ORLANDO, Fla.--A trial of a pharmacist-led intervention in primary care that aimed to optimize preventive heart failure (HF) treatment modestly improved the prescription of lifesaving drugs but did not improve clinical outcomes, according to the Post-MI FREE late-breaking clinical trial presented Nov. 14 at the 2011 American Heart Association’s scientific sessions.
Collaborative care models that include pharmacists and physicians in the hospital setting have been shown to improve patient outcomes. Richard Lowrie, MSc, MPC, a pharmacist at the Greater Glasgow and Clyde Health Services in Scotland, and colleagues designed a prospective cluster randomized trial to test a similar model in the primary care setting, in an attempt to ensure that patients with left ventricular systolic dysfunction (LVSD) receive guideline-recommended drugs before the condition progressed to HF.
“It had not been tested for patients who had not been hospitalized previously,” Lowrie told Cardiovascular Business. “This was a very low-risk patient group who had been recently diagnosed with left ventricular systolic dysfunction and heart failure symptoms in the community, but who hadn’t gotten to the point where they had to go into hospital. An intervention to improve outcomes for that patient group, as far as I am aware, hasn’t been tested in a long-term morbidity and mortality trial.”
Patients with confirmed LVSD were included in the study. Patients recently hospitalized for HF, with a concurrent acute disease other than HF, severe cognitive impairment, renal failure or institutionalized in a long-term care facility were excluded.
A total of 2,164 patients from 174 practices were enrolled between October 2004 and September 2007. They were cluster randomized to an arm that received pharmacist intervention (87 practices and 1,090 patients) and a control arm that provided standard care (87 practices and 1,074 patients). Patients in the intervention arm met with a pharmacist who made recommendations for medications, Lowrie said.
Median follow-up was 4.7 years using the U.K.’s National Health Registry, which covers 220 family medical centers that serve the entire population.
The primary outcome tracked was death from any cause or hospitalization for worsening HF. Secondary outcomes included death from any cause, hospital admission for cardiovascular causes, hospital admission for any cause, total number of admissions, visits to the emergency room, hospital, outpatient clinics and primary care, and prescription of medications that modify disease.
Lowrie noted that most of the patients had multiple comorbidities such as hypertension, MI and atrial fibrillation or flutter. In an analysis of baseline medication use, they found 86 percent of the intervention group and 85 percent of the control group received prescriptions for ACE inhibitors and/or ARBs. “That was much higher than we anticipated,” he said.
Beta-blockers were prescribed to 62 percent of patients in both arms. At baseline, only a fraction of those patients received guideline-recommended doses for ARBs and beta-blockers though, Lowrie said.
At the end of the first-year follow-up, the intervention arm showed a statistically significant improvement in ACE inhibitor or ARB prescribing and increasing dosages to 100 percent of the target, but first-year follow-up for beta-blockers was less promising. “The improvement was more modest,” Lowrie said. “We expected more and got actually less,” he said.
Five-year trend lines of the percentage of patients over time who died or were hospitalized for HF for the two arms were almost identical, as were trends for the primary outcome components.
“There was no improvement in outcomes due to the pharmacist intervention,” Lowrie concluded.
“Why was there a gap between prescribing changes and outcome?” Lowrie asked in an interview after his presentation. He speculated that modest changes in prescribing translated into no gains in outcomes. “If the extent of the changes to prescribing was sufficiently high, then there is no doubt it would have impacted on hospitalizations.”
The results show room for improvement, he said, including a more direct intervention and better training of pharmacists.
Mariell L. Jessup, MD, of the Hospital of the University of Pennsylvania in Philadelphia, followed Lowrie’s presentation with a recap on increasing incidence of HF in the U.S. and its risk factors. “This is an epidemic and now is the number one reason