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"These results suggest that the combination of the angiotensin-convertingenzyme inhibitor (ACEI) and calcium channel blocker in Lotrel yielded betterpatient outcomes in high-risk hypertensive patients than the ACEI and HCTZcombination," explained Kenneth Jamerson, MD, professor of internal medicineat the University of Michigan Medical Center in Ann Arbor and leadinvestigator of the trial. "Further, a strategy of starting patients in thetrial on a single-pill combination proved to be very efficient insignificantly increasing blood pressure control rates."
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Lotrel is approved for the treatment of high blood pressure. It should notbe used before other medications have been tried first.
Treatment with combination therapy resulted in exceptional blood pressurecontrol at 30 months. Before entering the study, almost all patients weretreated with multiple high blood pressure medicines. At study entry, only 37%of the study population had a blood pressure of <140/90 mmHg, regarded intreatment guidelines as the appropriate goal for most patients. Afterswitching to a single-pill combination of the study medications, 82% ofpatients taking Lotrel and 79% of patients taking the benazepril and HCTZcombination achieved blood pressure goal after 30 months. Some patientsreceived additional medication to treat their high blood pressure.
"Evidence from trials like ACCOMPLISH provides physicians with additionalinformation to better inform their treatment decisions in high-riskhypertensive patients," said Marjorie Gatlin, MD, Vice President and Head ofCardiovascular and Metabolism Medical Franchise US Medical and Drug RegulatoryAffairs at Novartis Pharmaceuticals Corporation. "Novartis is an innovator ofunique medications for the treatment of high blood pressure, including single-pill combinations, and is committed to further develop this approach foreffective patient care."
The results were presented today in a late-breaking session at theAmerican College of Cardiology 57th Annual Scientific Session in Chicago.
ACCOMPLISH is the first large clinical outcomes trial to directly comparetwo single-pill combinations of commonly used high blood pressure medicines inthe reduction of a composite endpoint including heart attacks, strokes,hospitalizations for unstable angina and cardiovascular deaths in high bloodpressure patients at high cardiovascular risk. In October 2007, the study wasstopped early because the pre-defined efficacy outcome had been achieved.
The study was a multi-national, double-blind trial and included more than11,000 patients at 550 study sites in the US and Scandinavia. One day afterstopping their current high blood pressure medication, patients received asingle-pill combination of either Lotrel or a combination of benazepril andHCTZ. In the first two months of the study, doses of study medications wereincreased. Patients in the Lotrel arm started on 5/20 mg. The dose wasincreased to Lotrel 5/40 mg and, for patients not at goal blood pressure, thento 10/40 mg. Patients taking benazepril and HCTZ started at 20/12.5 mg andwere increased to 40/12.5 mg and, for patients not at goal blood pressure, to40/25 mg. The combination doses of benazepril and HCTZ 40/12.5 mg and 40/25 mgused in this study were investigational. In both
