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Biomedical subjects

B H Stricker

Publications and source records attributed to B H Stricker.

At least 19 recordsLinked to original sources
PubMed1999

Minocycline and lupuslike syndrome in acne patients.

BACKGROUND: Recently several case reports described the association between minocycline and lupuslike syndrome. Minocycline, one of the tetracyclines, is widely used to treat acne. We aimed to examine the association of exposure to minocycline and other tetracyclines with the development of lupuslike syndrome. METHODS: We conducted a nested case-control study in a cohort of 27 688 acne patients aged 15 to 29 years, using data automatically recorded on general practitioners' office computers in the United Kingdom. Controls were matched to cases on age, sex, and practice. The main outcome was lupuslike syndrome defined as the occurrence of polyarthritis or polyarthralgia of unknown origin, with negative rheumatoid factor or latex agglutination test, positive or unmeasured antinuclear factor, elevated or unmeasured erythrocyte sedimentation rate, and absence of or unmeasured antinative DNA antibody levels. RESULTS: We identified 29 cases and selected 152 controls. Current single use of minocycline was associated with an 8.5-fold (95% confidence interval [CI], 2.1-35) increased risk of developing lupuslike syndrome compared with non-users and past users of tetracyclines combined. The risk of past exposure to any of the tetracyclines was closely similar to nonuse (relative risk, 1.3; 95% CI, 0.5-3.3). Current use of doxycycline, oxytetracycline, or tetracycline combined was associated with a 1.7-fold (95% CI, 0.4-8.1) increase of risk. The risk increased with longer use. CONCLUSION: Current use of minocycline increased the risk of developing lupuslike syndrome 8.5-fold in the cohort of young acne patients. The effect was stronger in longer-term users. However, the absolute risk of developing lupuslike syndrome seems to be relatively low.

Acne Vulgaris↗
PubMed1999

A population-based case-cohort study of drug-associated agranulocytosis.

BACKGROUND: Agranulocytosis is a life-threatening disorder, often caused by drugs. Incidences or risks of drug-induced agranulocytosis are not well known, since it is rare. METHODS: To determine the risk of drug-associated agranulocytosis as a reason for admission to Dutch hospitals, we performed a population-based case-cohort study. Hospital discharge data came from the Dutch Centre for Health Care Information, Utrecht, which contains data on all general and university hospitals in the Netherlands. The reference cohort consisted of all persons in the catchment area of the Pharmaco Morbidity Record Linkage System (PHARMO RLS) in the Netherlands, composing a population of approximately 220 000 to 484 000 persons from 1987 through 1990. All admissions during that period with agranulocytosis or related diagnoses were included in the study (n = 923). The potential causes of agranulocytosis were assessed in all cases classified as probable or possible agranulocytosis. RESULTS: Discharge summaries were received of 753 admissions, of which 678 contained enough information for analysis. Of the 678,108 were classified as "agranulocytosis probable" or as "agranulocytosis possible." In 75 of these 108 cases, agranulocytosis had been the reason for admission. Fifteen patients had used methimazole within 10 days before developing agranulocytosis; 2, carbimazole; 9, sulfasalazine; 8, sulfamethoxazole-trimethoprim; 4, clomipramine hydrochloride; and 2, dipyrone with analgesics, yielding adjusted relative risks of agranulocytosis of 114.8 (for thyroid inhibitors combined) (95% confidence interval [CI], 60.5-218.6), 74.6 (95% CI, 36.3-167.8), 25.1 (95% CI, 11.2-55.0),20.0 (95% CI, 6.1-57.6), and 26.4 (95% CI, 4.4-11.1), respectively. CONCLUSIONS: The highest relative risks were found for thyroid inhibitors, sulfamethoxazole-trimethoprim, sulfasalazine, clomipramine, and dipyrone combined with analgesics.

Adult↗
PubMed1999

Course of the international Normalized Ratio in response to oral vitamin K1 in patients overanticoagulated with phenprocoumon.

