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PubMed1991

Treatment of lichen planus with acitretin. A double-blind, placebo-controlled study in 65 patients.

Sixty-five patients with lichen planus were included in a multicenter trial of acitretin. At the end of an 8-week placebo-controlled, double-blind phase, a significantly higher number of patients treated with 30 mg/day acitretin (64%) showed remission or marked improvement compared with placebo (13%). Furthermore, during the subsequent 8-week open phase, 83% of previously placebo-treated patients responded favorably to acitretin therapy. Typical retinoid adverse reactions were present in all patients on active drug. Laboratory studies did not show any clinically significant changes. This study shows that acitretin is an effective and acceptable therapy for severe cases of lichen planus.

Acitretin↗
PubMed1995

Simultaneous determination of etretinate, acitretin and their metabolites in perfusate, perfusate plasma, bile or hepatic tissue with reversed-phase high-performance liquid chromatography.

Etretinate is a synthetic aromatic retinoid used in the treatment of psoriasis and other disorders affecting the skin. Acitretin is the primary active metabolite of etretinate. The in situ perfused rat liver model was used to study the first-pass hepatic metabolism of etretinate and acitretin and a reliable method of quantifying etretinate and its metabolites was needed. Previously published assays allow for the simultaneous quantitation of etretinate and acitretin in blood or plasma. This paper describes an accurate and reliable reversed-phase HPLC method for the determination of etretinate, acitretin and their metabolites in whole perfusate, plasma, bile and hepatic tissue.

Acitretin↗
PubMed2002

Acitretin for prophylaxis of cutaneous malignancies after cardiac transplantation.

BACKGROUND: Heart transplant recipients have an increased risk of developing actinic keratoses and non-melanotic skin cancers when compared with the general population. Systemic retinoids have been shown to be beneficial in the treatment of such lesions in recipients of other organs, but as of yet the heart transplant model has rarely been studied. In this investigation we describe our experience with the use of acitretin in a group of heart transplant patients. METHODS: Five heart transplant recipients with multiple new skin cancer presentations were treated with acitretin at doses of either 10 or 25 mg/day. Inclusion criteria were based on progressive actinic keratoses, recurrent skin malignancies or continuous lesions despite treatment with appropriate topical therapies. Patients were excluded if they were women of child-bearing age, had severe hepatic or renal impairment or were taking contraindicated medications. RESULTS: Over the treatment period all patients showed a reduction in the number of new non-melanotic skin cancers excised and histologically confirmed. Three patients had a very large reduction and 2 patients had a more moderate reduction in the number of new presentations. All patients had an objective decrease in the number of actinic keratoses. All patients tolerated the drug well with only 1 patient transiently discontinuing the Acitretin due to side effects. No significant alterations in the biochemical tests or serum lipids were reported. CONCLUSIONS: Over the treatment period, low-dose acitretin proved a valuable addition in the long-term strategy of reduction and treatment of non-melanotic skin cancers in heart transplant recipients with multiple skin cancers and actinic keratoses.

Acitretin↗
PubMedDate not supplied

Treatment of hyperkeratotic dermatitis of the palms (eczema keratoticum) with oral acitretin. A single-blind placebo-controlled study.

Hyperkeratotic dermatitis of the palms--also called eczema keratoticum--is a chronic, sometimes disabling condition in middle-aged persons. We carried out a single-blind, placebo-controlled study using acitretin in 29 patients. Fourteen patients received active therapy (30mg acitretin daily) and 15 placebo. All had hyperkeratotic changes of the palms with painful fissures and most had involvement of the volar aspects of their fingers. Approximately half of the patients had similar plantar changes. A semi-quantitative score of six parameters was used: hyperkeratosis, fissuring, scaling, itch, redness and vesicle count. After 4 weeks of treatment, a 51% reduction of all symptoms was observed among patients receiving acitretin (p < 0.01) compared with a 9% reduction in the placebo group (p>0.05). No further improvement was seen over another 4 weeks of treatment. There were no changes in blood biochemistry, including serum lipids. No patients discontinued therapy because of side effects. We conclude that 30 mg of acitretin is efficacious and safe to use in patients with hyperkeratotic dermatitis of the palms.

Acitretin↗
PubMedDate not supplied

Effects of short-term oral acitretin therapy on peripheral nerve function: a prospective neurological and neurophysiological study.

