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Biomedical subjects

D M Coulter

Publications and source records attributed to D M Coulter.

At least 19 recordsLinked to original sources
PubMed2001

Antipsychotic drugs and heart muscle disorder in international pharmacovigilance: data mining study.

OBJECTIVES: To examine the relation between antipsychotic drugs and myocarditis and cardiomyopathy. DESIGN: Data mining using bayesian statistics implemented in a neural network architecture. SETTING: International database on adverse drug reactions run by the World Health Organization programme for international drug monitoring. MAIN OUTCOME MEASURES: Reports mentioning antipsychotic drugs, cardiomyopathy, or myocarditis. RESULTS: A strong signal existed for an association between clozapine and cardiomyopathy and myocarditis. An association was also seen with other antipsychotics as a group. The association was based on sufficient cases with adequate documentation and apparent lack of confounding to constitute a signal. Associations between myocarditis or cardiomyopathy and lithium, chlorpromazine, fluphenazine, haloperidol, and risperidone need further investigation. CONCLUSIONS: Some antipsychotic drugs seem to be linked to cardiomyopathy and myocarditis. The study shows the potential of bayesian neural networks in analysing data on drug safety.

Antipsychotic Agents↗
PubMed2001

Privacy issues and the monitoring of sumatriptan in the New Zealand Intensive Medicines Monitoring Programme.

PURPOSE: The purpose of this paper is to describe how the New Zealand (NZ) Intensive Medicines Monitoring Programme (IMMP) functions in relation to NZ privacy laws and to describe the attitudes of patients to drug safety monitoring and the privacy of their personal and health information. METHODS: The IMMP undertakes prospective observational event monitoring cohort studies on new drugs. The cohorts are established from prescription data and the events are obtained using prescription event monitoring and spontaneous reporting. Personal details, prescribing history of the monitored drugs and adverse events data are stored in databases long term. The NZ Health Information Privacy Code is outlined and the monitoring of sumatriptan is used to illustrate how the IMMP functions in relation to the Code. Patient responses to the programme are described. RESULTS: Sumatriptan was monitored in 14,964 patients and 107,646 prescriptions were recorded. There were 2344 reports received describing 3987 adverse events. A majority of the patients were involved in the recording of events data either personally or by telephone interview. There were no objections to the monitoring process on privacy grounds. CONCLUSION: Given the fact that all reasonable precautions are taken to ensure privacy, patients perceive drug safety to have greater priority than any slight risk of breach of confidentiality concerning their personal details and health information.

Attitude↗
PubMed1999

A comparison of the use, effectiveness and safety of bezafibrate, gemfibrozil and simvastatin in normal clinical practice using the New Zealand Intensive Medicines Monitoring Programme (IMMP).

AIMS: Because of the importance of treating dyslipidaemia in the prevention of ischaemic heart disease and because patient selection criteria and outcomes in clinical trials do not necessarily reflect what happens in normal clinical practice, we compared outcomes from bezafibrate, gemfibrozil and simvastatin therapy under conditions of normal use. METHODS: A random sample of 200 patients was selected from the New Zealand Intensive Medicines Monitoring Programme's (IMMP) patient cohorts for each drug. Questionnaires sent to prescribers requested information on indications, risk factors for ischaemic heart disease, lipid profiles with changes during treatment and reasons for stopping therapy. RESULTS: 80% of prescribers replied and 83% of these contained useful information. The three groups were similar for age, sex and geographical region, but significantly more patients on bezafibrate had diabetes and/or hypertension than those on gemfibrozil or simvastatin. After treatment and taking the initial measure into account, the changes in serum lipid values were consistent with those generally observed, but with gemfibrozil being significantly less effective than expected. More patients (15.8%S) stopped gemfibrozil because of an inadequate response compared with bezafibrate (5.4%) and simvastatin (1.6%). Gemfibrozil treatment was also withdrawn significantly more frequently due to a possible adverse reaction compared with the other two drugs. CONCLUSIONS: In normal clinical practice in New Zealand gemfibrozil appears less effective and more frequently causes adverse effects leading to withdrawal of treatment than either bezafibrate or simvastatin.

Bezafibrate↗
PubMed1998

The New Zealand Intensive Medicines Monitoring Programme.

