Clinical Pharmacy Specialist Implementation of Lisinopril
Clinical Pharmacy Specialist Implementation of Lisinopril
Study Objective: As the results of the Heart Outcomes Prevention Evaluation trial suggested that patients with both coronary artery disease (CAD) and diabetes mellitus would benefit from angiotensin-converting enzyme (ACE) inhibitor therapy, our objective was to increase the percentage of patients with both of these conditions receiving the goal dosage (20 mg/day) or highest tolerated dosage of the ACE inhibitor lisinopril through intervention of a clinical pharmacy service.
Study Design: Prospective study with historic comparison (control group).
Setting: Clinical Pharmacy Cardiac Risk Service.
Patients: Hospitalized patients with CAD and type 2 diabetes mellitus.
Measurements and Main Results: At hospital discharge, lisinopril 5 mg/day was started in eligible patients; the drug was titrated to a goal dosage of 20 mg/day or the highest tolerated dosage. Potassium level, serum creatinine level, and blood pressure were monitored at baseline, at each dosage titration, and 2 weeks after the goal or highest tolerated dosage was reached. The group receiving usual care (control group) consisted of 95 patients; the treatment group had 101 patients. At baseline, 19 patients (20%) in the control group were receiving the goal dosage of lisinopril, 34 (36%) were taking a suboptimal dosage, 16 (17%) were excluded from treatment, and 26 (27%) were eligible but were not receiving lisinopril therapy. After 9 months, ACE inhibitor dosages had changed minimally in the control group. In the treatment group, at baseline, 37 patients (36%) were at their goal dosage and therefore titration was not necessary; 15 (15%) were receiving a suboptimal dosage, 35 (35%) were excluded from treatment, and 14 (14%) were eligible but not receiving therapy. After the titration period, 55 (54%) treatment group patients were at the goal dosage, 11 (11%) were taking a suboptimal dosage, and 35 (35%) were not candidates for ACE inhibitor therapy. The most common reasons for exclusion were renal insufficiency, cough, and baseline hypotension. Changes in potassium level, serum creatinine level, and blood pressure were not significant during the study.
Conclusion: The clinical pharmacy service more than doubled the number of patients with CAD and diabetes who achieved the goal dosage of an ACE inhibitor, a drug class that has been shown to decrease morbidity and mortality in this patient population.
Two thirds of patients with diabetes mellitus die of cardiovascular disease. Epidemiologic studies show that the risk of cardiovascular mortality is 2 times higher in men with diabetes and 2-3 times higher in women with diabetes than in people without the disease. The age-adjusted prevalence of coronary artery disease (CAD) in Caucasian adults who have diabetes is approximately 45% versus 25% in those without diabetes.
Angiotensin-converting enzyme (ACE) inhibitors have been shown to be beneficial in patients with cardiovascular diseases and diabetes. Since the late 1980s, large trials have shown the benefits of these drugs in patients with heart failure. Trials such as the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS), the Studies of Left Ventricular Dysfunction (SOLVD), and the second Vasodilator-Heart Failure Trial (V-HeFT II) have confirmed the protective effects of ACE inhibitor therapy on survival in patients with mild-to-severe heart failure. Studies such as the fourth International Study of Infarct Survival Trial (ISIS-4) and the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico (GISSI-3) have shown that ACE inhibitor administration soon after myocardial infarction reduces mortality. Three other trials have demonstrated that ACE inhibitor therapy started days after myocardial infarction and continued long-term in patients with clinical signs of left ventricular dysfunction significantly reduces mortality. Studies have also demonstrated that ACE inhibitor therapy decreases proteinuria and preserves the glomerular filtration rate in patients with diabetes.
The Heart Outcomes Prevention Evaluation (HOPE) study evaluated 9297 high-risk patients who were not known to have a low ejection fraction or heart failure. Patients were eligible for the study if they had a history of CAD, stroke, peripheral vascular disease, or diabetes plus one other cardiovascular risk factor (hypertension, elevated total cholesterol level, low high-density lipoprotein cholesterol level, cigarette smoking, or documented microalbuminuria). The ACE inhibitor ramipril significantly reduced the rate of death, myocardial infarction, and stroke in a broad range of these high-risk patients. Thirty-nine percent of the high-risk population had diabetes mellitus, and a substudy -- the Microalbuminuria, Cardiovascular, and Renal Outcomes-Heart Outcomes Prevention Evaluation (MICRO-HOPE) -- evaluated the specific benefit of ramipril in this population. The drug significantly lowered the risk of major cardiovascular outcomes by 25-30% in patients with diabetes and lowered the risk of overt nephropathy.
These trials clearly show that ACE inhibitor therapy provides significant benefit for several patient populations, such as patients with diabetes or heart failure, those who experienced myocardial infarction, and those at high risk for or diagnosed with CAD. Therefore, the objective of this study was to increase the percentage of patients with both CAD and diabetes receiving the goal dosage or highest tolerated dosage of ACE inhibitor therapy through the intervention of a clinical pharmacy service. Study results were compared with outcomes achieved with conventional treatment.
