Multicentre trial in the united kingdom and ireland of a mixture of ethyl chlorophenoxyisobutyrate and androsterone (atromid): A preliminary report*

Abstract

Summary The results of a multicentre trial of Atromid in 601 patients have been presented. (1) The response to treatment does not differ markedly with the severity of the hypercholesterolaemia, the absolute reduction varying from 35 % for those with high initial levels to 26 % for those with low initial levels. (2) Female patients had higher initial cholesterol levels, but their response was otherwise similar to the males. (3) A marked seasonal variation in serum cholesterol of untreated patients was observed and it was apparent that the seasonal effect was not completely masked by treatment. (4) The response of 42 diabetics and 37 patients with xanthomatosis did not differ from that of the remainder. (5) Hypertensives responded in the same way as normotensive subjects. (6) An apparently paradoxical relationship between the cholesterol response and dose expressed in terms of body weight was observed. A possible explanation for this is suggested and no significance is attached to the observation. (7) Patients treated concurrently with unsaturated fats appeared to respond rather better during the early months of the trial, but this difference disappeared after the 3rd month. (8) Twenty-one deaths occurred during the trial, which is considered to have been too short for any conclusions to be drawn about the effect of Atromid on survival. (9) Concurrent use of anticoagulants resulted in haemorrhage in 26 patients and in death in 2. The great majority of these incidents occurred before the potentiating effect of Atromid was appreciated. (10) Side-effects, most commonly in the form of mild gastro-intestinal upset, were reported in 119 cases, most frequently in the first month of treatment. (11) No change in serum uric acid was detected on the pre-treatment levels. (12) No change in serum bilirubin was observed. (13) SGPT levels appeared to fall between the 2nd and 4th month but this fall is not statistically significant. (14) SGOT levels were examined in detail in 2 trials. A significant increase in SGOT was reported in both trials. The SGOT levels in smaller groups of patients were within the mean levels for these 2 trials. No simple explanation could be found for the variable results in different studies.