The New Zealand Intensive Medicines Monitoring Programme which has been in operation for 20 years is described. The methodology is reviewed in detail and illustrated in the results. Some of the principles of early postmarketing surveillance and advantages and problems associated with the IMMP are discussed. The methodology is based on establishing cohorts of patients and the aggregation of adverse events from a combination of prescription follow-up (PFU) and intensified spontaneous reporting. In signal detection particular emphasis is placed on provisional 'causality' assessment and a study of the events thought not to be reactions (incidents) and in addition, their use in controlling for reporting bias particularly in respect of reaction rates and the identification of risk factors. With the small population base, cohorts are built up more slowly, but the longer duration of observation has advantages. Monitoring has been completed for 20 drugs with an average cohort size of 10,511 patients and a mean monitoring period of 55 months. The use of duplicate prescriptions with PFU achieved much higher reporting rates than IMMP spontaneous reporting. Information on deaths was best obtained from questionnaires on reasons for cessation of therapy which also provided data on efficacy.

Journal Article↗
PubMed1996

Angiooedema and urticaria with angiotensin converting enzyme inhibitors.

OBJECTIVE: To review reports of angiooedema and urticaria associated with angiotensin converting enzyme inhibitors (ACEI) in the New Zealand Centre for Adverse Reactions Monitoring and Intensive Medicines Monitoring Programme (IMMP) database. METHODS: Adverse reaction reports describing angiooedema and/or urticaria between April 1981 and December 1994 were examined. Captopril, enalapril and lisinopril were intensively monitored on the IMMP during this period. RESULTS: Of a total of 116 reports there were 68 reports of angiooedema and 37 of urticaria alone and 11 where angiooedema and urticaria occurred in the same patient. The total number of patients is unknown, but cohorts of patients on captopril, enalapril and lisinopril in the IMMP were 16342, 25686 and 11235, totalling 53263 patients. There were 63 reports of angiooedema/urticaria in patients monitored on the IMMP, giving a reported rate of 1.2/1000 (0.9-1.5). Forty seven reactions occurred between 3 weeks and 4 years after commencement of therapy. Severe angiooedema occurred in 9 patients with early-onset angiooedema and 6 with late-onset angiooedema. There were no deaths. Seventeen patients had up to 12 episodes before diagnosis. Angiooedema/ urticaria occurred without gender preference. Although a dose relationship was not apparent, 3 patients developed angiooedema or urticaria after an increase in dose. CONCLUSION: Although reactions are more common shortly after initiation of ACEI therapy, late onset reactions may be less well recognised. Clinicians should be reminded, and ACEI data sheets should emphasise, that onset may be delayed for weeks or months, that patients may have multiple episodes with long symptom free intervals, and that angiooedema may occur with or without urticaria.

Adverse Drug Reaction Reporting Systems↗
PubMed1995

Fluoxetine and extrapyramidal side effects.

OBJECTIVE: The authors' goal was to determine whether fluoxetine is associated with extrapyramidal side effects. METHOD: They assessed the notifications of extrapyramidal manifestations in patients given fluoxetine in the New Zealand Intensive Medicines Monitoring Programme, a national system that monitored adverse reactions associated with fluoxetine over a 4-year period, and determined whether these adverse reactions were causally related to fluoxetine. RESULTS: In reports of adverse reactions in 5,555 patients given fluoxetine throughout New Zealand, there were 15 notifications of extrapyramidal events probably or possibly caused by fluoxetine. Fluoxetine was the only psychotropic agent used for seven of the 15 patients; two patients were also taking lithium, four were taking neuroleptics, two were taking tricyclic antidepressants, and one was taking metoclopramide. CONCLUSIONS: The authors conclude that fluoxetine may be associated with extrapyramidal reactions. These may occur with fluoxetine alone or fluoxetine may facilitate the reaction in patients receiving psychotropic medication or dopamine receptor blocking drugs.

Adult↗
PubMed1994

Fluoxetine and hyponatraemia--a potential hazard in the elderly.

AIMS: To review reports of the association between fluoxetine and hyponatraemia. METHODS: Reports of hyponatraemia associated with fluoxetine received over a four-year period in the New Zealand Intensive Medicines Monitoring Programme have been examined and these and other case reports in the literature, discussed. RESULTS: Seven patients, all women aged 68-88 years on fluoxetine 20 mg daily, developed hyponatraemia (serum sodium 114-128 mmol/L, five within 19 days of commencement of fluoxetine. The reported rate for women over 65 years was 8.5 per thousand. Withdrawal of fluoxetine was associated with recovery in all cases. CONCLUSIONS: Fluoxetine is associated with a significant incidence of hyponatraemia in the elderly, especially during the first weeks of therapy. It is advisable to monitor electrolytes in older patients during this period.

