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PubMed1990

Acitretin excretion into human breast milk.

Retinoid transfer into breast milk was studied in a psoriatric woman receiving oral acitretin at a dosage of 40 mg once daily. Concentrations of the parent compound and its main metabolite, 13-cis acitretin, were measured in serum and mature milk during the initial nine days of therapy, using reverse-phase high performance liquid chromatography. At steady-state, trace amounts of the drug and metabolite (30-40 ng/ml) appeared in breast milk corresponding to a milk/serum concentration ratio of about 0.18. Acitretin was almost exclusively distributed in the fatty layers of the milk. Although the estimated amount of the drug consumed by a suckling infant would correspond to only 1.5% of the maternal dose, the toxic potential of acitretin justifies its avoidance in breast-feeding women.

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PubMedDate not supplied

Evidence based or theoretical concern? Pseudotumor cerebri and depression as acitretin side effects.

Oral retinoids are among the first line agents for treatment of pustular and erythrodermic psoriasis, and they are effective in combination with phototherapy and other topical and systemic agents for the treatment of plaque psoriasis. Acitretin is the leading oral retinoid used today for the treatment of psoriasis. Recently, possible side effects such as pseudotumor cerebri and depression have gained a warning and precaution respectively on the acitretin package insert. This paper presents a review of the scientific literature and attempts to clarify whether warnings of these side effects have arisen from a scientific evidence base or from theoretical concern/class labeling. A paucity of scientific evidence was found in this review for acitretin-associated pseudotumor cerebri and depression. The authors conclude that these 2 acitretin side effects must be further investigated to assess whether these associations are scientifically certain or if class labeling has led to inclusion in the package insert.

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PubMed1989

Acitretin induces an increased adherence of S. aureus to epithelial cells.

Recently, synthetic retinoids have been implicated as causing a rise in the incidence of staphylococcal infections in patients orally treated with these compounds for various disorders of keratinization. Since the adherence of bacteria to epithelia is an important early event in the development of bacterial infections, in the present study we investigated the in vitro effects of acitretin on the adherence of Staphylococcus aureus to epithelial cells of the anterior nares of 15 healthy human subjects. It was found that pre-incubation of nasal epithelial cells with acitretin causes a statistically significant (p less than 0.001) increase in the adherence of S. aureus to these cells, as compared to the controls. The growth of S. aureus cultures in the presence of acitretin exerted no effect on the staphylococcal adherence. These results suggest that the oral acitretin-induced increase in S. aureus colonization and in the incidence of cutaneous staphylococcal infections may be related to the enhancement of staphylococcal adherence to epithelia caused by this compound.

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PubMedDate not supplied

Disposition of [14C]acitretin in humans following oral administration.

The disposition of the antipsoriatic agent, acitretin, was investigated in six healthy human volunteers who each received a single, oral 50 mg dose of [14C]acitretin (50 microCi). plasma, urine, and feces were collected for 240 hr after administration. Mean values of 20.9 and 62.6% of the administered dose were recovered in the urine and feces, respectively. The terminal elimination half-life of total radioactivity from the plasma was approximately 120 hr. Extraction of pooled plasma samples followed by separation by HPLC and quantitation by liquid scintillation counting indicated that acitretin and its 13-cis-isomer, isoacitretin, were minor fractions of the total drug-related material in the plasma at most time points up to 72-hr postdose. The structures of acitretin, isoacitretin, and two other metabolites--(5E,7E)-8-(4-methoxy,2,3,6-trimethylphenyl)-2,6 -dimethyl-5,7- octadienoic acid (I) and (5E,7E)-8-(4-hydroxy-2,3,6-trimethylphenyl)-2,6-dimethyl-5,7 -octadienoic acid (II)--were confirmed by MS and cochromatography with authentic standards. I and II were major fractions of the drug-related material in the plasma at all time points. Other compounds, whose structures could not be confirmed, also account for a significant fraction of the circulating radioactivity.

