Tuesday, October 16, 2007

Lamotrigine XR Proven Effective for Epileptics - GSK funded Study

I found this on a couple of sites but liked this MedScape article the best. One thing I do not understand about epileptics and patients with chronic illnesses in general is why they do not take their medications knowing the results. One of my friends in epileptic, something that I had forgotten until the day after another friend's wedding. She had a seizure at the Sunday brunch. This was a fit I had never seen and it was quite scary for all of us there, and can only imagine the effect on her. I am pretty sure it was a result of her non-adherence to her medication. Luckily many of her friends were there who had experienced her seizing before so they knew how to treat her.

As with all XR drugs, they aim to improve medication adherence, yet pharmaceutical companies usually start developing and testing XR fomulas when their patent is close to expiration. I am all for medication adherence (as we know) however why wasn't this the first drug to be released? Hey, we spent $800M on a drug and sold it for 6 years, but here is a better version because a generic is now available for the first version and we want to make more money and keep you as a patient. Yes, I know the answer and it always be the case until we are in the future world where all medications are free, have no side effects, and there is no global warming, polution, etc....

Just for fun, see who funded the study and who employs the MDs at the end.

October 15, 2007 — Once-daily adjunctive lamotrigine extended-release (XR) was effective in controlling partial seizures, according to the results of a double-blind, placebo-controlled, randomized trial reported in the October 15 issue of Neurology.

"The goal of enhancing dosing convenience and thereby compliance has motivated the development of lamotrigine extended-release (XR), an enteric-coated, slow-release formulation," write D.K. Naritoku, MD, from Southern Illinois University in Springfield, and colleagues. "Whereas conventional immediate-release (IR) lamotrigine tablets are recommended for twice-daily dosing when used with enzyme-inducing AEDs [antiepileptic drugs] or as monotherapy and for once- or twice-daily dosing when used with valproate, the pharmacokinetic properties of lamotrigine XR make it suitable for once-daily dosing in epilepsy regardless of concomitant AED."

In this parallel-group trial, 243 patients older than 12 years diagnosed with epilepsy with partial seizures and taking 1 to 2 baseline antiepileptic drugs were randomized to adjunctive once-daily lamotrigine XR or placebo. After the baseline phase, 239 patients entered a 7-week, double-blind escalation phase. During the 12-week, double-blind, maintenance phase, doses of study medication and concomitant antiepileptic drugs were maintained.

Of the 239 patients who entered the escalation phase and received study medication, 118 received lamotrigine XR, and 121 received placebo. Compared with placebo, lamotrigine XR was more effective in terms of median percent reduction from baseline in weekly partial seizure frequency (primary endpoint, entire 19-week treatment phase: 46.1% vs 24.2%; P = .0004; escalation phase: 28.0% vs 16.3%; P = .028; maintenance phase: 58.0% vs 26.7%: P < .0001).

The percentage of patients with at least a 50% decrease in frequency of partial seizures (42.2% vs 24.2%; P = .0037) and time to 50% or more reduction in partial seizure frequency (P = .0007) also favored lamotrigine XR over placebo. For secondarily generalized seizures, findings were comparable.

The most frequently reported adverse events were headache (17% with lamotrigine XR vs 15% with placebo) and dizziness (18% with lamotrigine XR vs 5% with placebo). Health outcome measures were not significantly different between groups. There were no serious rashes, and laboratory test results and electrocardiogram findings were unremarkable in both groups.

"Once-daily adjunctive lamotrigine extended-release compared with placebo effectively reduced partial seizure frequency and was well tolerated in this double-blind study," the authors write. "Results support the clinical utility of this new once-daily formulation."

Study limitations include small sample sizes for end-of-study health outcomes questionnaires, with resulting low power for detecting treatment differences.

GlaxoSmithKline, the maker of lamotrigine, sponsored and conducted this study, employs 2 of the authors, funded 1 of the authors, and has various financial relationships with 2 other authors.

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