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Can combining different risk interventions into a single formulation contribute to improved cardiovascular disease risk reduction? The single pill of amlodipine/atorvastatin.

Hobbs FD - Vasc Health Risk Manag (2007)

Bottom Line: The study was designed to assess the efficacy, safety, and utility of amlodipine/atorvastatin single-pill therapy in a real-world setting.The program utilized a newly developed questionnaire to gain better understanding of participants' beliefs and behaviors towards medical treatment of their multiple risk factors.The JEWEL program assessed the effectiveness of a single pill (amlodipine/atorvastatin) in targeting the two principal risk factors for cardiovascular disease simultaneously to achieve nationally applicable treatment targets in a routine clinical practice setting.

View Article: PubMed Central - PubMed

Affiliation: University of Birmingham, Edgbaston, Birmingham, UK. f.d.r.hobbs@bham.ac.uk

ABSTRACT
In order to prevent cardiovascular events, it is essential to effectively manage overall risk of cardiovascular disease. However, despite guideline recommendations to this effect, current management of the major, modifiable cardiovascular risk factors such as hypertension and dyslipidemia is disconnected and patient adherence to therapy is poor. This is particularly important for patients with multiple cardiovascular risk factors, who are often prescribed multiple medications. The JEWEL study program investigated the use of single-pill amlodipine/atorvastatin as a strategy to improve management of these patients. The JEWEL program consisted of two 16-week, international, open-label, multicenter, titration-to-goal studies in patients with hypertension and dyslipidemia. The two studies differed based on country of enrollment and certain tertiary endpoints, but the overall designs were very similar. Patients were enrolled from 255 centers across Canada and 13 European countries. The study was designed to assess the efficacy, safety, and utility of amlodipine/atorvastatin single-pill therapy in a real-world setting. Patients were initiated at a dose of amlodipine 5 mg/atorvastatin 10 mg, unless previously treated, and were uptitrated as necessary. The primary efficacy parameter was the percentage of patients, at different levels of cardiovascular risk, achieving country-specific guideline-recommended target levels for blood pressure and lipids. A secondary analysis of efficacy measured attainment of the same single goal for blood pressure across all study participants (JEWEL I and II) and the same single goal for LDL-C across all study participants (JEWEL I and II). The program utilized a newly developed questionnaire to gain better understanding of participants' beliefs and behaviors towards medical treatment of their multiple risk factors. Approximately 2850 patients were enrolled in the program, which was completed in August 2005. The JEWEL program assessed the effectiveness of a single pill (amlodipine/atorvastatin) in targeting the two principal risk factors for cardiovascular disease simultaneously to achieve nationally applicable treatment targets in a routine clinical practice setting.

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Blood pressure and lipid targets for the GEMINI and CAPABLE trials, based on JNC VI blood pressure and NCEP ATP lipid recommendations.
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fig2: Blood pressure and lipid targets for the GEMINI and CAPABLE trials, based on JNC VI blood pressure and NCEP ATP lipid recommendations.

Mentions: GEMINI was the first Real World trial conducted to examine the use of amlodipine/atorvastatin (Caduet) single-pill therapy for the concomitant treatment of hypertension and dyslipidemia (Wilson et al 1998). This 14-week, open-label, non-comparative, multicenter trial based in the US demonstrated the broad utility of the combination treatment in getting 1220 patients with uncontrolled hypertension and concurrent dyslipidemia to achieve both BP and LDL-C goals, based on JNC VI and NCEP ATP guidelines (Figure 2). At study end, more than half of the patients had reached both their BP and LDL-C therapeutic targets. Over 65% of patients reached their respective Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure VI (JNC VI) goal at study end, and 82% attained their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) goal. Figure 1 shows the percentages of patients reaching their BP, LDL-C or both therapeutic targets, based on baseline CVD risk category (Wilson et al 1998). Data were also presented regarding the performance of Caduet in patients who meet the IDF criteris for the metabolic syndrome (IDF).


