Pentoxifylline is as effective as captopril in the reduction of microalbuminuria in non-hypertensive type 2 diabetic patients--a randomized, equivalent trial.
OBJECTIVE
To compare the efficacy of pentoxifylline and captopril on urinary albumin excretion (UAE) rate in non-hypertensive diabetic patients with microalbuminuria.


METHODS
450 subjects were screened; of these 130 eligible, non-hypertensive, type 2 diabetic subjects were enrolled and randomly allocated to receive either pentoxifylline 400 mg t.i.d. (n = 65) or captopril 25 mg t.i.d. (n = 65) for six months in a randomized equivalent trial design study. Patients were eligible to participate if they had microalbuminuria, defined by UAE rate of 20-200 microg/min, and systolic/diastolic blood pressure lower than 140/85 mmHg. Diagnosis of high blood pressure and renal failure were exclusion criteria. In addition, subjects receiving ACE inhibitors or pentoxifylline were not included.


RESULTS
Both treatments were well tolerated, without serious adverse events; nonetheless, one subject (1.6%) in the group with pentoxifylline had severe headache, and three (4.7%) subjects in the group with captopril had intense dry cough and nasal congestion that required stopping pentoxifylline and captopril. In addition, slight headache and mild dry cough that did not require specific treatment or interruption of medication were present in two (3.2%) and five (7.8%) subjects treated with pentoxifylline and captopril. Four subjects dropped-out (one in the pentoxifylline group and three in the captopril group). Blood pressure and fasting glucose levels were similar between the two groups throughout the study. The UAE rate decreased from the first month of treatment in the subjects of both groups, a reduction that was sustained in the following months. At the end of the study, the average UAE rate in the subjects of both groups was lower than 25 microg/min.


CONCLUSIONS
Pentoxifylline showed to be an effective alternative to ACE inhibitors in reducing UAE in non-hypertensive diabetic patients with microalbuminuria.
Rodríguez-Morán
M
M
Medical Research Unit in Clinical Epidemiology of the Mexican Social Security Institute, and Research Group on Diabetes and Chronic Illnesses, Durango, Mexico. rodriquez_moran@hotmail.com
Guerrero-Romero
F
F
D000419:Albuminuria / Q000188:drug therapy* / Q000209:etiology; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D002216:Captopril / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003924:Diabetes Mellitus, Type 2 / Q000652:urine*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010431:Pentoxifylline / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D000806:Angiotensin-Converting Enzyme Inhibitors; D002216:Captopril; D010431:Pentoxifylline