-
A multicenter, randomized, double-blind, double-dummy, blind-endpoint crossover study (n=41) compared InnoPran XL® and non-chronotherapeutic propranolol ER
– Similar improvements in mean 24-hour BP (systolic and diastolic) were observed in both groups*10
BP and HR Reductions From 6:00 AM to Noon: InnoPran XL® vs propranolol ER in Beta-Blocker–Sensitive Patients10
Results shown are from beta-blocker–sensitive patients (n=11). Beta-blocker–sensitive patients were defined as the 25% of patients with the greatest reduction in diastolic BP between 6:00 AM and noon. In this study, patients received equivalent 120-mg doses of each study medication.10
*Systolic/diastolic BP changes were -9.0/-6.9 mm Hg InnoPran XL® and -10.4/-7.7 mm Hg propranolol ER. P=not significant.
†Double product=systolic BP x HR. Double product is a key measure of cardiac workload.
††Difference in diastolic blood pressure InnoPran XL vs propranolol ER was significant (P<.04).
Reference:
10. Neutel JM, Rotenberg K. Comparison of a chronotherapeutically administered beta-blocker vs. a traditionally administered beta-blocker in patients with hypertension. J Clin Hypertens (Greenwich). 2005;7(7):395-400
InnoPran XL® provided a 50% improvement in double-product relative to propranolol ER10
For patients with hypertension, rapid surges in morning blood pressure can cause problems. Morning surges in blood pressure have been associated with increased incidence of heart attack, stroke and other cardiovascular events. For this reason, the early morning hours are sometimes referred to as the Morning Risk Zone, a period of time when your patients may be at greater risk.
Elevation of Stroke and MI Upon Awakening2
[Adapted from Elliott 2001]

References:
1. Muller JE. Circadian variation and triggering of acute coronary events. Am Heart J. 1999;137:S1-S8.
2. Elliott WJ. Cyclic and circadian variations in cardiovascular events. Am J Hypertens. 2001;14:291S-295S.
Compared to non-chronotherapeutic propranolol (propranolol extended release [ER]), the release profile of InnoPran XL® provides full 24-hour control with peak blood levels during the AM hours6,10
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Lower serum levels in the PM hours may have less effect on HR during waking hours
Propranolol Blood Concentrations During the Morning Risk Zone
(InnoPran XL® vs Non-chronotherapeutic Propranolol ER)10
References:
6. InnoPran XL® (propranolol hydrochloride) [package insert]. Baudette, MN: ANI Pharmaceuticals, Inc.; 2017.
10. Neutel JM, Rotenberg K. Comparison of a chronotherapeutically administered beta-blocker vs. a traditionally administered beta-blocker in patients with hypertension. J Clin Hypertens (Greenwich). 2005;7(7):395-400
Data from a double-blind crossover study comparing InnoPran XL administered at 10:00 pm vs propranolol ER administered at 8:00 am (N=41)10
InnoPran XL® is a circadian-aligned formulation of propranolol. Its ability to deliver antihypertensive effects in the morning lies in its proprietary drug release technology. InnoPran XL® is formulated to take on dangerous morning surges in blood pressure and to control blood pressure for a full 24 hours.
Timed-Release Design Targets the Morning Risk Zone7a

Reference:
7a. Neutel JM, Rotenberg K. Comparison of a chronotherapeutically administered β blocker vs. a traditionally administered β blocker in patients with hypertension. J Clin Hypertens (Greenwich). 2005;7:395-400.
Adverse reactions occurring in ≥3% of subjects and at greater incidence than placebo during double-blind treatment with InnoPran XL® and plausibly related to treatment.
Most Common Adverse Reactions in Pivotal Study

In the pivotal clinical trial for InnoPran XL®, doses above 120 mg had no additional effect on BP.
*Dizziness excludes vertigo.
Please see additional safety information in Important Safety Information and Full Prescribing Information.
Healthcare Providers who have questions about InnoPran XL® may request clinical information at 1-800-308-6755 or drugsafety@anipharmaceuticals.com.
To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or drugsafety@anipharmaceuticals.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
For materials or more information, please visit www.anipharmaceuticals.com
In Hypertension, InnoPran XL® is Designed to… Take on the Surge1,2
Blood pressure and heart rate surge in the morning hours (6 am – 12 pm). Clinical studies have demonstrated an increase in the risk of MI and stroke during this same time period, known as the Morning Risk Zone. InnoPran XL® is a circadian-aligned beta-blocker therapy that helps to reduce the risk of cardiovascular events such as MI and stroke during the Morning Risk Zone. Learn here how one bedtime dose of InnoPran XL® can help your patients Take on the Surge and manage their hypertension for a full 24 hours.
References:
1. Muller JE. Circadian variation and triggering of acute coronary events. Am Heart J. 1999;137(4 pt 2):S1-S8.
2. Elliot WJ. Cyclic and circadian variations in cardiovascular events. Am J Hypertens. 2001;14(9 pt 2):291S-295S.