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At least 19 recordsLinked to original sources

PubMed1992

Continuation of long term treatment with hydroxychloroquine in systemic lupus erythematosus and rheumatoid arthritis.

BACKGROUND: Hydroxychloroquine is used for the treatment of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Long term studies have shown a high rate of termination of hydroxychloroquine treatment in patients with RA. Although it has been shown that discontinuation of treatment with hydroxychloroquine is associated with exacerbation of SLE, long term maintenance rates of treatment with hydroxychloroquine in patients with SLE have not been investigated. METHODS: Hydroxychloroquine use in patients with RA and SLE in a group of patients in a single community rheumatology practice was studied. Information was drawn from a computer drug use database containing details of the beginning and end of treatment. Data were analysed using life table methods. RESULTS: Four hundred and three treatment episodes (366 patients with RA, 37 patients with SLE) were observed over eight years. In patients with RA, the cumulative probability of discontinuing treatment was 37% at 12 months and 54% at 24 months. In contrast, hydroxychloroquine treatment of patients with SLE continued over significantly longer periods of time (p < 0.001); the discontinuation probabilities at 12 and 24 months were 8 and 24% respectively. Treatment terminations were predominantly for inefficacy; terminations for toxicity were limited to the first 19 months of treatment. No ocular toxicity was observed. CONCLUSIONS: Treatment of patients with RA in a community rheumatology practice with hydroxychloroquine has a low probability of long term continuation, mostly because of inadequate control of disease manifestations rather than toxicity. In patients with SLE, treatment with hydroxychloroquine has a significantly higher probability of long term continuation.

Adult↗

PubMed1988

Treatment of primary Sjögren's syndrome with hydroxychloroquine.

Sjögren's syndrome is an autoimmune disease characterized by lymphocytic infiltration of the salivary/lacrimal glands, autoantibody production, and polyclonal hyperglobulinemia. In view of the efficacy and relative safety of hydroxychloroquine in other autoimmune disorders, the potential benefit of hydroxychloroquine (200 mg per day for 12 months) in 10 patients with Sjögren's syndrome was evaluated. Changes in levels of total immunoglobulin, antibody against Sjögren's syndrome-associated antigen B, rheumatoid factor, and in vitro production of immunoglobulin in the serum were evaluated. For comparison, 10 patients matched according to age and sex, who did not receive hydroxychloroquine were studied. In the hydroxychloroquine-treated group, the following observations were made: (1) significantly decreased total immunoglobulin G (IgG) and IgA levels with little change in IgM levels; (2) significant decrease in IgA-rheumatoid factor with a smaller decrease in IgM-rheumatoid factor; (3) decreased IgG anti-Sjögren's syndrome-associated antigen B autoantibody; and (4) decreased erythrocyte sedimentation rate and increased hemoglobin level. Further, a specific idiotype present on their rheumatoid factor (defined by monoclonal antibody 17-109) was significantly decreased, with disappearance of detectable circulating paraprotein in two hydroxychloroquine-treated patients. Finally, rheumatoid factor production in vitro by lymphocytes from hydroxychloroquine-treated patients using a T cell-dependent mitogen was significantly decreased. These results suggest that hydroxychloroquine modulates lymphoproliferation in patients with Sjögren's syndrome and may prevent progression to extraglandular sites of neoplastic transformation.

Autoantibodies↗

PubMed1988

Hydroxychloroquine in steroid dependent asthma.

A recent case report suggested that hydroxychloroquine had a steroid sparing effect in a patient with severe chronic asthma. We have studied the effect of hydroxychloroquine in a group of nine steroid dependent adult asthmatic patients using a randomised double blind crossover comparison of hydroxychloroquine and placebo. Each patient received hydroxychloroquine (400 mg/day) or placebo for 2 month periods. The effect of hydroxychloroquine or placebo on asthma control was assessed by change in steroid dosage, visual analogue symptom scores, response to beta 2 agonist and peak expiratory flow rate (PFR) measurement. The dose of prednisolone required during hydroxychloroquine treatment did not differ from that during placebo treatment or in pre-trial period. There was no significant change in symptom scores of PFR measurement. In this study an 8 week treatment with hydroxychloroquine was of no benefit to patients with chronic steroid dependent asthma.

Adult↗

PubMed1990

Hydroxychloroquine in decompensated, treatment-refractory noninsulin-dependent diabetes mellitus. A new job for an old drug?

