Data from the trial also showed that ALTACE 20mg monotherapy once daily provide significant reductions in mean 24-hour SBP and DBP of 11.4 mmHg and 6.2 mmHg, respectively. Importantly, as compared to office measurements, statistically significant greater reductions in mean 24-hour blood pressure, as measured by ambulatory blood pressure monitoring, were obtained with the combination therapy. Ambulatory blood pressure measurements have been shown to correlate better than office measurements for predicting adverse effects on end organs such as the kidney, heart, or brain. The safety profile of the combination was consistent with current labeling for the individual monotherapy drugs as approved by the U.S. Food and Drug Administration (FDA).
"As described in the current JNC-7 hypertension treatment guidelines, if SBP is 20 mmHg or DBP is 10 mmHg above a patient's goal, consideration should be given to initiating therapy w ith two antihypertensive drugs, one of which is usually a thiazide diuretic. In the study, combining ALTACE 20mg with HCT 25mg was significantly better than monotherapy in achieving blood pressure control. Our results also show that the maximum approved dose of 20mg a day of ALTACE was well tolerated and showed significant reductions in systolic and diastolic blood pressure," said Dr. William B. White, Professor and Chief of Hypertension and Clinical Pharmacology at the University of Connecticut Health Center, and the study's lead investigator. "These data provide evidence that ALTACE 20mg monotherapy and the combination of ALTACE 20mg with HCT 25mg provide meaningful clinical blood pressure reductions and 24-hour control."
"We're excited about the results of the study," said Dr. Eric Carter, Chief Science Officer of King. "These data demonstrate the efficacy and tolerability benefits of 20mg of ALTACE, the maximum approved dose, and the benefits of 20mg of ALTACE combined with HCT 25mg for patients who require an antihypertensive agent as well as a diuretic. We plan to submit these data as part of a New Drug Application to the FDA later this year, a major milestone for King Pharmaceuticals."
About the Clinical Trial
The primary endpoint of the trial was designed to demonstrate that the reduction in DBP in patients taking the combination of ALTACE 20mg and HCT 25mg once daily is statistically superior to that achieved in patients taking either monotherapy alone. The trial met the primary endpoint in that DBP reduction is statistically superior (p less than 0.001) with the combination compared to either monotherapy. The DBP was reduced by 15.5 mmHg with the combination compared to 8.5 mmHg with HCT 25mg and 9.2 mmHg with ALTACE 20mg.
A secondary endpoint of the trial was designed to demonstrate that the reduction in SBP in patients taking the combination of ALTACE 20mg and HCT 25mg once daily is statistically superior to that achieved in p atients taking either monotherapy alone. The trial met the secondary endpoint in that SBP reduction is statistically superior with the combination compared to either monotherapy. The SBP was reduced by 18.6 mmHg with the combination compared to 11.5 mmHg with HCT 25mg (p less than 0.001) and 10.4 mmHg with ALTACE 20mg (p=0.002).
The clinical trial was a randomized, double-blind, double-dummy, parallel-arm, multicenter study evaluating the effects of combining ALTACE 20mg and HCT 25mg once a day versus the monotherapy comparator arms of the component drugs. Patients were treated for eight weeks. A total of 341 patients comprised the intention-to-treat efficacy population. Blood pressure was measured using both a semi-automatic digital blood pressure device and 24-hour ambulatory blood pressure monitor.
A copy of the poster detailing the results of the trial and presented at ASH 2007 is available on King's website at: http://www.kingpharm.com/ashposter.asp.
ALTACE is the leading branded ACE inhibitor with multiple indications. ALTACE is indicated for the treatment of hypertension. ALTACE has also been shown to reduce the risk of death in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Based upon the results of the landmark HOPE trial, ALTACE 10mg is also indicated in patients age 55 or over at high risk of developing a major CV event either because of a history of coronary artery disease, stroke or peripheral vascular disease or because of diabetes that is accompanied by at least one other CV risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of stroke, myocardial infarction, or death from CV causes. ALTACE can be used in addition to other needed treatments (such as antihypertensive, antiplatelet or lipid-lowering therapies).
ALTACE should not be taken during pregnancy, as death or injury to an unborn child may result, or if serious side effects related to previous ACE inhibitors have occurred. Prescription ALTACE is not for everyone. ALTACE may cause swelling of the mouth, tongue, or throat, which could cause extremely serious risk and requires immediate medical care. ALTACE may lower blood sugar if taken for diabetes. A physician should be contacted if one experiences symptoms of low blood sugar such as sweating or shakiness. Common side effects include persistent dry cough, dizziness, and light-headedness due to low blood pressure.
For a copy of the ALTACE prescribing information, please visit http://www.altace.com/.
Hydrochlorothiazide is a thiazide diuretic used in the management of hypertension either alone or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. It is contraindicated in patients with hypersensitivity to hydrochlorothiazide or other sulfonamide-derived drugs. It should be used with caution in patients with renal disease, impaired hepatic function or progressive liver disease, diabetes, gout or lupus erythematosus. Common side effects include dizziness, light-headedness, low blood pressure, dehydration and stomach irritation.
About King Pharmaceuticals
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management.
This release contains forward-looking statements which reflect managem ent's current views of future events and operations, including, but not limited to, statements pertaining to the Company's plan to file a New Drug Application this year with respect to the combination. These forward-looking statements involve certain significant risks and uncertainties, and actual results may differ materially from the forward-looking statements. Some important factors which may cause actual results to differ materially from the forward-looking statements include dependence on King's ability to file the New Drug Application as planned; and dependence on the final outcome of the Company's review of the data. Other important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the "Risk Factors" section and other sections of King's Form 10-K for the year ended December 31, 2006 and Form 10-Q for the quarter ended March 31, 2007, which are on file with the U.S. Securities and Exchange Commission. King does not undertake to publicly update or revise any of its forward-looking statements even if experience or future changes show that the indicated results or events will not be realized.
David E. Robinson, 423-989-7045
Senior Director, Corporate Affairs
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