Study Objective: As the results of the Heart Outcomes Prevention Evaluation trial suggested that patients with both coronary artery disease (CAD) and diabetes mellitus would benefit from angiotensin-converting enzyme (ACE) inhibitor therapy, our objective was to increase the percentage of patients with both of these conditions receiving the goal dosage (20 mg/day) or highest tolerated dosage of the ACE inhibitor lisinopril through intervention of a clinical pharmacy service.
Study Design: Prospective study with historic comparison (control group).
Setting: Clinical Pharmacy Cardiac Risk Service.
Patients: Hospitalized patients with CAD and type 2 diabetes mellitus.
Measurements and Main Results: At hospital discharge, lisinopril 5 mg/day was started in eligible patients; the drug was titrated to a goal dosage of 20 mg/day or the highest tolerated dosage. Potassium level, serum creatinine level, and blood pressure were monitored at baseline, at each dosage titration, and 2 weeks after the goal or highest tolerated dosage was reached. The group receiving usual care (control group) consisted of 95 patients; the treatment group had 101 patients. At baseline, 19 patients (20%) in the control group were receiving the goal dosage of lisinopril, 34 (36%) were taking a suboptimal dosage, 16 (17%) were excluded from treatment, and 26 (27%) were eligible but were not receiving lisinopril therapy. After 9 months, ACE inhibitor dosages had changed minimally in the control group. In the treatment group, at baseline, 37 patients (36%) were at their goal dosage and therefore titration was not necessary; 15 (15%) were receiving a suboptimal dosage, 35 (35%) were excluded from treatment, and 14 (14%) were eligible but not receiving therapy. After the titration period, 55 (54%) treatment group patients were at the goal dosage, 11 (11%) were taking a suboptimal dosage, and 35 (35%) were not candidates for ACE inhibitor therapy. The most common reasons for exclusion were renal insufficiency, cough, and baseline hypotension. Changes in potassium level, serum creatinine level, and blood pressure were not significant during the study.
Conclusion: The clinical pharmacy service more than doubled the number of patients with CAD and diabetes who achieved the goal dosage of an ACE inhibitor, a drug class that has been shown to decrease morbidity and mortality in this patient population.
Two thirds of patients with diabetes mellitus die of cardiovascular disease. Epidemiologic studies show that the risk of cardiovascular mortality is 2 times higher in men with diabetes and 2-3 times higher in women with diabetes than in people without the disease. The age-adjusted prevalence of coronary artery disease (CAD) in Caucasian adults who have diabetes is approximately 45% versus 25% in those without diabetes.
Angiotensin-converting enzyme (ACE) inhibitors have been shown to be beneficial in patients with cardiovascular diseases and diabetes. Since the late 1980s, large trials have shown the benefits of these drugs in patients with heart failure. Trials such as the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS), the Studies of Left Ventricular Dysfunction (SOLVD), and the second Vasodilator-Heart Failure Trial (V-HeFT II) have confirmed the protective effects of ACE inhibitor therapy on survival in patients with mild-to-severe heart failure. Studies such as the fourth International Study of Infarct Survival Trial (ISIS-4) and the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico (GISSI-3) have shown that ACE inhibitor administration soon after myocardial infarction reduces mortality. Three other trials have demonstrated that ACE inhibitor therapy started days after myocardial infarction and continued long-term in patients with clinical signs of left ventricular dysfunction significantly reduces mortality. Studies have also demonstrated that ACE inhibitor therapy decreases proteinuria and preserves the glomerular filtration rate in patients with diabetes.
The Heart Outcomes Prevention Evaluation (HOPE) study evaluated 9297 high-risk patients who were not known to have a low ejection fraction or heart failure. Patients were eligible for the study if they had a history of CAD, stroke, peripheral vascular disease, or diabetes plus one other cardiovascular risk factor (hypertension, elevated total cholesterol level, low high-density lipoprotein cholesterol level, cigarette smoking, or documented microalbuminuria). The ACE inhibitor ramipril significantly reduced the rate of death, myocardial infarction, and stroke in a broad range of these high-risk patients. Thirty-nine percent of the high-risk population had diabetes mellitus, and a substudy -- the Microalbuminuria, Cardiovascular, and Renal Outcomes-Heart Outcomes Prevention Evaluation (MICRO-HOPE) -- evaluated the specific benefit of ramipril in this population. The drug significantly lowered the risk of major cardiovascular outcomes by 25-30% in patients with diabetes and lowered the risk of overt nephropathy.
These trials clearly show that ACE inhibitor therapy provides significant benefit for several patient populations, such as patients with diabetes or heart failure, those who experienced myocardial infarction, and those at high risk for or diagnosed with CAD. Therefore, the objective of this study was to increase the percentage of patients with both CAD and diabetes receiving the goal dosage or highest tolerated dosage of ACE inhibitor therapy through the intervention of a clinical pharmacy service. Study results were compared with outcomes achieved with conventional treatment.