STUDY OBJECTIVE: To evaluate the usefulness and safety of hydroxychloroquine in patients with decompensated, treatment-refractory noninsulin-dependent diabetes mellitus. DESIGN: Prospective, randomized, placebo, double-blind 6-month trial. PATIENTS: Thirty-eight patients with noninsulin-dependent diabetes resistant to commonly used therapies (oral drugs, insulin, combination of insulin and oral drugs). INTERVENTIONS: Two study groups: one received insulin (n = 22) and the other, glibenclamide (n = 16). In each group, half of the patients were randomly allocated into two subgroups who continued the previous treatment but took either placebo tablets or hydroxychloroquine, 200 mg three times a day. The four subgroups were as follows: insulin and placebo (n = 11); insulin and hydroxychloroquine (n = 11); glibenclamide and placebo (n = 8); and glibenclamide and hydroxychloroquine (n = 8). MEASUREMENTS AND MAIN RESULTS: At 6 months, relevant and statistically significant improvement occurred in the 11 patients who received the insulin and hydroxychloroquine (glucose profile decrease, -11.7 mmol/L; 95% CI, -13.9 to -9.5, P = 0.001; glycated hemoglobin A1c decrease, -3.3%; 95% CI, -3.9 to -2.7, P = 0.001). No significant changes were seen in patients on placebo. The daily insulin dose in patients treated with the combined insulin and hydroxychloroquine therapy had to be reduced an average of 30%. No important side effects were detected. CONCLUSIONS: Combining antidiabetic therapy with hydroxychloroquine in decompensated, treatment-refractory patients with noninsulin-dependent diabetes may help to break the vicious circle of hyperglycemia and lead to better management of the disease.

Adult↗

PubMed1989

Bioavailability of hydroxychloroquine tablets in healthy volunteers.

1. Five healthy volunteers received, in a randomised crossover design study, a 155 mg oral tablet and an intravenous infusion of 155 mg racemic hydroxychloroquine (200 mg hydroxychloroquine sulphate) to assess the bioavailability of the commercially available tablet (Plaquenil, Winthrop Laboratories, Australia). 2. The terminal elimination half-life of hydroxychloroquine is more than 40 days, thus blood and urine samples were collected for 5 months following each dose to characterise adequately the terminal elimination phase and obtain accurate estimates of the areas under the concentration-time curves. 3. The mean (+/- s.d.) fraction of the oral dose absorbed, estimated from the blood and urine data, was 0.74 (+/- 0.13). A wide range of estimates of the fraction of the oral dose absorbed was calculated from the plasma data (0.41 - 1.53), reflecting the difficulties of accurate measurement of hydroxychloroquine in plasma. 4. A period of 6 months is required to achieve 96% of steady-state levels of hydroxychloroquine with the usual once daily, oral dosage regimen. Pharmacokinetic factors may thus be partly responsible for the delayed action of the drug in rheumatic conditions. 5. Haemodialysis will not aid in the case of oral overdose with hydroxychloroquine. Although the proportionate increase in clearance may be large, the increase in the fraction of the dose excreted will be negligible. The extensive sequestration of the drug by tissues limits effectiveness of haemodialysis.

Biological Availability↗

PubMed1991

A randomized study of the effect of withdrawing hydroxychloroquine sulfate in systemic lupus erythematosus.

BACKGROUND: The antimalarial drug hydroxychloroquine is thought to be effective in controlling some of the manifestations of systemic lupus erythematosus, but its effectiveness has not been demonstrated conclusively. METHODS: We conducted a six-month, randomized, double-blind, placebo-controlled study of the effect of discontinuing hydroxychloroquine sulfate treatment in 47 patients with clinically stable systemic lupus erythematosus. The patients were randomly assigned to continue their same dose of hydroxychloroquine (n = 25) or to receive placebo (n = 22) for 24 weeks. Ten patients in each group were also taking prednisone. RESULTS: The relative risk of a clinical flare-up, defined as the development of specific clinical manifestations of systemic lupus erythematosus or an increase in their severity, was 2.5 times higher (95 percent confidence interval, 1.08 to 5.58) in the patients taking placebo than in those continuing to take hydroxychloroquine (16 of 22 patients vs. 9 of 25 had flare-ups), and the time to a flare-up was shorter (P = 0.02). The relative risk of a severe exacerbation of disease that required withdrawal from the study was 6.1 times higher (95 percent confidence interval, 0.72 to 52.44) for the patients taking placebo (5 of 22 patients vs. 1 of 25 had severe exacerbations of disease). Changes in the dose of prednisone were not different in the two groups. CONCLUSIONS: Patients with quiescent systemic lupus erythematosus who are taking hydroxychloroquine are less likely to have a clinical flare-up if they are maintained on the drug.

