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Savani N, Pfaffenrath V, Rice L, Boswell D, Black L, Jones M;
Sumatriptan SUMB4007 Study Group. Efficacy, tolerability, and patient
satisfaction with 50- and 100-mg sumatriptan tablets in those initially
dissatisfied with the efficacy of 50-mg sumatriptan tablets. Clin Ther.
2001 Feb;23(2):260-71.
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論文抄録
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BACKGROUND: Both 50- and 100-mg sumatriptan tablets are effective and well tolerated in the acute treatment of migraine. However, given a choice between the 2 doses, many patients in clinical practice and clinical studies prefer the 100-mg dose. OBJECTIVE: This study was designed to assess whether patients initially dissatisfied with the efficacy of 50-mg sumatriptan tablets would be satisfied with 100-mg sumatriptan tablets. METHODS: In phase 1 of the study, triptan-naive patients with migraine (International Headache Society diagnosis) received open-label treatment of 3 migraine attacks with 50-mg sumatriptan tablets. At the end of phase 1, those who were dissatisfied with the efficacy but satisfied with the tolerability of 50-mg sumatriptan tablets entered phase 2 and were randomized in a double-blind, parallel-group fashion to receive either 50- or 100-mg sumatriptan tablets for the treatment of 3 attacks. Patients who were satisfied with the efficacy or dissatisfied with the tolerability of the 50-mg tablets in phase 1 were given the option of continuing open-label treatment with 50-mg sumatriptan tablets in phase 2. The primary end point was the percentage of patients satisfied with medication at the end of phase 2 double-blind treatment. Patient satisfaction with specific medication attributes was assessed using the Patient Perception of Migraine Questionnaire. RESULTS: Seven hundred twenty-two patients were enrolled in phase 1 of the study (the intent-to-treat population), 609 of whom had evaluable satisfaction data at the end of open-label treatment. Three hundred twenty-six (54%) of these patients were satisfied with 50-mg sumatriptan tablets, whereas 283 (46%) were not satisfied. Among those who were dissatisfied, lack of efficacy was cited as the sole reason for dissatisfaction by 242 (86%). Two hundred thirty-one of those who were dissatisfied with efficacy only and wished to continue the study were randomized to double-blind treatment with either 50-mg sumatriptan tablets (n = 123; 82% female, 18% male; mean age, 37.6 years) or 100-mg sumatriptan tablets (n = 108; 86% female, 14% male; mean age, 36.0 years). The remaining 310 patients elected to continue open-label treatment with 50-mg sumatriptan tablets. At the end of double-blind treatment, 64 of 101 patients (63%) in the 100-mg group indicated that they were satisfied with treatment, compared with 55 of 113 (49%) in the 50-mg group (P = 0.031). Across the 3 attacks treated in the double-blind phase. headache relief 2 hours postdose was reported by 47% to 53% of patients in the 50-mg group and 45% to 60% of patients in the 100-mg group. The overall incidence of patients reporting > or =1 adverse event was 19% (23/123) in the 50-mg group and 22% (24/108) in the 100-mg group. CONCLUSIONS: For most patients, 50 mg is the appropriate starting dose of sumatriptan tablets. In patients who experience inadequate relief with 50 mg, increasing the dose to 100 mg is an appropriate therapeutic option. |
文献 PubMed−ID
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11293559
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エビデンスレベル
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㈵ b
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文献タイトル (日本語)
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スマトリプタン錠（ 50mgおよび100mg）の効果，忍容性，患者の満足度（初期量50mgで不満足であった症例における検討）
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目的
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50mgのスマトリプタンに不満足であった患者が，100mgの投与で満足すべき効果があるかを確認すること |
研究デザイン
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無作為二重盲検比較試験 |
対象患者
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７２２例 |
介入
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phase1：３回の片頭痛発作に50mg錠を使用，その後効果は不満足だが忍容性がよい患者をphase２に入れる．そこで無作為に50mgと100mgを割付け３回の発作時に服用する．また，phase1で満足であったか，忍容性に問題があった患者にはphase2には50mg服用のオプションをつけた．
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主要評価項目とそれに用いた
統計学的手法
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一次エンドポイントは， phase2終了時に投薬に満足した患者の割合で評価とする．また，投与による満足度は the Patient Perception of Migraine Questionnaire を使用して評価する |
結果
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６０９例が phase1で十分な評価が可能であった．３２５例が満足し，２８３例が満足しなかった．この中で不満足が効果の欠如による例は２４２例で，２３１例がphase2に組み込まれた．phase2の最後では，100mg投与群の６３％が満足した（50mgでは４９％で，有意差あり）．
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結論
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多くの患者には， 50mgが適切な量である．効果が不完全で50mgに不満足な患者には100mg投与が適切である． |
コメント
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中規模の無作為試験．効果不完全な時のスマトリプタンの増量が適切とするデータ．より多数の検討が必要 |
備考
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Publication Types:
• Clinical Trial
• Randomized Controlled Trial
MeSH Terms:
• Adult
• Double-Blind Method
• Female
• Human
• Male
• Migraine/drug therapy*
• Pain Measurement
• Patient Satisfaction*
• Sumatriptan/administration & dosage*
• Sumatriptan/adverse effects
• Sumatriptan/therapeutic use
• Support, Non-U.S. Gov't
• Vasoconstrictor Agents/administration & dosage*
• Vasoconstrictor Agents/adverse effects
• Vasoconstrictor Agents/therapeutic use
Substances:
• Vasoconstrictor Agents
• Sumatriptan |
作成者
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濱田 潤一 |