Amlodipine/Valsartan in Non-Whites With Hypertension
Amlodipine/Valsartan in Non-Whites With Hypertension
In view of the high rates of uncontrolled hypertension in African Americans, Hispanics/Latinos, and Asians, optimal therapy along with medication adherence and persistence are important. Evidence suggests that the majority of patients with hypertension will require combination therapy to reach their BP goals. Antihypertensive regimens that are less complex have been shown to improve medication adherence and persistence. Combination therapy is appropriate either as an SPC (i.e., multiple agents in a single pill) or free combination (FC) (i.e., multiple agents as separate pills). A study of 7,224 patients demonstrated that SPC therapy over 12 months was associated with better persistence (42.5 % higher; P< 0.002) and adherence (22.1 % higher; P< 0.001) compared with that seen in patients who were switched to FC therapy. Better adherence and persistence are likely to improve upon positive health benefits through enhanced hypertension control and positive economic benefits through lower costs for hypertension-related health care.
In addition to improved adherence and persistence, combination therapy in the management of hypertension allows for a reduction in BP variability. Short- and long-term effects of BP variability are associated with an increased risk of both renovascular and cardiovascular events and mortality. Evidence suggests that combination therapy, particularly the addition of a calcium channel blocker or diuretic to a renin–angiotensin–aldosterone system (RAAS) blocker, is associated with less BP variability, which may improve outcomes. Furthermore, in a meta-analysis of 42 trials, Wald and colleagues demonstrated that combining antihypertensive drugs from two different classes lowered BP five times more than doubling the dose of one agent. Of note, given that there are lower dosage requirements in combination therapy for each individual agent and the fact that combination therapy can provide additive or synergistic BP lowering, the result may lead to a reduction in side effects, thus improving compliance. Therefore, the use of an SPC may translate directly to achievement of BP goals more quickly with attenuation of adverse drug reactions.
SPCs appear to improve compliance especially if differences in acquisition costs can be controlled. In a retrospective cohort study, Malesker and Hilleman evaluated clinical and economic outcomes in patients using an SPC of amlodipine/valsartan versus the outcomes from conventional combination therapy. In the SPC cohort, 58/100 patients (58 %) achieved BP targets, compared with 47/100 control patients (47 %) (P = 0.119), and the absolute reduction in systolic/diastolic BP was significantly greater in the SPC group (22.8 ± 6.9/19.3 ± 5.2 mmHg) than in the control group (20.6 ± 6.4/17.8 ± 5.6 mmHg) (P ≤ 0.03). Overall, in the SPC cohort, there were significantly fewer patients who discontinued their antihypertensive therapy because of side effects and non-compliance compared with the control group (both P = 0.042). Even though the SPC patients had higher medication acquisition costs (US$479 vs. US$367), they accrued fewer clinic visits, laboratory tests, and electrocardiograms, thus translating into a reduction in comprehensive medical treatment costs over the 6 months of follow-up. Specifically, health care resource utilization costs per patient totaled US$2,734 with the SPC and US$3,490 in controls (P = 0.024). Total health care costs were similarly lowered (16–20 % reduction) with the SPC of amlodipine/valsartan compared with calcium channel blocker/angiotensin receptor blocker FC therapy (P< 0.0001).
Of note, the cost of SPC therapy to the patient has the potential to be lower since only a single copayment is necessary, compared with multiple copayments for FC therapy. Lower copayments may have the added benefit of improved adherence and persistence with hypertension medication.
4 Benefits of Single-Pill Combination Therapy
In view of the high rates of uncontrolled hypertension in African Americans, Hispanics/Latinos, and Asians, optimal therapy along with medication adherence and persistence are important. Evidence suggests that the majority of patients with hypertension will require combination therapy to reach their BP goals. Antihypertensive regimens that are less complex have been shown to improve medication adherence and persistence. Combination therapy is appropriate either as an SPC (i.e., multiple agents in a single pill) or free combination (FC) (i.e., multiple agents as separate pills). A study of 7,224 patients demonstrated that SPC therapy over 12 months was associated with better persistence (42.5 % higher; P< 0.002) and adherence (22.1 % higher; P< 0.001) compared with that seen in patients who were switched to FC therapy. Better adherence and persistence are likely to improve upon positive health benefits through enhanced hypertension control and positive economic benefits through lower costs for hypertension-related health care.
In addition to improved adherence and persistence, combination therapy in the management of hypertension allows for a reduction in BP variability. Short- and long-term effects of BP variability are associated with an increased risk of both renovascular and cardiovascular events and mortality. Evidence suggests that combination therapy, particularly the addition of a calcium channel blocker or diuretic to a renin–angiotensin–aldosterone system (RAAS) blocker, is associated with less BP variability, which may improve outcomes. Furthermore, in a meta-analysis of 42 trials, Wald and colleagues demonstrated that combining antihypertensive drugs from two different classes lowered BP five times more than doubling the dose of one agent. Of note, given that there are lower dosage requirements in combination therapy for each individual agent and the fact that combination therapy can provide additive or synergistic BP lowering, the result may lead to a reduction in side effects, thus improving compliance. Therefore, the use of an SPC may translate directly to achievement of BP goals more quickly with attenuation of adverse drug reactions.
SPCs appear to improve compliance especially if differences in acquisition costs can be controlled. In a retrospective cohort study, Malesker and Hilleman evaluated clinical and economic outcomes in patients using an SPC of amlodipine/valsartan versus the outcomes from conventional combination therapy. In the SPC cohort, 58/100 patients (58 %) achieved BP targets, compared with 47/100 control patients (47 %) (P = 0.119), and the absolute reduction in systolic/diastolic BP was significantly greater in the SPC group (22.8 ± 6.9/19.3 ± 5.2 mmHg) than in the control group (20.6 ± 6.4/17.8 ± 5.6 mmHg) (P ≤ 0.03). Overall, in the SPC cohort, there were significantly fewer patients who discontinued their antihypertensive therapy because of side effects and non-compliance compared with the control group (both P = 0.042). Even though the SPC patients had higher medication acquisition costs (US$479 vs. US$367), they accrued fewer clinic visits, laboratory tests, and electrocardiograms, thus translating into a reduction in comprehensive medical treatment costs over the 6 months of follow-up. Specifically, health care resource utilization costs per patient totaled US$2,734 with the SPC and US$3,490 in controls (P = 0.024). Total health care costs were similarly lowered (16–20 % reduction) with the SPC of amlodipine/valsartan compared with calcium channel blocker/angiotensin receptor blocker FC therapy (P< 0.0001).
Of note, the cost of SPC therapy to the patient has the potential to be lower since only a single copayment is necessary, compared with multiple copayments for FC therapy. Lower copayments may have the added benefit of improved adherence and persistence with hypertension medication.