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PubMed1993

[Chronic blepharoconjunctivitis during a treatment with acitretin (Soriatane)].

We report external ocular side effects after treatment with acitretin, a new synthetic vitamin A analogue and the main metabolite of etretinate. A patient treated with 20-25 mg/day of acitretin for psoriasis suffered from chronic blepharoconjunctivitis. Schirmer tests, tear lysozyme were normal while rose bengal and fluorescein staining disclosed epithelial punctate defects and tear break-up time was shortened. Meibomian glands of the lower lid were photographed with transillumination and appeared atrophic. Conjunctival cytology and biopsy showed snake-like chromatine appearance, keratinized epithelial cells and some lymphocytes infiltrates. Accessory salivary gland histological aspects were nonspecific. There was a clear relationship between restarting the acitretin therapy and recurrence of ocular symptoms. Acitretin, like other retinoids, may induce or exacerbate blepharoconjunctivitis in patients with psoriasis.

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PubMed2003

Efficacy of acitretin and commercial tanning bed therapy for psoriasis.

OBJECTIVE: To assess the efficacy of acitretin and commercial tanning bed therapy for the treatment of moderate to severe chronic plaque-type psoriasis. DESIGN: Retrospective medical record review and telephone survey of subjects and prospective open-label trial. SETTING: University dermatology clinic. PATIENTS: The study population comprised 26 subjects in the retrospective study and 17 subjects in the prospective study, all with moderate to severe plaque-type psoriasis. INTERVENTION: Twelve weeks of daily oral acitretin (25 mg) therapy and commercial tanning bed UV exposure (mean UV-B output of 4.7%) for 4 to 5 days per week. RESULTS: In the retrospective review, 19 (83%) of 23 subjects had clearance or near clearance, 2 (9%) of 23 had moderate improvement, and 2 (9%) of 23 had no improvement. Patients reported a high degree of satisfaction with the treatment. In the prospective trial, the Psoriasis Area and Severity Index (PASI) and National Psoriasis Foundation scores decreased an average of 78.6% and 79.0% from baseline, respectively. A reduction from baseline in the PASI score of 50% and 75% (PASI 50 and PASI 75) was achieved by 13 (76%) and 10 (59%) patients, respectively. Adverse events were generally mild to moderate. CONCLUSIONS: Acitretin use in combination with commercial tanning bed therapy appears to be effective and useful for psoriasis in areas without access to physician-directed phototherapy. The variability of tanning salon light and quality mandates caution when using this therapy.

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PubMed2005

Single crystal and powder diffraction characterization of three polymorphic forms of Acitretin.

Acitretin [all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid or 3-methoxy-2-methyl-17-nor-1,2,3,4-tetradehydroretinoic acid], a widely marketed oral synthetic retinoid, introduced for clinical use as effective therapy against psoriasis, was found to crystallize in three polymorphic modifications (hereafter, I, II, and III), the crystal structures of which have been determined by single-crystal diffractometry (form I) or X-ray powder diffraction methods (form II and III) from conventional laboratory data only. In these latter cases, real space techniques (simulated annealing and whole-profile pattern matching) have been employed. Polymorph I crystallizes in space group P2(1), Z = 8, with unit cell parameters a = 7.894(1), b = 58.454(6), c = 8.161(1) angstroms, beta = 102.04(1) degrees, and V = 3682.9(8) angstroms3. Polymorph II crystallizes in space group P2(1)/n, Z = 4, with unit cell parameters a = 13.999(2), b = 10.714(1), c = 12.465(2) angstroms, beta = 98.76(5) degrees, and V = 1847.9(3) angstroms3. Polymorph III crystallizes in space group P2(1)/c, Z = 4, with unit cell parameters a = 3.0751(4), b = 4.0487(4), c = 14.956(2) angstroms, beta = 100.41(7) degrees, and V = 1831.3(4) angstroms3. Polymorph I, found to be identical with that deposited in the European Pharmacopeia, shows four crystallographically independent Acitretin molecules, arranged in pairs through conventional hydrogen-bonded carboxylic dimers; also in form II, carboxylic dimers are observed, located on crystallographic inversion centres, while in form III, a catameric arrangement of the carboxylic residues, winding up about the rather short monoclinic axis, generates one-dimensional chains of hydrogen-bonded Acitretin molecules. Thermal analysis showed that form I can be quantitatively transformed into form II by moderate heating near 200 degrees C, under vacuum. These results show that ab initio structural studies from conventional laboratory X-ray powder diffraction (XRPD) data are fully providing the opportunity to investigate the structural aspects of moderately complex substances also in the absence of single crystals, disclosing the crystal chemistry of a few polymorphs of pharmaceutically relevant species.