Aged↗
PubMed1993

Short term safety assessment of cilazapril.

AIMS: To undertake an event monitoring study of cilazapril in general practice during the early marketing period, to provide some comparisons with other angiotensin converting enzyme inhibitors and to assess the monitoring method. METHODS: The monitoring was undertaken in the Intensive Medicines Monitoring Programme. Cilazapril was prescribed for mild to moderate hypertension in 996 patients at a recommended dose of 2.5-5.0 mg daily. The monitoring period was six months and practitioners were asked to report all adverse events. A reaction profile was prepared and compared with profiles for lisinopril, enalapril and captopril. The chi-square test was applied to differences in proportions. RESULTS: There were 84 (8.4%) reports describing 133 adverse events; 124 (93%) were assessed as reactions. Withdrawals totalled 53 (5.3%). The most common reactions were cough (2.9%), nausea and vomiting (1.3%) and lethargy (1.1%). Cilazapril had a higher proportion of neurological reactions (p < 0.001) (mainly headache) but a lower proportion of skin reactions (p = 0.001) than the other ACE inhibitors. It also had relatively less diarrhoea and there were differences in the patterns of psychiatric reactions. CONCLUSIONS: Cilazapril has a similar reaction profile to other ACE inhibitors but this paper shows differences, some not previously reported, that may assist selection when prescribing. Although there was a high rate of reporting of known adverse reactions, other events were reported at a very low rate and spontaneous reporting is thus confirmed as an unreliable method of monitoring for unexpected adverse reactions.

Arrhythmias, Cardiac↗
PubMed1993

Falling intracranial pressure: an important element in the genesis of intracranial hemorrhage in the beagle puppy.

To study the role of extravascular intracranial pressure (ICP) in the genesis of intracranial hemorrhage in the beagle puppy, we measured ICP in animals on the day of birth, untreated 3-day-old controls, and 3-day-old animals treated from birth with prolactin. Baseline ICP varied substantially in all 3 groups. Only 8% of this variability was attributable to variability in mean arterial pressure and central venous pressure. ICP was lower in the 3-day-old controls, animals at high risk for intracranial hemorrhage after a hypovolemic/hypotensive insult followed by rapid volume expansion, than in the other groups which are at lower risk. Administration of a hyperosmolar insult, intraperitoneal glycerol, to animals whose ICP was relatively high promptly lowered ICP. After this treatment, the risk of intracranial hemorrhage was markedly increased in these previously low-risk groups. We conclude that the normal neonatal decrease in brain water content and the consequent fall in ICP substantially increase the risk of intracranial hemorrhage in the beagle puppy, a model which appears similar in pathophysiology to hemorrhage in the preterm human infant.

Age Factors↗
PubMed1992

Selective in vivo localization of daunorubicin small unilamellar vesicles in solid tumors.

Small unilamellar vesicles (SUVs), consisting of highly purified distearoyl phosphatidylcholine and cholesterol (2:1 mol ratio) selectively increased the delivery of entrapped daunorubicin to solid tumors in vivo. When measured against free drug, SUV-entrapped daunorubicin produced a nearly 10-fold increase in tumor uptake and efficacy when used to treat a murine lymphosarcoma model (P-1798). In a second murine solid tumor model, MA16C mammary adenocarcinoma, the median survival time for daunorubicin SUV treatment at 2 mg/kg (72 days) was equivalent to the median survival time for the free drug optimal dose, 20 mg/kg (70 days), again indicating a 10-fold increased therapeutic efficacy. When compared at maximum efficacious doses in the MA16C model, the proportion of long-term survivors was greater with daunorubicin SUVs: 10 long-term survivors of 10 mice treated with daunorubicin SUVs at 25 mg/kg versus 4 long-term survivors of 10 mice treated with free drug at 20 mg/kg. The lowest toxic doses for MA16C tumor-bearing animals (treatment median survival times less than controls) were 25 mg/kg for free drug and 40 mg/kg for daunorubicin SUVs. The demonstration of enhanced antineoplastic activity and an increased tolerance for daunorubicin suggests that this specific SUV composition may be an effective delivery system for a wide range of chemotherapeutic agents in the treatment of solid tumors.

Adenocarcinoma↗