Oral vitamin K1 is used for the treatment of excessive anticoagulation. Detailed information on changes in the International Normalized Ratio (INR) in response to vitamin K1 is not available. We therefore measured the INR for the first 7 d following the oral intake of 1-5 mg of vitamin K1 in 24 patients routinely treated with phenprocoumon who had an INR > or =6.0 at presentation. On the first 2 d after administration of vitamin K1, the mean INR decreased by 40% and 23% respectively. After day 2, the day-to-day proportional change in the mean INR depended on the dose of vitamin K1 and varied from a decrease of 12% to an increase of 21%. On day 7 the mean INR was higher than on day 2 in three out of five treatment groups. Between day 2 and day 7, in general, 32% of the patients had an INR value within the target zone, 25% had an INR value > or =6.0 and 8% had an INR value <2.0. These findings suggest that our routine treatment of overanticoagulation in patients on phenprocoumon should be intensified to improve its efficacy.

Administration, Oral↗
PubMed1999

Heart failure treatments: issues of safety versus issues of quality of life.

Congestive heart failure is an important cause of morbidity and mortality in western countries. The profound impact that congestive heart failure has on life expectancy and quality of life has been a continuous stimulus for the development of new drugs for the treatment of this condition. Despite favourable effects on (aspects of) quality of life in short term studies, several of these new agents have been shown to reduce survival in mortality trials. However, patients with severe congestive heart failure may experience such incapacitating symptoms that the question should be raised as to whether an improvement in quality of life makes the increased risk of mortality associated with these new agents acceptable. Drugs which improve quality of life at the expense of an increased risk of mortality can be of value in the treatment of patients with severe congestive heart failure. However, this is only the case if the probability of improvement in quality of life and prolongation of life expectancy for those using the drug exceeds the probability of improvement in quality of life and prolongation of life expectancy for those not using the drug. Unfortunately, most clinical trials in which both mortality and quality of life are evaluated fail to provide information on this composite probability. Despite disappointing results of some recent mortality trials on new pharmacological treatments of congestive heart failure, sound and well designed clinical trials on innovative heart failure treatments in which these composite probabilities are also assessed should be carried out.

Heart Failure↗
PubMed1998

[Lipodystrophy and 'buffalo hump' during treatment with HIV protease inhibitors].

In three patients, a 36-year-old HIV seropositive homosexual man and two women aged 35 and 59 years who had acquired HIV infection through heterosexual contact, signs of lipodystrophy developed after prolonged anti-HIV triple therapy. The observed syndrome is seen after prolonged use of HIV protease inhibitors: it is characterized by peripheral fat wasting, central fat accumulation, hyperlipidaemia and insulin resistance. Typically the subcutaneous fatty tissue disappears resulting in prominent zygomata, veins and muscles and thinning of extremities and buttocks. In addition to abdominal fat accumulation, there have been reports on the occurrence of a dorsocervical fat pad, the so-called buffalo hump. Lipodystrophy caused by protease inhibitors is a risk factor for cardiovascular disease. Recognition of the syndrome is essential for adequate follow-up and possible treatment.

Adult↗
PubMed1998

[Acute hepatocytic necrosis during ketoconazole therapy for treatment of onychomycosis. National Foundation for Registry and Evaluation of Adverse Effects].

The imidazole derivative ketoconazole is approved in the Netherlands for treatment of local and systemic fungal infections. Despite the risk of major hepatic damage, this antimycotic drug is still being used in daily practice for the oral treatment of patients with onychomycosis. Since April 1986, 18 cases of relatively severe hepatic damage in the Netherlands were ascribed to the oral use of ketoconazole for the treatment of onychomycosis, skin infection or vaginal candidiasis. Given the potential risk for the patients concerned, ketoconazole should no longer be prescribed for relatively mild cosmetic disorders such as onychomycosis.

Adolescent↗
PubMed1998

[Cholestatic hepatitis ascribed to the use of thiabendazole].

