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Biomedical subjects

B H Stricker

Publications and source records attributed to B H Stricker.

At least 37 records · Page 2Linked to original sources

Incidence and mortality of acute pancreatitis between 1985 and 1995.

BACKGROUND: The incidence of acute pancreatitis seems to have increased in Western countries. It has been suggested that this increase can be explained by improved diagnostic procedures. We performed a nationwide study to assess the annual sex- and age-specific incidence and mortality rates of acute pancreatitis in the Netherlands between 1985 and 1995, a period in which diagnostic procedures did not change considerably. METHODS: We conducted a population-based retrospective follow-up study in which we used automated hospital discharge data accumulated by Prismant Health Care Information. All patients admitted with acute pancreatitis (ICD-9CM, 577.0) in the Netherlands were identified. We accounted for referrals to other hospitals to avoid double counting and for miscoding of chronic pancreatitis as acute pancreatitis. The annual population size was retrieved from the Netherlands Central Statistics Office. RESULTS: The observed incidence of acute pancreatitis increased from 12.4/100,000 person-years (95% confidence interval (CI), 11.8-12.9) in 1985 to 15.9/100,000 person-years (95% CI, 15.3-16.5) in 1995. The annual mortality rate of acute pancreatitis remained fairly stable at 1.5/100,000 person-years. The incidence and mortality rate of acute pancreatitis increased considerably with age. The case-fatality proportion of first admissions for acute pancreatitis decreased from 14.3% to 10.7%. The case-fatality for relapses remained stable at 3.2%. CONCLUSIONS: In this retrospective study the observed incidence of acute pancreatitis increased by 28% between 1985 and 1995. Due to a decrease in the case-fatality proportion, the mortality remained stable during this period.

Acute Disease↗

Mesenteric venous thrombosis attributed to docetaxel.

We present a case of a 57-year-old woman with metastatic breast cancer unresponsive to several chemotherapeutic and hormonal regimens. Because of progressive pulmonary metastases and a painful osteolytic metastasis in the sternum, treatment with docetaxel was initiated. She developed mesenteric venous thrombosis within 1 week after the first dose of docetaxel. Although docetaxel may be regarded as an important advancement in the chemotherapeutic treatment of several cancers, ongoing and future trials must assess its position in the standard chemotherapeutic treatment of cancer. Well-documented adverse reactions, either common or rare, may contribute to a balanced risk-benefit profile of docetaxel.

Antineoplastic Agents, Phytogenic↗

[Undertreatment of hypertension and the risk of stroke in the oldest old].

The benefit of pharmacological treatment of hypertension in the prevention of cardiovascular diseases has been established mainly in subjects younger than 80 years of age. The consequences of undertreatment of hypertension with regard to the occurrence of stroke was studied in the Netherlands. About 33% of the hypertensives younger than 80 years and 55% of the hypertensives older than 80 years were not pharmacologically treated, although they were 'candidates' for pharmacological treatment of hypertension. About 19% (n = 1350) of all strokes that occurred in the Netherlands in 1994 among hypertensives younger than 80 years may be attributable to untreated hypertension. Among hypertensives older than 80 years this percentage was 32% (n = 1345). Although the benefit of pharmacological treatment of hypertension in persons older than 80 years has not been established experimentally, the results suggest that a considerable proportion of the strokes among this group of hypertensives may be prevented.

Aged↗

Confounding by indication: an example of variation in the use of epidemiologic terminology.

Confounding by indication is a term used when a variable is a risk factor for a disease among nonexposed persons and is associated with the exposure of interest in the population from which the cases derive, without being an intermediate step in the causal pathway between the exposure and the disease. However, in the literature, the term confounding by indication is not always used consistently. The authors found three different situations in which the term has been applied or might have been used but was not: confounding by indication as protopathic bias, as confounding by severity, or as a form of selection bias. It might be helpful to limit use of the term confounding by indication to the situation in which the disease that forms the indication acts as a confounder irrespective of its severity and to apply the term confounding by severity if the severity of this disease acts as a confounder. Protopathic bias and selection bias should not be confused with these terms. The use of appropriate terms ultimately will improve communication among researchers and contribute to the clarity of their papers.

