A comparison of the gastrointestinal side effects of two forms of erythromycin.
BACKGROUND
The gastrointestinal (GI) side effects of erythromycin frequently limit therapy and compliance. PCE Dispertab, a more expensive brand of erythromycin, has been promoted as a well-tolerated new dosage form; however, no studies compare its GI side effects with those of other forms of erythromycin. We compared erythromycin PCE (particles-in-tablet) with E.E.S. (erythromycin ethylsuccinate) to determine whether there is a difference in the incidence and severity of GI side effects.


METHODS
This was a multicenter, prospective, single-blind, randomized trial. Observers, but not participants, were blinded to the brand of erythromycin taken until after data analysis. We enrolled ambulatory patients who were at least 18 years old and weighed at least 90 lb for whom erythromycin had been prescribed at a dosage of 1.0 g/d. Subjects were given either the particles-in-tablet form, 333 mg three times daily, or the ethylsuccinate form, 400 mg four times daily, for 10 days and asked to report efficacy, compliance, and the frequency and severity of four GI symptoms (abdominal pain, nausea, vomiting, and diarrhea) in a daily diary.


RESULTS
There were no significant differences between the particles-in-tablet and ethylsuccinate forms in incidence of GI side effects (63% and 61%, respectively), average daily GI symptom severity score (0.62 and 0.68, respectively), and GI-related discontinuations (8.5% and 8.2%, respectively). The incidence of moderate or severe nausea was 5% for the particles-in-tablet form and 25% for the ethylsuccinate form (P < .001).


CONCLUSIONS
Although ethylsuccinate caused a higher incidence of moderate to severe nausea, there were no differences in the three main outcome measures: incidence of GI side effects, average daily GI-symptom severity score, and GI-related discontinuations. Therefore, we support prescribing erythromycin ethylsuccinate as a first line of treatment because it costs less.
Anastasio
G D
GD
Department of Family Practice, Carolinas Medical Center, Charlotte 28232-2861.
Robinson
M D
MD
Little
J M
JM
Leitch
B B
BB
Pettice
Y L
YL
Norton
H J
HJ
D000328:Adult; D004917:Erythromycin / Q000008:administration & dosage / Q000009:adverse effects*; D015643:Erythromycin Ethylsuccinate / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced*; D006801:Humans; D008297:Male; D010349:Patient Compliance; D011446:Prospective Studies; D016037:Single-Blind Method; D013608:Tablets, Enteric-Coated
D013608:Tablets, Enteric-Coated; D015643:Erythromycin Ethylsuccinate; D004917:Erythromycin