Two women, aged 27 and 42 years, both born in Surinam and both suffering from heterozygous thalassemia, developed cholestatic hepatitis three and two weeks respectively after the start of a two-day course of thiabendazol for Strongyloides stercoralis infection. Other causes of cholestasis were unlikely in view of the results of blood tests, echography and the endoscopic retrograde cholangiopancreaticography. The symptoms persisted for several months, and the liver function disorders for 7 years and one year, respectively. The incidence of thiabendazole-induced cholestatic hepatitis is unknown, but probably low.

Adult↗
PubMed1998

NSAIDs associated with increased risk of congestive heart failure in elderly patients taking diuretics.

BACKGROUND: Both diuretics and nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used, in particular among the elderly. The use of NSAIDs may decrease the efficacy of diuretics and induce congestive heart failure (CHF) in patients treated with diuretics. OBJECTIVE: To investigate the risk of CHF associated with combined use of diuretics and NSAIDs in patients older than 55 years. METHODS: We conducted a study in a base cohort of 10,519 recipients of diuretics and NSAIDs identified in the PHARMO database during the period from 1986 through 1992. The incidence density of hospitalizations for CHF during exposure to both diuretics and NSAIDs (index) was compared with that during exposure to diuretics only (reference). RESULTS: We found an overall increased risk of hospitalization for CHF during periods of concomitant use of diuretics and NSAIDs compared with use of diuretics only (crude relative risk, 2.2; 95% confidence interval, 1.7-2.9). After adjusting for cofactors including age, sex, history of hospitalization, and drug use, a 2-fold increased risk remained (relative risk, 1.8; 95% confidence interval, 1.4-2.4). CONCLUSION: Use of NSAIDs in elderly patients taking diuretics is associated with a 2-fold increased risk of hospitalization for CHF, especially in those with existing serious CHF.

Aged↗
PubMed1998

[Neuropsychiatric adverse effects attributed to use of oxybutynin].

Since 1988, the Netherlands Pharmacovigilance Foundation Lareb and the Inspectorate for Health Care have received 17 reports of patients with neuropsychiatric adverse reactions attributed to the use of oxybutynin hydrochloride. These concerned 6 males and 11 females and 6 out of the 17 patients were children under the age of 13. In all cases patients had been treated according to a normal dosage regimen. Complaints included hallucinations, psychosis, concentration and orientation problems, apathy, listlessness, agitation, drowsiness and sleepiness. Symptoms improved or disappeared in all patients after dose reduction or withdrawal of oxybutynin.

Aged↗
PubMed1998

[Provision of taxoids in 1996: inequality of care].

OBJECTIVE: To inventory the utilization of taxoids in 1996. METHODS: A survey was conducted in february 1997 among the medical heads of 130 Dutch hospitals. The questions about the use of taxoids (paclitaxel and docetaxel) in 1996 concerned indications, numbers of patients treated, the funding and possible financial restrictions on the treatment. Three weeks after the mailing of the questionnaire, a reminder was sent to hospitals that had not responded. The data from 120 hospitals where oncological care was administered were analysed. RESULTS: Of the 120 hospitals, 111 (92.5%) returned the questionnaire, from 114 locations. Twelve locations reported not having used taxoids, four of them partly for financial reasons. Taxoids had been used at 102 locations: at the expense of the hospital budget at 101 locations, and exclusively at the expense of sickness insurers at one location. At 27 locations, paclitaxel and docetaxel had also been issued in the context of trials, and at 7 locations also via special agreements with the insurers and (or) at the expense of the patient himself. Fifty-three of the 102 taxoid using hospitals had a financial upper limit or a maximum number of patients to be treated. Eighteen of the 102 locations where paclitaxel or docetaxel was issued reported that for financial reasons not all patients eligible for taxoids had been given these drugs. The indications varied from one hospital to another: 67 locations used them for first-phase treatment of patients with ovarian carcinoma, 96 locations for second-phase treatment of patients with ovarian carcinoma and at 91 locations, patients with mammary carcinoma were given taxoids when anthracyclines were no longer indicated. CONCLUSION: Hospitals in 1996 varied greatly with regard to issuing of taxoids. This diversity in part had financial causes. Restrictions on the issuing of taxoids for financial reasons lead to unequal access to care.