Can combining different risk interventions into a single formulation contribute to improved cardiovascular disease risk reduction? The single pill of amlodipine/atorvastatin.

Hobbs FD - Vasc Health Risk Manag (2007)

Blood pressure and lipid targets for the GEMINI and CAPABLE trials, based on JNC VI blood pressure and NCEP ATP lipid recommendations.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2291315&req=5

fig2: Blood pressure and lipid targets for the GEMINI and CAPABLE trials, based on JNC VI blood pressure and NCEP ATP lipid recommendations.
Mentions: GEMINI was the first Real World trial conducted to examine the use of amlodipine/atorvastatin (Caduet) single-pill therapy for the concomitant treatment of hypertension and dyslipidemia (Wilson et al 1998). This 14-week, open-label, non-comparative, multicenter trial based in the US demonstrated the broad utility of the combination treatment in getting 1220 patients with uncontrolled hypertension and concurrent dyslipidemia to achieve both BP and LDL-C goals, based on JNC VI and NCEP ATP guidelines (Figure 2). At study end, more than half of the patients had reached both their BP and LDL-C therapeutic targets. Over 65% of patients reached their respective Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure VI (JNC VI) goal at study end, and 82% attained their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) goal. Figure 1 shows the percentages of patients reaching their BP, LDL-C or both therapeutic targets, based on baseline CVD risk category (Wilson et al 1998). Data were also presented regarding the performance of Caduet in patients who meet the IDF criteris for the metabolic syndrome (IDF).

Bottom Line: The study was designed to assess the efficacy, safety, and utility of amlodipine/atorvastatin single-pill therapy in a real-world setting.The program utilized a newly developed questionnaire to gain better understanding of participants' beliefs and behaviors towards medical treatment of their multiple risk factors.The JEWEL program assessed the effectiveness of a single pill (amlodipine/atorvastatin) in targeting the two principal risk factors for cardiovascular disease simultaneously to achieve nationally applicable treatment targets in a routine clinical practice setting.

View Article: PubMed Central - PubMed

Affiliation: University of Birmingham, Edgbaston, Birmingham, UK. f.d.r.hobbs@bham.ac.uk

ABSTRACT
In order to prevent cardiovascular events, it is essential to effectively manage overall risk of cardiovascular disease. However, despite guideline recommendations to this effect, current management of the major, modifiable cardiovascular risk factors such as hypertension and dyslipidemia is disconnected and patient adherence to therapy is poor. This is particularly important for patients with multiple cardiovascular risk factors, who are often prescribed multiple medications. The JEWEL study program investigated the use of single-pill amlodipine/atorvastatin as a strategy to improve management of these patients. The JEWEL program consisted of two 16-week, international, open-label, multicenter, titration-to-goal studies in patients with hypertension and dyslipidemia. The two studies differed based on country of enrollment and certain tertiary endpoints, but the overall designs were very similar. Patients were enrolled from 255 centers across Canada and 13 European countries. The study was designed to assess the efficacy, safety, and utility of amlodipine/atorvastatin single-pill therapy in a real-world setting. Patients were initiated at a dose of amlodipine 5 mg/atorvastatin 10 mg, unless previously treated, and were uptitrated as necessary. The primary efficacy parameter was the percentage of patients, at different levels of cardiovascular risk, achieving country-specific guideline-recommended target levels for blood pressure and lipids. A secondary analysis of efficacy measured attainment of the same single goal for blood pressure across all study participants (JEWEL I and II) and the same single goal for LDL-C across all study participants (JEWEL I and II). The program utilized a newly developed questionnaire to gain better understanding of participants' beliefs and behaviors towards medical treatment of their multiple risk factors. Approximately 2850 patients were enrolled in the program, which was completed in August 2005. The JEWEL program assessed the effectiveness of a single pill (amlodipine/atorvastatin) in targeting the two principal risk factors for cardiovascular disease simultaneously to achieve nationally applicable treatment targets in a routine clinical practice setting.

Show MeSH
Related in: MedlinePlus