Clinical Drug Investigation

, Volume 25, Issue 1, pp 23–31 | Cite as

Effect of a Simple Dose-Escalation Schedule on Tramadol Tolerability

Assessment in the Clinical Setting
  • I. TagarroEmail author
  • J. Herrera
  • C. Barutell
  • M. C. Díez
  • M. Marín
  • D. Samper
  • C. Busquet
  • M. J. Rodríguez
Original Research Article


Objective: To assess the effect of a very simple dose-escalation schedule on tramadol tolerability in clinical practice. This schedule consists of starting treatment with sustained-release tramadol 50mg twice daily, and escalating the dose around 7 days later to 100mg twice daily.

Methods: Data from 1925 outpatients with non-malignant chronic pain were collected in this multicentre, prospective, comparative, non-randomised, open, observational study.

Results: A total of 1071 patients (55.6%) were included in the dose-escalation group (50mg group) and 854 patients (44.4%) in the control group (sustained-release tramadol 100mg twice daily; 100mg group). The proportion of patients who interrupted tramadol treatment due to the occurrence of adverse reactions was significantly lower in the 50mg group (5.6%) than in the 100mg group (12.6%) [p = 0.001]. In line with this, the proportion of patients who experienced at least one adverse reaction was significantly lower in the 50mg group (18.4%) than in the 100mg group (30.4%) [p = 0.001] and, interestingly, the two most frequently reported adverse reactions, nausea and dizziness, were found with a significantly lower frequency in the 50mg group (p < 0.001). Multivariate analysis showed that the risk of safety-related treatment cessations was 2.3 times higher in the 100mg group than in the 50mg group, and 2.2 times higher in females than in males. The two treatments were equally effective in reducing pain intensity (p = 0.121), measured as a reduction in pain score obtained by means of a visual analogue scale.

Conclusion: The instauration of tramadol treatment, starting with sustained-release 50mg capsules twice daily and escalating the dose some days later to 100mg twice daily, was shown to be an effective and easy way to improve tramadol tolerability in clinical practice, whilst maintaining its analgesic efficacy.


Adverse Reaction Tramadol Visual Analogue Scale Score Treatment Interruption Treatment Cessation 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



Funding for this study was provided by Viatris Pharmaceuticals SAU (formerly ASTA Medica SAU), Madrid, Spain.


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Copyright information

© Adis Data Information BV 2005

Authors and Affiliations

  • I. Tagarro
    • 1
    Email author
  • J. Herrera
    • 2
  • C. Barutell
    • 3
  • M. C. Díez
    • 1
  • M. Marín
    • 4
  • D. Samper
    • 5
  • C. Busquet
    • 6
  • M. J. Rodríguez
    • 7
  1. 1.Viatris Pharmaceuticals SASan Fernando de Henares, MadridSpain
  2. 2.Hospital de ValmeSevillaSpain
  3. 3.Hospital Vall d’HebronBarcelonaSpain
  4. 4.Hospital San Juan de DiosSan SebastiánSpain
  5. 5.Hospital Germans Trias i PujolBarcelonaSpain
  6. 6.Hospital Dr. Josep TruetaGironaSpain
  7. 7.Hospital Civil de MálagaMálagaSpain

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