Adult↗

PubMed1992

Bioavailability of hydroxychloroquine tablets assessed with deconvolution techniques.

Four deconvolution methods (staircase, delta function, and least squares methods using single and sequential first-order input functions) were used to assess the absolute bioavailability of hydroxychloroquine tablets in nine healthy fasting volunteers. The volunteers received, in a random crossover design, a 155-mg oral tablet and a 155-mg iv infusion of racemic hydroxychloroquine. The mean fractions of the dose absorbed, calculated using the four deconvolution methods, were not statistically different (p = 0.70). The mean fraction absorbed (+/- SD) was 0.67 +/- 0.12, which was not significantly different from that reported previously in a conventional bioavailability study (p = 0.22). The mean absorption half-life was calculated to be 4.0 +/- 1.3 h. The mean lag time before absorption commenced was 0.57 +/- 0.30 h. The fraction of the dose absorbed ranged from 0.44 to 0.86. Low and/or variable bioavailability of hydroxychloroquine may be a cause of therapeutic failure in some patients. Validation of the deconvolution methods means that these techniques may now be used to assess the bioavailability of hydroxychloroquine in patients. An advantage of these methods is that samples need only be collected over the expected time period of absorption, rather than the whole time drug can be detected in the body, as is required in conventional area under the concentration-time curve ratio methods. Deconvolution studies may be completed in 2 weeks rather than the 10 months required for a conventional bioavailability study of hydroxychloroquine.

Adult↗

PubMed1988

Hydroxychloroquine treatment of rheumatoid arthritis.

A variety of placebo-controlled and open studies have demonstrated the effectiveness of hydroxychloroquine in the treatment of rheumatoid arthritis. The excellent responses to recurrent treatment in a sample patient illustrate the value of hydroxychloroquine. Because low daily doses of hydroxychloroquine are associated with greater ophthalmologic safety, it would be advantageous to use the smallest effective daily dose, but there are no published controlled efficacy studies using daily doses of less than 400 mg. Hydroxychloroquine may best be employed to treat patients with new onset of disease or those in whom disease is not rapidly progressive. Great potential exists for the use of hydroxychloroquine in combination therapy, but optimal utilization of combination regimens will require performances of additional controlled studies.

Anti-Inflammatory Agents↗

PubMed1992

High-dose hydroxychloroquine treatment of porphyria cutanea tarda.

BACKGROUND: High-dose hydroxychloroquine is rarely used in the treatment of porphyria cutanea tarda (PCT). OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of a novel high-dose hydroxychloroquine regimen in patients with PCT. METHODS: Sixty-five first episodes and 28 recurrent episodes of PCT were treated with hydroxychloroquine, 250 mg three times daily, for 3 days. In patients with a high urine porphyrin concentration a single phlebotomy of 500 ml was performed before therapy of the first episode. Modified high-dose hydroxychloroquine regimens were used in patients with markedly elevated liver transaminases with or without associated chronic liver disease. RESULTS: Long-term follow-up data showed an overall relapse rate of 33%, significantly higher among male patients (45%) than among female patients (17%) (p less than 0.05). A transient hepatotoxic reaction occurred in the majority of patients. The reaction seemed to be especially severe among phlebotomized female patients. CONCLUSION: Hydroxychloroquine, 250 mg three times daily, is a rapid, efficacious, and safe treatment in patients with PCT.

Alkaline Phosphatase↗

PubMed1991

Hydroxychloroquine retinopathy.

