肺炎球菌ワクチンには主に以下3種類
「ニューモバックスNP®（23価ワクチン）」
「バクニュバンス（沈降15価肺炎球菌結合型ワクチン）」
「プレベナー20®（20価結合型ワクチン）」
「キャップバックス（21価肺炎球菌結合型ワクチン）」
スケジュールは各学会合同で以下のプロトコルが推奨
(2025年9月の段階で改訂されいていた様子・・・2024年12月の記事のアップデートです。)
なお以下は2024年9月のです。
自分が65歳になったら、
① ニューモバックスの定期接種
② 上記接種1年開けて、キャップバックス
③ ①の5年後にニューモバックス
を接種しようかな、と思うが、
今後も新しいワクチンが出たらアップデートします。
Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial
JAMA. 2026 Jan 13;335(2):129-139.
Trial registration: ClinicalTrials.gov Identifier: NCT05952869.
Abstract
Importance: Persons with heterozygous familial hypercholesterolemia (HeFH) are at increased risk of atherosclerotic cardiovascular disease due to lifelong elevated levels of low-density lipoprotein cholesterol (LDL-C). Many patients with HeFH do not achieve guideline-recommended LDL-C goals with the currently available lipid-lowering therapies.
Objective: To evaluate the efficacy of enlicitide decanoate (an oral proprotein convertase subtilisin/kexin type 9 inhibitor) vs placebo in adults with HeFH requiring further lowering of LDL-C levels despite use of statin therapy.
Design, setting, and participants: This phase 3, randomized clinical trial included persons aged 18 years or older with HeFH currently using lipid-lowering therapy (taking at least a moderate- or high-intensity statin) and either an LDL-C level of 55 mg/dL or greater and a history of major atherosclerotic cardiovascular disease or an LDL-C level of 70 mg/dL or greater without a history of major atherosclerotic cardiovascular disease. The trial was conducted at 59 sites across 17 countries; the first participant was screened on August 8, 2023, and the last follow-up visit occurred on April 7, 2025.
Interventions: Participants were randomized (2:1) to 20 mg of enlicitide (n = 202) or placebo (n = 101) once daily for 52 weeks.
Main outcomes and measures: The primary outcome was the mean percentage change in LDL-C level at week 24. The secondary outcomes included the mean percentage change in LDL-C level at week 52, the mean percentage change at week 24 in levels of non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein B, and the median percentage change at week 24 in lipoprotein(a).
Results: Of the 303 participants (mean age, 52.4 [SD, 13.5] years; 51% were female) randomized, 293 (96.7%) completed the trial. The mean LDL-C level was 119.0 mg/dL (SD, 41.0 mg/dL) at baseline, all had statin current use (81.5% were taking a high-intensity statin), and 64.4% were taking ezetimibe. The mean percentage change in LDL-C level at week 24 was -58.2% in the enlicitide group vs 2.6% in the placebo group (between-group difference, -59.4% [95% CI, -65.6% to -53.2%]; P < .001). The mean percentage change in LDL-C level at week 52 was -55.3% in the enlicitide group vs 8.7% in the placebo group (between-group difference, -61.5% [95% CI, -69.4% to -53.7%]; P < .001). At week 24, the mean percentage change in non-HDL-C level was -52.3% in the enlicitide group vs 2.1% in the placebo group (between-group difference, -53.0% [95% CI, -58.5% to -47.4%]; P < .001), the mean percentage change in apolipoprotein B level was -48.2% vs 1.8%, respectively (between-group difference, -49.1% [95% CI, -54.0% to -44.3%]; P < .001), and the median percentage change in lipoprotein(a) level was -24.7% vs -1.6% (between-group difference, -27.5% [95% CI, -34.3% to -20.6%]; P < .001). The incidence of adverse events, serious adverse events, and study discontinuation due to adverse events was similar between groups.
Conclusions: Among adults with HeFH, treatment with enlicitide was well tolerated and significantly reduced levels of LDL-C, apolipoprotein B, non-HDL-C, and lipoprotein(a).
PICOで評価
フェイズ3、
P（Population：対象集団）
成人（≥18歳）の ヘテロ接合型家族性高コレステロール血症（HeFH）
中等度〜高強度スタチン治療中 多くが LDL-C未達（エゼチミブ併用あり：約2/3）
✔ 臨床的妥当性は高い → 日常診療で「次の一手」に困る典型的HeFH集団
✔ 既存治療（スタチン±エゼチミブ）を十分反映
⚠ ASCVD既往の有無は混在→ 二次予防集団としての純粋な評価ではない
⚠ 日本人・アジア人は少数（外的妥当性の制限）
I（Intervention：介入）
Enlicitide 20 mg 経口・1日1回 と プラセボ、2:1の割り付け
背景治療（スタチン±エゼチミブ）継続
C（Comparator：比較）
プラセボ 背景治療は同一 ✔ 内的妥当性は高い（RCTとして明確）
O（Outcome：アウトカム）
① 主要アウトカム
24週時点のLDL-C変化率
✔ −58%超の有意なLDL低下
✔ 効果は52週まで持続
② 副次アウトカム（脂質）
non-HDL-C、ApoB、Lp(a)
✔ すべて有意に低下
✔ ApoB低下が明確 → 動脈硬化リスク低減の代理指標として重要
③ LDL目標達成率（重要な臨床的Outcome）
目標 Enlicitide プラセボ
LDL <70 mg/dL + ≥50%低下 約70% 約1%
LDL <55 mg/dL + ≥50%低下 約67% 約1%
✔ ESC/EAS超高リスク基準を多数で達成
④ 心血管イベント（MACE）
❌ 主要・副次アウトカムに含まれていない
❌ 統計学的検討なし
気になる点：LDL目標達成（24週時点）
LDL-Cが50%以上低下かつLDL < 70 mg/dLを達成した患者：
→ 約70.8%（エンリシチド群） vs 約1%（プラセボ群）
LDL-Cが50%以上低下かつLDL < 55 mg/dLを達成した患者：
→ 約67.3%（エンリシチド群） vs 約1%（プラセボ群）
