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Tiagabine Hydrochloride Tablets | TIAGABINE HYDROCHLORIDE

13:56 EDT 24th July 2014 | BioPortfolio

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Table 1 Median Reduction and Median Percent Reduction from Baseline in 4-Week Seizure Rates in Study 1
Placebo (N=91)
Tiagabine Hydrochloride 16 mg/day
(N=61)
Tiagabine Hydrochloride 32 mg/day
(N=87)
Tiagabine Hydrochloride 56 mg/day
(N=56)
Combined 32 + 56 mg/day (N=143)
Complex
Partial
Median
Reduction
0.6
0.8
2.2p <0.05
2.9
2.6
Median %
ReductionStatistical significance was not assessed for median % reduction.
9%
13%
25%
32%
29%
All
Partial
Median
Reduction
0.2
1.2
2.7
3.5
2.9
Median %
Reduction
3%
12%
24%
36%
27%
Table 2 Median Reduction and Median Percent Reduction from Baseline in 4-Week Seizure Rates in Study 2
Placebo (N=107)
Tiagabine Hydrochloride 16 mg BID
(N=106)
Tiagabine Hydrochloride 8 mg QID
(N=104)
Complex
Partial
Median Reduction
0.3
1.6
1.3p <0.027, necessary for statistical significance due to multiple comparisons.
Median % ReductionStatistical significance was not assessed for median % reduction.
4%
22%
15%
All
Partial
Median Reduction
0.5
1.6
1.3
Median % Reduction
5%
19%
13%
Table 3 Median Reduction and Median Percent Reduction from Baseline in 4-Week Seizure Rates in Study 3
    Placebo (N=77)
 
Tiagabine Hydrochloride 30 mg/day
(N=77)
Complex PartialN=72 and 75 for placebo and tiagabine hydrochloride, respectively.
Median Reduction
-0.1
1.3p <0.05
Median % ReductionStatistical significance was not assessed for median % reduction.
-1%
14%
All Partial
Median Reduction
-0.5
1.1
Median % Reduction
-7%
11%
Table 4: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis
Indication
Placebo Patients with Events per 1000 Patients
Drug Patients with Events per 1000 Patients
Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients
Risk Difference: Additional Drug Patients with Events per 1000 Patients
Epilepsy
1
3.4
3.5
2.4
Psychiatric
5.7
8.5
1.5
2.9
Other
1
1.8
1.9
0.9
Total
2.4
4.3
1.8
1.9
Table 5: Treatment-Emergent Adverse EventPatients in these add-on studies were receiving one to three concomitant enzyme-inducing antiepilepsy drugs in addition to tiagabine hydrochloride or placebo. Patients may have reported multiple adverse experiences; thus, patients may be included in more than one category. Incidence in Parallel-Group, Placebo-Controlled, Add-On Trials (events in at least 1% of patients treated with Tiagabine Hydrochloride and numerically more frequent than in the placebo group)
Body System/
COSTART
Tiagabine Hydrochloride
N=494
%
Placebo
N=275
%
Body as a Whole
Abdominal Pain
7
3
Pain (unspecified)
5
3
Cardiovascular
Vasodilation
2
1
Digestive
Nausea
11
9
Diarrhea
7
3
Vomiting
7
4
Increased Appetite
2
0
Mouth Ulceration
1
0
Musculoskeletal
Myasthenia
1
0
Nervous System
Dizziness
27
15
Asthenia
20
14
Somnolence
18
15
Nervousness
10
3
Tremor
9
3
Difficulty with Concentration/AttentionCOSTART term substituted with a more clinically descriptive term.
6
2
Insomnia
6
4
Ataxia
5
3
Confusion
5
3
Speech Disorder
4
2
Difficulty with Memory
4
3
Paresthesia
4
2
Depression
3
1
Emotional Lability
3
2
Abnormal Gait
3
2
Hostility
2
1
Nystagmus
2
1
Language Problems
2
0
Agitation
1
0
Respiratory System
Pharyngitis
7
4
Cough Increased
4
3
Skin and Appendages
Rash
5
4
Pruritus
2
0
Table 6: Treatment-Emergent Adverse Event Incidence in Study 1Patients in this study were receiving one to three concomitant enzyme-inducing antiepilepsy drugs in addition to tiagabine hydrochloride or placebo. Patients may have reported multiple adverse experiences; thus, patients may be included in more than one category. (events in at least 5% of patients treated with Tiagabine Hydrochloride 32 or 56 mg and numerically more frequent than in the placebo group)
Body System/
COSTART Term
Tiagabine Hydrochloride 56 mg
(N=57)
%
Tiagabine Hydrochloride 32 mg
(N=88)
%
Placebo
(N=91)
%
Body as a Whole
Accidental Injury
21
15
20
Infection
19
10
12
Flu Syndrome
9
6
3
Pain
3
7
2
Abdominal Pain
5
7
4
Digestive System
Diarrhea
2
10
6
Hemic and Lymphatic System
Ecchymosis
0
6
1
Musculoskeletal System
Myalgia
5
2
3
Nervous System
Dizziness
28
31
12
Asthenia
23
18
15
Tremor
21
14
1
Somnolence
19
21
17
Nervousness
14
11
6
Difficulty with Concentration/AttentionCOSTART term substituted with a more clinically descriptive term.
14
7
3
Ataxia
9
6
6
Depression
7
1
0
Insomnia
5
6
3
Abnormal Gait
5
5
3
Hostility
5
5
2
Respiratory System
Pharyngitis
7
8
6
Special Senses
Amblyopia
4
9
8
Urogenital System
Urinary Tract Infection
5
0
2
Table 7: Typical Dosing Titration Regimen for Patients Already Taking Enzyme-Inducing AEDs
  Initiation and Titration Schedule Total Daily Dose
Week 1
Initiate at 4 mg once daily
4 mg/day
Week 2
Increase total daily dose by 4 mg
8 mg/day
(in two divided doses)
Week 3
Increase total daily dose by 4 mg
12 mg/day
(in three divided doses)
Week 4
Increase total daily dose by 4 mg
16 mg/day
(in two to four divided doses)
Week 5
Increase total daily dose by 4 to 8 mg
20 to 24 mg/day
(in two to four divided doses)
Week 6
Increase total daily dose by 4 to 8 mg
24 to 32 mg/day
(in two to four divided doses)
Usual Adult Maintenance Dose in Induced Patients:
32 to 56 mg/day in two to four divided doses

Do not stop tiagabine hydrochloride tablets without first talking to a healthcare provider.

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Manufacturer

Sun Pharmaceutical Industries Limited

Active Ingredients

Source

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