The aim of the present prospective study was to substantiate possible side effects of short-term oral acitretin therapy (1 mg/kg/day) on peripheral nerve function of 13 patients with severe keratinization disorders. Clinical neurological examination before and 1 and 3 months after onset of treatment was unremarkable in all patients; however, a significant alteration of one or more neurophysiological, predominantly sensory, parameters was demonstrated in 3 out of 13 patients (23%) after 1 month and in 9 out of 13 (69%) after 3 months of oral acitretin therapy. These findings indicate that oral acitretin might be capable of causing a dysfunction of predominantly sensory nerve fibres in some individuals. Although in the investigated patients this dysfunction remained subclinical, it seems reasonable to suggest that neurological and neurophysiological evaluation of peripheral nerves should be added to the list of investigations that are routinely performed in patients receiving oral acitretin.

Acitretin↗
PubMed2004

Single-center retrospective study of long-term use of low-dose acitretin (Soriatane) for psoriasis.

BACKGROUND: Indicated as monotherapy for severe psoriasis in adults, acitretin (Soriatane) can be used in combination therapy or as a 'disease-stabilizing, maintenance' agent. While its efficacy for psoriasis and other disorders of keratinization is well established, its safety is often a concern for many dermatologists. The possible side effects associated with short-term treatment of oral retinoids include mucocutaneous effects, elevation in serum lipid chemistries and liver enzymes, and teratogenicity. However, the only possible long-term, cumulative side effect is skeletal and ligamentous calcification such as hyperostosis. There is a specific syndrome of hyperostosis associated with oral retinoids called DISH (diffuse idiopathic skeletal hyperostosis). OBJECTIVE: To examine the incidence of DISH syndrome in long-term acitretin use for psoriasis and to quantify the incidence of other side effects. METHODS: All patients seen at the UCSF Psoriasis and Skin Treatment Center who had been on acitretin for more than 1 year were identified. RESULTS: A chart review of these patients revealed no X-ray-confirmed cases of DISH syndrome, minimal changes in coronary heart disease risk indicators, and extremely rare significant elevation of liver enzymes. CONCLUSION: Acitretin does not appear to cause significant long-term side effects at low doses; the implications for thousands of patients are that use of this medication can be continued for long periods of time with routine monitoring.

Acitretin↗
PubMed1991

Effects of 13-cis-retinoic acid, all-trans-retinoic acid, and acitretin on the proliferation, lipid synthesis and keratin expression of cultured human sebocytes in vitro.

The aim of this study was to determine the effects of 13-cis-RA, all-trans-RA, and acitretin on the proliferation, lipid synthesis, and keratin expression of human sebocytes in vitro and to elucidate possible mechanisms of retinoid action on sebaceous glands at the cellular level. It was found that 13-cis-RA and all-trans-RA decreased sebocyte proliferation in a dose- and time-dependent manner, with a 13-cis-RA-IC50 of 10(-5) M (after 7 d) and 10(-6) M (after 14 d) and an all-trans-RA-IC50 of 10(-7) M (after 14 d; no IC50 after 7 d). Acitretin inhibited sebocyte proliferation only at 10(-5) M. Furthermore, 13-cis-RA was the most potent inhibitor of acetate incorporation into lipids, which indicated lipid synthesis (48.2% reduction), followed by all-trans-RA (-38.6%), and by acitretin (-27.5%). All retinoids tested markedly decreased the synthesis of triglycerides, wax/stearyl esters, and free fatty acids in cultured sebocytes, whereas squalene synthesis remained uninfluenced and cholesterol synthesis slightly increased. On the other hand, keratin 5 was down-regulated, keratin 17 was up-regulated, and the expression of keratin 13 was virtually unaffected by all retinoids tested. Keratins 6 and 16 were down-regulated by 13-cis-RA and by all-trans-RA, keratin 14 was down-regulated by 13-cis-RA only, and keratin 19 was up-regulated by all-trans-RA. These investigations indicate that 13-cis-RA and, to a lesser extent, all-trans-RA are potent inhibitors of both cell proliferation and lipid synthesis in human sebocytes in vitro, whereas acitretin only decreases lipogenesis in this model. In addition, retinoids may modify the differentiation of sebocytes in vitro by modulating keratin expression. Models of cultured human sebocytes are useful tools for further investigations on the sebaceous gland and its activity at the cellular level.

Acitretin↗
PubMed1993

Clinical efficacy and side effects of acitretin on the disorders of keratinization: a one-year study.

Acitretin, Ro 10-1670, the principal and free acid metabolite of etretinate, was used to treat twenty patients with disorders of keratinization. An open, prospective study of clinical efficacy, tolerability, and the effects of acitretin on lipid metabolism, hepatic function, and the osteoarticular system was performed over a one year period. Each patient was initially treated with 30 mg/day of acitretin or approximately 0.6 mg/kg/day. Doses were adjusted according to the clinical efficacy and maintained for one year. There were no statistically significant changes in liver function tests or lipid profile. Twelve of eighteen evaluated patients developed asymptomatic skeletal changes; the most common change was disc space narrowing, especially at thoracic-spine level (7 of 18 patients). The earliest bone change was detected 9 months after treatment. Acitretin is effective in improving the disorders of keratinization with mild mucocutaneous side effects and asymptomatic osteoarticular changes.

