of CKD-AP
• Exclusive renal elimination
• Boardman et al. (2008) reported the efficacy of 6% topical gabapentin for the treatment of vulvodynia 171.23678 g/mol
BACKGROUND OF THE STUDYGABAPENTIN
Lau T, Leung S, Lau W. Gabapentin for uremic pruritus in hemodialysis patients: a qualitative systematic review. Canadian journal of kidney health and disease. 2016;3:14. doi: 10.1186/s40697-016-0107-8. PubMedPMID: 27022475; PubMed Central PMCID: PMC4809033.Aramwit P, Supasyndh O. Uremic Pruritus; Its Prevalence, Pathophysiology and Management: IntechOpen; 2015. Available from: https://http://www.intechopen.com/books/updates-in-hemodialysis/uremic-pruritus-its-prevalence-pathophysiology-and-management.Kfoury LW, Jurdi MA. Uremic pruritus. Journal of nephrology. 2012;25(5):644-52. doi: 10.5301/jn.5000039. PubMed PMID: 21983988.Kukkar A, Bali A, Singh N, Jaggi AS. Implications and mechanism of action of gabapentin in neuropathic pain. Archives of pharmacal research. 2013;36(3):237-51. doi: 10.1007/s12272-013-0057-y. PubMed PMID:23435945.
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To assess the early safety of topical gabapentin in the treatment of CKD-AP
2
To assess the early efficacy of topical gabapentin in the treatment of CKD-AP
1
STUDY OBJECTIVES
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Recruitment done in two tertiary hospitals3
Block randomization2
Randomized, Double-blind, Placebo-controlled Study1
STUDY DESIGNMETHODS
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Unrelieved by antihistamines or emollients4
Baseline visual analog scale (VAS) pruritus score ≥ 53
Hemodialysis (at least 2x/week) for at least 8 weeks2
Adult (>18 years old) patients on hemodialysis 1
INCLUSION CRITERIAMETHODS
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With prior use of anti-pruritic medications (oral or topical) within one week of recruitment
4
Patients with pre-existing infectious/non-infectious dermatitis at baseline
3
Patients with known allergy to gabapentin/vehicle2
Pregnant/nursing mothers1
5 Attained less than a high-school degree
EXCLUSION CRITERIAMETHODS
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Gabapentin capsules
Dissolved in water
Compounded to a permeation cream
(PG+PEG)
6% GABAPENTIN PREPARATIONMETHODS
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Back83%
Neck4%
Arm3%
Thigh3%
Buttocks7%
DISTRIBUTION OF PRIMARY SITE OF APPLICATION
BackNeckArmThighButtocks
METHODSSITE OF APPLICATION
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PRIMARY OUTCOME MEASUREMETHODS
VISUAL ANALOG SCALE
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SECONDARY OUTCOME MEASUREMETHODS
Adverse Events Questionnaire2
5-D Pruritus Scale1
• 5-component scale quantifying: duration, degree, direction, disability & distribution
• Elman et al. (2010) - good correlation with VAS pruritus scores
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METHODSSAMPLE SIZE
• Based on prior trials which investigated similar outcomes (10-point VAS scores) in similar population but using different agents.• Young et al. (n=28) Topical pramoxine-based agent• Gunal et al (n=25) Oral gabapentin
• Central limit theorem• n=30 deemed large enough to yield data that will
approximate the normal distribution
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Assessed for eligibility (n=30)
Randomized (n=30)
Allocated to Experimental (Gabapentin) (n= 15)Received allocated intervention (n=15)
Allocated to Control (Placebo) (n=15)Received allocated intervention (n=15)
Allocation
Follow-up
Lost to follow-up at week 2 (change of schedule) (n=1)
Lost to follow-up at week 2 (change of schedule) (n=1)
Analysis
Analysed (n=15) *ITT analysis was done, missing data were handled using LOCF
Analysed (n=15) *ITT analysis was done, missing data were handled using LOCF
METHODS
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4 Data analysis was done using SPSS® Statistics Version 24
3 Change in Pruritus Score (Experimental VS Placebo)• Wilcoxon rank sum test
2Change in Pruritus Score (within groups)Baseline à wk1 & Baseline à wk2• Paired T-Test
1 Baseline Characteristics• T test for independent samples
METHODSSTATISTICAL ANALYSIS
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PATIENT CHARACTERISTICSRESULTS & DISCUSSION
EXPERIMENTAL (n=15) CONTROL (n = 15) p-value
GENDERMale 12 14 0.5977*Female 3 1
AGEMean 46.1 41.2
0.298203Standard Deviation 13.4 11.6Range 29 - 70 27 - 62
DURATION OF DIALYSIS
Mean (months) 23.7 16.5
0.477493Median (months) 12 8Standard Deviation 34.1 18.4Range 2 - 132 2 - 60
DURATION OF PRURITUS
Mean (months) 18.7 13.8
0.60029Median (months) 6 8Standard Deviation 31.9 16.4Range 1 - 120 2 - 60
*Analyzed via Chi-square statistic; Comparison of means analyzed via paired t-test for independent samples
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01234567
Baseline Week 1 Week 2
Mea
n VA
S Sc
ores
Mean VAS Pruritus Scores
Gabapentin Placebo