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PubMed1994

Communicating a drug alert. A case study on acitretin in The Netherlands.

In October 1990, a recall procedure was initiated for the teratogenic drug acitretin, and the recommended post-therapy contraception period after acitretin therapy was extended from 2 months to 2 years due to the possibility of its conversion to the lipophilic compound etretinate. The aim of the present study was to evaluate the communication procedures and their effects as a drug alert from the health authorities, the pharmaceutical company and professional associations of health professionals to the population at risk. A model was used to evaluate communication between three hierarchical levels. Data were obtained via semi-structured interviews and structured questionnaires. Communication procedures were evaluated according to channel characteristics and by analysis of their contents. The effect was measured as whether the drug dispensers identified acitretin users, contacted physicians, and whether physicians communicated in person with the population at risk. The penetration of direct mail from the health authorities and from the pharmaceutical company ranged from 97-98% and 65-94% at Level 2 (health professionals). The population at risk was informed via personal communication with health professionals, and/or the mass media. Of the women at risk, 19% were contacted by a dermatologist, 30% by their GP, and 39% by the pharmacist. 35% was never informed by any health professional. The Dutch health care system is adequately equipped for effective communication between health authorities, pharmaceutical industry and health professionals.(ABSTRACT TRUNCATED AT 250 WORDS)

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PubMed1995

The role of pharmacists in the recruitment of a cohort for postmarketing surveillance. A case study of acitretin in The Netherlands.

In October 1990, a recall procedure was issued regarding the drug acitretin. The recommended post-therapy contraception period after acitretin therapy was extended from 2 months to 2 years. For a postmarketing surveillance study, we recruited a cohort from the source population of women aged 15-45 years who were exposed to acitretin. Recruitment occurred through dermatologists, and pharmacists plus dispensing general practitioners. We describe the speed of and the response to the recruitment procedures, and the representativeness of the recruited cohort. We also studied whether the individuals who gave informed consent would have preferred to be recruited by either dermatologists or pharmacists, and whether the information obtained from pharmacists and dispensing general practitioners was valid. This study revealed that pharmacists and dispensing general practitioners (drug dispensers) recruited their subjects rapidly, with no or little selection; they attained a 42% response. Dermatologists recruited their subjects slowly and selectively; they attained a 24% response. The majority of women (60%) recruited by dermatologists would have given their informed consent if they would have been recruited by their pharmacists. Drug dispensers are essential contributors to the recruitment of a study population. We do advise that such recruitment for a postmarketing surveillance study occurs by means of a collaboration between pharmacists and physicians.

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PubMed1995

Mechanistic studies on the ethyl-esterification of acitretin by human liver preparations in vitro.

Studies have been performed with human liver microsome preparations in vitro, to investigate the reaction mechanisms involved in the conversion of acitretin to the corresponding ethyl ester, etretinate. The results indicate that: Three fresh samples of human liver, which had been stored in liquid nitrogen for up to 8 months, all produced traces of etretinate (5.8 +/- 0.8 ng/ml) in the presence of ethanol but not when the acitretin was added in acetone, or when the sample was denatured by preheating. Studies with pooled human liver microsomes, to identify the cellular location of the enzymes and the co-factors involved in this esterification, indicate a primary requirement for both ethanol and CoA + ATP with a secondary potentiation in the presence of an NADPH regenerating system. A possible explanation for these finding is that the microsomal ligase enzymes form an intermediate ester between CoA and acitretin, which is then trans-esterified by the ethanol. The low formation with CoA + ATP may indicate that second stage of this process occurs spontaneously, with the NADPH potentiation suggesting that it could also be mediated enzymically.

