Wednesday July 25, 2007
Ibandronate IV: Step forward in the treatment of osteoporosis
Jaime Urdinola MD
AK 9 116-20 326 - Medical Association of the Andes - Bogotá DC Colombia
Phone: 571 / 215 23 00 - Phone: 57 / 315 236 August 28
e-mail: jaimeurdinolamd@gmail.com
blogger: http://www.urdinola.blogspot.com
Symposium / Luncheon on Women's Health - Wednesday, July 27, 2007
Boardroom - First Floor, Medical Association of the Andes - Bogotá DC Colombia
no doubt about the overall effectiveness of bisphosphonates for the treatment of postmenopausal osteoporosis. These drugs have been constituted today, the mainstay of treatment for postmenopausal osteoporosis 1-2.
This year 2007 was marked by the appearance of intravenous bisphosphonate therapy, which means a step forward in the treatment of osteoporosis. It is assumed that parenteral treatment can be an advantage for women who have problems of intolerance to these drugs when given orally. But given the simplicity and safety with the use of ibandronate may be considered that this could be the paradigm, a nitrogenous bisphosphonate powerful and easy to administer an IV.
The excellent tolerance to be shown by mouth and features that allow its connection to the bone, allowed ibandronate can be administered not only orally but also via the extended intervals in dose.
Pierre Delmas et al 3 performed a randomized study (DIVA called by its acronym), double-blind, double dummy "(roughly translated as double placebo), of inferiority, comparing 2 regimens intermittent IV injections of ibandronate (2 mg c / 2 months and 3 mg every 3 months) with a regimen of 2.5 mg daily oral ibandronate. The latter has already proven anti-fracture efficacy.
This clinical trial includes 1 395 women aged 55 to 80 years, and who were at least 5 years postmenopause stage. We require all of them had osteoporosis (lumbar T Index in bone mineral density (BMD) L2-L4 < 2.5 ). A todas las participantes se les administró diariamente calcio ( 500 mg ) y vitamina D ( 400 UI ). El desenlace primario que se analizó al año, fue el cambio de la DMO desde la línea basal en relación a la columna vertebral. Se midieron también la DMO de la cadera así como el telopéptido C del colágeno tipo I ( CTX ) y la seguridad y la tolerabilidad de los tratamientos.
was not accepted for women who had received prior IV bisphosphonate therapy at any time.
Or to those who have received during the 6 months preceding oral bisphosphonates or any type of medication affect bone metabolism, or had renal impairment or a history of upper gastrointestinal disease or allergy to bisphosphonates, because they were excluded. The study was conducted in 58 centers in the U.S., Canada, Mexico, Europe, Australia and South Africa.
A year after the treatment performed, BMD increased 5.1% in 353 patients who received 2 mg IV ibandronate c / 2 months, 4.8% among 365 patients treated w / 3 months with 3 mg IV ibandronate and 3.8% between 377 patients who received 2.5 mg oral ibandronate day.
Both IV regimens were not not only not less, but the analysis showed their superiority (P < 0.001 ).
BMD rose hip which was higher in the groups receiving IV medication in the group who took orally. CTX
strong decreases were observed in all study groups.
Both IV regimens were well tolerated and did not compromise renal function.
The authors conclude that, taking into account the assessed BMD, IV injections of ibandronate (2 mg c / 2 months or 3 mg every 3 months) are as effective as the regimen of 2.5 mg / day orally, which has previously demonstrated anti-fracture efficacy (52% at 3 years with the daily dose and 50% with intermittent doses in relation to vertebral fractures). With the application
IV have raised concerns about the presentation of "influenza-like illness."
This may also occur with oral bisphosphonates. In the study, the incidence was higher in the groups that received IV than in the mouth, 5.1% and 4.9% in group IV c / 2 c / 3 months, respectively, vs. 1.1% in the oral group.
Considering the typical onset of this condition, which occurs within 3 days of dosing and lasts < 7 días, la incidencia respectiva en los 3 grupos de tratamiento fue 3.8 %, 3.6 % y 0.6 % respectivamente.
= or 80% of affected patients reported no symptoms recur.
Having the availability of IV therapy, the concern arises only if those patients with problems for the administration of the preparation by mouth would be the candidates for IV therapy, such as those with gastrointestinal intolerance to the drug, patients with cognitive problems (dementia, etc..), those receiving multiple medications by mouth those with abnormalities of the esophagus that delay emptying them, or will prevail in the future comfort of the IV w / 3 months, on the other reasons?
IV injection to be administered in the office, in 15 to 30 seconds, an advantage over the other annual presentation that requires an infusion in a hospital or temporary placement.
Highlights
● Bisphosphonates are currently the mainstay in the treatment of osteoporosis in postmenopausal women, for their proven
● bisphosphonate ibandronate is a potent nitrogen, which has proven anti-fracture efficacy and good tolerance, research on oral treatment
● The DIVA study, which considered two regimes IV, shows superiority over oral regimen
● The "influenza-like illness" can occur with IV or oral administration of bisphosphonates , but more often with IV therapy. No repeats in most cases with subsequent doses and does not seem important factor in discontinuation of therapy
● Finally, the IV treatment for its simplicity and convenience, you can replace in many cases the oral, not only in cases of digestive intolerance or difficulties in administration, signifying a step forward in the treatment of osteoporosis
References 1 - Chesnut CH III, Skag A, Christiansen C, Recker R, Stakkestad JA, Hoiseth A, Felsenberg D, Huss H, Gilbride J, Schimmer RC, Delmas PD, Oral Ibandronate Osteoporosis Vertebral Fracture Trial in North America and Europe (BONE). J Bone Miner Res 2004, 19: 1241-9.
2 - Baussan F, Russel RG. Ibandronate in osteoporosis: preclinical data and rationale for intermittent dosing. Osteoporosis Int 2004, 15: 423-33.
3 - Delmas PD, Adami S, Strugala C, Stakkestad JA, Reginster JY, Felsenberg D, Christiansen C, Civitelli R, Drezner MK, Recker RR, Bolognese M, Hughes C, Masanauskaite D, Ward P, Sambrook P, Reid DM. Injections Intravenous ibandronate in postmenopausal Women with osteoporosis: one-year results from the dosing Intravenous administration study. Arthritis Rheum 2006, 54: 1838-1846.
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