Antineoplastic Agents, Phytogenic↗
PubMed1998

[Acute myocardial infarct following sulprostone administration].

Because of intrauterine foetal death at 35 weeks, parturition in a woman aged 35 years was induced by intravenous sulprostone. A few hours after its start she sustained a myocardial infarction for which she was treated. Coronary angiography 4 weeks later showed normal coronary arteries and good left ventricular function. Mild cardiovascular reactions such as bradycardia and mild hypotension are frequently observed adverse effects. In some instances, sulprostone can induce myocardial ischaemia. However, the possibility of a myocardial infarction is not mentioned in the product information of sulprostone. As there was an obvious temporal relationship and other causative factors were sufficiently excluded, the causal relation between the administration of sulprostone and the occurrence of myocardial infarction can be regarded as almost certain. Several experimental studies provide support for the hypothesis that coronary spasms play a major role in the pathophysiology of a myocardial infarction during the administration of sulprostone.

Abortifacient Agents, Nonsteroidal↗
PubMed1998

Drug-associated agranulocytosis: 20 years of reporting in The Netherlands (1974-1994).

In this descriptive study, all 425 reports were included concerning drug-associated agranulocytosis as registered between 1974 and 1994 in the files of the Drug Safety Unit of the Dutch Inspectorate for Health Care. All reports were analysed as to the probability of agranulocytosis or neutropenia according to previously defined criteria. Subsequently, the causal relationship between exposure and outcome was assessed. It concerned 149 men and 271 women. One hundred and twelve reports were unclassifiable because age, gender, or total number of leukocytes at the time of reaction were unknown. In 100 reports agranulocytosis was probable, in 78 possible, in 8 reports neutropenia was probable, in 20 reports neutropenia was possible, and in 107 reports agranulocytosis or neutropenia were unlikely. In the 13 reports of probable agranulocytosis or neutropenia with a certain causal relationship, causative drugs were cimetidine, dipyrone, sulphasalazine, methyldopa, spironolactone, propylthiouracil (2), thiamazole, sulphamethoxazole with trimethoprim, gentamicin, a combination preparation containing aminophenazone, benzylpenicillin and indomethacin. The individual drugs most often reported to cause agranulocytosis or neutropenia were: dipyrone (19), mianserin (15), sulphasalazine (13), sulphamethoxazole with trimethoprim (11), the group of penicillins (9), cimetidine (8), the thiouracil derivatives (8), phenylbutazone (8), and penicillamine (8). Agranulocytosis is a serious and fairly frequently reported adverse reaction. The reporting system of the Drug Safety Unit can be used very well for signal generation concerning adverse reactions to drugs.

Adult↗
PubMed1998

Exercise testing in patients with chest pain to sumatriptan.

OBJECTIVES: In order to assess whether chest pain attributed to sumatriptan is associated with abnormalities on cardiac exercise testing, we performed a case-control study. SUBJECTS: Cases were selected as consumers of sumatriptan who reported sumatriptan associated chest pain. A reference group was selected randomly from consumers of sumatriptan with the same GP as the case, who reported no chest pain after use of sumatriptan. If possible, controls were matched for age (within 5-year groups) and gender. OUTCOMES: In a total of 74 cases and 55 controls symptom-limited exercise tests were performed. Besides a small difference in age, there were no differences in basic characteristics between cases and controls. Three cases had ST-depression on ECG during exercise. However, none of the variables measured during exercise testing differed significantly between cases and controls. CONCLUSIONS: The prevalence of abnormal exercise tests in patients with sumatriptan-induced chest pain is low, and not statistically different from patients without chest pain after intake of sumatriptan. Routine performance of exercise testing in patients with sumatriptan-associated chest pain is not recommended.

