메뉴 건너뛰기




Volumn 21, Issue 6, 2014, Pages 567-573

Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause

Author keywords

Clinical meaningfulness.; Gabapentin; Gastroretentive; Hot flashes; Menopause; Vasomotor symptoms

Indexed keywords

GABAPENTIN; PLACEBO; 4 AMINOBUTYRIC ACID; AMINE; CALCIUM CHANNEL BLOCKING AGENT; CYCLOHEXANECARBOXYLIC ACID DERIVATIVE; DELAYED RELEASE FORMULATION;

EID: 84901610440     PISSN: 10723714     EISSN: 15300374     Source Type: Journal    
DOI: 10.1097/GME.0b013e3182a7c073     Document Type: Article
Times cited : (43)

References (27)
  • 1
    • 0032980218 scopus 로고    scopus 로고
    • Vasomotor flushes in menopausal women
    • Bachmann GA. Vasomotor flushes in menopausal women. Am J Obstet Gynecol 1999;180:S312-S316.
    • (1999) Am J Obstet Gynecol , vol.180
    • Bachmann, G.A.1
  • 2
    • 0033927412 scopus 로고    scopus 로고
    • Management of the climacteric Options abound to relieve women's midlife symptoms
    • 93-94 97-100
    • Morrissey DR, Kirchner JT. Management of the climacteric. Options abound to relieve women's midlife symptoms. Postgrad Med 2000;108: 85-88, 93-94, 97-100.
    • (2000) Postgrad Med , vol.108 , pp. 85-88
    • Morrissey, D.R.1    Kirchner, J.T.2
  • 3
    • 0027513343 scopus 로고
    • Impact of climacteric on well-being. A survey based on 5213 women 39 to 60 years old
    • Oldenhave A, Jaszmann LJ, Haspels AA, Everaerd WT. Impact of climacteric on well-being. A survey based on 5213 women 39 to 60 years old. Am J Obstet Gynecol 1993;168:772-780.
    • (1993) Am J Obstet Gynecol , vol.168 , pp. 772-780
    • Oldenhave, A.1    Jaszmann, L.J.2    Haspels, A.A.3    Everaerd, W.T.4
  • 4
    • 0037311026 scopus 로고    scopus 로고
    • Gabapentin's effects on hot flashes in postmenopausal women: A randomized controlled trial
    • Guttuso T Jr, Kurlan R, McDermott MP, Kieburtz K. Gabapentin's effects on hot flashes in postmenopausal women: a randomized controlled trial. Obstet Gynecol 2003;101:337-345.
    • (2003) Obstet Gynecol , vol.101 , pp. 337-345
    • Guttuso Jr., T.1    Kurlan, R.2    McDermott, M.P.3    Kieburtz, K.4
  • 5
    • 26944497954 scopus 로고    scopus 로고
    • Gabapentin for hot flashes in 420 women with breast cancer: A randomised double-blind placebocontrolled trial
    • Pandya KJ, Morrow GR, Roscoe JA, et al. Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebocontrolled trial. Lancet 2005;366:818-824.
    • (2005) Lancet , vol.366 , pp. 818-824
    • Pandya, K.J.1    Morrow, G.R.2    Roscoe, J.A.3
  • 6
    • 40449101303 scopus 로고    scopus 로고
    • Gabapentin for the treatment of menopausal hot flashes: A randomized controlled trial
    • Butt DA, Lock M, Lewis JE, Ross S, Moineddin R. Gabapentin for the treatment of menopausal hot flashes: a randomized controlled trial. Menopause 2008;15:1-9.
    • (2008) Menopause , vol.15 , pp. 1-9
    • Butt, D.A.1    Lock, M.2    Lewis, J.E.3    Ross, S.4    Moineddin, R.5
  • 7
    • 1542298877 scopus 로고    scopus 로고
    • Hot flashes refractory to HRT and SSRI therapy but responsive to gabapentin therapy
    • Guttuso T Jr. Hot flashes refractory to HRT and SSRI therapy but responsive to gabapentin therapy. J Pain Symptom Manage 2004;27: 274-276.
    • (2004) J Pain Symptom Manage , vol.27 , pp. 274-276
    • Guttuso Jr., T.1
  • 8
    • 33746896231 scopus 로고    scopus 로고
    • Gabapentin, estrogen, and placebo for treating hot flushes: A randomized controlled trial
    • Reddy SY, Warner H, Guttuso T Jr, et al. Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial. Obstet Gynecol 2006;108:41-48.
    • (2006) Obstet Gynecol , vol.108 , pp. 41-48
    • Reddy, S.Y.1    Warner, H.2    Guttuso Jr., T.3
  • 9
