Study VIBE: First comparison head to head "on fracture risk in women treated with monthly oral ibandronate [Bonviva (R)] or weekly bisphosphonates
Wednesday April 30, 2009
VIBE Study: First compared head to head "on fracture risk in women treated with monthly oral ibandronate [Bonviva (R)] or weekly bisphosphonates
Urdinola Jaime MD
Andes Medical Association 9116 AK 20 CS 326 Bogotá DC Colombia
Phone 571/215 23 00 e-mail: jaimeurdinolamd@gmail.com
blogger: http://www.urdinola.blogspot.com/ www.urdinolamenopausia2.blogspot.com
Symposium / Luncheon on Women's Health and Medical MenopausiaAsociación
Andes Board Room - Wednesday April 30, 2009
VIBE study a is important and topical, as it is the first to establish a comparison head to head "between the rates of monthly ibandronate fracture and weekly bisphosphonates administered orally. This is a large study of older women or 45aňos of age, who were given first monthly ibandronate or weekly bisphosphonates - alendronate or risedronate - orally, they did not display any type of malignancy or Paget's disease of bone.
The primary analysis included patients who had adherence to treatment during the first 90 days after the index date. The risk of hip fracture, no spinal cord and any clinical fracture were compared using risk models and adjusted Cox proportional to factors that could potentially lead to confusion.
A secondary analysis of "intention to treat including all patients who received at least one prescription of bisphosphonates.
sensitivity analysis based on the primary analysis compared patients who received ibandronate to patients who had received weekly alendronate or risedronate separately and explored the effect of excluding patients with factors that potentially could lead to confusion analysis. Further analysis of sensitivity varied the requirement of adherence during the first 90 days after the index date.
The primary analysis population included patients 7 345 56 837 monthly ibandronate with weekly bisphosphonate . Fracture rates after 12 months of observation period were < 2% y el riesgo de fractura no fué significativamente diferente entre pacientes que recibieron Ibandronato mensual o bisfosfonatos semanales, para fractura de cadera, fractura no vertebral o cualquier tipo de fractura clínica (riesgo relativo ajustado: cadera= 1.06, p=0.84; no vertebral=0.88, p=0.255; cualquier fractura clínica=0.82, p= 0.052).
But patients receiving ibandronate had a significantly lower risk of vertebral fracture than those who received weekly bisphosphonates (adjusted relative risk 0.36, confidence interval 95% 0.18 to 0.75, p = 0.006).
In the secondary analysis of "intent to treat" fractrura relative risks were not significantly different between treatment groups for any type of fracture. The results of sensitivity analysis were generally consistent with the primary analysis.
This retrospective cohort study found that patients treated with bisphosphonates ibandronate monthly or - alendronate, risedronate - weekly orally, had a similar and reduced risk of hip fracture, vertebral fracture and any fracture clinic.
But ibandronate patients had a significantly lower relative risk of vertebral fracture than patients who received weekly bisphosphonates. The clinical implications of these findings require further exploration and validation. In the beginning
bisphosphonates were marketed for daily administration and its efficacy in reducing vertebral and nonvertebral fractures was evaluated in clinical trials. The efficacy and regulatory approval of new dosage regimens (weekly monthly or quarterly), checking anti-fracture efficacy was established on the basis of changes in bone mineral density (BMD) compared to those seen with daily dosing.
But until now no study had been made "head to head" between bisphosphonates administered daily or the new extended dosing regimens. The monthly oral ibandronate 150 mg provides approx. twice the cumulative annual dose oral formulation of 2.5 mg daily. The effectiveness of this dose was examined in the study MOBILE 2, as well as in meta-analysis comparing monthly dose of 150 mg doses with quarterly 2 and 3 mg IV, which showed a significant reduction in nonvertebral fractures compared with placebo 3.
had not been studied head to head "comparison of the aforementioned anti-fracture efficacy, taking into account the large sample size needed to reliably detect differences in fracture risk and high costs associated. For this reason, databases used for analysis, which may allow sufficient sample sizes for the comparison of marketed doses in routine clinical practice. But as it is not randomized, it is possible that the study groups are different analysis of databases. To avoid the impact of these differences, is used to reduce the statistical adjustment, although the factors that potentially lead to confusion and biases may persist.
should also note the limitation that implies that this cohort study was based on data from patients seeking financial reimbursement for their medication, not research. Among other things, for example, there is no guarantee that the medication has been ingested properly or that the diagnosis of osteoporosis or fracture can not be wrong. But by chance, this could have occurred similarly in the 2 comparison groups. Neither fractures were evaluated so morphometrically. As non-randomized study may be significant differences between groups of patients, although this is not clinically important. Nor were adjusted p values \u200b\u200bfor multiple comparisons.
can conclude, therefore, that the observational analysis of the databases provide additional information to information obtained from randomized trials.
Summary of Important
● This study includes a fairly large sample, more diverse and the real world, that would allow a randomized trial with inclusion and exclusion criteria ●
stricter patient populations, treatment patterns and outcomes in routine clinical practice may differ from those we see in randomized trials. It is important and it is also necessary to assess outcomes in real world scenarios
● This study demonstrates, in real life, the risk of vertebral fracture in general or of hip fracture in particular women received up to one year of treatment with monthly ibandronate or bisphosphonates - alendronate, risedronate - orally, was similar
● But it also notes the study, vertebral fracture risk is lower in patients with adequate adhesion and receiving monthly ibandronate, compared with those receiving a weekly bisphosphonates
● Obviously, the clinical implications for the findings in reducing fractures need further exploration / research and validation of the data found
References
1 - Harris ST, et al. Risk of fracture in Women Treated with weekly or monthly oral bisphosphonates ibandronate: The Evaluation of Ibandronate Efficacy (VIBE) database fracture study. Bone. 2009, doi: 10.1016/j.bone.2009.01.002.
2 - Reginster JY, Adamis, Lakatos P, Greenwald M, Stepan JJ, Silverman SL, et al. Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. Ann Rheum Dis. 2006, 65: 654-61.
3 - Harris ST, Blumentals WA, Miller PD. Ibandronate and the Risk of non-vertebral fractures in postmenopausal Women with osteoporosis: results of a meta-analysis of phase III studies. Curr Med Res Opin 2008, 24: 237-45.
If you have any comments, questions or concerns, you can "click" on comments and sending your message. Or if you prefer, you can send your comments, questions or concerns e-mail jaimeurdinolamd@gmail.com
0 comments:
Post a Comment