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Phenylindalnedione As an Anticoagulant

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Phenylindalnedione As an Anticoagulant BRmsH 650 MARCH 21, 1953 PHENYLlNDANEDIONE AS AN ANTICOAGULANT MEDICAL JOURNAL CLINICAL TRIAL OF Rapidity of Action and Recovery In practically all cases 200 mg. of phenylindanedione PHENYLINDALNEDIONE AS AN ((divided into two equal doses) was given in the first 24 hours, followed by 100 mg. (in two equal doses) in the next ANTICOAGULANT 24 hours. On this dosage only 6 cases out of the 68 failed reach an level in 4& BY to adequate therapeutic prothrombin hours, whilst in only one of these was the prothrombin M. TOOHEY, M.D., M.R.C.P. level above 40% at this time. In many cases in which the time was estimated at 36 hours it was found Physician, New End Hospital, London prothrombin that an adequate therapeutic level had been attained by this time. In most of the 68 cases an appreciable lowering At present dicoumarol and ethyl biscoumacetate (bis-3, of the prothrombin concentration to 50% or below was 3'-(4-oxycoumarinyl)-ethyl acetate; "tromnexan") are reached by 24 hours. the two drugs with a prothrombopenic action which are The effective action of phenylindanedione passes off fairly in common use as anticoagulants. DicoumaroL was the rapidly, and therefore the risk of cumulative effects is slight first prothrombopenic drug to come into use, but its except where very large doses are given. Twenty-four hours, there was either no or toxic effect (due, however, in many instances to indis- after stopping the drug change only a small fall in the times in those patients in crimipate heavy overdosage and also to lack of proper prothrombin whom the prothrombin had previously been maintained at control, including unreliable estimations of the pro- a full therapeutic level (10-20%) for at least several days. to severe many thrombin time) has led haemorrhage in Up to 36 hours after cessation of phenylindanedione there cases. The great drawback with dicoumarol is its cumu- was still an appreciable effect, but between 36 and 48 hours lative action, which may continue long after the drug after the last dose there was a sudden sharp drop in the has been stopped. This cumulative effect necessitates prothrombin time to near normal levels. By 72 hours the particularly skilled and detailed control of the drug with prothrombin times in practically all cases had become normal frequent estimations of- the prothrombin time if severe or almost so. haemorrhiage is to be. avoided. Another disadvantage The return to normal of the prothrombin time in patients with dicoumarol is the long delay, usually 48 to 72 hours, on phenylindanedione depends (as with other similar anti- on the level to which the before a full therapeutic effect is reached. coagulants) largely prothrombin had been depressed. The lower the prothrombin concen- Ethyl biscoumacetate has a much more rapid action than tration, the longer it takes for a normal prothrombin con- dicoumarol, a therapeutic effect usually being achieved in tent to be regained. Again, any lowering of renal function 18 to 24 hours. Moreover, the effect of ethyl biscoum- will delay the excretion of the drug. In the very few cases acetate, unlike that of dicoumarol, is, owing to the rapid in which the prothrombin time failed to return to normal metabolism and elimination of the drug, almost never or near normal within 48 to 72 hours after the last dose cumulative. The rapid inactivation of ethyl biscoum- there were signs of deficient renal function. acetate, however, often makes it difficult to maintain an The absorption and recovery rates of phenylindanedione even therapeutic prothrombin concentration, especially are therefore midway between those of dicoumarol and in the initial stages of treatment. In addition, the wide ethyl biscoumacetate. Phenylindanedione has many advan- individual variation in the reaction to ethyl biscoum- tages over dicoumarol in its quicker effect and the very of cumulative action. On the other hand, acetate is another factor requiring detailed and meticu- slight danger although it is not as rapid in action as ethyl biscoumacetate! lous control in every case. its more prolonged effect makes it much easier to maintain In recent years a new prothrombopenic drug, phenyl- a therapeutic prothrombin level over a prolonged period. indanedione, has aroused interest and been the subject Ethyl biscoumacetate is practically all metabolized andi of clinical trial. In 1944 Kabat, Stohlman, and Smith excreted within 24 hours, so that omission of the drug for showed that certain indanedione derivatives have a only one day will result in even an excessively prolonged specific action in reducing the plasma prothrombin. prothrombin time returning to normal or near normal and, Soulier and Gueguen (1947) reported satisfactory results the drug therefore losing its therapeutic effect. This rapidc combined with the wide individual variation in from using phenylindanedione, the most active of the inactivation, the reaction to the drug, necessitates the most detailed andc indanedione derivatives. Jaques et al. (1949) found no used. experienced control when ethyl biscoumacetate is toxic effects from phenylindanedione in animals. With phenylindanedione, however, the time-lag of 36 hours. Blaustein et al. (1950) reported their o-bservations on the before there is any really appreciable change in the pro- use of the drug in 53 patients, and concluded that thrombin concentration allows ample time for the clinician phenylindanedione had an action similar to but more to ascertain the prothrombin level and to readjust the dose rapid than that of dicoumarol. Bjerkelund (1950) found of phenylindanedione when necessary without wide fluctua- that phenylindanedione had not only a more rapid effect tions in the prothrombin level occurring. but also a more uniform action than dicoumarol. In addition, Bjerkelund showed that phenylindanedione had Dosage no effect on factor V. The initial dosage in all 68 cases was 200 mg. (100 mg. The present paper is a report on the use of phenyl- morning and evening) the first day, followed by 100 mg.. indanedione in 68 patients. Most of them were suffering on the second day. By 48 hours the full effect of this was to the prothrombin level from coronary thrombosis or deep venous thrombosis, dosage evident, and, according then it was possible to estimate with a fair degree and in several there was evidence of cardiac failure. reached, of accuracy* the further doses needed for maintenance Quick's one-stage method was used for estimation of the therapy. The greater the rise in the prothrombin time by prothrombin time, and the was a thromboplastin phenol- 36 to 48 hours the more sensitive the patient is to the drug. saline emulsion prepared from human brain. Thera- and the smaller the daily maintenance dose that is required peutic prothrombin levels of 10-20% (or approximately In 44 of the 68 cases this daily maintenance dose lay twice to three times the normal prothrombin time) were between 75 and 100 mg. and in only 5 cases did it fall out- aimed at. side the range of 50-150 mg. (see Table). The variatioo BRrrISs MARCH 21, 1953 PIHENYLINDANEDIONE AS AN ANTICOAGULANT MEDICAL JoUADML 651 Maintenance Doses of Phenylindanedione given in order to produce a severe prothrombin deficiency Daily Daily far in excess of that required for no No. of Maintenance No. of Maintenance therapeutic purposes, Cases Doses in mg. Cases Doses in mg. toxic effects were noticed apart from haematuria in one 2 50 3 125 case only. In most patients on the urine 4 50-75 2 125-150 phenylindanedione 22 75 4 150 turns a pinkish-orange colour; this is of no significance. 4 75-100 2 150-175 Antidote.-The great drawback in 18 100 1 . .175 anticoagulant therapy 4 100-125 2 175-200 with drugs of the coumarin group has up till recently been the lack of a really effective antidote. Water-soluble vita- in individual susceptibility to phenylindanedione is there- min-K analogues have only a very limited effect in correct- fore not very great and seems to be much less than with ing a severe prothrombin deficiency. Vitamin Ki, however, either dicoumarol or ethyl biscoumacetate. even by mouth, has a most dramatic and rapid effect (within In all cases the total daily dose of phenylindanedione was 8 to 20 hours in most cases) in overcoming the prothrom- given in approximately two equal amounts morning and bopenic action of dicoumarol, ethyl biscoumacetate, and evening. Dividing up the total daily dose seems to give phenylindanedione (Toohey, 1952). more uniform results. Frequency of Prothrombin Estimations Guides to Dosage After the initial two or three prothrombin estimations There are several factors which help greatly in estimat- necessary in the first four to five days of therapy, it is ing the required maintenance doses in individual cases. usually sufficient to carry out prothrombin estimations only Before, however, these are considered it is necessary to twice or, at the most, three times a week. Phenylindanedione stress one important point. The initial doses for the first is very stable in its' action, so that once the individual varia- two days should (subject to the exceptional cases mentioned tion in reaction has been assessed it is not necessary to do below) invariably be kept constant. To give a larger dose daily prothrombin estimations. mg. on on of one than 100 the second day, solely the result It is perhaps advisable to point out here that minor prothrombin estimation taken 24 hours or less after starting unimportant fluctuations in the prothrombin time, as treatment, will lead in most cases to too high a dose being measured by the are often seen in is not evident one-stage method, prac- given. The full effect of phenylindanedione tice in patients on anticoagulants. Therefore, to avoid for 36 to 48 hours.
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