Improving Adherence With Amlodipine/Atorvastatin Therapy: IMPACT Study

Abstract

Hypertension is prevalent in the United States and remains uncontrolled. The primary objective of the study was to determine the effect of once-daily dosing of a combination therapy for blood pressure (BP) and dyslipidemia using home BP monitoring on reaching clinical BP and the effect of daily dosing of combination therapy on reaching lipid goals. The study was conducted in middle-aged, indigent, African Americans who had high-risk, resistant hypertension and dyslipidemia. Patients were randomly assigned to either the home and clinic BP group or usual care group and were followed for 6 months. The average BPs for each group were compared and used to titrate the study drug appropriately. Both groups achieved significant declines in BP, total cholesterol, and low-density lipoprotein (LDL) (P<.0001). These findings demonstrate that BP control could be achieved at a rate of 43.5% compared with the 2004 national control rate of 35%. The LDL control rate was also improved. Cardiovascular risk reduction has been proven to be achieved through managing lipids and BP. This trial demonstrates that these goals can be achieved similar to other groups in indigent African Americans with high-risk hypertension and dyslipidemia. J Clin Hypertens (Greenwich). 2011;13:598-604. Ó2011 Wiley Periodicals, Inc.One in three adults in the United States has hypertension.1 African Americans are among the population with the highest prevalence of hypertension, currently at 41.4% and 44% in black men and women, respectively.2 Although awareness and treatment have improved significantly to 72% and 63%, respectively, control rates remain at 37% in African Americans. Often multiple risk factors for cardiovascular disease occur concurrently.3 Among nondiabetic veterans, the prevalence of concomitant hypertension (HTN) and dyslipidemia (DYS) was 23.8%. 4 According to the heart disease and stroke statistics of 2008, the prevalence of DYS among US adults was 35.6% and only one third of those treated reached the National Cholesterol Education Program (NCEP)-defined goal for low-density lipoprotein (LDL) cholesterol.2 Although control rates for DYS improved from 1999 to 2004 from 4% to 25.1%, there is still need for improvement.2 The control rates of combined HTN ⁄ DYS are even lower, at 9%. Combined HTN and DYS lead to an increased risk of cardiovascular (CV) events, and this risk is greater than the sum of CV event risks of HTN and DYS alone. 5,6 Therefore, developing better approaches to managing both HTN and DYS can improve control rates and decrease CV morbidity and mortality. 7 Many tools have been used to improve control of HTN and DYS. One tool is the use of combination therapy, which can improve adherence to medication. 8Another tool specifically for HTN is home blood pressure (BP) monitoring (HBPM), which has many potential advantages, including improvement of patient adherence to medication.9 However, the reports in the literature regarding improvements in BP using HBPM have been inconsistent. 10 Yet, there is sufficient evidence that HBP...

A randomized, double‐blind clinical trial to evaluate the efficacy and safety of a fixed‐dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension

“…18,20 Based on these results, the importance of multifactorial intervention with respect to CVD risk factors has been emphasized in clinical practice. [21][22][23] Based on these previous studies, the efficacy and safety of a single-pill combination of atorvastatin and amlodipine have been demonstrated in hypertensive patients with dyslipidemia, 17,[24][25][26] and they are commercially available in the real clinical world. However, single-pill combination consisting of rosuvastatin, one of the most potent statins in patients with dyslipidemia, has never been studied.…”

Fixed Combination of Amlodipine/Atorvastatin

“…In the GEMINI Australia, Asia, Latin America, Africa/Middle East (AALA) study, the LDL target goal was achieved in 87% of the patients with a fixed combination of amlodipine and atorvastatin. 22 In the GEMINI 14 and GEMINI-AALA 22 trials, the mean blood pressure was reduced from baseline by 17.1/9.6 mm Hg 14 and 20.2/11.4 mm Hg, 22 and the mean reduction in LDL cholesterol (LDL-C) was 32.7% 14 and 28.6%. 22…”

“…The CRUCIAL study results support a proactive correction of risk factors. 22 The study included patients with AH, moderately elevated levels of total cholesterol (≤6.5 mmol/L), and with at least 3 more risk factors. Blood pressure goals were achieved to a slightly greater extent in the proactive intervention (amlodipine/atorvastatin) versus the usual care arm at week 16 (49% vs 46%), and this increased to 58% versus 48% ( P < .001) at week 52.…”

Desenvolvimento e caracterização de minicomprimidos contendo besilato de anlodipino

“…No entanto, há relatos de superdosagem (muitas vezes originada por auto-medicação indevida), que resultaram em casos de hipotensão grave, bradicardia, disritmia, náuseas, edema pulmonar e insuficiência renal aguda. O tratamento emergencial para a overdose de anlodipino compreende lavagem intestinal e administração intravenosa de dopamina, epinefrina e cálcio (KUTE et al, 2011;BENSON et al, 2010;EZIDIEGWU et al, 2008 (CHRYSANT et al, 2012;DEEKS, 2011;CALHOUN et al, 2009) (BLACK et al, 2011;ALLEMANN et al, 2008;JAMERSON et al, 2008;SMITH et al, 2007 (OLIVER et al, 2011;CURRAN, 2010;HUSSEIN et al, 2010).…”

“…Em vista do intenso uso desse fármaco no tratamento de doenças cardiovasculares, especialmente em associação com outras drogas (CHRYSANT et al, 2012;BLACK et al, 2011;OLIVER et al, 2011), a formulação de minicomprimidos de anlodipino pode ser o primeiro passo para a obtenção de formulações inovadoras para o tratamento da hipertensão.…”