Adult↗
PubMed1998

Skin reactions to antibacterial agents in general practice.

OBJECTIVES: To quantify the risk of skin reactions to antibacterial drugs under everyday circumstances in a large population with automated data from general practitioners (GP). DESIGN: A retrospective cohort study in a dynamic population. SETTING: Data came from the Integrated Primary Care Information (IPCI) database. The IPCI database consists of all data on consultations, morbidity, and prescriptions and other interventions, as registered by the GP in a source population of approximately 150,000 persons. METHODS: The study period started on April 1, 1994, and ended on September 30, 1995. All patients who were treated with an antibacterial drug were enrolled on the first day of starting treatment until the end of the study period or until the occurrence of one or more of the following diagnoses within the risk period: allergic reaction, rash, erythema, pruritus and urticaria, or a notification of a skin reaction in the free text. Subsequently, patient profiles were assessed by two authors who were blinded to exposure. The risk period was defined as the legend duration of the antibacterial drug plus 14 days to control for carry-over of drug effects and delay in patient presentation. Age, gender, and comedication were examined as potential confounders. RESULTS: In the study period 13,679 patients received 19,961 prescriptions of an antibacterial drug. It concerned 5330 men (39.0%) and 8349 (61.0%) women with a mean age of 41 and 42 years, respectively. One hundred thirty-five patients developed a skin reaction in the risk period. Rash, pruritus, urticaria, and miscellaneous skin reactions were encountered in 76 (56.3%), 18 (13.3%), 19 (14.1%), and 22 (16.3%) patients, respectively. The three most frequently reported causes of skin reactions were combinations of trimethoprim with sulfonamides (2.1% of users; incidence density [ID]: 2.1/1000 exposed days), fluoroquinolones (1.6% of users; ID: 1.5/1000 person days), and penicillins (1.1% of users; ID: 1.3/1000 person days). Compared to tetracyclines, the broad-spectrum penicillins showed an incidence density ratio (IDR) of 3.7, the combination of amoxicillin with clavulanic acid of 3.3, the fluoroquinolones of 2.8, and the combination of trimethoprim with sulphonamides of 4.4. The presence of infectious mononucleosis increased the risk of rash in amoxicillin users with a factor of 58. CONCLUSIONS: We found that the frequency of skin reactions to antibacterial drugs in general practice is around 1% and highest for the combination of trimethoprim with sulphonamides, penicillins, and fluoroquinolones. The outpatient incidence for skin reactions is probably lower than the incidence in hospitalized patients. Although this may be partly explained by negative misclassification, it is also likely that the actual incidence is lower as some hospitalized patient groups may be more prone to develop a skin reaction.

Adolescent↗
PubMed1998

Differences in perceived and presented adverse drug reactions in general practice.

BACKGROUND: Postmarketing surveillance (PMS) studies are frequently based on data from general practitioners (GPs). Patients, however, do not always report to their GP suspected adverse drug reactions. SETTING: A postmarketing cohort study on adverse reactions to sumatriptan, performed with assistance of drug dispensing GPs in The Netherlands. METHODS: Questionnaires were sent to all drug-dispensing GPs in The Netherlands, as well as to their patients on sumatriptan. To avoid bias, no specific adverse reactions were mentioned in the questionnaires. RESULTS: Of the GPs, 589 (86%) responded; of the patients, 1202 (70%) responded. The most frequently reported suspected adverse reactions to sumatriptan reported by the GPs were dizziness (1.7%), nausea or vomiting (1.5%), drowsiness or sedation (1.4%), and chest pain (1.3%). The most frequently reported suspected adverse reactions by the patients were paraesthesia (11.7%), dizziness (8.1%), feeling of heaviness (8.0%), and chest pain (7.9%). Neither the GPs nor the patients reported serious adverse reactions. CONCLUSIONS: First, patients experience significantly more suspected adverse reactions than are registered by their GP. In view of this higher frequency of reporting of suspected adverse reactions, postmarketing studies with data from GPs only, may underestimate the cumulative incidence of adverse reactions. Second, we conclude that it is possible to obtain useful additional information about adverse drug reactions from patients by sending them questionnaires via their GP.

