Healthcare Industry News: Boniva
News Release - September 19, 2006
Higher Persistency Rates Seen with FOSAMAX(R) Once Weekly Therapies Compared to Other Weekly and Monthly Oral Bisphosphonates, According to Two New Outcomes StudiesPHILADELPHIA--(HSMN NewsFeed)--Sept. 19, 2006--Higher persistency rates were seen among osteoporosis patients taking FOSAMAX® Once Weekly (alendronate) therapies than were seen among patients taking ibandronate once monthly or once weekly risedronate therapies, according to results from two new outcomes studies conducted by Merck & Co., Inc. that compared persistency rates of weekly versus monthly oral bisphosophate dosing frequency. Both studies were based on a review of two prescription drug databases containing prescription records from a total of over 300,000 patients in the U.S. These data were presented yesterday at the 28th Annual Meeting of the American Society for Bone Mineral Research (ASBMR).
"The results from both studies are noteworthy because they suggest that persistency rates are not higher with monthly dosing of oral bisphosphonates versus weekly dosing," said Thomas W. Weiss, Dr PH, senior manager, Outcomes Research, Merck & Co., Inc. and lead study author. "Another recent study showed patients placed a higher importance on a drug's proven ability to reduce the risk of bones breaking versus other attributes of osteoporosis therapy - including dosing frequency." (Current Medical Research and Opinion, May, 2006).
Monthly versus weekly persistency study
This first study evaluated whether monthly dosing of oral bisphosphonates improved treatment persistency compared to weekly dosing.
The study included 272,232 women aged 50 or older who had filled a new (index) prescription for weekly alendronate or alendronate/cholecalciferol (n=157,692), weekly risedronate or risedronate with calcium (Actonel or Actonel with Calcium; n=98,496), or monthly ibandronate (Boniva; n=16,044) from April 2005 to July 2005 and who had no prescriptions for the newly prescribed bisphosphonate during the 12 months prior to the date of their initial prescription fill. All patients were followed for 365 days after the date of the initial prescription fill (the follow-up period).
- At 91-120 days, persistency rates were 50.0 percent (alendronate or alendronate/cholecalciferol), 47.4 percent (risedronate or risedronate with calcium) and 42.1 percent (ibandronate)
- At 181-210 days, persistency rates were 36.0 percent (alendronate or alendronate/cholecalciferol), 33.8 percent (risedronate or risedronate with calcium ) and 29.5 percent (ibandronate)
- At 271-300 days, persistency rates were 26.7 percent (alendronate or alendronate/cholecalciferol), 24.8 percent (risedronate or risedronate with calcium) and 21.7 percent (ibandronate)
- At greater than 360 days, persistency rates were 18.9 percent (alendronate or alendronate/cholecalciferol), 17.4 percent (risedronate or risedronate with calcium) and 15.6 percent (ibandronate)
In this study, persistency rate was defined as the percent of patients who refilled their prescription within a 60-day period following the last supply day of the previous dispensing.
Second persistency study
This study included 44,635 women over the age of 50 who had a bisphosphonate prescription (index) filled between December 30, 2004 and May 31, 2005 and who had no prescriptions for the newly prescribed bisphosphonate during the 12 months prior to the date of their initial prescription fill. Data for these patients were reviewed for at least five months, from their initial fill date to November 2, 2005 (the follow-up period), and evaluated to see if they stayed on treatment.
Results showed that patients on Fosamax Once-Weekly had higher persistency rates (35.1 percent; n=8,837) than those patients on Boniva Once-Monthly (30.4 percent; n=225) or Actonel Once-Weekly (32.5 percent; n=6,066) during the follow up period.
In this study, the persistency rate was defined as the percent of patients who refilled their prescription within a 45-day period following the last supply day of the previous dispensing and who did not change to another therapy during the follow-up period.
FOSAMAX is the only bisphosphonate that is indicated to significantly reduce the risk of both osteoporotic hip and spine fractures. The sustained efficacy of FOSAMAX for the treatment of osteoporosis in postmenopausal women was demonstrated in a trial that found in over 10 years of therapy FOSAMAX 10 mg once daily maintained or continued to help build bone.
Osteoporosis can lead to bone loss and an increased risk of fractures. Osteoporosis is especially common in women after menopause, but also occurs in men. Most often, it is due to an increase in the rate of resorption (breakdown) of bone tissue that is not matched by the rate of bone formation.
Important information about FOSAMAX and FOSAMAX PLUS D(TM) (alendronate/cholecalciferol)
Patients should talk to their doctor if they have or have had problems with swallowing. In addition, patients should talk to their doctor if they have conditions which may cause an overproduction of vitamin D (e.g., sarcoidosis, leukemia, lymphoma). Patients should tell their doctor about all medicines they are taking, including prescription and non-prescription medicines, vitamins and herbal supplements.
Some patients may develop severe digestive reactions including irritation, inflammation or ulceration of the esophagus. The risk of severe esophageal experiences appears to be greater in patients who fail to follow dosing instructions (see prescribing information for more details). Patients who experience new or worsening heartburn, difficulty or pain when swallowing or chest pain should stop taking the drug and call their doctor right away. Patients who develop severe bone, joint and/or muscle pain at any time should contact their doctor. The most commonly reported side effects with FOSAMAX in clinical studies have been abdominal pain (3.7 percent), musculoskeletal pain (2.9 percent), indigestion (2.7 percent), regurgitation (1.9 percent) and nausea (1.9 percent).
The standard dosing regimen for FOSAMAX and FOSAMAX PLUS D(TM) includes swallowing the tablet with six to eight ounces of plain water the first thing upon arising for the day and at least 30 minutes before the first food, beverage or medication of the day. After swallowing FOSAMAX or FOSAMAX PLUS D, patients should not lie down for at least 30 minutes and not until after consuming their first food of the day. Patients should not chew or suck on a tablet of FOSAMAX or FOSAMAX PLUS D.
Merck & Co., Inc., is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.
FOSAMAX® is a registered trademark of Merck & Co., Inc. FOSAMAX PLUS D(TM) is a trademark of Merck & Co., Inc. All other brands are trademarks of their respective owners and are not trademarks of Merck & Co., Inc.
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