VISUAL ANALOG SCALERESULTS & DISCUSSION
p value 0.58
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-5
-4.5
-4
-3.5
-3
-2.5
-2
-1.5
-1
-0.5
0
Baseline Week 1 Week 2
Mea
n C
hang
e in
VA
S Sc
ores
Mean Change in VAS Pruritus Scores
Gabapentin Placebo
RESULTS & DISCUSSION
p value 0.80
VISUAL ANALOG SCALE
p value 0.01
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EXPERIMENTAL (n=15)
CONTROL (n = 15)
p-value(Experimental vs
Control)
Mean pruritus score at baseline 5.9 ± 1.3/5 (5-8) 6.2 ± 1.4/6 (5-10) 0.58*Mean pruritus score at week 1 2.7 ± 2.1/2 (0-5) 3.3 ± 2.2/4 (0-7)
Mean pruritus score at week 2 1.3 ± 1.5/1 (0-5) 3.6 ± 2.0/4 (1-7)
Change in pruritus score from baseline to week 1 -3.2 ± 2.1/3 (0-7) -2.9± 2.0/3 (-1-6) 0.80*
p value^ (Baseline vs week 1) <0.001 <0.001Change in pruritus score from baseline to
week 2 -4.6 ± 2.0/5 (0-7) -2.6 ± 1.9/3 (-1-5) 0.01*p value^ (Baseline vs week 2) <0.001 <0.001
Data are mean ± standard deviation/ median (range)^Difference in pruritus score between baseline and week 1/ week 2 analyzed via paired t-test*Difference in pruritus score between control and experimental groups analyzed via Wilcoxon rank sum testp value < 0.05 considered as statistically significant
RESULTS & DISCUSSIONVISUAL ANALOG SCALE
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0
5
10
15
20
25
Baseline Week 2
Mea
n 5-
D P
rurit
us S
core
s
5-D Pruritus Scores
Gabapentin Placebo
5D PRURITUS SCALERESULTS & DISCUSSION
p value 0.07
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-8
-7
-6
-5
-4
-3
-2
-1
0
Baseline Week 2Mea
n C
hang
e in
5-D
Pru
ritus
Sc
ores
Change in 5-D Pruritus Scores
Gabapentin Placebo
RESULTS & DISCUSSION
p value 0.47
5D PRURITUS SCALE
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EXPERIMENTAL (n=15)
CONTROL (n = 15)
p-value(Experimental vs
Control)Mean pruritus score at
baseline16.8 ± 5.0/17 (11-30) 20.1 ± 5.9/18 (13 – 29) 0.07*
Mean pruritus score at week 2 11.2 ± 3.6/10 (7-22) 13.3 ± 5.7/11 (7-25)
Change in pruritus score from baseline to week 2
-4.86 ± 5.24/4 (0 - 20) -6.8 ± 7.2/6 (0-21) 0.47*p value^
(Baseline vs week 2) 0.003 0.002
Data are mean ± standard deviation/ median (range)Mean scores are the sum of all 5 components of the 5-D scale^Difference in pruritus score between baseline and week 2 analyzed via paired t-test *Difference in pruritus score between control and experimental groups analyzed via Wilcoxon rank sum testp value < 0.05 considered as statistically significant
RESULTS & DISCUSSION5D PRURITUS SCALE
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Component
EXPERIMENTAL CONTROL*p-value(Experimental vs Control)
Mean change in scores at 2 weeks ^p-value
Mean change in scores at 2 weeks ^p-value
1. Duration -0.087 (SD 3.6) 0.008 -1.5 (SD 1.7) 0.005 0.093
2. Degree -1.13 (SD 0.74) <0.001 -0.4 (SD 0.5) 0.008 0.0123. Direction -1.1 (SD 1.4) 0.01 -0.5 (SD 1.0) 0.09 0.234. Disability
Sleep -0.86 (SD 1.18) 0.01 -1.6 (SD 1.6) 0.002 0.21Leisure/social -0.46 (SD 1.5) 0.23 -1.0 (SD 1.1) 0.004 0.26
Housework/errands -0.6 (SD 1.3) 0.09 -0.8 (SD 1.16) 0.07 0.57Work/school -0.33 (SD 1.4) 0.11 -0.53 (SD 1.7) 0.25 0.74
5. Distribution -0.73 (0.96) 0.01 -0.6 (1.12) 0.057 0.69
SD standard deviation; ^Difference in pruritus score between baseline and week 2 analyzed via paired t-test*Difference in pruritus score between control and experimental groups analyzed via Wilcoxon rank sum testp value < 0.05 considered as statistically significant
RESULTS & DISCUSSION5D PRURITUS SCALE
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RESULTS & DISCUSSION
PLACEBOEXPERIMENTAL(GABAPENTIN)<
MEANCHANGEINSCORESofVisualAnalogScale& Degreecomponentof5D(at2weeks)
Effect size of 1.02 (VAS) and 1.16 (5D degree component)
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• No adverse events noted in a 2-week span
ADVERSE EVENTSRESULTS & DISCUSSION
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Pain and itch share afferent similar pathway2
Boardman et al. (2008) – significant clinical effect of thedrug on the peripheral component of pain1
RESULTS & DISCUSSION
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RESULTS & DISCUSSION
Cutaneous Mechanism of Neurogenic Inflammation
Generates action potential
Binding to a specific-itch or pain receptor
Exogenous or endogenousfactors
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Important in CKD-AP because gabapentin toxicity may be higher in patients with CKD patients5
Topical formulation of gabapentin in our study minimized any systemic effect4
Significantly decreased VAS pruritus scores after 2weeks of use compared to placebo3
RESULTS & DISCUSSION
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Longer follow-up may be needed to adequately assesslong-term efficacy and possible late toxicities withtopical gabapentin
3
No reports of local or systemic adverse events2
Short-term, topical 6% gabapentin use was able todecrease VAS pruritus scores at 1 and 2 weeks versusbaseline
1
CONCLUSIONS