Adult↗
PubMed1998

Risk factors for mortality in users of ibopamine.

AIMS: In September 1995, the indication for the oral dopamine agonist ibopamine was restricted in the Netherlands and in several other European countries to patients with NYHA-class II heart failure as a result of an interim analysis of the PRIME-II trial. This trial demonstrated an increased risk of mortality in patients with NYHA-class III/IV heart failure on ibopamine. In September 1995, we initiated an assessment of the effects of ibopamine under everyday circumstances in a cohort of users of ibopamine in all NYHA-classes. METHODS: In a nationwide retrospective cohort study all 2147 community pharmacies and drug dispensing general practitioners received a request to list all patients to whom they had dispensed ibopamine in the preceding years. All responding drug dispensing outlets (DDO) received a questionnaire on cardiovascular risk factors and mortality for the general practitioner of a random sample of these patients. DDO were also requested to send an anonymised printout of the complete medication record. On the end-date of follow-up, February 15th 1996, mortality rates were compared across categories of ibopamine use, adjusted for potential confounders. To assess medication use, drug exposure was compared in a 3 months' period before date of death in the deceased, and before a random date in those patients who were still alive. RESULTS: In patients with NYHA-class III/IV heart failure, multivariate analysis indicated that current use of ibopamine was significantly associated with mortality (RR 1.37;95% CI: 1.15-1.64). In patients with NYHA-class I/II heart failure, however, multivariate analysis showed a 2.03 (95% CI: 1.10-3.72) risk of mortality in current users of ibopamine. Apart from current use of ibopamine, male gender and increased serum creatinine were also independent risk factors for mortality in all NYHA-classes. No statistically significant association was found between mortality and current use of amiodarone or use of amiodarone at baseline. CONCLUSIONS: The increased risk of mortality in patients with NYHA-class III and IV heart failure on ibopamine seems to confirm the main finding of the recently published PRIME-II trial. However, our results indicate that also patients with NYHA-class I/II heart failure may be at an increased risk of mortality when using ibopamine. Additional research on the effects of ibopamine in these patients is warranted and the use of ibopamine in NYHA-class II heart failure patients may have to be reconsidered.

Aged↗
PubMed1998

Agreement between the pharmacy medication history and patient interview for cardiovascular drugs: the Rotterdam elderly study.

AIMS: To study whether there is agreement between cardiovascular drugs presented at patient interview and pharmacy records in an elderly population. SETTING: The Rotterdam Elderly Study, a prospective population based cohort study of people older than 55 years of age. METHODS: We compared cardiovascular drug use as presented during patient interview with the computerized pharmacy medication history. Concordance of cardiovascular drug use in patient interview and pharmacy data was measured by merging the two data sets and assessed in two episodes: in a period of 6 months before patient interview and within the legend duration of each cardiovascular drug. RESULTS: We found 2706 concordant pairs in a total of 3365 prescriptions (80.4%) in the merged data. There were 195 prescriptions presented at patient interview which had not been filled at the pharmacy, and 464 which had been filled but were not presented by the patient. The percentage of concordant pairs slightly increased to 80.6% (2275 of a total of 2824) for prescriptions of which the legend duration included the date of patient interview. The highest agreement was noted with beta-adrenoceptor blocking agents with Kappa statistics of 0.97 for atenolol and metoprolol. The lowest Kappa statistic was found for organo-heparinoid, mainly as ointments against haemorrhoids (0.26). CONCLUSION: The agreement between patient interview and pharmacy records is good for prescription only drugs, and pharmacy records are a useful resource for pharmacoepidemiological studies on cardiovascular agents.

Adult↗