We analyzed ocular findings from two patients (aged 49 and 60 years) with hydroxychloroquine (Plaquenil, Winthrop Pharmaceuticals, Division of Sterling Drug, Inc., New York, New York) retinopathy. Both patients were treated for systemic lupus erythematosus; one patient was treated with 400 to 800 mg of hydroxychloroquine per day (6.1 to 12.2 mg/kg of body weight/day) over a ten-year period. Cumulative doses were 1,788 and 2,920 g, respectively. Neither patient had ever been treated with chloroquine. One patient complained of glare and difficulty in adjusting to changes in illumination, whereas the other was asymptomatic. Both had bilateral visual acuities of 20/25, pericentral scotomata, and increased final dark-adapted rod thresholds in the two retinal areas that were tested. Fullfield electroretinograms were reduced and delayed, and focal cone electroretinography showed abnormal foveal responses as well. Ophthalmoscopy and fluorescein angiography showed a bull's-eye maculopathy in both eyes of one patient and perifoveal depigmentation in both eyes of the other patient. Retinal function remained stable at follow-up examinations 18 to 24 months after the cessation of hydroxychloroquine treatment. These two cases demonstrate that peripheral retinopathy, as well as maculopathy, can develop in patients who are treated with hydroxychloroquine for systemic lupus erythematosus, and that retinal function may remain stable after discontinuation of hydroxychloroquine treatment.

Electroretinography↗

PubMed1992

Treatment of cutaneous lupus erythematosus with acitretin and hydroxychloroquine.

A randomized, double-blind, multicentre study was performed to compare the efficacy of acitretin (50 mg/day) with hydroxychloroquine (400 mg/day) in 28 and 30 patients, respectively, suffering from cutaneous lupus erythematosus (LE). The study was carried out over an 8-week period. Improvement of facial LE lesions after treatment with acitretin and hydroxychloroquine was assessed using several clinical parameters. In the acitretin group there was marked improvement or clearing of erythema in 10/24 patients (42%), of infiltration in 15/24 (63%) and of scaling/hyperkeratosis in 12/20 (60%). In the hydroxychloroquine group there was complete clearing or marked improvement of erythema in 17/25 patients (68%), of infiltration in 17/25 (68%) and of scaling/hyperkeratosis in 15/23 (65%). Overall improvement occurred in 13/28 patients (46%) treated with acitretin and in 15/30 patients (50%) with hydroxychloroquine. The incidence of side-effects was higher in the acitretin group, and necessitated discontinuation of treatment in four patients. The present results demonstrate that both acitretin and hydroxychloroquine provide effective treatment in approximately 50% of cases of cutaneous LE.

Acitretin↗

PubMed1987

Hydroxychloroquine treatment of hypercalcemia in a patient with sarcoidosis undergoing hemodialysis.

Hypercalcemia developed in a patient undergoing long-term hemodialysis, and she was found to have noncaseating granulomas on lymph node biopsy. Hydroxychloroquine was administered as therapy for the hypercalcemia. Over 24 weeks of treatment with the drug, concentrations of calcium and 1,25-dihydroxyvitamin D returned to normal. The results demonstrate the capacity of hydroxychloroquine to inhibit the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D, and emphasize the efficacy of hydroxychloroquine as an alternate to corticosteroids in the treatment of hypercalcemia of granulomatous disease. Hydroxychloroquine may be preferred when existing skeletal disease, or a predisposition to osteopenia, provides relative contraindications to corticosteroid therapy.

Female↗

PubMed1989

Effects of hydroxychloroquine and sulphasalazine on progression of joint damage in rheumatoid arthritis.

The effects of hydroxychloroquine and sulphasalazine on progression of joint damage shown by X-rays were compared in a double-blind, randomised trial in 60 patients with rheumatoid arthritis not previously treated with slow-acting antirheumatic drugs. X-rays of the hands and feet at the start and after 24 and 48 weeks of treatment were available for 28 patients treated with hydroxychloroquine and 22 treated with sulphasalazine. Erosions and joint space narrowing were scored by a single observer unaware of treatment. At baseline there were no significant differences in demographic, clinical, or radiographic characteristics between the treatment groups. Patients withdrawn because of lack of effect were included in the analysis. The median number of erosions was lower in the sulphasalazine than the hydroxychloroquine group at 24 weeks of treatment (2.5 vs 10) and the difference was significant at 48 weeks (5 vs 16; p less than 0.02). The difference in median total score of joint damage was significant at 24 weeks (6.5 vs 17; p less than 0.02) and at 48 weeks (8 vs 33; p less than 0.02). The increase in number of erosions and total score was significantly greater in the hydroxychloroquine than the sulphasalazine group, both after 24 weeks and after 48 weeks of treatment.

Adult↗

PubMed1986

Penicillamine and hydroxychloroquine in the treatment of severe juvenile rheumatoid arthritis. Results of the U.S.A.-U.S.S.R. double-blind placebo-controlled trial.