Acitretin↗
PubMed1989

Pharmacokinetics of acitretin and its 13-cis metabolite in patients on haemodialysis.

1. Plasma concentrations of acitretin and its metabolite (13-cis acitretin) were measured in six patients on haemodialysis and six subjects without renal failure following a single oral dose of 50 mg of acitretin. 2. The mean areas under the plasma concentration vs time curves of acitretin and its metabolite were about 50% lower in patients on haemodialysis. 3. No retinoids were detectable in the dialysate.

Acitretin↗
PubMed1992

The distribution of cis- and trans-acitretin in human epidermis.

The concentrations of trans-acitretin and its principal metabolite, cis-acitretin, were measured by h.p.l.c. after single and multiple dosing (50 mg orally for 13 days) in plasma, blister fluid and epidermal samples from four healthy male volunteers. Within-day epidermal concentrations of trans-acitretin exceeded those of the cis-form which were at the limit of assay sensitivity. No accumulation of trans-acitretin was observed in plasma or blister fluid but AUC values for the drug in blister roof cells tended to be higher after multiple dosing.

Acitretin↗
PubMed1988

Acitretin and etretinate in the treatment of palmoplantar pustulosis: a double-blind comparative trial.

Sixty patients with palmoplantar pustulosis were treated in a double-blind trial with either acitretin (etretin, Ro 10-1670) or with etretinate. The study consisted of 4 weeks of therapy with three 10 mg capsules/day followed by 8 weeks of therapy with a varying number of capsules given daily according to therapeutic response. At the end of the 12-week treatment period, the mean number of pustules (+/- SEM) had decreased from 57.8 (+/- 8.6) to 3.9 (+/- 1.6) in the acitretin group and from 57.1 (+/- 14.1) to 5.7 (+/- 2.7) in the etretinate group. With regard to influence on erythema, infiltration, scaling, and area involved, similar improvements were obtained in both treatment groups. Adverse reactions of the hypervitaminosis A type were observed with almost the same frequency and severity in both treatment groups. The mean number of 10 mg capsules used daily was comparable in the two groups: 2.82 (range 1.23-4.67) for acitretin and 2.77 (range 1.60-4.82) for etretinate. It can be concluded that acitretin and etretinate do not significantly differ with regard to efficacy and overall safety in the treatment of patients with palmoplantar pustulosis.

Acitretin↗
PubMed1989

A double-blind comparison of acitretin and etretinate in combination with bath PUVA in the treatment of extensive psoriasis.

Thirty-four patients with extensive psoriasis were treated in a double-blind parallel fashion with either acitretin plus bath PUVA (trimethylpsoralen bath + UVA) or etretinate plus bath PUVA. Each group consisted of 17 patients. The dose of retinoid was 40 mg/day during the 2-week monotherapy phase and subsequently 20 mg/day during the combination treatment. Bath PUVA was given three times a week starting with a UVA dose of 0.06 J/cm2. Remission (greater than 90% improvement) was achieved in all patients in 6-10 weeks. There were no significant differences in clinical response between the two groups; the mean +/- SD PASI score (psoriasis area and severity index) before treatment was 22.6 +/- 7.1 in the acitretin-PUVA group and 19.4 +/- 7.8 in the etretinate-PUVA group. The corresponding figures after treatment were 0.6 +/- 0.6 and 1.0 +/- 0.5, respectively. Side-effects related to retinoid treatment were frequent in both groups but they were usually mild and well-tolerated. There was only one case of diffuse alopecia after 8 weeks in the etretinate-PUVA group. Scaling of the palms and soles was seen in six patients in the acitretin-group but only in two patients in the etretinate-group. Triglycerides were elevated in about half of the patients in both groups. The present study shows that acitretin is as effective as etretinate in the combination with bath PUVA.

Acitretin↗
PubMed1994

Acitretin in the treatment of lamellar ichthyosis.

Etretinate and its metabolite acitretin have been shown to be highly effective in the treatment of various disorders of keratinization, including lamellar ichthyosis. The aim of the present study was to provide further information on acitretin dosage regimens in the management of lamellar ichthyosis. Seven patients with classical manifestations of lamellar ichthyosis participated in the study. Five patients improved markedly, and the remaining patients showed mild to moderate improvement. Two patients improved following gradual incremental increase in dosage (> or = 35 mg/day). Four patients, including a patient with the erythrodermic variant, required low-dose acitretin treatment (< or = 25 mg/day), as higher doses resulted in a marked deterioration in their skin condition. The dichotomy with respect to the response to acitretin suggests that lamellar ichthyosis is a spectrum of at least two conditions.

