ST LOUIS (MD Consult) - On June 1, 2009, Novartis announced that the US Food and Drug Administration (FDA) has approved Reclast for the prevention of osteoporosis in postmenopausal women. One single-dose infusion of the drug is intended to serve as osteoporosis preventive therapy for a period of 2 years. Reclast is already approved as a once-yearly infusion to treat postmenopausal osteoporosis, to increase bone mass in men with osteoporosis, and to treat and prevent osteoporosis caused by glucocorticoid therapy. The drug is also approved for the treatment of Paget's disease of bone.

This newly approved indication for Reclast was granted on the basis of results from a 2-year, randomized, multicenter study that included 581 postmenopausal women aged ≥45 years with osteopenia. Study participants were either experiencing early menopause (ie, within 5 years of menopause) or late menopause (ie, more than 5 years from menopause). At the end of the study, patients assigned to Reclast experienced significantly increased lumbar spine bone mineral density (BMD) scores compared with patients assigned to placebo. At 2 years after a single-dose infusion, treatment with Reclast was associated with a 6.3% increase in lumbar spine BMD in the early menopause group and a 5.4% increase in lumbar spine BMD in the late menopause group (both P < .0001).

The most common adverse events associated with Reclast are transient post-dose symptoms such as fever and muscle pain. Most of these symptoms occur within the first 3 days after drug administration and resolve within 3 days. The incidence of such post-dose symptoms can be reduced with the administration of paracetamol or ibuprofen shortly after a Reclast infusion.

圣路易斯(MD Consult)——2009年6月1日，诺华公司宣布，美国食品药品管理局(FDA)已批准Reclast用于预防绝经后骨质疏松症。此药单次单剂输注可作为两年内骨质疏松症的预防性治疗。 Reclast每年单次输注已获准用于治疗女性绝经后骨质疏松症，增加骨质疏松症男性患者的骨量，以及预防和治疗糖皮质激素疗法导致的骨质疏松症。此外，该药还获准用于治疗变形性骨病(Paget's disease of bone)。

FDA新近对Reclast该适应证的批准是依据一项为期2年、随机、多中心研究的结果，该研究纳入了581例年龄≥ 45岁、伴有骨量减少的绝经后女性，这些受试者处于绝经早期(即绝经5年以内)或绝经晚期(即绝经5年以上)。研究结束时，与安慰剂组相比， Reclast治疗组患者的腰椎骨矿密度(BMD)评分显著增加。单剂输注Reclast两年后，绝经早期组腰椎BMD增加6.3%，绝经晚期组腰椎BMD增加5.4%(两组P值均<0.0001)。

Reclast最常见的不良事件为发热和肌肉疼痛等一过性给药后症状，其中大多数症状出现在给药后前3d内，且在3d内消失。减少此类症状发生的做法为，输注Reclast后立刻给予对乙酰氨基酚(扑热息痛)或异丁苯丙酸(布洛芬)。

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