mdlinx mdlinx
Latest (262) Full Text Articles (5432) Focus on Arrhythmias Article Summary

Randomized Clinical Study of a Histamine H3 Receptor Antagonist for the Treatment of Adults with Attention-Deficit Hyperactivity Disorder
CNS Drugs,

Weisler RH et al. – Bavisant, a highly selective, wakefulness–promoting H3 antagonist, did not display significant clinical effectiveness in the treatment of adults with attention–deficit hyperactivity disorder.

Methods
  • his randomized, double-blind, placebo- and active-controlled, parallel-group, multicentre study evaluated three dosages of bavisant (1 mg/day, 3 mg/day or 10 mg/day) and two active controls in adults with ADHD.
  • The study consisted of a screening phase of up to 14 days, a 42-day double-blind treatment phase and a 7-day post-treatment follow-up phase.
  • Efficacy and safety assessments were performed.
  • The study was conducted at 37 study centres in the US from April 2009 through January 2010.
  • Men and women aged 18-55 years with an established diagnosis of ADHD as confirmed by clinician and self-report diagnostic measures were enrolled.
  • Participants were randomly assigned equally to one of six treatment groups: placebo, bavisant 1 mg/day, 3 mg/day or 10 mg/day, atomoxetine hydrochloride 80 mg/day or osmotic-release oral system (OROS) methylphenidate hydrochloride 54 mg/day.
  • The primary efficacy endpoint was the change in the Attention Deficit Hyperactivity Disorder Rating Scale, Version IV (ADHD-RS-IV) total score from baseline (day 1) to the end of the treatment phase (day 42), and included all randomized participants who received one or more doses of study drug and had baseline and one or more post-baseline assessments (intent-to-treat [ITT] population).
  • Safety assessments included treatment-emergent adverse events (TEAEs), laboratory tests and ECG readings.

Results
  • 430 participants were randomized, 424 received one or more doses of study medication and 335 (78%) of those randomized completed the study.
  • Study participants had a mean age of 33.9 years and were predominantly White men.
  • Mean treatment duration ranged from 31.4 to 38.8 days across groups.
  • Mean change from baseline in the total ADHD-RS-IV score at day 42 (primary efficacy endpoint) was -8.8 in the placebo group versus -9.3, -11.2 and -12.2 in the bavisant 1 mg/day, 3 mg/day and 10 mg/day groups, respectively; the change in the 10 mg/day group was not statistically superior to placebo (p = 0.161), and hence statistical comparisons of the 1 mg/day and 3 mg/day groups with placebo based on a step-down closed testing procedure were not performed.
  • Mean change from baseline in the total ADHD-RS-IV score at day 42 was superior to placebo in the atomoxetine (-15.3) and OROS methylphenidate (-15.7) groups (p < 0.005).
  • Secondary efficacy assessments demonstrated a similar pattern with a non-significant trend towards improvement in the bavisant groups.
  • The two lower dosages showed a good tolerability profile, but the higher dosage of bavisant was less well tolerated, as evidenced by the incidence of total TEAEs (61.8%, 82.4%, 89.0%), and discontinuations due to TEAEs (4.4%, 7.4%, 19.2%) in the bavisant 1 mg/day, 3 mg/day and 10 mg/day groups, respectively, compared with 58.9% and 2.7%, respectively on placebo.
  • In the atomoxetine and OROS methylphenidate groups, the incidence of total TEAEs was 83.8% and 82.4% and discontinuations due to TEAEs was 10.8% and 8.8%, respectively.