Confounding Factors, Epidemiologic↗

[The need for 'postmarketing surveillance'].

Postmarketing surveillance of medicines includes two activities: pharmacovigilance and pharmaco-epidemiology. Despite the importance of postmarketing surveillance, too few surveillance studies are performed. The studies carried out by the pharmaceutical industry predominantly consist of 'seeding trials': offering prescribing physicians financial rewards if they prescribe a particular product, thus trying to change the prescription habits. The results of such trials are scientifically worthless. These activities cast a shadow on sincere postmarketing surveillance. A recent nationwide cohort study by the Inspectorate for Health Care on mortality in users of ibopamine demonstrates that Dutch medical doctors and pharmacists are very co-operative if further studying of a particular adverse reaction is warranted.

Adverse Drug Reaction Reporting Systems↗

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↗

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↗

Drug-induced heart failure.

Heart failure is a clinical syndrome that is predominantly caused by cardiovascular disorders such as coronary heart disease and hypertension. However, several classes of drugs may induce heart failure in patients without concurrent cardiovascular disease or may precipitate the occurrence of heart failure in patients with preexisting left ventricular impairment. We reviewed the literature on drug-induced heart failure, using the MEDLINE database and lateral references. Successively, we discuss the potential role in the occurrence of heart failure of cytostatics, immunomodulating drugs, antidepressants, calcium channel blocking agents, nonsteroidal anti-inflammatory drugs, antiarrhythmics, beta-adrenoceptor blocking agents, anesthetics and some miscellaneous agents. Drug-induced heart failure may play a role in only a minority of the patients presenting with heart failure. Nevertheless, drug-induced heart failure should be regarded as a potentially preventable cause of heart failure, although sometimes other priorities do not offer therapeutic alternatives (e.g., anthracycline-induced cardiomyopathy). The awareness of clinicians of potential adverse effects on cardiac performance by several classes of drugs, particularly in patients with preexisting ventricular dysfunction, may contribute to timely diagnosis and prevention of drug-induced heart failure.

Adjuvants, Immunologic↗

Achilles tendinitis associated with fluoroquinolones.

AIMS: To determine whether there is an association between use of fluoroquinolones and tendinitis in a large population under everyday circumstances. METHODS: A retrospective cohort study was carried out in a dynamic population. Data came from the IPCI-database which consists of all data on consultations, morbidity, prescriptions and other interventions, as registered by GPs in a source population of approximately 250 000 persons. For this study data were collected from 41 general practices in the period from January 1st, 1995 through December 31st, 1996. All persons treated with either fluoroquinolones, amoxicillin, trimethoprim, cotrimoxazole or nitrofurantoin were followed from the first day of treatment until the outcome of interest, death, transfer to another practice, or end of the study period, whichever came first. The risk window was defined as the legend duration +1 month. Potential cases were defined as a registration of a tendinitis or tendon rupture. Patients with a history of tendinitis or tendon rupture, preceding trauma or inadequate diagnoses were excluded on the basis of a review of the patient profiles and additional clinical data, blinded as to the exposure status. Results were adjusted for age, gender, concurrent corticosteroid exposure and number of GP visits. RESULTS: There were 1841 users of fluoroquinolones and 9406 users of the other antibacterial drugs with an average duration of 9 and 7 days, respectively. Tendinitis or tendon rupture was registered in 97 profiles, but after review only 22 complied with the case definition. The adjusted relative risk of tendinitis to fluoroquinolones was 3. 7 (95%CI: 0.9-15.1) for Achilles tendinitis and 1.3 (95%CI: 0.4-4.7) for other types of tendinitis. Achilles tendinitis to ofloxacin had a relative risk of 10.1 (95%CI: 2.2-46.0) and an excess risk of 15 cases per 100 000 exposure days. CONCLUSIONS: Although the numbers in our study are small, our results suggest that some fluoroquinolones may increase the risk of Achilles tendinitis, and that this risk increase is highest for ofloxacin.

Achilles Tendon↗

Attitudinal survey of voluntary reporting of adverse drug reactions.

