1 / 12

Federal Study of Adherence to Medications (FAME) Trial

FAME Trial. 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: Background.

lani
Download Presentation

Federal Study of Adherence to Medications (FAME) Trial

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

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

  2. 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. Presented at AHA 2006

  3. FAME Trial: Study Design 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 Run-in Phase for baseline endpoint evaluation (2 months) Observation Phase (6 months): 6-month intervention phase including medication education, pharmacist follow-up, and medications dispensed in time-specific packets n=200 Continuation of Intervention (6 months) n=83 Usual Care (6 months) n=76 • Primary Endpoints: Observation phase: Change in pills taken versus baseline Randomization phase: Medication use after 6 months • Secondary Endpoint: Changes in blood pressure and LDL-C during observation phase Presented at AHA 2006

  4. FAME Trial: Medications at Baseline • The mean number of chronic medications taken at baseline was 8.7. • Medications included treatment for hypertension (91.5%) and • hyperlipidemia (80.6%). • Mean medication adherence was 61.2% at baseline. Presented at AHA 2006

  5. FAME Trial: Primary Endpoint Observation Phase Medication Adherence Rate (%) 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). Presented at AHA 2006

  6. FAME Trial: Primary Endpoint Observation Phase (cont’d) Adherence Rate of Taking at least 80% of all Medications (%) 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). Presented at AHA 2006

  7. FAME Trial: Secondary Endpoint ObservationPhase Reduction in Systolic Blood Pressure (SBP) (mmHg) p=0.02 Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dl) p=0.001 mg/dl mmHg • Systolic blood pressure (SBP) was reduced (133.2 mmHg at baseline to 129.9 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. Presented at AHA 2006

  8. FAME Trial: Primary Endpoint Randomization Phase Medication Adherence Rate in the Usual Care Group vs. Intervention Group (%) 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). Presented at AHA 2006

  9. FAME Trial: Primary Endpoint Randomization Phase (cont.) Adherence Rate of Taking at least 80% of all Medications in the Usual Care Group vs. Intervention Group (%) 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). Presented at AHA 2006

  10. 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 Usual Care Group Intervention Group Usual Care Group Intervention Group mm Hg mg/dl • The reduction in SBP among treated hypertensives was greater in the intervention group compared with the usual care group (-6.9 mm Hg vs. -1.0 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. -5.8 mg/dl, p=0.85). Presented at AHA 2006

  11. 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. • 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. Presented at AHA 2006

  12. 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. • 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

More Related