Again, nothing directly relevant to Sibia, but it was an issue that old Ronnie grabbed and ran with, so, an update.......
Wednesday July 31, 12:27 pm Eastern Time
Press Release
SOURCE: Eisai Inc.; Pfizer Inc
In a Newly Published Study More Alzheimer's Disease Patients Were Able To Benefit From ARICEPT(R) (donepezil HCl tablets) Treatment Than Exelon(R) (rivastigmine tartrate)
One of Two Head-to-Head Studies Comparing ARICEPT(R) With Another Approved Alzheimer's Disease Treatment
NEW YORK, July 31 /PRNewswire/ -- Newly published results from the first head-to-head study between ARICEPT® (donepezil HCl tablets) and Exelon® (rivastigmine tartrate) demonstrated that ARICEPT® was better tolerated than Exelon® in patients with mild to moderate Alzheimer's disease (AD), allowing more patients on ARICEPT® to benefit from treatment. Almost twice as many patients were able to remain at the maximum effective daily dose of ARICEPT® (88 percent vs. 47 percent) due to a lower occurrence of treatment-related side effects. Furthermore, when surveyed, physicians and caregivers significantly favored ARICEPT® versus Exelon® with respect to satisfaction and ease of use. Findings from this study are published in the July issue of the peer-reviewed journal, International Journal of Clinical Practice.
"It is important to use effective medications that are well tolerated and easy to use, such as ARICEPT®, so that Alzheimer's patients can remain on therapy and sustain the maximum benefit possible over time," said study investigator David Wilkinson, MD, director of the Memory Assessment and Research Centre, Moorgreen Hospital, Southampton University, Southampton, England. "Publication of these data provides physicians with very practical clinical information regarding the tolerability and safety of two of the available AD treatments to help them prescribe the most appropriate therapy for their patients."
The multinational, randomized, head-to-head, open-label study was designed to compare the tolerability, safety, and ease of use of ARICEPT® to Exelon® in 111 patients with mild to moderate Alzheimer's disease. The secondary endpoint assessed cognition.
Key study findings:
Safety and Tolerability
Overall, ARICEPT® was better tolerated than Exelon® in patients with
mild to moderate AD. Nearly three times as many Exelon®-treated
patients discontinued treatment compared with ARICEPT® (31 percent vs.
11 percent; p = 0.009).
Almost three times as many patients in the Exelon®-treatment group discontinued treatment due to side effects judged to be treatment related compared with the ARICEPT®-treatment group (20 percent vs. 7 percent).
Almost twice as many patients were able to remain at the maximum effective daily dose of ARICEPT®, 10 mg once a day, than the maximum daily dose of Exelon®, 12 mg daily (6 mg twice a day) (88 percent vs. 47 percent), until the end of the study or the patient's final visit.
Almost four times as many patients in the Exelon®-treatment group reported nausea, and three times as many reported vomiting, compared with the ARICEPT®-treatment group (42 percent vs. 11 percent) and (24 percent vs. 7 percent), respectively.
Satisfaction/Ease of Use
* Physicians and caregivers favored ARICEPT(R) over Exelon(R) with respect
to satisfaction and ease of use.(A) While physicians had experience
with both drugs, caregivers were reflecting only on their satisfaction
with the treatment that the patient had been administered. Physicians
reported significantly better mean (+/- SE) total satisfaction/ease of
use with ARICEPT(R) (8.2 +/- 0.4, 8.5 +/- 0.4) than with Exelon(R)
(12.9 +/- 0.4, 11.5 +/- 0.5) at Weeks 4 (p<0.0001) and 12 (p<0.0001),
respectively. Similarly, caregivers of patients taking ARICEPT(R) also
reported better mean (+ SE) total scores (9.9 +/- 0.4, 10.9 +/- 0.5)
than caregivers of patients taking Exelon(R) (12.8+0.5, 12.4+0.6) at
Weeks 4 (p<0.0001) and 12 (p<0.05), respectively.
Cognition
* The two treatment groups had similar cognitive improvements from
baseline in Alzheimer's disease Assessment Scale-cognitive subscale
(ADAS-cog) scores throughout the 12-week treatment period. ADAS-cog is a
clinically validated measure of cognitive function.(3A) Testing was
administered by independent raters who were blinded to study medication
and side effects. Similar results were seen in the Mini-Mental State
Examination (MMSE), which was administered by clinicians who were not
blinded to study medication.
The ARICEPT® vs. Exelon® study is the second head-to-head study reported recently to compare the benefits of ARICEPT® treatment with another approved cholinesterase inhibitor. The other study, reported earlier this year at the 7th International Geneva/Springfield Symposium on Advances in Alzheimer Therapy (AAT) in Geneva, Switzerland, found that more ARICEPT®-treated patients were able to remain on the maximum effective daily dose of treatment compared to Reminyl® (galantamine HBr) tablets. This study also showed significantly greater improvements in cognition (at Week 12) and activities of daily living (at Week 12) as compared to Reminyl®.
ARICEPT® vs. Exelon® Study Details
The primary purpose of this 12-week, open-label, multinational (19 sites in the United Kingdom, South Africa and Switzerland) study was to directly compare the tolerability, safety, and ease of use of ARICEPT® to Exelon® in 111 patients with mild to moderate AD, using the recommended daily dosages in the same patient population. The study also evaluated cognition. Patients were randomized to receive ARICEPT® (n=56) or Exelon®(n=55). Patients were treated according to the recommended dosing on the approved product labeling (3,4) and dosing adjustments were allowed, based on clinician judgment.