One hundred sixty-two children with severe juvenile rheumatoid arthritis were entered in a randomized, double-blind, placebo-controlled 12-month clinical trial designed to establish the efficacy and safety of two slower-acting antirheumatic drugs, penicillamine and hydroxychloroquine. The study was a cooperative effort of the United States and the Soviet Union. One group of subjects received 10 mg of penicillamine per kilogram of body weight per day, another group received 6 mg of hydroxychloroquine per kilogram daily, and a third group received placebo. All three groups were allowed a single concurrent nonsteroidal antiinflammatory drug, but no other antirheumatic medications, including corticosteroids. All three groups had dramatic improvement in many of the clinical and laboratory outcome variables after one year of study. There were no significant differences in efficacy between the penicillamine and placebo groups. Pain on movement was the only index of articular disease that was alleviated more by hydroxychloroquine than by placebo. Serious adverse drug reactions attributable to the active agents were rare. We were unable to demonstrate that, in the presence of a nonsteroidal antiinflammatory drug, either penicillamine or hydroxychloroquine is superior to placebo in the treatment of children with juvenile rheumatoid arthritis.

Administration, Oral↗

PubMed1987

The prescribing of chloroquine and hydroxychloroquine by consultant rheumatologists in the UK.

A questionnaire on chloroquine and hydroxychloroquine prescribing was circulated nationally to 212 consultant rheumatologists and 119 replies were analysed. Of all patients receiving second-line drugs, 10% were prescribed antimalarials, with hydroxychloroquine being used four times more frequently than chloroquine. Eighty-five per cent of rheumatologists always used the same dose of hydroxychloroquine or chloroquine. Only 5% considered patient's weight in deciding the dose. Fear of ocular toxicity was expressed by many physicians; 54% had experienced corneal deposits; 4% retinopathy and 40% believed cumulative dose determined toxicity. Much confusion existed over the necessity for and frequency of ophthalmological monitoring. Only 56% requested ophthalmological tests before commencing treatment, although 86% monitored the eyes during therapy. Other side-effects were believed to affect 1-10% of patients, with no anticipated difference between doses of 250 mg chloroquine and 400 mg hydroxychloroquine daily.

Arthritis, Rheumatoid↗

PubMed1985

Hydroxychloroquine treatment and the eye.

The eyes of 63 patients, age range 28 to 79 years, affected by rheumatoid arthritis and undergoing long-term hydroxychloroquine treatment were followed from 3 to 95 months. The daily dose of hydroxychloroquine was 300 mg, and after 5 months there was a pause of one month in the treatment. The total amount of hydroxychloroquine received ranged between 27 and 630 g. In the eye examination only one patient had corneal changes, and another patient had suspected retinal damage. This is in agreement with earlier studies. Hydroxychloroquine seems to be a safe alternative among the antimalarial drugs as far as eyes are concerned.

Adult↗

PubMed1988

Hydroxychloroquine and postoperative thromboembolism after total hip replacement.

Evidence for the usefulness of hydroxychloroquine as prophylaxis against thromboembolism after total hip replacement is examined. This agent causes reduction in red blood cell aggregation without prolonging the bleeding time in humans and, experimentally, reduces the size of the thrombus. There is a variably demonstrable reduction in platelet aggregation and blood viscosity in humans. After hip replacement, the venographic incidence of deep vein thrombosis is not influenced by hydroxychloroquine. The incidence of fatal pulmonary embolism appears to be reduced, but a controlled trial against placebo does not exist. There are no serious or irreversible side effects, and wound healing is not affected by the administration of this drug. Hydroxychloroquine remains the prophylaxis of choice in use at the Hip Center, Wrightington Hospital, England, 13 years after its introduction.

Biomechanical Phenomena↗

PubMed1991

High-performance liquid chromatographic separation of the enantiomers of hydroxychloroquine and its major metabolites in biological fluids using an alpha 1-acid glycoprotein stationary phase.

An enantioselective two-stage off-line assay has been developed for the analysis of hydroxychloroquine and its three major metabolites in biological fluids. The first non-stereoselective stage of the assay (PRP-1 column) separates and quantitates parent drug and metabolites. Fractions containing hydroxychloroquine and each of the metabolites are collected manually, evaporated, reconstituted in mobile phase and re-injected onto an alpha 1-acid glycoprotein column to separate and determine proportions of individual enantiomers. Preliminary results from patients samples indicate that the disposition of hydroxychloroquine and its major metabolites is enantioselective. p6

Body Fluids↗