Topamax vs Amitriptyline – March 2009

Hi Gang,

A new 26-week randomised controlled trial (RCT) involving 331 migraineurs.

Scott 8)

[size=150]Topiramate versus amitriptyline in migraine prevention: A 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority trial in adult migraineurs[/size]
DW Dodick et al
Clinical Therapeutics 31 (3), 542-559

Objective: The primary objective of this study was to compare the efficacy and tolerability of topiramate and amitriptyline in the prophylaxis of episodic migraine headache. Methods: This was a 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority study. Adults with 3 to 12 migraines per month were randomized in a 1:1 ratio to receive an initial dose of 25 mg/d of either topiramate or amitriptyline, subsequently titrated to a maximum of 100 mg/d (or the maximum tolerated dose). Results: The intent-to-treat population included 331 subjects (172 topiramate, 159 amitriptyline; 84.9% female; 84.6% white; mean [SD] age, 38.8 [11.0]years; mean weight, 77.1 [20.1] kg) who provided at least 1 efficacy assessment. The least squares mean (LSM) change from baseline in the mean monthly number of migraine episodes was not significantly different between the topiramate and amitriptyline groups (-2.6 and -2.7, respectively; 95% CI, -0.6 to 0.7). There were no significant differences between treatment groups in any of the prespecified secondary outcome measures. Subjects receiving topiramate had a significantly greater improvement in mean functional disability scores during migraine attacks compared with amitriptyline (p = 0.040) and in the role function-restrictive, role function-preventive, and emotional function domains of the MSQ (P = 0.012, P = 0.014, and P = 0.029, respectively). Subjects receiving topiramate had a mean weight loss of 2.4 kg, compared with a mean weight gain of 2.4 kg in subjects receiving amitriptyline. Adverse events (AEs) of mild or moderate severity were reported in 118 subjects (66.7%) in the topiramate group and 112 subjects (66.3%) in the amitriptyline group. Among the most common AEs in the topiramate group were paresthesia (29.9%), fatigue (16.9%), somnolence (11.9%), hypoesthesia (10.7%), and nausea (10.2%). The most commonly reported AEs in the amitriptyline group were dry mouth (35.5%), fatigue (24.3%), somnolence (17.8%), weight increase (13.6%), dizziness (10.7%), and sinusitis (10.7%).

[size=130]Conclusions[/size]: Topiramate was at least as effective as amitriptyline in terms of reducing the rate of mean monthly migraine episodes. Topiramate was associated with improvement in some quality-of-life indicators compared with amitriptyline and was associated with weight loss and improved weight satisfaction.

http://www.mvertigo.org/articles/topamax_vs_amitriptyline09.pdf

Yet another great find! Thanks, Scott!

Hi Ben,

What I can’t get over is how relatively well the patients all did on Topamax. Not one comment about anyone wanting to slit their wrists on it (which is how I felt after 3 days of it). Really annoying that it’s so hard to stay on these meds.

Scott :slight_smile:

Scott, I hear that…although I have not tried it yet, it still amazes me when I see many success stories on it. I have been scared of it but may come to it down the line after I give Verapamil (current med) a solid try and then maybe add a SSRI (Effexor and Nortriptyline were not for me). I met someone at my Dr’s office on Monday who is on 300 mg of Topamax for migraine, not MAV and she is doing well on it - I was amazed at the dose. She did admit that cognitive issues were ever present but manageable. I have been having some very tough days and Topamax is not a scary when I am feeling this lousy. Good luck with Paxil and keep us posted - I was on that for a few months 10 years ago after a bad bout with salmonella and suffering from some type of post tramatic issues. It was fairly easy on and off but I do remember having some feeling like I wasnt myself on it, although nothing horrible. Ben

Gosh, I want to add in Topomax to help me lose the weight that Nortriptalyne added on !!! :mrgreen: But then again, not sure i want to suffer any of the side effects

Pam

Scott,

I have been meaning to tell you that my headache doc’s clinic, has a study running. Its a study to see if migraineurs have the hole in thier heart that should’ve closed at birth. They think there is some link between the hole and aura, part of the study is that you take Topomax. I think some have a test to see if they do have the hole and if they do, they are able to have it closed as part of the study. If the study is running in the fall, I think I might go for it. I know that my g-ma had terrible migraine and she had a stroke…so I wonder if she in fact had the hole in her heart. i think there is some link also between the hole, migraine AND stroke. Sorry this is so sketchy.

Pam

— Begin quote from "pamg6"

Scott,

I have been meaning to tell you that my headache doc’s clinic, has a study running. Its a study to see if migraineurs have the hole in thier heart that should’ve closed at birth. They think there is some link between the hole and aura, part of the study is that you take Topomax. I think some have a test to see if they do have the hole and if they do, they are able to have it closed as part of the study. If the study is running in the fall, I think I might go for it. I know that my g-ma had terrible migraine and she had a stroke…so I wonder if she in fact had the hole in her heart. i think there is some link also between the hole, migraine AND stroke. Sorry this is so sketchy.

Pam

— End quote

The hole in the heart is called a PFO. If you do a search for “PFO” on the web you’ll find numerous articles about it. My first neurologist sent me for an echocardiogram with a bubble study to see if I have it. My test came back clear. Approximately 25% of the general population has a PFO. It is a hole we all have during development that usually closes at birth. There is a higher prevalence of PFO in migraine and stroke sufferers. Early studies indicate closing the hole may improve migraine symptoms, but as you mentioned, studies are ongoing.