番茄社区

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BARCELONA -- A series of trials has pinpointed factors that contribute to medication nonadherence, and has shown that a polypill can increase compliance among patients who've had a heart attack, researchers reported here.

In the FOCUS (Fixed-Dose Combination Drug for Secondary Cardiovascular Prevention) series of studies, post-MI patients who were taking the polypill -- a combination of aspirin, a statin, and an ACE inhibitor -- had significantly greater medication adherence than those taking the three pills separately, according to , of Mount Sinai Hospital in New York, and colleagues.

They also found that a younger age, depression, and a complex treatment regimen were significantly associated with a lack of adherence, they reported here at the European Society of Cardiology meeting, and .

Fuster said the results suggest that the polypill has the potential to prevent more patients from having a second heart attack.

He explained that a lack of adherence impedes adequate secondary prevention. Within 2 years of a cardiovascular event, for instance, about half of patients don't comply with their prescribed regimens, which likely leads to the recurrence of events, Fuster said.

To investigate both the characteristics that are associated with adherence and to test the efficacy of the pill, Fuster and his team conducted the FOCUS series of trials. In the first phase, they assessed 2,118 post-MI patients for medication compliance via the Morisky Green Adherence Questionnaire (MGAQ).

In the second phase, they randomized 695 patients to either the polypill (100 mg acetylsalicylic acid, 40 mg simvastatin, and a range of doses of ramipril [2.5, 5, or 10 mg]) or to taking these three agents separately.

They found in the first phase that self-reported baseline adherence was 45.5%, and that general characteristics associated with nonadherence included an age below 50, following a complex drug regimen, depression, less social support, and less insurance coverage.

In a controlled analysis, three of those factors -- younger age, depression, and a complex treatment regimen – were significantly associated with a lack of adherence.

Adherence increased with more health insurance coverage and more social support, they reported.

In the second phase, Fuster and colleagues found that over a period of 9 months, adherence was significantly better with the polypill than when taking the three drugs separately:

• Intention-to-treat analysis: 50.8% versus 41%, P=0.019
• Per-protocol analysis, 65.7% versus 55.7%, P=0.012

"We have to look at the ways that we approach the problem [of nonadherence]," Fuster told 番茄社区. "I think that regardless of what the causes are ... the polypill is coming in with increased adherence."

Fuster added that the present results are an "open door to do the final trial to show whether the polypill reduces events. That is really exciting."

, of McMaster University, in Hamilton, Ontario, liked the concept of a polypill and said it could definitely help increase compliance.

"If the healthcare system can provide one drug instead of multiple drugs and take the thinking steps -- which are usually steps of indecision instead of decision -- out of the picture, more patients will get the appropriate drug therapy," he said.

"The likelihood is when you package three things into one, your distribution, packaging, and marketing costs are less," Yusuf added. "So the costs could well be half of giving each drug separately. This is one more step of the many trials on the polypill."

An FDA advisory committee is next week.