Please login or register to follow this author.
Are you sure you want to Unfollow this Author?
► Click here to access PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

Your Unread Messages in Family Medicine

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Family Medicine Articles

Last month's top read Top Articles of 2013

1 Coffee consumption and prostate cancer risk: An updated meta-analysis Cancer Causes and Control, March 3, 2014    Evidence Based Medicine    Clinical Article

2 Coffee intake and gastric cancer risk Cancer Epidemiology, Biomarkers & Prevention, March 10, 2014    Clinical Article

3 Tea consumption and the risk of five major cancers: A dose-response meta-analysis of prospective studies Full Text BMC Cancer, March 18, 2014    Free full text    Evidence Based Medicine    Review Article

4 Coffee intake and gastric cancer risk Cancer Epidemiology, Biomarkers & Prevention, March 19, 2014    Clinical Article

5 Is ginger effective for the treatment of irritable bowel syndrome? A double blind randomized controlled pilot trial Complementary Therapies in Medicine, March 4, 2014    Clinical Article

6 Associations between serum 25-hydroxyvitamin D concentrations and multiple health conditions, physical performance measures, disability, and all-cause mortality: The Concord Health and Ageing in Men Project Journal of the American Geriatrics Society, March 13, 2014    Clinical Article

7 Egg consumption and cardiovascular disease among diabetic individuals: A systematic review of the literature Full Text Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, March 28, 2014    Free full text    Review Article

8 Effects of pomegranate juice consumption on inflammatory markers in patients with type 2 diabetes: A randomized, placebo-controlled trial Journal of Research in Medical Sciences, March 20, 2014    Clinical Article

9 Effects of yoga on cardiovascular disease risk factors: A systematic review and meta-analysis International Journal of Cardiology, March 17, 2014    Evidence Based Medicine    Review Article    Clinical Article

10 Effect of omega-3 fatty acid supplementation on cancer incidence, non-vascular death, and total mortality: a meta-analysis of randomized controlled trials Full Text BMC Public Health, March 5, 2014    Free full text    Evidence Based Medicine    Clinical Article

11 The effect of green tea on blood pressure and lipid profile: A systematic review and meta-analysis of randomized clinical trials Nutrition, Metabolism & Cardiovascular Diseases, March 27, 2014    Evidence Based Medicine    Review Article

12 The effect of three weeks green tea extract consumption on blood pressure, heart rate responses to a single bout resistance exercise in hypertensive women High Blood Pressure & Cardiovascular Prevention, March 14, 2014    Clinical Article

13 Meat consumption and the risk of hepatocellular carcinoma Alimentary Pharmacology and Therapeutics, March 6, 2014    Review Article

14 Tea consumption and leukemia risk: A meta-analysis Tumor Biology, February 12, 2014    Evidence Based Medicine    Clinical Article

15 Is breakfast skipping associated with physical activity among US adolescents? A cross-sectional study of adolescents aged 12–19 years, National Health and Nutrition Examination Survey (NHANES) Public Health Nutrition, March 12, 2014    Clinical Article

16 Dietary carrot consumption and the risk of prostate cancer European Journal of Nutrition, February 17, 2014    Clinical Article

17 The association between caffeine and cognitive decline: Examining alternative causal hypotheses International Psychogeriatrics, March 18, 2014    Review Article

18 Estimation of fish intake in Asian and white female adolescents, and association with 2-year changes in body fatness and body fat distribution: The Female Adolescent Maturation Study Journal of the Academy of Nutrition and Dietetics, March 24, 2014    Clinical Article

19 The low-carbohydrate diet and cardiovascular risk factors: Evidence from epidemiologic studies Nutrition, Metabolism & Cardiovascular Diseases, March 12, 2014    Evidence Based Medicine    Review Article

20 A green and black tea extract benefits urological health in men with lower urinary tract symptoms Therapeutic Advances in Urology, March 26, 2014    Clinical Article

Indexed Journals in Family Medicine: American Family Physician, Archives of Family Med, Annals of Family Medmore

Other Topics in Family Medicine

Register now to view all the MDLinx contents (FREE)!

  • Stay current on the latest literature, research and clinical news
  • Get special communications and offers from MDLinx and our sponsors
  • Receive invitations to paid market research
View Samples and Register

Stay current - Media Tool

Newsletter
RSS
Follow
Like

Receive the latest mecial news
updates for free via email

Sign up!

Subscribe to our free RSS feeds:

Get the latest news in your specialty automatically added to your newsreader or your personal My Yahoo!, Google, My MSN or My AOL page. Learn More

Close