Integrium’s expertise in ambulatory blood pressure monitoring helps assess and demonstrate drug safety and efficacy
INTEGRIUM'S EXPERTISE IN AMBULATORY BLOOD PRESSURE MONITORING HELPS ASSESS AND DEMONSTRATE DRUG SAFETY AND EFFICACY
Tustin, Calif. — December 16, 2010 – A higher than usual blood pressure reading at the doctor’s office does not necessarily mean that a patient suffers from hypertension. While elevated blood pressure readings that occur only in the physician’s office – termed “white coat hypertension” – may be a sign of chronic high blood pressure, clinicians know that organ damage from high blood pressure arises from chronic high blood pressure, not just an occasional elevated reading.
As a result, ambulatory blood pressure readings are better predictors of clinical outcomes than casual blood pressure measurements. Ambulatory blood pressure monitoring (ABPM) is an automated technique in which multiple blood pressure measurements are obtained at regular intervals over a 24-hour period, providing a continuous blood pressure record during the course of a patient’s daily activities.
Because ABPM accurately and reliably measures changes in blood pressure, it accurately predicts cardiovascular drug efficacy as well drug safety. The average of multiple blood pressure readings correlates with the degree of target-organ damage from hypertension better than the average of a few readings obtained in a physician's office. As a result, ABPM is used to evaluate white coat hypertension and other blood pressure problems. ABPM is also a key component of new drug safety and efficacy studies.
Integrium’s Cardiovascular Core Laboratory Service pioneered the application of ABPM in drug development studies and advises pharmaceutical and biotechnology companies on how to apply ABPM and analyze the resulting data in clinical trials.
“By establishing ABPM as a key biomarker during safety or efficacy trials, we are better able to assess cardiovascular risk and safety,” said Integrium founder and ABPM expert Dr. David H.G. Smith, MD. “Thoughtful analysis of these data enables us to demonstrate the drug’s cardiovascular safety profile.”
Integrium believes that ABPM is a critical measure for cardiovascular drugs because it provides information about a drug’s duration of action. Integrium is also seeing ABPM increasingly used as a measure for other classes of drugs as well.
“Because hypertension affects nearly one third of American adults, it’s essential to ensure that drugs prescribed for other indications, such as anti-inflammatory agents and anti-diabetic drugs, don’t dangerously elevate blood pressure,” said Eileen McAuley, Chief Operating Officer of Integrium. “It is vitally important that treatment for one condition does not create or increase risk for cardiovascular disease.”
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About Integrium, LLC
Integrium is a therapeutically-focused, full-service contract research organization that specializes in dermatology, cardiovascular and metabolic clinical research. It has a strong reputation for delivering high-quality management of global clinical development programs and service to its clients. Combining the Integrium Clinical Excellence (ICE) study start-up and management methodology, and therapeutic expertise leads sponsors to more confident, better-informed drug and device development decisions. For more information please visit www.integrium.com.