Featured Research

from universities, journals, and other organizations

Added benefit of lisdexamfetamine is not proven

Date:
September 3, 2013
Source:
Institute for Quality and Efficiency in Health Care
Summary:
A short-term study on the new ADHD drug lisdexamfetamine was unsuitable for several reasons, mainly because the treatment was not conducted as part of a comprehensive treatment program, and no added benefit of the drug can be derived.

Lisdexamfetamine dimesylate (trade name: Elvanse) has been approved in Germany since March 2013 as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in children aged 6 years and over when response to previous treatment with the drug methylphenidate was inadequate. No added benefit of the drug versus the appropriate comparator therapy could be established in the assessment of the drug manufacturer's dossier according to the Act on the Reform of the Market for Medicinal Products (AMNOG). The manufacturer did not present any relevant studies. This was the result of the report published by the German Institute for Quality and Efficiency in Health Care (IQWiG) on 2 September 2013.

Medication only as part of a comprehensive treatment programme

Both lisdexamfetamine (short for lisdexamfetamine dimesylate) and the appropriate comparator therapy specified by the Federal Joint Committee (G-BA) atomoxetine are approved for administration as part of a comprehensive treatment programme (multimodal treatment for ADHD). According to the Summaries of Product Characteristics (SPC) of these drugs, a comprehensive treatment programme typically includes psychological, educational and social measures. The SPC of lisdexamfetamine additionally regards appropriate educational placement as "essential" and psychosocial intervention as "generally necessary."

Moreover, according to the G-BA's Pharmaceutical Directive, both drugs as stimulants in ADHD can only be prescribed at all as part of a comprehensive treatment programme for the treatment of ADHD.

In agreement with the G-BA, the manufacturer cited atomoxetine as appropriate comparator therapy, but did not present any relevant studies for the comparison with lisdexamfetamine.

ADHD drugs were not used in compliance with their approval

In the only study presented (SPD489-317), lisdexamfetamine and atomoxetine were only seen as drug treatment -- without being part of a comprehensive treatment programme. This was neither sensible nor did it comply with the approval, and therefore did also not cover the appropriate comparator therapy.

There was no offer of psychological, educational or social measures, for example. There was also no consultation for the children (and parents) to adapt measures or take on other, more suitable measures, if necessary.

Moreover, it was only possible to a limited extent to continue previous ongoing non-drug treatment in the study: Only 8% of the children and adolescents continued receiving non-drug treatment. Only 22% of the study participants in total had received a non-drug treatment of ADHD before anyway.

Short-term study insufficient

ADHD is a chronic disease for which drug treatment over a longer period of time may be necessary according to the SPC of lisdexamfetamine. The study SPD489-317 had a treatment duration of 9 weeks in total and was therefore also too short to draw conclusions on an added benefit.

Hence there were several reasons why the study presented by the manufacturer was unsuitable. An added benefit of lisdexamfetamine is therefore not proven.


Story Source:

The above story is based on materials provided by Institute for Quality and Efficiency in Health Care. Note: Materials may be edited for content and length.


Cite This Page:

Institute for Quality and Efficiency in Health Care. "Added benefit of lisdexamfetamine is not proven." ScienceDaily. ScienceDaily, 3 September 2013. <www.sciencedaily.com/releases/2013/09/130903102105.htm>.
Institute for Quality and Efficiency in Health Care. (2013, September 3). Added benefit of lisdexamfetamine is not proven. ScienceDaily. Retrieved August 20, 2014 from www.sciencedaily.com/releases/2013/09/130903102105.htm
Institute for Quality and Efficiency in Health Care. "Added benefit of lisdexamfetamine is not proven." ScienceDaily. www.sciencedaily.com/releases/2013/09/130903102105.htm (accessed August 20, 2014).

Share This




More Health & Medicine News

Wednesday, August 20, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Ebola-Hit Sierra Leone's Freetown a City on Edge

Ebola-Hit Sierra Leone's Freetown a City on Edge

AFP (Aug. 19, 2014) Residents of Sierra Leone's capital voice their fears as the Ebola virus sweeps through west Africa. Duration: 00:56 Video provided by AFP
Powered by NewsLook.com
101-Year-Old Working Man Has All The Advice You Need

101-Year-Old Working Man Has All The Advice You Need

Newsy (Aug. 19, 2014) Herman Goldman has worked at the same lighting store for almost 75 years. Find out his secrets to a happy, productive life. Video provided by Newsy
Powered by NewsLook.com
Researcher Testing on-Field Concussion Scanners

Researcher Testing on-Field Concussion Scanners

AP (Aug. 19, 2014) Four Texas high school football programs are trying out an experimental system designed to diagnose concussions on the field. The technology is in response to growing concern over head trauma in America's most watched sport. (Aug. 19) Video provided by AP
Powered by NewsLook.com
American Ebola Patient Apparently Improving, Outbreak Is Not

American Ebola Patient Apparently Improving, Outbreak Is Not

Newsy (Aug. 19, 2014) Nancy Writebol, an American missionary who contracted Ebola, is apparently getting better, according to her husband. The outbreak, however, is not. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins