Dixyrazine

Betamethasone-dixyrazine versus metoclopramide as antiemetic treatment in cancer chemotherapy

In a prospective randomized and double-blind cross-over study betamethasone-dixyrazine was compared with metoclopramide as antiemetic treatment in cisplatin and doxorubicin chemotherapy. Sixty-two consecutive patients without prior experience of chemotherapy entered the study and were followed during 1-4 courses of treatment. Effect parameters were recorded on questionnaires using the visual analog scale for quantification. The median number of courses per patient was 3.0 (range 1-4). Full protection against nausea and vomiting was achieved in 74% with betamethasone-dixyrazine and in 45% with metoclopramide regardless of the chemotherapy regimen employed. With doxorubicin regimens betamethasone-dixyrazine gave full protection in 94% and metoclopramide in 45%. In cisplatin regimens full emetic protection was achieved in 40% with betamethasone-dixyrazine and in 29% with metoclopramide. Adverse reactions were a significant problem with metoclopramide: restlessness 48%, akathisia 26%, parkinsonism 13%, and acute dystonia 3%. One case (3.2%) of parkinsonism was noted as the only extrapyramidal reaction in the dixyrazine group. Various degrees of sedation were noted in 84% during dixyrazine treatment compared with 71% during metoclopramide therapy. Diarrhea was encountered in 48% after high-dose metoclopramide compared with 6% after antiemetic treatment with betamethasone-dixyrazine. Betamethasone-dixyrazine appears to be a promising antiemetic combination with regard to both efficacy and side effects, but further refinement of the regimen is probably possible through dose adjustments and alternative routes of administration.

Dixyrazine for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy

Background: The study assessed the efficacy and safety of dixyrazine, an alternative neuroleptic drug to droperidol, in the prophylaxis of postoperative nausea and vomiting (PONV).
Methods: A total of 197 patients scheduled for laparoscopic cholecystectomy under general anesthesia were randomized to receive either dixyrazine 10 mg or placebo double-blinded at the end of surgery. Scores pertaining to PONV episodes, analgetic supply, rescue medication, adverse events and patient satisfaction were collected over the first 2 h in the PACU and the next 22 h in the ward.
Results: The incidence of PONV over the entire 24-h period was reduced from 32% in the placebo group to 13% in the dixyrazine group (P< or =0.004). The incidence of nausea in the first 2 h was reduced from 15% in the placebo group to 4% in the dixyrazine group (P< or =0.02) and from 12% to 5% in the next 22 h. The incidence of emetic episodes was not different between the two groups. Postoperative shivering was significantly less prevalent in the dixyrazine than in the placebo group (2% vs. 13%; P< or =0008), and opioid analgesics were required significantly less often (61% vs. 75%; P< or =0.01). No significant adverse effects were observed. Patient satisfaction was similar in both groups.
Conclusion: Prophylactic dixyrazine is an effective, safe, and cheap antiemetic drug for laparoscopic cholecystectomy without involving any significant adverse events.

Betamethasone-dixyrazine combination versus high-dose metoclopramide as antiemetic treatment in doxorubicin and cisplatin chemotherapy

In a prospective randomized and double-blind cross-over study, a new antiemetic regimen consisting of betamethasone (1 x 8 mg) and dixyrazine (a phenothiazine derivative) (4 x 10 mg) was compared with a standard high-dose metoclopramide (4 x 1 mg/kg) schedule for antiemetic treatment in doxorubicin and cisplatin chemotherapy. 100 consecutive patients (62 without prior experience of chemotherapy and 38 with prior experience) entered the study and were followed during 1-4 courses of chemotherapy. Effect and side effect parameters were recorded on questionnaires for patients and nurses using the visual analog scale for quantification. The correlation between the two ways of recording (self-scoring versus recording by nursing staff) was very high, both for effect variables (nausea and vomiting) and the adverse reactions (sedation and extrapyramidal reactions). The median number of courses per patient was 3.0 (range 1-4) and altogether 299 courses were studied. Full emetic protection was achieved in 58% with betamethasone-dixyrazine and in 34% with high-dose metoclopramide regardless of prior patient experience or the cytostatic agents administered. With doxorubicin regimens, betamethasone-dixyrazine gave full protection in 80% compared to 40% for metoclopramide. Cisplatin regimens were a greater challenge and protection against nausea and vomiting was achieved only in 27% with betamethasone-dixyrazine and in 18% with metoclopramide. Adverse reactions were a significant problem with metoclopramide: restlessness 33%, akathisia 19%, parkinsonism 16%, and acute dystonia 3%. Sedation was the same with the two regimens (80%).

Betamethasone-dixyrazine versus betamethasone-metoclopramide as antiemetic treatment of cisplatin-doxorubicin-induced nausea in ovarian carcinoma patients

In a prospective and randomized pilot study two antiemetic regimens comprising dixyrazine (240 mg) and metoclopramide (10 mg/kg) in high doses and given by continuous i.v. infusion were compared as means of preventing cisplatin-doxorubicin-induced nausead and vomiting. Twenty chemotherapy-naive women with the diagnosis of ovarian carcinoma stages III-IV (FIGO) were included in the study. Medium doses (50 mg/m2) of cisplatin and doxorubicin were used. The antiemetic drugs (the above-mentioned ones plus betamethasone 20 mg, and biperiden 5 mg) were administered by small portable infusion pumps during 24 hours. The effects and adverse reactions were evaluated during the course of chemotherapy and the first week thereafter. Complete protection from nausea during the first 24 hours was achieved in 80% by the metoclopramide cocktail and in 50% by the dixyrazine combination. During days 2-7 there were no significant differences between the two regimens. Vomiting was not satisfactorily prevented by either treatment. Sedation was significantly more common after dixyrazine than after metoclopramide but other recorded side effects were similar for the two antiemetic regimens. Serum concentrations of dixyrazine and metoclopramide were determined.

Increased antipanic efficacy in combined treatment with clomipramine and dixyrazine

A double-blind 12 week trial was undertaken to compare the effects of clomipramine + dixyrazine with clomipramine + placebo in the treatment of panic disorder with or without agoraphobia. Of 45 patients included (21 dixyrazine, 24 placebo), 16 dropped out (6 dixyrazine, 10 placebo). The number of panic attacks and the scores on the panic disorder subscale of the Hamilton Anxiety Rating Scale were significantly reduced in response to both treatment regimens, but the reduction was significantly greater in the dixyrazine group. The patients' daily functioning was significantly more improved with the dixyrazine combination. The serum concentration of desmethylclomipramine monotherapy was significantly higher and the side effects significantly lower in the combined treatment with dixyrazine than with clomipramine monotherapy. Clomipramine combined with dixyrazine seems superior to clomipramine in the treatment of panic disorder.