Posts Tagged ‘MedScape’

Guanfacine XR Is Effective and Improves Adherence with ADHD

01/10/2008 , 9:39 AM by Alex Sicre

This is just the first couple of paragraphs from a MedScape story I read. I always find it sad when children are prescribed meds for mental instabilities. But we do live in a medicated world and pills fix problems. As I always say, anything that improves adherence works for me, but check out my comments at the end.

I went to high school and college with kids who were diagnosed ADHD and took Ritalin. I never really understood why. I mean isn’t concentration something you learn in grammar school? Would any child choose to focus on their school work unless they were taught how to do so?

You don’t automatically know how to study or prepare for an exam or write a term paper without learning how to do it. I guess when you call a kid spaz and they have some energy, you should just medicate. I really am not looking forward to seeing what happens to my son in a few years when he starts to act up and the psychologist recommends putting him on medication.

There is more technical information at MedScape, but it is not relevant to my comments.

January 9, 2008 — Guanfacine extended release (Shire Inc.) at doses of 2, 3, and 4 mg/day was effective vs placebo and was generally well tolerated in a multicenter, 8-week, fixed-dose escalation study in children aged 6 to 17 years old with attention-deficit/hyperactivity disorder (ADHD).

The study, part of a new drug application, is published in the January issue of Pediatrics.

“I think it is very important for clinicians and families to have alternative treatments…to treat a condition in which many patients cannot tolerate or do not respond to treatment,” lead author, Joseph Biederman, MD, from Massachusetts General Hospital in Boston, told Medscape Psychiatry, adding that guanfacine extended release offers a unique option for patients who do not do well taking other treatments.

Any Stimulant Is Ineffective for 1 in 4 Patients

ADHD is a very prevalent, very morbid disorder, said Dr. Biederman. Although stimulants are the mainstay of treatment, any 1 stimulant is ineffective in 25% to 30% of cases, the group writes.

Guanfacine extended release, a nonstimulant, is an alpha-2 adrenergic agonist like clonidine (Catapres; Boehringer-Ingelheim) but is more selective. Both of these drugs came to market as antihypertensive agents, said Dr. Biederman, adding that they have been used off label in psychiatry for many years for managing withdrawal reactions, treating severe hyperactivity in ADHD, and, more recently, treating insomnia that frequently develops as a consequence of stimulant treatment.

The study aimed to assess the efficacy and safety of guanfacine extended release for the treatment of children and adolescents with ADHD.

The trail was conducted in 48 centers in the United States. Patients aged 6 to 17 years old who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD were eligible to participate.

COMMENTS

Did you read what Guanfacine came on to the market for? Did you read what it was prescribed off label for? These really disturb me that all of a sudden, hey, lets give it to kids who are too stimulated already! I do not know that much about medicine or science, but I would assume that there is a large gap between hypertension and ADHD.

Maybe I am wrong.

When a junkie goes through withdrawal, uh, I guess it is just like a hyperactive child – this sort of makes sense to me with frazzled nerves and brain functions. Also insomnia? I know that for people who do not suffer from ADHD, taking medications that are prescribed for ADHD makes them speedy, but puts them to sleep?

I need to learn more to properly comment on these items, but this is what I thought when I read it.

Stay adherent!

Lamotrigine XR Proven Effective for Epileptics – GSK funded Study

10/16/2007 , 11:13 AM by Alex Sicre

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.