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The combination therapy of hypertension to prevent cardiovascular events (COPE) trial: rationale and design
Toshio Ogihara1, Masunori Matsuzaki, Hiroaki Matsuoka
1Department of Geriatric Medicine, Osaka University Graduate School of Medicine, Osaka, Japan. ogihara@geriat.med.osaka-u.ac.jp
Insights
The Combination Therapy of Hypertension to Prevent Cardiovascular Events (COPE) trial compares antihypertensive drug combinations in Japanese patients. It aims to find the best combination for preventing cardiovascular events and controlling blood pressure with minimal side effects.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Lowering blood pressure is clinically beneficial, but most hypertension patients need multiple drugs for optimal control.
- Limited data exists on which antihypertensive combinations best prevent cardiovascular events and minimize adverse effects.
Purpose of the Study:
- To directly compare cardiovascular mortality and morbidity of different antihypertensive drug combinations.
- To evaluate the incidence of adverse drug reactions and the degree of blood pressure reduction.
- To provide evidence for selecting optimal combination therapies for hypertensive patients.
Main Methods:
- The Combination Therapy of Hypertension to Prevent Cardiovascular Events (COPE) trial is a large-scale, investigator-initiated, multicenter study.
- It employs a prospective, randomized, open, blinded endpoint evaluation (PROBE) design.
- Compares angiotensin receptor blockers, beta-blockers, or thiazide diuretics combined with benidipine hydrochloride in 3,000 Japanese hypertensive patients over 3 years.
Main Results:
- Enrollment of 3,000 Japanese hypertensive patients from May 2003 to May 2006.
- Follow-up duration of 3 years for each patient.
- Data collection on cardiovascular events, adverse drug reactions, and blood pressure reduction.
Conclusions:
- Results from the COPE trial are expected to offer new insights into effective hypertension management.
- The study will guide the selection of optimal antihypertensive drug combinations for improved patient outcomes.
Abstract:
A number of major clinical trials have demonstrated the clinical benefits of lowering blood pressure and have indicated that a majority of patients with hypertension will require more than one drug to achieve optimal blood pressure control. However, there is little data showing which antihypertensive combination best protects patients from cardiovascular events and which best achieves the target blood pressure with the fewest adverse events. The Combination Therapy of Hypertension to Prevent Cardiovascular Events (COPE) trial is the first large-scale investigator-initiated multicenter study with a prospective, randomized, open, blinded endpoint evaluation (PROBE) design to directly compare cardiovascular mortality and morbidity, incidence of adverse drug reaction, and degree of blood pressure reduction in Japanese hypertensive patients for a combination of angiotensin receptor blockers, beta-blockers or thiazide diuretics in addition to a calcium antagonist, benidipine hydrochloride, with a response-dependent dose titration scheme. The COPE trial is being conducted with the cooperation of more than 100 centers and clinics in Japan and involves 3,000 patients, who will be followed for 3 years. Eligible patients are being enrolled from May 2003 until May 2006. Results from the COPE trial should provide new evidence for selecting optimal combination therapies for hypertensive patients.
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