Alendronate better than risedronate, same UGI safety
Alendronate better than risedronate, same UGI safety
Oct 21, 2004
San Antonio, TX - In women with postmenopausal osteoporosis, once-weekly alendronate (Fosamax, Merck) showed superior antiresorptive efficacy compared with risedronate (Actonel, Procter & Gamble Pharmaceuticals), according a 12-month head-to-head trial. These results—originally released last month at the 27th annual meeting of the American Society for Bone and Mineral Research [ 1 ]—were presented with more details in a poster session at the American College of Rheumatology 2004 meeting [ 2 ]. This study emphasized the similarity of the two drugs on upper gastrointestinal (UGI) safety and tolerability.
This is the first head-to-head trial comparing the administration once a week of these bisphosphonates.
The randomized, double-blind, active-comparator trial involved 1053 postmenopausal women with low bone mass (T-score <-2 at hip trochanter, total hip, femoral neck, or spine). The patients were randomized to receive alendronate (70 mg once weekly [OW]) plus risedronate placebo or risedronate (35 mg OW) plus alendronate placebo. Both treatments were taken fasting on arising and patients were asked to remain fasting for at least 30 minutes. Daily elemental calcium (1000 mg) and vitamin D (400 IU) were prescribed. The efficacy end points included the mean percentage change from baseline to 12 months in BMD and changes in markers of bone turnover (urine NTx, serum CTx, BSAP, and P1NP).
"Looking at both gains in BMD and reductions in biochemical markers of bone turnover, alendronate showed significant advantages compared with risedronate," investigator Dr Richard A Petruschke (Merck & Co) told rheumawire . "If you look at BMD, it was significant as early as 6 months," he added.
Click on the images to see a larger version.
No difference in UGI adverse events
"We focused on the interest of rheumatologists, which is the UGI safety," main author Dr Marc Hochberg (University of Maryland, Baltimore, MD) commented to rheumawire .
UGI tolerability was evaluated through reported adverse events (AE). There were no specific GI exclusions other than those stated as contraindications in the respective product labels, according the authors.
"We really focused on the analysis of this [UGI issue] in this presentation because of the potential of local irritation of the medication on the UGI," Petruschke told rheumawire . "Between the 2 [medications] there were no significant differences in the overall study, and we looked at patients with a history of UGI AEs," he added.
UGI adverse events among patients with prior or recent history of UGI disorders
OW=once weekly
There was no difference between alendronate and risedronate regarding the other kind of side effects (musculoskeletal pain, etc), said Hochberg.
The study - supported by Merck & Co. -- received a 2-year extension, and longer-term data are expected to be released soon.
Oct 21, 2004
San Antonio, TX - In women with postmenopausal osteoporosis, once-weekly alendronate (Fosamax, Merck) showed superior antiresorptive efficacy compared with risedronate (Actonel, Procter & Gamble Pharmaceuticals), according a 12-month head-to-head trial. These results—originally released last month at the 27th annual meeting of the American Society for Bone and Mineral Research [ 1 ]—were presented with more details in a poster session at the American College of Rheumatology 2004 meeting [ 2 ]. This study emphasized the similarity of the two drugs on upper gastrointestinal (UGI) safety and tolerability.
This is the first head-to-head trial comparing the administration once a week of these bisphosphonates.
The randomized, double-blind, active-comparator trial involved 1053 postmenopausal women with low bone mass (T-score <-2 at hip trochanter, total hip, femoral neck, or spine). The patients were randomized to receive alendronate (70 mg once weekly [OW]) plus risedronate placebo or risedronate (35 mg OW) plus alendronate placebo. Both treatments were taken fasting on arising and patients were asked to remain fasting for at least 30 minutes. Daily elemental calcium (1000 mg) and vitamin D (400 IU) were prescribed. The efficacy end points included the mean percentage change from baseline to 12 months in BMD and changes in markers of bone turnover (urine NTx, serum CTx, BSAP, and P1NP).
"Looking at both gains in BMD and reductions in biochemical markers of bone turnover, alendronate showed significant advantages compared with risedronate," investigator Dr Richard A Petruschke (Merck & Co) told rheumawire . "If you look at BMD, it was significant as early as 6 months," he added.
Click on the images to see a larger version.
No difference in UGI adverse events
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Dr Marc Hochberg |
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"We focused on the interest of rheumatologists, which is the UGI safety," main author Dr Marc Hochberg (University of Maryland, Baltimore, MD) commented to rheumawire .
UGI tolerability was evaluated through reported adverse events (AE). There were no specific GI exclusions other than those stated as contraindications in the respective product labels, according the authors.
"We really focused on the analysis of this [UGI issue] in this presentation because of the potential of local irritation of the medication on the UGI," Petruschke told rheumawire . "Between the 2 [medications] there were no significant differences in the overall study, and we looked at patients with a history of UGI AEs," he added.
UGI adverse events among patients with prior or recent history of UGI disorders
|
OW=once weekly
There was no difference between alendronate and risedronate regarding the other kind of side effects (musculoskeletal pain, etc), said Hochberg.
The study - supported by Merck & Co. -- received a 2-year extension, and longer-term data are expected to be released soon.