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PubMed2005

Recurrent dysphonia and acitretin.

We report the case of a woman complaining of dysphonia while she was treated by acitretin. Her symptoms totally regressed after drug withdrawal and reappeared when acitretin was reintroduced. To our knowledge, this is the first case of acitretin-induced dysphonia. This effect may be related to the pharmacological effect of this drug on mucous membranes.

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PubMed1994

Acitretin in the treatment of severe lichen sclerosus et atrophicus of the vulva: a double-blind, placebo-controlled study.

BACKGROUND: Promising results have been reported from treatment with oral retinoids in patients with severe lichen sclerosus et atrophicus (LSA) of the vulva. OBJECTIVE: The aim of our study was to determine the efficacy of acitretin (20 to 30 mg/day) for 16 weeks in LSA. METHODS: Seventy-eight patients were enrolled into a multicenter, randomized, placebo-controlled, double-blind trial. The primary measure of efficacy was the "responder" rate based on the assessment of characteristic clinical features of LSA of the vulva (pruritus, burning, atrophy, hyperkeratosis, and secondary features such as erosions, ulcers, edema, or lichenification) and on the extent of the lesions. RESULTS: From the 46 patients eligible for efficacy analysis, a significantly higher number of responders was observed in the acitretin-treatment group (14 of 22 patients) as compared with the placebo-treatment group (6 of 24 patients). Typical retinoid adverse reactions were observed in all patients receiving active drug. CONCLUSION: Acitretin is effective in treating women with severe LSA of the vulva.

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PubMed1999

Acitretin combination therapy.

Systemic therapies used in psoriasis such as methotrexate, PUVA, cyclosporine, and acitretin often have side effects that limit their usefulness. Combination therapy, an effective strategy for treating psoriasis, allows use of lower doses of medications to achieve superior therapeutic results with fewer side effects. Acitretin is one of the most popular drugs used in combination with other systemic therapies for psoriasis. Details of the regimens used and results obtained from combining acitretin with PUVA, cyclosporine, and methotrexate are discussed.

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PubMed1999

Acitretin in combination with UVB or PUVA.

Combination therapy of psoriasis with acitretin and phototherapy (psoralen-ultraviolet A [PUVA] or ultraviolet B [UVB]) offers multiple advantages over use of either modality alone. As monotherapy, acitretin in doses of 50 mg/day is moderately effective, but is associated with numerous side effects. Single modality treatment with UVB or PUVA involves multiple visits over a period of months and is also associated with dose-limiting side effects. When used in combination, lower doses of both modalities can be used more effectively, helping to reduce side effects. In addition, clearing occurs much more quickly, reducing treatment time and number of phototherapy visits. Moreover, patients whose psoriasis does not clear with monotherapy will often achieve significant clearing with the combination of acitretin and phototherapy.

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PubMed1999

Skin cancer chemoprophylaxis in renal transplant recipients: 5 years of experience using low-dose acitretin.

Renal transplant recipients have an increased risk of developing skin cancers, which are often multiple and aggressive. Frequently, these tumours develop on a background of widespread epidermal dysplasia. Systemic retinoids are known inhibitors of skin cancer but reports of their use in renal transplant patients are limited. We describe our experience using 0.3 mg/kg daily of acitretin in 16 patients over a 5-year period. Overall, there was a significant reduction in the number of new tumours excised in 12 of 16 patients during treatment compared with the same pretreatment interval. A significant chemoprophylactic effect was shown for up to 4 years of treatment. Patients with five or more tumours prior to acitretin benefited most. Two patients discontinued treatment because of side-effects and two patients developed hyperlipidaemia. Two patients with end-stage graft failure proceeded to haemodialysis. The introduction of low-dose acitretin proved to be a useful strategy in the long-term reduction of skin cancer in renal transplant recipients with multiple skin cancers and extensive epidermal dysplasia.

