To the editor:
In a Patient-Oriented Evidence that Matters (POEM) review in the July issue, Drs Hartnett and Saver1 reviewed results of the Overactive Bladder: Judging Effective Control and Treatment (OBJECT) study.2 I read this POEM with considerable interest because, in addition to having served on the US Agency for Health Care Policy and Research Urinary Incontinence Guideline Panel, I have also written extensively about urinary incontinence and regularly lecture on the topic (occasionally including, I should acknowledge, those supported by the manufacturer of tolterodine).
Drs Hartnett and Saver concluded that the OBJECT study found extended-release oxybutynin (Ditropan XL) to be more effective than tolterodine (Detrol). While this conclusion is literally correct, it misses the point that the OBJECT study, which was funded by the manufacturer of Ditropan XL, did not compare extended-release oxybutynin with long-acting tolterodine (Detrol LA). Rather, it compared extended-release oxybutynin with the old immediate-release form of tolterodine. This is an inappropriate comparison, because the extended-release forms of oxybutynin and tolerodine are both more effective than their immediate-release counterparts. Just as extended-release oxybutynin is more effective than immediate-release oxybutynin and immediate-release tolterodine, long-acting tolterodine is also more effective than immediate-release tolterodine.3
A more meaningful comparison would have been between extended-release oxybutynin and long-acting tolerodine. Such a study would have provided patient-oriented evidence that really mattered, but such a study has not yet been performed. Until it is, readers should be careful in their interpretation of studies reporting on the benefits and risk of these anticholinergic drugs for treatment of overactive bladder.
Barry D. Weiss, MD
University of Arizona College of Medicine
- Hartnett NM, Saver BG. Is extended-release oxybutynin (Ditropan XL) or tolterodine (Detrol) more effective in the treatment of an overactive bladder? J Fam Pract 2001; 50:571.
- Appel RA, Sand P, Dmochowski R, et al. Prospective randomized controlled trial of extend-release oxybutynin chloride and tolterodine. in the treatment of overactive bladder: results of the OBJECT study. Mayo Clin Proc 2001; 76:358-63.
- Van Kerrenbroeck P, Kreder K, Jonas U, et al. Tolterodine once-daily: superior efficacy and tolerability in the treatment of the overactive bladder. Urology 2001; 57:414-21.
Drs Hartnett and Saver responded as follows:
The OBJECT study compared immediate-release tolterodine (Detrol) and extended-release oxybutynin (Ditropan XL), the 2 newest medications available during the 1998-2000 study. We agree that a direct comparison of Ditropan XL and long-acting tolterodine (Detrol LA) would be more clinically useful. Currently, providers must choose between Ditropan XL, Detrol, and Detrol LA (approved by the Food and Drug Administration in December 2000) in the absence of a study that directly compares all 3 drugs. In patient populations where prescription drug coverage is minimal or nonexistent, the comparably priced Ditropan XL and Detrol may be more realistic options than Detrol LA: An informal survey of several pharmacies in the Seattle and Los Angeles areas reveals a consistently higher price for a month’s supply of Detrol LA ($100-$110) than for Ditropan XL ($80). It would be interesting to compare the pattern of use of oxybutynin (Ditropan), which costs less than $20 per month, with the more expensive, longer-acting formulations in patients without prescription drug coverage. Finally, as suggested in our review, the benefit of Ditropan XL over Detrol was quite modest; the more important patient-oriented evidence in our POEM was that behavioral techniques alone or in combination with pharmacologic therapy may provide the greatest benefit in the treatment of overactive bladder, outweighing the benefit of pharmacologic therapy alone.1,2
Nicole M. Hartnett, MD
Barry G. Saver, MD, MPH
University of Washington
Seattle
- Burgio, KL, Locher JL, Goode PS, et al. Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial. JAMA 1998; 280:1995-2000.
- Burgio, KL, Locher JL, Goode PS. Combined behavioral and drug therapy for urge incontinence in older women. J Am Geriatr Soc 2000 48:370-74.
To the editor:
We have read with interest the Patient-Oriented Evidence that Matters (POEM) review by Drs Kauffman and Dobie1 entitled, “Does a multivalent pneumococcal vaccine given to infants prevent otitis media?” in the May issue. While, in general, the authors present the publication by Eskola and colleagues2 accurately, their conclusion that “[heptavalent pneumococcal-CRM197 conjugate vaccine] does not reduce the overall number of episodes of clinical AOM” is not correct.
The Finnish Otitis Media Vaccine Trial (FinOM trial), the subject of the article by Eskola and coworkers, was designed and powered to evaluate efficacy of the heptavalent pneumococcal conjugate vaccine against culture-confirmed serotype-specific pneumococcal acute otitis media in children. It was not powered to evaluate the impact on any/all cause otitis media (OM). However, this endpoint was evaluated in a Northern California Kaiser Permanente (NCKP) population, where more than 17,000 infants received heptavalent pneumococcal-CRM197 conjugate vaccine.3 In that study, a significant 7.0% (95% confidence interval, 4.1-9.7) reduction of OM episodes and even more pronounced effects on recurrent otitis media and ventilatory tube placement were noted. Even though the FinOM trial was not powered to evaluate this difference, it is interesting to note the similarity in efficacy for reduction of any acute OM/OM episodes between these 2 trials (6.0% in the FinOM trial versus 7.0% in the NCKP trial).