دورية أكاديمية
Safety and effectiveness of topiramate for the management of painful diabetic peripheral neuropathy in an open-label extension study
العنوان: | Safety and effectiveness of topiramate for the management of painful diabetic peripheral neuropathy in an open-label extension study |
---|---|
المؤلفون: | Donofrio, Peter D.1 donofrio@wfubmc.edu, Raskin, Philip2, Rosenthal, Norman R.3, Hewitt, David J.3, Jordan, Donna M.3, Xiang, Jim3, Vinik, Aaron I.4 |
المصدر: | Clinical Therapeutics. Sep2005, Vol. 27 Issue 9, p1420-1431. 12p. |
مصطلحات موضوعية: | *FRUCTOSE derivatives, *PLACEBOS, *THERAPEUTICS, *PEOPLE with diabetes |
مستخلص: | Abstract Objective:: The aim of this study was to further assess the long-term safety and effectiveness of open-label topiramate therapy in subjects with moderately to severely painful diabetic peripheral neuropathy (DPN). Methods:: Adults aged 18 to 75 years received open-label topiramate (25–600 mg/d for 26 weeks) in an extension of a previously published randomized, double-blind trial comparing topiramate with placebo. Safety analyses included adverse event (AE) reports and clinical laboratory tests. Metabolic end points included body weight and glycosylated hemoglobin (HbA1c). Effectiveness analyses included a 100-mm pain visual analog (PVA) scale, worst and current pain severity, and sleep disruption. Results:: Two hundred five subjects participated in this open-label extension study (118 formerly treated with topiramate and 87 who formerly received placebo). The groups did not differ in baseline demographics or disease characteristics. One hundred twenty-four (60.5%) subjects (68.6% of former topiramate recipients and 49.4% of former placebo recipients) completed the extension study; the most common reason for discontinuation was an AE (27.3% of subjects). AEs among subjects who received ≥1 dose of topiramate (n = 298) included upper respiratory tract infection (16.1%), anorexia (15.1%), diarrhea (12.8%), nausea (12.8%), paresthesia (10.7%), and headache (10.1%). Baseline pain scores were lower in those formerly treated with topiramate (n = 117) than in the former placebo group (n = 86) (PVA: 43.3 vs 52.5, P = 0.014; worst pain: 1.9 vs 2.5, P < 0.001; current pain: 1.6 vs 1.9, P = 0.026; sleep disruption: 3.6 vs 4.6, P = 0.021). At the final visit, PVA, current pain, and sleep disruption scores were not significantly different between the former topiramate and former placebo groups, but worst pain differed significantly (1.4 vs 1.8; P = 0.025). Mean weight loss from the start of topiramate therapy was 5.2 and 5.3 kg in the former topiramate and former placebo groups, respectively (P < 0.001 vs baseline). Mean HbA1c values before and after topiramate treatment were 7.7% and 7.4%, respectively, in the former topiramate group (P = 0.004 vs baseline), and 7.6% and 7.1%, respectively, in the former placebo group (P < 0.001 vs baseline). Conclusion:: Although 39.5% of subjects discontinued, most often due to AEs, the results of this 26-week, open-label extension study with topiramate (up to 600 mg/d) in subjects with moderately to severely painful DPN suggest that pain relief was effective and durable. [Copyright &y& Elsevier] |
قاعدة البيانات: | Academic Search Index |
ResultId |
1 |
---|---|
Header |
asx Academic Search Index 19042570 1202 6 Academic Journal academicJournal 1202.35229492188 |
PLink |
https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&scope=site&db=asx&AN=19042570&custid=s6537998&authtype=sso |
FullText |
Array
(
[Availability] => 0
)
|
Items |
Array
(
[Name] => Title
[Label] => Title
[Group] => Ti
[Data] => Safety and effectiveness of topiramate for the management of painful diabetic peripheral neuropathy in an open-label extension study
)
Array ( [Name] => Author [Label] => Authors [Group] => Au [Data] => <searchLink fieldCode="AR" term="%22Donofrio%2C+Peter+D%2E%22">Donofrio, Peter D.</searchLink><relatesTo>1</relatesTo><i> donofrio@wfubmc.edu</i><br /><searchLink fieldCode="AR" term="%22Raskin%2C+Philip%22">Raskin, Philip</searchLink><relatesTo>2</relatesTo><br /><searchLink fieldCode="AR" term="%22Rosenthal%2C+Norman+R%2E%22">Rosenthal, Norman R.</searchLink><relatesTo>3</relatesTo><br /><searchLink fieldCode="AR" term="%22Hewitt%2C+David+J%2E%22">Hewitt, David J.</searchLink><relatesTo>3</relatesTo><br /><searchLink fieldCode="AR" term="%22Jordan%2C+Donna+M%2E%22">Jordan, Donna M.</searchLink><relatesTo>3</relatesTo><br /><searchLink fieldCode="AR" term="%22Xiang%2C+Jim%22">Xiang, Jim</searchLink><relatesTo>3</relatesTo><br /><searchLink fieldCode="AR" term="%22Vinik%2C+Aaron+I%2E%22">Vinik, Aaron I.</searchLink><relatesTo>4</relatesTo> ) Array ( [Name] => TitleSource [Label] => Source [Group] => Src [Data] => <searchLink fieldCode="JN" term="%22Clinical+Therapeutics%22">Clinical Therapeutics</searchLink>. Sep2005, Vol. 27 Issue 9, p1420-1431. 