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PubMed2002

Treatment of arsenical keratosis and Bowen's disease with acitretin.

BACKGROUND: Long-term exposure to arsenic is associated with the development of arsenical keratosis, Bowen's disease, squamous cell carcinoma, and basal cell carcinoma. The efficacy of acitretin therapy was examined in two patients with cutaneous arsenical neoplasms. METHODS: Lipid profile, hematological and liver function tests were performed regularly during the therapy at monthly intervals. RESULTS: After the third month of treatment, improvement of lesions of arsenical keratosis and Bowen's disease were observed in both patients. For the first patient who received 1 mg/kg daily acitretin for 10 months nearly total clearing was obtained at the end of therapy. The second patient discontinued the treatment after a period of 5 months because of symptomatic side-effects. During therapy no new lesions and no laboratory side-effects were observed in either patient. CONCLUSIONS: Although these results need to be confirmed by larger, long-term trials, it appears that acitretin is effective in the treatment of Bowen's disease related with arsenic, as well as arsenical keratosis.

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PubMed2001

Consensus conference: acitretin in combination with UVB or PUVA in the treatment of psoriasis.

Although adjunctive treatment with retinoids in concert with either psoralen-ultraviolet A (PUVA) or ultraviolet B (UVB) phototherapy has been a treatment option for chronic, moderate to severe plaque psoriasis for nearly two decades, acitretin-UV therapy is an underutilized therapeutic modality. According to a recent member survey by the National Psoriasis Foundation, many psoriasis patients are frustrated with available treatment options, which they perceive as ineffective, inconvenient, and/or excessively conservative. Treatment of psoriasis with acitretin in concert with UVB or PUVA is emerging as a viable clinical strategy. Compared with either acitretin or UV light monotherapy alone, the combination regimen enhances efficacy and limits treatment frequency, duration, and cumulative doses. These effects translate into care that is more effective, better tolerated, more convenient, less costly, and, perhaps, safer during long-term treatment than phototherapy alone. Drawing from an extensive literature search and the expertise of its participants, this consensus conference advances clinical recommendations as well as "clinical pearls" for health providers who treat patients with chronic, moderate to severe plaque psoriasis and suggests avenues for future research.

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PubMed2003

Epidermodysplasia verruciformis with multiple mucosal carcinomas treated with pegylated interferon alfa and acitretin.

Epidermodysplasia verruciformis (EV) is characterized by abnormal genetically-determined susceptibility to widespread and persistent infection of the skin with human papillomaviruses (HPV). The infection results in disseminated pityriasis versicolor-like lesions and flat warts. Skin malignant changes are very common and occur on sun-exposed areas. Several treatments have been used but without consistent benefit. Recently, retinoids and alpha-interferon, alone or in combination, have been reported to be of value in the therapy of EV lesions. We present the case of a 43-year-old white female affected by EV who developed multiple squamous cell carcinomas in the oral and genital mucosae during the previous four years. Both wart and cancer lesions harbored HPV24 along with the novel putative HPV type FA51. The patient was treated with a combination of acitretin (0.2 mg/kg per day) and peginterferon alfa-2b (1 microg/kg per week s.c.) for one year, with marked improvement of verrucous lesions and no recurrence of mucosal cancer. Thereafter, interferon was stopped whereas acitretin therapy was continued, but a new Bowen's disease developed in the perianal region, and the acitretin dose was increased at 0.5 mg/kg per day. At six-month follow-up, only a low number of flat warts persisted, and no clinical signs of cutaneous or mucosal carcinoma were evident.

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