AIMS: Voluntary adverse drug reaction (ADR) reporting schemes have operated since the early sixties in many Western countries. It is generally recognized, however, that only a small proportion of ADRs is actually reported. The current survey was conducted to assess attitudes towards reporting of ADRs, and to study which types of ADRs are reported. METHODS: A questionnaire seeking reasons for nonreporting was sent to a random sample of 10% of medical practitioners in The Netherlands in October 1997. After 6 weeks, a reminder was sent to those who had not responded. RESULTS: One thousand four hundred and forty-two (73%) questionnaires were returned, of which 94% were complete. The percentage of GPs (51%) which had ever reported an ADR to the national reporting centre was significantly higher than the percentage of specialists (35%), who reported more often to the pharmaceutical industry (34% vs 48%). 86% of GPs, 72% of surgical specialists and 81% of medical specialists had ever diagnosed an ADR, which they had not reported. Uncertainty as to whether the reaction was caused by a drug (72%), the ADR being trivial (75%) or too well known (93%) were the most important reasons for not reporting. 18% were not aware of the need to report ADRs, 22% did not know how to report ADRs, 38% did not have enough time, 36% thought that reporting was too bureaucratic and only 26% of Dutch physicians knew which ADRs to report. A serious ADR, an unlabelled ADR, an ADR to a new drug, history of reporting of one or more ADRs, and specialty were all independently associated with reporting of 16 hypothetical ADRs. Surgical and medical specialists tended to report less often than GPs. CONCLUSIONS: There is a considerable degree of underreporting, which might partly be explained by lack of knowledge and misconceptions about spontaneous reporting of adverse drug reactions.

Adverse Drug Reaction Reporting Systems↗

A cohort study on the risk of acute liver injury among users of ketoconazole and other antifungal drugs.

AIMS: The aim of this cohort study was to estimate the risk of clinical acute liver injury among users of oral antifungals identified in the general population of the General Practice Research Database in UK. METHODS: The cohort included 69 830 patients, 20-79 years old, free of liver and systemic disease, who had received at least one prescription for either oral fluconazole, griseofulvin, itraconazole, ketoconazole, or terbinafine between 1991 and 1996. RESULTS: Sixteen cases of acute liver injury were identified and validated. Ten cases occurred during nonuse of oral antifungals with a background rate of 0.6 per 100,000 person-months (95% confidence interval 0.3,1.1). Five cases occurred during current use of oral antifungals. Two were using ketoconazole, another two itraconazole, and one terbinafine. Incidence rates of acute liver injury were 134.1 per 100 000 person-months (36.8,488.0) for ketoconazole, 10.4 (2.9-38.1) for itraconazole, and 2.5 (0.4,13. 9) for terbinafine. The remaining case was associated with past use of fluconazole. Ketoconazole was the antifungal associated with the highest relative risk, 228.0 (95% confidence interval 33.9,933.0), when compared with the risk among nonusers, followed by itraconazole and terbinafine with relative risks of 17.7 (2.6,72.6) and 4.2 (0.2, 24.9), respectively. CONCLUSIONS: Ketoconazole and itraconazole were the two oral antifungal associated with a marked increase of clinical acute liver injury. The risk associated with ketoconazole should be taken into account when prescribing it as initial treatment for uncomplicated fungal infections.

Acute Disease↗

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↗

Colitis may be part of the antiepileptic drug hypersensitivity syndrome.

PURPOSE: To show that colitis may be part of the antiepileptic hypersensitivity syndrome. METHODS: Description of two case histories. RESULTS: The first patient was a 47-year-old man who developed fever, lymphadenopathy, influenza-like symptoms, facial edema, skin rash and diarrhea after 3 weeks of carbamazepine (CBZ) treatment. Laparotomy because of severe abdominal pain 2 weeks later showed severe colitis with perforations. The second patient was a 41-year-old woman who developed fever, diarrhea, and skin rash 4 weeks after start of CBZ treatment. A colon biopsy confirmed colitis. Stool examinations did not show pathogenic microorganisms, and there was no evidence of Crohn's disease or ulcerative colitis. Both patients had elevated liver enzymes, peripheral eosinophilia, and eosinophils in the infiltrate of the colon. CONCLUSIONS: In view of the close temporal relation between start of CBZ intake and development of colitis, the presence of fever, lymphadenopathy, and rash, and improvement after discontinuation of CBZ, we conclude that the two patients developed an AED hypersensitivity syndrome. Our case histories demonstrate that severe colitis may be part of this syndrome.