    • 84901593157 scopus 로고    scopus 로고
    • NeurontinA (gabapentin) Capsules NeurontinA (gabapentin) Tablets New York NY: Pfizer Inc; 2012. Available at Accessed July 18 2012
    • NeurontinA (gabapentin) Capsules, NeurontinA (gabapentin) Tablets, NeurontinA (gabapentin) Oral Solution [US prescribing information]. New York, NY: Pfizer Inc; 2012. Available at: http://labeling.pfizer.com/ShowLabeling. aspx?id=630. Accessed July 18, 2012.
    • NeurontinA (Gabapentin)Oral Solution US Prescribing Information
  • 10
    • 84865333818 scopus 로고    scopus 로고
    • Clinical development of a once-daily gastroretentive formulation of gabapentin for treatment of postherpetic neuralgia: An overview
    • Argoff CE, Chen C, Cowles VE. Clinical development of a once-daily gastroretentive formulation of gabapentin for treatment of postherpetic neuralgia: an overview. Expert Opin Drug Deliv 2012;9:1147-1160.
    • (2012) Expert Opin Drug Deliv , vol.9 , pp. 1147-1160
    • Argoff, C.E.1    Chen, C.2    Cowles, V.E.3
  • 12
    • 39049179556 scopus 로고    scopus 로고
    • Case studies in swelling polymeric gastric retentive tablets
    • Berner B, Cowles VE. Case studies in swelling polymeric gastric retentive tablets. Expert Opin Drug Deliv 2006;3:541-548.
    • (2006) Expert Opin Drug Deliv , vol.3 , pp. 541-548
    • Berner, B.1    Cowles, V.E.2
  • 13
    • 44849085415 scopus 로고    scopus 로고
    • Pharmacokinetics of gabapentin after a single day and at steady state following the administration of gastric-retentive, extended-release, and immediate-release tablets: A randomized, open-label, multiple-dose, three-way crossover, exploratory study in healthy subjects
    • Gordi T, Hou E, Kasichayanula S, Berner B. Pharmacokinetics of gabapentin after a single day and at steady state following the administration of gastric-retentive, extended-release, and immediate-release tablets: a randomized, open-label, multiple-dose, three-way crossover, exploratory study in healthy subjects. Clin Ther 2008;30:909-916.
    • (2008) Clin Ther , vol.30 , pp. 909-916
    • Gordi, T.1    Hou, E.2    Kasichayanula, S.3    Berner, B.4
  • 14
    • 84874939151 scopus 로고    scopus 로고
    • Gastroretentive gabapentin (G-GR) formulation reduces intensity of pain associated with postherpetic neuralgia (PHN)
    • Sang CN, Sathyanarayana R, Sweeney M. Gastroretentive gabapentin (G-GR) formulation reduces intensity of pain associated with postherpetic neuralgia (PHN). Clin J Pain 2013;29:281-288.
    • (2013) Clin J Pain , vol.29 , pp. 281-288
    • Sang, C.N.1    Sathyanarayana, R.2    Sweeney, M.3
  • 15
    • 84872426563 scopus 로고    scopus 로고
    • Positive efficacy data from a phase 2 trial of gabapentin extended-release in the treatment of menopausal hot flashes [Abstract]
    • Abstract P-61 16
    • Sweeney M, Sathyanarayana R, Gordi T, Cowles VE, Heritier M. Positive efficacy data from a phase 2 trial of gabapentin extended-release in the treatment of menopausal hot flashes [Abstract]. Menopause 2008;15: 1225. Abstract P-61 16.
    • (2008) Menopause , vol.15 , pp. 1225
    • Sweeney, M.1    Sathyanarayana, R.2    Gordi, T.3    Cowles, V.E.4    Heritier, M.5
  • 16
    • 84901639420 scopus 로고    scopus 로고
    • The effect of outliers on hot flash frequency in the Breeze 1 Study of gabapentin-ER for the non-hormonal treatment of vasomotor symptoms
    • [Abstract] Abstract S-14
    • Kagan R, Sathyanarayana R, Sweeney M, Pratt J, Zheng Y. The effect of outliers on hot flash frequency in the Breeze 1 Study of gabapentin-ER for the non-hormonal treatment of vasomotor symptoms [Abstract]. Menopause 2010;17:1219. Abstract S-14.
    • (2010) Menopause , vol.17 , pp. 1219
