合剤の心疾患治療薬の方が患者の内服する確率が高い（LBCT-19865）

UMPIRE：心疾患患者は薬剤が合剤になっている方がアドヒアランスが良好である
UMPIRE: People with heart disease are more likely to adhere to medication regimen if drugs are combined in a single pill
心疾患治療薬が組み合わさって1つの錠剤になっているいわゆる"ポリピル"の方が患者の内服率が高いとのLate-Breaking Clinical Trialの結果が2012年American Heart Association学会で発表された。一般的に高所得国においては、必要な心血管治療薬をすべて内服している患者は約50%に過ぎない。低～中所得国ではその割合はわずか5～20%である。UMPIRE（Use of a Multidrug Pill In Reducing cardiovascular Events）トライアルにおいて研究者らは、いくつかの薬剤の内服を固定用量の合剤に変更することによりアドヒアランスが改善し血圧やコレステロールのコントロールが改善するか否かを調査した。研究者らは、心血管疾患を有するヨーロッパおよびインドの2,000人以上の男女（平均年齢62歳）を平均15か月追跡した。参加者の半数はアスピリン、スタチンおよび2種類の降圧剤の合剤を投与された。残りの半数は複数の錠剤および用量による通常通りの内服薬を内服した。単剤内服群では複数錠剤内服群と比較し、アドヒアランスが3分の1改善し血圧およびコレステロールが改善した。
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People are much more likely to take heart medicines if they're combined in one pill, according to a late-breaking clinical trial presented at the American Heart Association's Scientific Sessions 2012.

"This is the first time the impact of a fixed-dose, combination strategy has been tested in people with cardiovascular disease," said Simon Thom, M.D., F.R.C.P., lead author of the Use of a Multidrug Pill In Reducing cardiovascular Events (UMPIRE) trial and professor of cardiovascular medicine and pharmacology at Imperial College London, U.K.

"People who have suffered heart attacks or strokes or those at high risk of such problems need to take preventive medications, including antiplatelet drugs (such as aspirin), cholesterol-lowering and hypertension drugs. But the reality is that many people in this high-risk category get out of the habit of taking the recommended medications," Thom said. "This happens for a variety of reasons; some of which may be corrected by a single, simple, fixed dose combination pill – a combination known as a 'polypill.'"

There has been uncertainty about a fixed dose combination strategy for cardiovascular disease prevention. While many physicians have anticipated that adherence might be improved, the reduced number of drugs and doses could offset the benefits of simplicity, Thom said.

"This trial showed improvements in adherence being paralleled by improvements in blood pressure and cholesterol, despite the control group in the trial being treated much better than average."

Typically, in high-income countries such as the United States only about 50 percent of people take all the needed cardiovascular medications, Thom said. In low- and middle-income countries, only 5 percent to 20 percent do.

Researchers studied whether changing the delivery of several medications into one fixed-dose, combination pill might improve adherence and, therefore, improve blood pressure and cholesterol control. The researchers followed more than 2,000 men and women (average age 62) with cardiovascular disease in Europe and India for an average 15 months. Half of the participants were given a combination pill of aspirin, a cholesterol-lowering agent (statin) and two blood pressure-lowering drugs. The other half took their medications as usual, with multiple pills and doses.

Researchers noted that the group taking a single pill improved adherence by a third and had improved blood pressure and cholesterol levels compared to those taking multiple pills.

The findings also likely apply to other countries, Thom said. "We deliberately chose two quite different settings – Western Europe and India, with half the patients from each region, although the trial did include well-treated populations in both locations. Seeing broadly similar findings in each region suggests generalizability."

Similar trials are being conducted in Australia and New Zealand.

Co-authors are: Jane Field, B.Sc.; Neil Poulter, M.D., F.R.C.P.; Anushka Patel, M.D., Ph.D.; Dorairaj Prabhakaran, M.D., Ph.D.; Alice Stanton, M.D., Ph.D.; Rick Grobbee, M.D., Ph.D.; Michiel Bots, M.D., Ph.D.; Srinath Reddy, M.D., Ph.D.; Raghu Cidambi, L.L.B.; Severine Bompoint, B.Sc.; Laurent Billot, B.Sc.; and Anthony Rodgers, M.D., Ph.D.

The European Union's 7th Framework Program funded the study. Dr. Reddy's Laboratories in Hyderabad, India provided the fixed-dose, combination medication.