ADHD症状の改善

Guanfacineは反抗的な症状のあるADHD患者の症状を有意に改善する
Guanfacine shows significant ADHD symptom improvement in patients with oppositional symptoms
用量変更可能な無作為化プラセボコントロールスタディにおいて選択的α2A 作動薬guanfacine徐放製剤は、ADHD評価スケールIVを用いた計測で反抗的症状を有すると診断された6～12歳のADHD小児のADHD症状を有意に改善することが示された。このデータは第162回American Psychiatric Association学会で発表された。Guanfacineはまた、三つの異なる評価スケール（Clinical Global Impressions-Improvement [CGI-I]、Conduct Problem Subscale of the New York Parent Rating Scale-School-Aged [NYPRS-S]、および Parent Stress Index-Short Form [PSI/SF]アンケート）で計測した症状も改善した。CGI-Iスケールにおいては10人中7人においてプラセボと比較し"非常によく改善”または"よく改善"と評価された（71.5%対32.0%；P<0.001）。Conduct Problem Subscale of the NYPRS-Sにおいてもguanfacine群においてプラセボ群と比較し有意な症状の軽減が認められた(-16.0対-9.6；P<0.001）。PSI/SFスケールにおいては、guanfacine群は17.0点減少したのに対しプラセボ群では7.7点の減少であった（P=0.002）。重篤な有害事象は認められなかった。
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In a randomized, placebo-controlled, flexible-dose study, guanfacine extended release, a selective alpha-2A-agonist, demonstrated significant ADHD symptom improvement in children aged 6 to 12 years with a diagnosis of ADHD and the presence of oppositional symptoms as measured by the ADHD Rating Scale-IV. The data was presented at the American Psychiatric Association's 162nd annual meeting.

"A significant number of pediatric ADHD patients present with behaviors such as anger, resentfulness, defiance, and arguing with adults. It can be complicated for physicians and caregivers to find the right medication to control symptoms for children with ADHD exhibiting these behaviors," said Daniel Connor, M.D., professor and division chief of child and adolescent psychiatry at the University of Connecticut Medical School. "When considered with the primary efficacy results of the current study, these data provide additional support for the clinical efficacy of guanfacine for treating ADHD in this patient population."

In this randomized, placebo-controlled, flexible-dose study, guanfacine demonstrated significant ADHD symptom improvement in patients with oppositional symptoms as measured by the ADHD Rating Scale-IV (ADHD-RS-IV), a scale frequently used in ADHD clinical trials. In results from this study, guanfacine also demonstrated symptom improvement as measured by three different rating scales: the Clinical Global Impressions-Improvement (CGI-I), the Conduct Problem Subscale of the New York Parent Rating Scale-School-Aged (NYPRS-S), and the Parent Stress Index-Short Form (PSI/SF) questionnaire.

When using the CGI-I scale, investigators rated 7 out of 10 patients as "very much improved" or "much improved" compared with placebo (71.5 percent vs 32.0 percent; P<0.001). The CGI-I scale is a standard assessment used to rate the severity of a patient's illness and improvement over the course of the study.

Significantly greater symptom reductions were also seen on the Conduct Problem Subscale of the NYPRS-S in the guanfacine group compared to placebo (-16.0 vs -9.6; P<0.001). In this parent-rated scale, numerous symptoms including anger, defiance, arguing with adults, and loss of temper were assessed in children on a four-point scale and a higher score indicated greater problems. Additional improvement was demonstrated on the PSI/SF, a parent rated 36-item questionnaire that measured stressful areas in parent-child interactions. On the PSI/SF scale, the guanfacine group reduced its score by 17.0 compared to 7.7 for the placebo group (P=0.002).

In this study, the most commonly reported treatment emergent adverse events (greater than or equal to 10 percent) were somnolence, headache, sedation, upper abdominal pain, fatigue and irritability. The majority of treatment emergent adverse events were mild to moderate in severity. There were no serious adverse events.