The Gemini Study: Clinical Utility of Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular
The Gemini Study: Clinical Utility of Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia
Presenter: Roy Blank, MD, Presbyterian Healthcare Associates of Monroe (Monroe, North Carolina)
Patients treated with a single pill combining 2 drugs -- one for treating hypertension and the other for treating dyslipidemia -- are more likely to reach their blood pressure and low-density lipoprotein (LDL)-cholesterol goals, according to results of a trial in patients with concomitant hypertension and dyslipidemia. The Gemini study is the first to be presented that describes results with the new combined medication, Caduet (Pfizer, New York, NY), which contains the calcium channel blocker amlodipine besylate and the HMG-CoA reductase inhibitor atorvastatin calcium. Caduet was approved for marketing by the US Food and Drug Administration in February 2004.
Hypertension and dyslipidemia are highly prevalent, and up to 50% of patients with one condition also have the other; this comorbidity confers a high risk of cardiovascular disease. Control of concomitant hypertension and dyslipidemia is poor, with less than 10% of patients achieving both goals.
Gemini was a 14-week, open-label, noncomparative, multicenter trial designed to evaluate the efficacy and safety of the atorvastatin/amlodipine fixed-dose combination pill as initial or add-on (integrated) therapy in the treatment of concomitant hypertension and dyslipidemia.
A total of 1220 adult patients were enrolled in Gemini, of whom almost 50% had diabetes or coronary heart disease. Their mean (+/- SD) systolic/diastolic blood pressure was 146.6 +/- 11.0/87.9 +/- 8.6 mm Hg and mean LDL-cholesterol 152.7 +/- 33.2 mg/dL. All patients received lifestyle modification counseling and were treated with 1 or more of 8 dosage strengths of the amlodipine/atorvastatin pill (5/10 mg, 10/10 mg, 5/20 mg, 10/20 mg, 5/40 mg, 10/40 mg, 5/80 mg, or 10/80 mg). (Titration of dosage level was optional and at the discretion of the investigator.) The combined amlodipine/atorvastatin treatment was either integrated into the patients' existing antihypertensive and lipid-lowering regimens or was initiated in patients not receiving either treatment.
The primary efficacy assessment of the study was based on the percentage of patients attaining both their blood pressure goals (as established by the sixth report of the Joint National Committee on Prevention, Detection, and Treatment of High Blood Pressure [JNC VI]) and LDL-cholesterol goals (as recommended by the National Cholesterol Education Program Adult Treatment Panel III) at endpoint.
Of the 1220 patients enrolled, 704 (57.7%) reached both their blood pressure and LDL-cholesterol therapeutic goals. The majority of patients without diabetes or coronary heart disease (76% to 77%) achieved both goals.
Fifty-eight patients (4.8%) discontinued this fixed-dose combination therapy due to adverse events. The most common adverse events were respiratory tract infection (11.9%), peripheral edema (8.8%), headache (5.4%), and myalgia (4.2%).
According to Roy Blank, MD, Gemini lead investigator, these results "provide important news for people who have both hypertension and high cholesterol, who generally have difficult achieving clinical management goals."
The dual amlodipine/atorvastatin therapy Caduet is indicated in patients for whom both amlodipine besylate and atorvastatin calcium is appropriate. The drug was submitted for marketing approval in Europe at the end of 2003.
References
Patients treated with a single pill combining 2 drugs -- one for treating hypertension and the other for treating dyslipidemia -- are more likely to reach their blood pressure and low-density lipoprotein (LDL)-cholesterol goals, according to results of a trial in patients with concomitant hypertension and dyslipidemia. The Gemini study is the first to be presented that describes results with the new combined medication, Caduet (Pfizer, New York, NY), which contains the calcium channel blocker amlodipine besylate and the HMG-CoA reductase inhibitor atorvastatin calcium. Caduet was approved for marketing by the US Food and Drug Administration in February 2004.
Hypertension and dyslipidemia are highly prevalent, and up to 50% of patients with one condition also have the other; this comorbidity confers a high risk of cardiovascular disease. Control of concomitant hypertension and dyslipidemia is poor, with less than 10% of patients achieving both goals.
Gemini was a 14-week, open-label, noncomparative, multicenter trial designed to evaluate the efficacy and safety of the atorvastatin/amlodipine fixed-dose combination pill as initial or add-on (integrated) therapy in the treatment of concomitant hypertension and dyslipidemia.
A total of 1220 adult patients were enrolled in Gemini, of whom almost 50% had diabetes or coronary heart disease. Their mean (+/- SD) systolic/diastolic blood pressure was 146.6 +/- 11.0/87.9 +/- 8.6 mm Hg and mean LDL-cholesterol 152.7 +/- 33.2 mg/dL. All patients received lifestyle modification counseling and were treated with 1 or more of 8 dosage strengths of the amlodipine/atorvastatin pill (5/10 mg, 10/10 mg, 5/20 mg, 10/20 mg, 5/40 mg, 10/40 mg, 5/80 mg, or 10/80 mg). (Titration of dosage level was optional and at the discretion of the investigator.) The combined amlodipine/atorvastatin treatment was either integrated into the patients' existing antihypertensive and lipid-lowering regimens or was initiated in patients not receiving either treatment.
The primary efficacy assessment of the study was based on the percentage of patients attaining both their blood pressure goals (as established by the sixth report of the Joint National Committee on Prevention, Detection, and Treatment of High Blood Pressure [JNC VI]) and LDL-cholesterol goals (as recommended by the National Cholesterol Education Program Adult Treatment Panel III) at endpoint.
Of the 1220 patients enrolled, 704 (57.7%) reached both their blood pressure and LDL-cholesterol therapeutic goals. The majority of patients without diabetes or coronary heart disease (76% to 77%) achieved both goals.
Fifty-eight patients (4.8%) discontinued this fixed-dose combination therapy due to adverse events. The most common adverse events were respiratory tract infection (11.9%), peripheral edema (8.8%), headache (5.4%), and myalgia (4.2%).
According to Roy Blank, MD, Gemini lead investigator, these results "provide important news for people who have both hypertension and high cholesterol, who generally have difficult achieving clinical management goals."
The dual amlodipine/atorvastatin therapy Caduet is indicated in patients for whom both amlodipine besylate and atorvastatin calcium is appropriate. The drug was submitted for marketing approval in Europe at the end of 2003.
References
Blank R, LaSalle J, Reeves R, et al. Amlodipine/Atorvastatin Single Pill Dual Therapy Improves Goal Attainment in the Treatment of Concomitant Hypertension and Dyslipidemia: The Gemini Study. Program and abstracts from the American College of Cardiology 53rd Annual Scientific Session; March 7-10, 2004; New Orleans, Louisiana. Abstract 1008-190.
Joint National Committee on Prevention, Detection, and Treatment of High Blood Pressure. The sixth report of the Joint National Committee on Prevention, Detection, and Treatment of High Blood Pressure (JNC VI). Arch Intern Med. 1997;157:2413-2446.
National Cholesterol Education Program. Third Report of the National Cholesterol Education Program (NCEP) on Detection, Evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). Bethesda, Maryland: National Heart, Lung, and Blood Institute, National Institutes of Health; 2001.