Adherence to Drug Regimens: Implications for Drug Developers

Approximately 50% of patients do not take their medications as prescribed.  This lack of adherence severely compromises patient outcomes and increases patient mortality and is estimated to incur costs of approximately $100 billion per year.  Some physicians believe that increasing the number of patients that adhere to their prescribed medications could have a greater effect on health than improvements in specific medical therapy. ¹

However, the increasingly complicated medical regimens make it more difficult for physicians to follow Hippocrates’ exhortation to “not only be prepared to do what is right himself, but also to make the patient…cooperate.”  Between 2000 and 2002, the typical Medicare beneficiary saw a median of seven physicians per year – two primary care physicians and five specialists, and typically patients recall as little as 50% of what is discussed during those visits. Although the responsibility of medication adherence is primarily on the patient, the complexity of both health care and drug regimens is causing patients to prevaricate that responsibility. ¹

The Number One Cause of Death, Yet Less Than Half Adhering to Medications

Heart disease is the number one cause of death in the United States, with 26.5 million people suffering from the disease according to the Centers for Disease Control (CDC).  Taking aspirin, cholesterol-lowering and blood pressure-lowering drugs long-term more than halves heart attack and stroke recurrence; however only 50% of patients with coronary disease and 35% in those with stroke are adhering to the medications prescribed to them.

Is Fixed Dose Combination the Answer?

Simon Thom, M.B., B.S., M.D. of the international Centre for Circulatory Health, Imperial College London, conducted the first study to compare a fixed dose combination (FDC) medication with usual care in patients with or at high risk of cardiovascular disease (CVD).  The FDC included aspirin for blood clots, simvastatin (Zocor) for high cholesterol and two blood pressure medications. The trial of 2,000 patients showed a significant improvement in medical adherence with the use of an FDC medication for blood pressure, cholesterol, and platelet control.

Thom found that 86 percent of the people that received the FDC kept up with their medications, compared to 65 percent of patients on the usual care.  People who began the trial with the lowest adherence had the greatest improvement – 77 percent instead of 23 percent took their medication regularly.

Overall, the FDC group also had slight declines in two major CVD risk factors – systolic blood pressure and LDL cholesterol – compared to those receiving the usual care.

More Data Needed

J. Michael Gaziano, M.D., M.P.H., cautioned, “Although the potential remains for use of various CVD polypills in certain settings, the precise advantage of this strategy remains largely unproven.  Until additional rigorous data are available that demonstrate that the polypill improves clinical CVD outcomes, it may be more important to carefully assess the multiple medications many patients currently are prescribed, often by several physicians.”