Actualización en el tratamiento médico expulsivo de litiasis ureterales. CASP (critical assesment program) del estudio SUSPEND publicado en lancet.

1. MEDICAL EXPULSIVE
THERAPY IN ADULTS WITH
URETERIC COLIC

21. This randomized, multicenter, double-blind placebo controlled trial took place at
24 UK centers. Adults with ureteric colic and a single stone in the ureter (10
mm) identified on kidney, ureter, and bladder computed tomography were
randomized remotely into either the tamsulosin (0.4 mg QD), nifedipine (30 mg
QD), or placebo groups.
Spontaneous stone passage within 4 weeks, without the need for additional
interventions, was defined as the primary outcome.
Secondary outcomes, assessed at 4 and 12 weeks via questionnaires or case
report forms, were number of days of analgesic use, pain visual analog, time to
stone passage assessed by the post passage imaging date, health status, and
safety assessed by various questionnaires.
Exclusion criteria included adults outside 18-65 years of age, multiple stones,
or a stone larger than 10 mm, those in need of immediate intervention, sepsis,
a glomerular filtration rate <30 mL/min or those with contraindications to either
medication. Minimization covariates included center, stone size (5mm or>5
mm), and stone location (upper, mid, or lower ureter). Between January 2011
and December 2013, 391, 387, and 389 patients were assigned to tamsulosin,
nifedipine, and placebo groups, respectively. At 4 weeks 80% and at 12 weeks
87% of the placebo group experienced stone passage without intervention.

22. Over a 23-month period, 4483 patients were screened, 1998 found
eligible and 1167 randomly assigned.
Of those, 17 (1.5%) were subsequently excluded and 14 (1.2%) were lost
to follow-up, leaving 1136 for the final analysis.
By 4 weeks, 303/379 (80%) participants in the placebo group, 307/378
(81%) in the tamsulosin group and 304/379 (80%) in the nifedipine group
did not require intervention. There were no significant differences
(p<0.05) in any of the four comparisons. Four participants (three in the
nifedipine group and one in the placebo group) suffered serious adverse
events.

26. ¿QUE DICE LA COMUNIDAD
CIENTÍFICA?

29. - Overall, this paper challenges current urologic dogma that MET is an
effective means to treat ureteric stones.
- What remains to be seen is whether the urologic community will embrace
this new level-1 evidence in clinical practice.
Crítica: como las midieron?, como definieron las partes del ureter?,
adherencia a farmacos?

30. - Use of α blockers to facilitate stone passage has increased in popularity, even though efficacy has only been supported
by level 2a evidence.
- This study therefore removes, beyond any reasonable doubt, any positive expectations with respect to α blockers in the
treatment of ureter stones.
- Several things can be learned from Pickard and colleagues’ study and its findings—the main one being the important
role of quality of evidence and reporting of outcomes. It raises the question of whether well powered RCTs are indeed the
ultimate way to prove efficacy of a specific treatment. Taking the accompanying study as an example, the answer is
indisputably yes.
- Crítica: The primary outcome was “the proportion of participants in each group who did not need further intervention for
stone clearance within 4 weeks of randomization”.

31. By addressing the methodological weaknesses in the majority of previous
MET trials, the authors have demonstrated the superiority of quality over
quantity in the quest for evidence-based practice and, in this case, the
futility of either α-blocker or calcium-channel blockers for patients suffering
from ureteric stones regardless of stone size and location.

33. - Currently recommended in both the American Urological Association (AUA) and European
Association of Urology (EAU) guidelines; however, these recommendations are supported by
lower level (2a) evidence only, from a variety of smaller studies and meta-analyses.
- Now, results from the recently completed SUSPEND trial, published in The Lancet,
conclusively prove that medical expulsive therapy with either tamsulosin or nifedipine is no
more effective than placebo at increasing stone passage in patients with ureteral colic.

34. A professional research librarian carried out literature searches for all
sections of the urolithiasis guidelines covering the period up to august
2014.

37. GRACIAS .