12p. ) Array ( [Name] => Subject [Label] => Subject Terms [Group] => Su [Data] => *<searchLink fieldCode="DE" term="%22FRUCTOSE+derivatives%22">FRUCTOSE derivatives</searchLink><br />*<searchLink fieldCode="DE" term="%22PLACEBOS%22">PLACEBOS</searchLink><br />*<searchLink fieldCode="DE" term="%22THERAPEUTICS%22">THERAPEUTICS</searchLink><br />*<searchLink fieldCode="DE" term="%22PEOPLE+with+diabetes%22">PEOPLE with diabetes</searchLink> ) Array ( [Name] => Abstract [Label] => Abstract [Group] => Ab [Data] => Abstract Objective:: The aim of this study was to further assess the long-term safety and effectiveness of open-label topiramate therapy in subjects with moderately to severely painful diabetic peripheral neuropathy (DPN). Methods:: Adults aged 18 to 75 years received open-label topiramate (25–600 mg/d for 26 weeks) in an extension of a previously published randomized, double-blind trial comparing topiramate with placebo. Safety analyses included adverse event (AE) reports and clinical laboratory tests. Metabolic end points included body weight and glycosylated hemoglobin (HbA1c). Effectiveness analyses included a 100-mm pain visual analog (PVA) scale, worst and current pain severity, and sleep disruption. Results:: Two hundred five subjects participated in this open-label extension study (118 formerly treated with topiramate and 87 who formerly received placebo). The groups did not differ in baseline demographics or disease characteristics. One hundred twenty-four (60.5%) subjects (68.6% of former topiramate recipients and 49.4% of former placebo recipients) completed the extension study; the most common reason for discontinuation was an AE (27.3% of subjects). AEs among subjects who received ≥1 dose of topiramate (n = 298) included upper respiratory tract infection (16.1%), anorexia (15.1%), diarrhea (12.8%), nausea (12.8%), paresthesia (10.7%), and headache (10.1%). Baseline pain scores were lower in those formerly treated with topiramate (n = 117) than in the former placebo group (n = 86) (PVA: 43.3 vs 52.5, P = 0.014; worst pain: 1.9 vs 2.5, P < 0.001; current pain: 1.6 vs 1.9, P = 0.026; sleep disruption: 3.6 vs 4.6, P = 0.021). At the final visit, PVA, current pain, and sleep disruption scores were not significantly different between the former topiramate and former placebo groups, but worst pain differed significantly (1.4 vs 1.8; P = 0.025). Mean weight loss from the start of topiramate therapy was 5.2 and 5.3 kg in the former topiramate and former placebo groups, respectively (P < 0.001 vs baseline). Mean HbA1c values before and after topiramate treatment were 7.7% and 7.4%, respectively, in the former topiramate group (P = 0.004 vs baseline), and 7.6% and 7.1%, respectively, in the former placebo group (P < 0.001 vs baseline). Conclusion:: Although 39.5% of subjects discontinued, most often due to AEs, the results of this 26-week, open-label extension study with topiramate (up to 600 mg/d) in subjects with moderately to severely painful DPN suggest that pain relief was effective and durable. [Copyright &y& Elsevier] ) |
RecordInfo |
Array
(
[BibEntity] => Array
(
[Identifiers] => Array
(
[0] => Array
(
[Type] => doi
[Value] => 10.1016/j.clinthera.2005.09.011
)
)
[Languages] => Array
(
[0] => Array
(
[Code] => eng
[Text] => English
)
)
[PhysicalDescription] => Array
(
[Pagination] => Array
(
[PageCount] => 12
[StartPage] => 1420
)
)
[Subjects] => Array
(
[0] => Array
(
[SubjectFull] => FRUCTOSE derivatives
[Type] => general
)
[1] => Array
(
[SubjectFull] => PLACEBOS
[Type] => general
)
[2] => Array
(
[SubjectFull] => THERAPEUTICS
[Type] => general
)
[3] => Array
(
[SubjectFull] => PEOPLE with diabetes
[Type] => general
)
)
[Titles] => Array
(
[0] => Array
(
[TitleFull] => Safety and effectiveness of topiramate for the management of painful diabetic peripheral neuropathy in an open-label extension study
[Type] => main
)
)
)
[BibRelationships] => Array
(
[HasContributorRelationships] => Array
(
[0] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Donofrio, Peter D.
)
)
)
[1] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Raskin, Philip
)
)
)
[2] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Rosenthal, Norman R.
)
)
)
[3] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Hewitt, David J.
)
)
)
[4] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Jordan, Donna M.
)
)
)
[5] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Xiang, Jim
)
)
)
[6] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Vinik, Aaron I.
)
)
)
)
[IsPartOfRelationships] => Array
(
[0] => Array
(
[BibEntity] => Array
(
[Dates] => Array
(
[0] => Array
(
[D] => 01
[M] => 09
[Text] => Sep2005
[Type] => published
[Y] => 2005
)
)
[Identifiers] => Array
(
[0] => Array
(
[Type] => issn-print
[Value] => 01492918
)
)
[Numbering] => Array
(
[0] => Array
(
[Type] => volume
[Value] => 27
)
[1] => Array
(
[Type] => issue
[Value] => 9
)
)
[Titles] => Array
(
[0] => Array
(
[TitleFull] => Clinical Therapeutics
[Type] => main
)
)
)
)
)
)
)
|
IllustrationInfo |