Adult↗

Drug-associated acute pancreatitis: twenty-one years of spontaneous reporting in The Netherlands.

OBJECTIVE: Drugs are considered a rare cause of acute pancreatitis. We conducted a descriptive study to assess which drugs have been associated with acute pancreatitis in spontaneous adverse drug reaction reports in The Netherlands. METHODS: Our study is based on reports of drug-associated acute pancreatitis reported to the Netherlands Center for Monitoring of Adverse Reactions to Drugs and The Netherlands Pharmacovigilance Foundation LAREB between 1 January 1977 and 1 January 1998. We used an algorithm to validate the diagnosis and to assess the causal relationship between acute pancreatitis and use of the suspected drug. RESULTS: A total of 55 cases were available for review. We excluded 11 (20.0%) reports, as we could not confirm the diagnosis of acute pancreatitis. Another 10 (18%) cases were excluded, as the causal relationship with the suspected drug was unlikely. In the remaining 34 reports, acute pancreatitis was labeled as definite in 11 (32%) and as probable in 23 (68%). The age of the patients ranged from 17 to 84 yr with a median of 41; 24 (71%) patients were female. Of the 34 cases, 27 (79%) recovered, five (15%) died, and in two (6%) the outcome is unknown. Azathioprine, cimetidine, interferon-alpha, methyldopa, metronidazole, olsalazine, and oxyphenbutazon all had a definite causal relationship with acute pancreatitis. Doxycycline, enalapril, famotidine, ibuprofen, maprotiline, mesalazine, and sulindac had a probable causal relationship with acute pancreatitis. CONCLUSIONS: A variety of drugs was associated with acute pancreatitis in Dutch adverse drug reaction reports. Quantitative information about drug-induced pancreatitis is scanty. Epidemiological studies to assess the risk of drug-induced acute pancreas, therefore, are needed.

Acute Disease↗

Excess stroke among hypertensive men and women attributable to undertreatment of hypertension.

BACKGROUND AND PURPOSE: Most population-based studies indicate that a considerable proportion of hypertensive subjects are undertreated and that undertreatment is more prevalent among hypertensive men than among hypertensive women. The aim of our study was to investigate the consequences of undertreatment of hypertension for women and men in terms of stroke occurrence. METHODS: Approximately 45 000 men and women aged >/=20 years were examined in 2 population-based studies in the Netherlands. A cohort of 2616 hypertensive subjects (pharmacologically treated hypertensives and untreated hypertensives who needed pharmacological treatment according to the severity of their hypertension and the coexistence of additional cardiovascular risk factors) was selected for a follow-up study. Follow-up (mean duration, 4.6 years) was complete for 2369 (91%) of the enrolled hypertensive subjects. RESULTS: Compared with treated and controlled hypertensives, the relative risks of stroke for treated and uncontrolled hypertensives and for untreated hypertensives who needed treatment were 1.30 (95% CI, 0.70 to 2.44) and 1.76 (95% CI, 1.05 to 2.94), respectively. These relative risks and the prevalence of (undertreated) hypertension in the total population of 45 000 subjects were used to estimate the number of strokes in the Netherlands attributable to undertreatment. Among hypertensive men and women aged >/=20 years in the Netherlands, the proportions of strokes attributable to treated but uncontrolled blood pressure were 3.1% (95% CI, -5.2% to 18.7%) and 4.1% (95% CI, -7.2% to 20.7%), respectively. For untreated hypertensive men and women who should have been treated, these proportions were 22.8% (95% CI, 0.8% to 38.4%) and 25.4% (95% CI, 0. 5% to 42.5%), respectively. CONCLUSIONS: Increasing the detection of hypertension and improving adherence to current guidelines might prevent a considerable proportion of the incident strokes among hypertensives. The potential impact of achieving control of blood pressure in patients already being treated on the reduction of strokes requires further investigation.

Adult↗

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↗

[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↗