Expert opinion on drug safety · 2013
Safety concerns with the long-term management of osteoporosis.
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Reginster Jean-Yves, Pelousse Franz, Bruyère Olivier
Аннотация
INTRODUCTION: Postmenopausal osteoporosis is a chronic disease that exerts a significant burden on both individuals and the community. Hence, there is a requirement for long-term treatment to be associated with a positive benefit-risk balance.
AREAS COVERED: In this descriptive review, the long-term safety of calcitonin, selective estrogen receptor modulators (SERMs), bisphosphonates, denosumab and strontium ranelate was reviewed based on randomized controlled trials of 3 years or longer supplemented by extension study data and data from large, observational studies.
EXPERT OPINION: Rare adverse events become apparent with all currently available treatments for osteoporosis with long-term therapy. Due to the rarity of these adverse events and to the worldwide burden of osteoporosis, the benefit-risk balance remains in favor of the beneficial effects of treatment on an outcome rather than the probability of an adverse effect. No single antiosteoporosis agent is appropriate for all patients. Treatment decisions should be made on an individual basis, taking into account the relative benefits and risks in different patient populations.
AREAS COVERED: In this descriptive review, the long-term safety of calcitonin, selective estrogen receptor modulators (SERMs), bisphosphonates, denosumab and strontium ranelate was reviewed based on randomized controlled trials of 3 years or longer supplemented by extension study data and data from large, observational studies.
EXPERT OPINION: Rare adverse events become apparent with all currently available treatments for osteoporosis with long-term therapy. Due to the rarity of these adverse events and to the worldwide burden of osteoporosis, the benefit-risk balance remains in favor of the beneficial effects of treatment on an outcome rather than the probability of an adverse effect. No single antiosteoporosis agent is appropriate for all patients. Treatment decisions should be made on an individual basis, taking into account the relative benefits and risks in different patient populations.