    • Kagan, R.1    Sathyanarayana, R.2    Sweeney, M.3    Pratt, J.4    Zheng, Y.5
  • 17
    • 84901585776 scopus 로고    scopus 로고
    • Efficacy of gabapentin extended-release (G-ER) on vasomotor symptoms in post-menopausal women in Breeze 2 Study [Abstract]
    • Abstract P-76
    • Baron M, Cowles VE, Utian W, Koltun W, Sathyanarayana R, Sweeney M. Efficacy of gabapentin extended-release (G-ER) on vasomotor symptoms in post-menopausal women in Breeze 2 Study [Abstract]. Menopause 2011;18:1369. Abstract P-76 18.
    • (2011) Menopause , vol.18 , pp. 1369
    • Baron, M.1    Cowles, V.E.2    Utian, W.3    Koltun, W.4    Sathyanarayana, R.5    Sweeney, M.6
  • 20
    • 33745678256 scopus 로고    scopus 로고
    • Severe hot flashes are associated with chronic insomnia
    • Ohayon MM. Severe hot flashes are associated with chronic insomnia. Arch Intern Med 2006;166:1262-1268.
    • (2006) Arch Intern Med , vol.166 , pp. 1262-1268
    • Ohayon, M.M.1
  • 21
    • 74549202116 scopus 로고    scopus 로고
    • Hot flashes, sleep, and mood
    • Regestein QR. Hot flashes, sleep, and mood. Menopause 2010;17:16-18.
    • (2010) Menopause , vol.17 , pp. 16-18
    • Regestein, Q.R.1
  • 22
    • 84865145863 scopus 로고    scopus 로고
    • Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extendedrelease formulation in postmenopausal women with vasomotor symptoms
    • Cowles VE, Gordi T, Hou SY. Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extendedrelease formulation in postmenopausal women with vasomotor symptoms. Clin Drug Investig 2012;32:593-601.
    • (2012) Clin Drug Investig , vol.32 , pp. 593-601
    • Cowles, V.E.1    Gordi, T.2    Hou, S.Y.3
  • 23
    • 84881008614 scopus 로고    scopus 로고
    • Bayer HealthCare Pharmaceuticals; Available at Accessed May 31 2013
    • Angeliq [US prescribing information]. Wayne, NJ: Bayer HealthCare Pharmaceuticals; 2012. Available at: http://berlex.bayerhealthcare.com/html/ products/pi/fhc/Angeliq-PI.pdf. Accessed May 31, 2013.
    • (2012) Angeliq [US Prescribing Information]
    • Wayne, N.J.1
  • 24
    • 84970857770 scopus 로고
    • Regression towards the mean
    • Bland JM, Altman DG. Regression towards the mean. BMJ Open 1994;308:1499.
    • (1994) BMJ Open , vol.308 , pp. 1499
    • Bland, J.M.1    Altman, D.G.2
  • 25
    • 84860489420 scopus 로고    scopus 로고
    • Placebo effect in hot flush research
    • Mahon SM, Kaplan M. Placebo effect in hot flush research. Lancet Oncol 2012;13:e188.
    • (2012) Lancet Oncol , vol.13
    • Mahon, S.M.1    Kaplan, M.2
  • 26
    • 0038714895 scopus 로고    scopus 로고
    • Clinically important drug interactions in epilepsy: Interactions between antiepileptic drugs and other drugs
    • Patsalos PN, Perucca E. Clinically important drug interactions in epilepsy: interactions between antiepileptic drugs and other drugs. Lancet Neurol 2003;2:473-481.
    • (2003) Lancet Neurol , vol.2 , pp. 473-481
    • Patsalos, P.N.1    Perucca, E.2
  • 27
    • 84901623918 scopus 로고    scopus 로고
    • Safety and efficacy of low-dose mesylate salt of paroxetine (LDMP) for the treatment of vasomotor symptoms (VMS) associated with menopause: A 24-week, randomized, placebo controlled phase 3 study [Abstract]
    • Abstract S-2
    • Simon JA, Sanacora G, Bhaskar S, Lippman J. Safety and efficacy of low-dose mesylate salt of paroxetine (LDMP) for the treatment of vasomotor symptoms (VMS) associated with menopause: a 24-week, randomized, placebo controlled phase 3 study [Abstract]. Menopause 2012;19:1371. Abstract S-2.
    • (2012) Menopause , vol.19 , pp. 1371
    • Simon, J.A.1    Sanacora, G.2    Bhaskar, S.3    Lippman, J.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.