Federal Study of Adherence to Medications (FAME) Trial Presented at The American Heart Association Annual Scientific Session 2006 Presented by Dr. Allen Taylor FAME Trial

www. Clinical trial results.org FAME Trial: Background The goal of the FAME Trial was to evaluate the effect of a pharmacy intervention program compared with usual care on medication adherence among elderly patients treated with ≥4 chronic medications.The goal of the FAME Trial was to evaluate the effect of a pharmacy intervention program compared with usual care on medication adherence among elderly patients treated with ≥4 chronic medications. Presented at AHA 2006

www. Clinical trial results.org FAME Trial: Study Design  Primary Endpoints: Observation phase: Change in pills taken versus baseline Randomization phase: Medication use after 6 months Randomization phase: Medication use after 6 months  Secondary Endpoint: Changes in blood pressure and LDL-C during observation phase  Primary Endpoints: Observation phase: Change in pills taken versus baseline Randomization phase: Medication use after 6 months Randomization phase: Medication use after 6 months  Secondary Endpoint: Changes in blood pressure and LDL-C during observation phase 200 patients > 65 years taking >4 chronic medications daily who are living independently and without any serious medical condition with expected survival >1 year Randomized. 23% female, mean age 78 years, mean follow-up 14 months 200 patients > 65 years taking > 4 chronic medications daily who are living independently and without any serious medical condition with expected survival >1 year Randomized. 23% female, mean age 78 years, mean follow-up 14 months Continuation of Intervention (6 months) n=83 n=83 Presented at AHA 2006 Observation Phase (6 months): 6-month intervention phase including medication education, pharmacist follow-up, and medications dispensed in time-specific packets n=200 Observation Phase (6 months): 6-month intervention phase including medication education, pharmacist follow-up, and medications dispensed in time-specific packets n=200 Usual Care (6 months) n=76 n=76 Run-in Phase for baseline endpoint evaluation (2 months)

www. Clinical trial results.org FAME Trial: Medications at Baseline Presented at AHA 2006 Medications taken at Baseline Percent of Patients (%) Statins80.0% Angiotensin-Converting Enzyme (ACE) Inhibitors Angiotensin-Converting Enzyme (ACE) Inhibitors50.2% Beta-Blockers47.3% Calcium Channel Blockers 36.8% Thiazide Diuretic 25.9% The mean number of chronic medications taken at baseline was 8.7. The mean number of chronic medications taken at baseline was 8.7. Medications included treatment for hypertension (91.5%) and Medications included treatment for hypertension (91.5%) and hyperlipidemia (80.6%). hyperlipidemia (80.6%). Mean medication adherence was 61.2% at baseline. Mean medication adherence was 61.2% at baseline.

www. Clinical trial results.org FAME Trial: Primary Endpoint Observation Phase FAME Trial: Primary Endpoint Observation Phase Upon completion of the observation intervention phase, the primary endpoint of medication adherence increased significantly from baseline (61.2% vs. 96.9%, p<0.001).Upon completion of the observation intervention phase, the primary endpoint of medication adherence increased significantly from baseline (61.2% vs. 96.9%, p<0.001). Medication Adherence Rate (%) p<0.001 Presented at AHA 2006

www. Clinical trial results.org FAME Trial: Primary Endpoint Observation Phase (cont’d) FAME Trial: Primary Endpoint Observation Phase (cont’d) An adherence rate of taking 80% of all medications increased from 5.0% at baseline to 98.7% after intervention (p<0.001).An adherence rate of taking 80% of all medications increased from 5.0% at baseline to 98.7% after intervention (p<0.001). Adherence Rate of Taking at least 80% of all Medications (%) p<0.001 Presented at AHA 2006

www. Clinical trial results.org FAME Trial: Secondary Endpoint Observation Phase Reduction in Systolic Blood Pressure (SBP) (mmHg) p=0.02 Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dl) p=0.001 Systolic blood pressure (SBP) was reduced (133.2 mmHg at baseline to mmHg at 6 months, p=0.02) among patients with treated hypertension.Systolic blood pressure (SBP) was reduced (133.2 mmHg at baseline to mmHg at 6 months, p=0.02) among patients with treated hypertension. Low-density lipoprotein cholesterol (LDL-C) was also reduced (91.7 mg/dl at baseline to 86.8 mg/dl after 6 months, p=0.001) among patients with treated hyperlipidemia.Low-density lipoprotein cholesterol (LDL-C) was also reduced (91.7 mg/dl at baseline to 86.8 mg/dl after 6 months, p=0.001) among patients with treated hyperlipidemia. Presented at AHA 2006 mmHg mg/dl