Acitretin↗
PubMed1994

Acitretin biotransformation into etretinate: role of ethanol on in vitro hepatic metabolism.

The aim of this study was to investigate the possible esterification of acitretin into etretinate by using hepatocytes in primary culture from the rat, monkey, dog and man. With rat and human hepatocytes, etretinate was detectable only when ethanol was co-administered with acitretin. With monkey and dog cells, traces of etretinate were found without ethanol addition, but the esterification of acitretin was highly enhanced by ethanol. The metabolic profile was not changed when cells were pre-incubated with ethanol. Therefore acitretin seems to act rather as a substrate than an enzymatic inducer.

Acitretin↗
PubMed1990

Acitretin in the treatment of erythrokeratodermia variabilis.

A patient with erythrokeratodermia variabilis (Mendes da Costa's disease) is presented, and the clinical and histological response to acitretin is described. An initial dose of 35 mg of acitretin and a maintenance dose of 25-35 mg resulted in a pronounced and sustained improvement. Further reduction of the dosage resulted in a relapse within a few days. At the histological level the extensive hyperkeratosis and the moderate dermal inflammatory infiltrate decreased during treatment with acitretin. In comparison with the other retinoids available so far, acitretin is the derivative of first choice in the treatment of erythrokeratodermia variabilis Mendes da Costa.

Acitretin↗
PubMed1989

Lack of effect of acitretin on the hypothrombinemic action of phenprocoumon in healthy volunteers.

A possible influence of the aromatic retinoid acitretin on the hypothrombinemic action of phenprocoumon was investigated in 10 healthy male volunteers, 22-33 years of age. In a run-in period of 17 days the prothrombin complex activity (Quick) of the subjects was adjusted by individual doses of phenprocoumon (range 1.5-3 mg/day) to a therapeutic level of around 20% (INR = 3.6). Afterwards the dosage regimens were kept unchanged until day 40 when 60 mg oral vitamin K1 were administered. From day 18 to day 28 once daily doses of 50 mg acitretin were applied concurrently with phenprocoumon. The mean (+/- SD) prothrombin complex activity increased slightly and steadily from 19 +/- 1% on day 10 over 22 +/- 1% on day 18 to 24 +/- 4% on day 28 and reached 27 +/- 4% on day 38 (the corresponding INRs were 3.30, 2.91, 2.71 and 2.46 respectively). There were, however, no relevant changes of the Quick values in any subject which could be attributed to acitretin. It can be concluded that, under the present experimental conditions, acitretin did not affect significantly the anticoagulant action of phenprocoumon.

4-Hydroxycoumarins↗
PubMed1988

Acitretin (Ro 10-1670, etretin): overall evaluation of clinical studies.

Acitretin (Ro 10-1670, etretin) is the free acid derivative of etretinate. This compound possesses a much shorter half-life of elimination than etretinate and was therefore proposed for clinical development. A total of 635 patients with various dermatoses were studied in 12 main clinical trials performed in Europe and in the United States. It was shown that acitretin is effective in the treatment of psoriasis and other diseases of keratinization. Doses between 25 and 35 mg per day are recommended to initiate treatment since marked improvement or clearing was obtained in the majority of patients within this range. Hypervitaminosis A signs and symptoms have been observed in patients treated with acitretin. It is concluded that the efficacy and safety profile of acitretin resembles that of etretinate.

Acitretin↗
PubMed1995

Effects of gemfibrozil (Lopid) on hyperlipidemia in acitretin-treated patients. Results of a double-blind cross-over study.

Hyperlipidemia is a common side-effect of oral retinoid treatment, which sometimes interferes with long-term therapy. To evaluate the safety and efficacy of the lipid-lowering drug gemfibrozil on retinoid-associated hyperlipidemia, we studied the clinical response and the plasma lipoprotein levels in 22 acitretin-treated (0.25-0.75 mg/kg) patients mainly suffering from psoriasis. Gemfibrozil or placebo was given in a double-blind cross-over fashion to 14 patients, who after 8 weeks of acitretin therapy and dietary advice exhibited hyperlipidemia (triglyceride levels > or = 50% above baseline and/or > or = 2.0 mmol/l). Serum triglycerides remained high (3.7 +/- 2.4 mmol/l) during placebo treatment but were reduced after 8 weeks of gemfibrozil treatment (p < 0.01). The total cholesterol level decreased slightly (p < 0.05) during gemfibrozil treatment, but the LDL/HDL ratio did not change significantly. No untoward effects of gemfibrozil on acitretin dose-response and clinical side-effects were noted. Gemfibrozil thus appears useful in patients prone to retinoid-induced hyperlipidemia unresponsive to dietary treatment and acitretin dose reductions.

Acitretin↗