Patients receiving ARICEPT® were given 5 mg once daily for 28 days, which was increased to 10 mg per day. Exelon®-treated patients received 1.5 mg twice daily, then their dosage was increased to 3 mg at day 14, 4.5 mg at day 28 and 6 mg at day 42 (all twice daily with food). Patients who could not tolerate higher dosages of either drug were allowed to continue in the study at the next lower tolerated effective dosage, and attempts were made to increase the dosage again at the next scheduled visit.
In this study, the most frequent treatment-emergent adverse events for ARICEPT® versus Exelon® included: nausea (10.7 percent vs. 41.8 percent); vomiting (7.1 percent vs. 23.6 percent); headache (7.1 percent vs. 18.2 percent); anorexia (1.8 percent vs. 9.1 percent); abnormal dreams (7.1 percent vs. 1.8 percent); back pain (7.1 percent vs. 0.0 percent); somnolence (1.8 percent vs. 5.5 percent); and urinary tract infection (5.4 percent vs. 0.0 percent). (B)
Second Head-to-Head Comparative Study - ARICEPT® vs. Reminyl® (galantamine HBr)
In a separate comparative, open-label 12-week study between ARICEPT® (n=64) and Reminyl® (n=56) (galantamine HBr), another cholinesterase inhibitor, results showed more patients were able to tolerate and remain on the maximum effective daily dose of ARICEPT® (10 mg once daily) than the maximum effective daily dose of Reminyl® (12 mg twice daily) until study end or final patient visit (92 percent vs. 71 percent). Furthermore, more gastrointestinal adverse events were observed in Reminyl®-treated patients than the ARICEPT® treatment group.
Additionally, the study demonstrated significantly greater improvements in cognition and activities of daily living (ADLs) in mild to moderate Alzheimer's disease (AD) patients treated with ARICEPT®, as measured by the modified(*)13-item Alzheimer's Disease Assessment Scale-cognitive subscale (modified ADAS-cog), the Mini-Mental State Examination (MMSE), and the Disability Assessment for Dementia (DAD) scale. Cognitive testing was administered by independent raters who were blinded to study medication and side effects. In this study, the most frequent treatment-emergent adverse events for ARICEPT® versus Reminyl® included: nausea (15.6 percent vs. 23.2 percent); vomiting (0 percent vs. 12.5 percent); anorexia (4.7 percent vs. 8.9 percent); diarrhea (9.4 percent vs. 14.3 percent); headache (6.3 percent vs. 5.4 percent); dizziness (1.6 percent vs. 5.4 percent); and urinary tract infection (3.1 percent vs. 7.1 percent).(**) The first-ever presentation of these data took place at the 7th International Geneva/Springfield Symposium on Advances in Alzheimer Therapy (AAT) in Geneva, Switzerland, in April 2002.
Information About ARICEPT® (donepezil hydrochloride tablets) Treatment
While there is no cure for Alzheimer's disease, medical treatments are available to manage symptoms of the disease. Once-a-day prescription ARICEPT®, indicated for mild to moderate Alzheimer's disease, can improve cognition and maintain patient function.
In a progressively degenerative disease such as Alzheimer's, improvement, stabilization or a less-than-expected decline over time is considered a positive response to treatment. These types of responses have been observed in patients treated with ARICEPT® in clinical trials. Individual responses to treatment may vary.
ARICEPT® is well tolerated but may not be for everyone. Some people may experience nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, or loss of appetite. In studies, these side effects were usually mild and temporary. Some people taking ARICEPT® may experience fainting. People at risk for ulcers should tell their doctors because their condition may get worse. ARICEPT® (donepezil hydrochloride tablets) is the number-one prescribed Alzheimer's medication worldwide with more than 717 million patient days of ARICEPT® therapy sold. More than 1.7 million people in the United States alone have begun ARICEPT® therapy.
It is estimated that 1 in 10 individuals older than age 65 has Alzheimer's disease. Approximately four million Americans are thought to have the disease; by the year 2050, it is estimated that nearly 14 million Americans will suffer from Alzheimer's.
For more information about managing Alzheimer's disease and about ARICEPT®, please call (888) 999-9616, or see aricept.com.
ARICEPT® is co-marketed in the United States by Eisai Inc. and Pfizer Inc, who are dedicated to advances in Alzheimer's therapy.
Full prescribing information attached and available at aricept.com. ARICEPT® is a registered trademark of Eisai Co., Ltd.
Exelon® is a registered trademark of Novartis AG. Reminyl® is a registered trademark of Janssen.
A The Physician's Satisfaction/Ease of Use Questionnaire consisted of six
questions (total score range 6 to 30) and the Caregiver's
Satisfaction/Ease of Use Questionnaire had eight questions (total score
range 8 to 40) with lower scores indicating greater satisfaction/ease
of use. Questions to physicians related to factors such as ease of
use, satisfaction with dosing frequency, titration schedule, frequency
of patient monitoring, etc. and were designed to address the relevant
issues facing physicians and their use of ChE inhibitor therapy.
B Treatment-emergent adverse events occurred in greater than or equal to
five percent of patients and at least twice as frequently in either
treatment group (all causalities).
* The modified version used in this trial added two additional items:
delayed recall and concentration/distractibility.
** Treatment-emergent adverse events (all causalities) occurred in
>5 percent of patients in either group or at least twice the rate of
the comparator group.
SOURCE: Eisai Inc.; Pfizer Inc
(One doesn't need to find a CURE, or even necessarily a MEDICINE, to profit from selling a molecule.) |