www. Clinical trial results.org FAME Trial: Primary Endpoint Randomization Phase FAME Trial: Primary Endpoint Randomization Phase During the randomization phase, medication adherence decreased in the usual care group but was maintained in the intervention group. (69.1% vs. 95.5% adherence rate, (p<0.001).During the randomization phase, medication adherence decreased in the usual care group but was maintained in the intervention group. (69.1% vs. 95.5% adherence rate, (p<0.001). Medication Adherence Rate in the Usual Care Group vs. Intervention Group (%) p<0.001 Presented at AHA 2006

www. Clinical trial results.org FAME Trial: Primary Endpoint Randomization Phase (cont.) FAME Trial: Primary Endpoint Randomization Phase (cont.) Adherence rate of at least 80% of all medications was higher in the intervention group compared with the usual care group (97.4% vs. 21.7%, p<0.001).Adherence rate of at least 80% of all medications was higher in the intervention group compared with the usual care group (97.4% vs. 21.7%, p<0.001). Adherence Rate of Taking at least 80% of all Medications in the Usual Care Group vs. Intervention Group (%) p<0.001 Presented at AHA 2006

www. Clinical trial results.org FAME Trial: Secondary Endpoint Randomization Phase Reduction in Systolic Blood Pressure (SBP) (mmHg) p=0.04 Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dl) p=0.85 The reduction in SBP among treated hypertensives was greater in the intervention group compared with the usual care group (-6.9 mm Hg vs mm Hg, p=0.04). The reduction in SBP among treated hypertensives was greater in the intervention group compared with the usual care group (-6.9 mm Hg vs mm Hg, p=0.04). Among treated hyperlipidemics, reduction in LDL-C did not differ between the intervention and usual care group (-2.8 mg/dl vs mg/dl, p=0.85). Among treated hyperlipidemics, reduction in LDL-C did not differ between the intervention and usual care group (-2.8 mg/dl vs mg/dl, p=0.85). Presented at AHA 2006 mm Hg mg/dl Usual Care Group Intervention Group Usual Care Group Intervention Group

www. Clinical trial results.org FAME Trial: Limitations Patients taking multiple chronic medications are at high risk for medication nonadherence. The risk can be even higher for asymptomatic conditions, including hypertension and hyperlipidemia.Patients taking multiple chronic medications are at high risk for medication nonadherence. The risk can be even higher for asymptomatic conditions, including hypertension and hyperlipidemia. Nonadherence can lead to worsening health problems, increased hospitalizations, and subsequently higher overall health costs.Nonadherence can lead to worsening health problems, increased hospitalizations, and subsequently higher overall health costs. While the present trial showed the intervention program was effective, the time and cost necessary for pharmacies to provide patient education may be a barrier to widespread use of the program.While the present trial showed the intervention program was effective, the time and cost necessary for pharmacies to provide patient education may be a barrier to widespread use of the program. Patients taking multiple chronic medications are at high risk for medication nonadherence. The risk can be even higher for asymptomatic conditions, including hypertension and hyperlipidemia.Patients taking multiple chronic medications are at high risk for medication nonadherence. The risk can be even higher for asymptomatic conditions, including hypertension and hyperlipidemia. Nonadherence can lead to worsening health problems, increased hospitalizations, and subsequently higher overall health costs.Nonadherence can lead to worsening health problems, increased hospitalizations, and subsequently higher overall health costs. While the present trial showed the intervention program was effective, the time and cost necessary for pharmacies to provide patient education may be a barrier to widespread use of the program.While the present trial showed the intervention program was effective, the time and cost necessary for pharmacies to provide patient education may be a barrier to widespread use of the program. Presented at AHA 2006

www. Clinical trial results.org FAME Trial: Summary Among patients age ≥65 years treated with multiple chronic medications, use of a pharmacy intervention program was associated with better medication use adherence compared with usual care.Among patients age ≥65 years treated with multiple chronic medications, use of a pharmacy intervention program was associated with better medication use adherence compared with usual care. In addition to demonstrating an association between the intervention program and medication compliance, the trial also demonstrated clinical effects on blood pressure, with a reduction in SBP in treated hypertensive patients in the intervention group compared with the usual care group.In addition to demonstrating an association between the intervention program and medication compliance, the trial also demonstrated clinical effects on blood pressure, with a reduction in SBP in treated hypertensive patients in the intervention group compared with the usual care group. Among patients age ≥65 years treated with multiple chronic medications, use of a pharmacy intervention program was associated with better medication use adherence compared with usual care.Among patients age ≥65 years treated with multiple chronic medications, use of a pharmacy intervention program was associated with better medication use adherence compared with usual care. In addition to demonstrating an association between the intervention program and medication compliance, the trial also demonstrated clinical effects on blood pressure, with a reduction in SBP in treated hypertensive patients in the intervention group compared with the usual care group.In addition to demonstrating an association between the intervention program and medication compliance, the trial also demonstrated clinical effects on blood pressure, with a reduction in SBP in treated hypertensive patients in the intervention group compared with the usual care group. Presented at AHA 2006