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Results of a study in patients with baseline systolic blood pressuregreater than or equal to 160 mmHg published in The Journal of the AmericanSociety of Hypertension, showed that 51.8% of patients on Exforge achievedsystolic blood pressure control, defined as <140 mmHg at week four, comparedto 27.7% of those on amlodipine alone. Systolic blood pressure, measured whenthe heart contracts and pumps, is an important indicator of a person's risk ofcardiovascular events.
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The primary endpoint of the study was the change from baseline MeanSitting Systolic Blood Pressure (MSSBP) at week four. Results showed that onaverage, patients on Exforge experienced a significant 30.1 mmHg reduction insystolic blood pressure compared to a 23.5 mmHg reduction in patients onamlodipine alone.
In the same study, patients with systolic blood pressure greater than orequal to 180 mmHg treated with Exforge experienced significant systolic bloodpressure reductions of up to 40.1 mmHg, compared with 31.7 mmHg for thosetreated with amlodipine alone. High blood pressure is estimated to affect onein three adults in the US -- approximately 73 million adults.
"All patients who received Exforge achieved significant blood pressuredrops, with the bigger blood pressure drops of up to 40 mmHg being seen inthose patients with a higher baseline level," said Maurizio Destro, MD, thelead investigator from the Azienda Ospedaliera di Pavia in Italy. "Inaddition, Exforge was well tolerated which is important for patients inmanaging their blood pressure."
Treatment guidelines recommend that patients with high blood pressuregreater than or equal to 160/100 mmHg should be considered for a combinationof two medicines from different drug classes.
Exforge also demonstrated significantly better blood pressure-loweringefficacy than amlodipine alone across certain difficult-to-treat patientgroups, including the elderly (over 65 years), obese people and those withdiabetes.
"Exforge has shown significant benefit in difficult-to-treat patients withhigh blood pressure," said Marjorie Gatlin, MD, Vice President and Head ofCardiovascular and Metabolism Medical Franchise, US Medical and DrugRegulatory Affairs at Novartis Pharmaceuticals Corporation. "This is importantas high blood pressure remains a highly prevalent condition and underlyingcause of cardiovascular disease."
The study was designed to investigate and compare the efficacy and safetyof Exforge with amlodipine in patients with stage 2 high blood pressure (amore severe stage of the disease, with systolic blood pressure between 160 and200 mmHg). It was a randomized, double-blind, multi-center parallel-groupstudy carried out in 75 centers across Europe and the US. In total, 646patients were randomized to receive treatment with Exforge 5-10/160 mg (n=322)or amlodipine 5-10 mg (n=324). Demographic and high blood pressure baselinecharacteristics were similar for both groups.
Overall blood pressure measurements consist of two values, both expressedin millimeters of mercury (mmHg). The first is the systolic blood pressurewhen the heart beats and the second is the diastolic pressure when the heartrelaxes between beats. In this study, overall blood pressure control rates(<140/90 mmHg) were higher at all assessment points for patients treated withExforge than for those receiving amlodipine alone. In this study bothmedications were well tolerated.
Novartis is focused on improving the lives of the hundreds of millions ofpeople with cardiovascular and metabolic diseases. As a
