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M A Wallander

Publications and source records attributed to M A Wallander.

25 records · Page 2Linked to original sources
PubMed1993

The way towards adverse event monitoring in clinical trials.

Different approaches to the monitoring of adverse reactions to drugs have been used over the years, with the aim of preventing catastrophes like the thalidomide episode and to rationalise drug usage. In the 1960s, the use of national and international adverse event monitoring was first suggested by the British statistician, David Finney. According to Finney, the method was well suited for the postmarketing surveillance of drugs. The idea was rejected by the World Health Organization (WHO) but was later taken up by the Prescription Event Monitoring Event System in the UK. Subsequent to problems with practolol in the 1970s it was suggested that adverse event monitoring could also be useful in clinical trials to detect adverse reactions before a drug is launched. The idea of adverse event monitoring has been tested by Astra Hässle in Sweden in clinical trials with felodipine and omeprazole, and is now the standard method within the company. Adverse event monitoring is an expensive and time-consuming method seen from a short term perspective. However, such monitoring offers an opportunity to optimise the use of clinical trials in safety monitoring, and its ability to predict possible adverse drug reactions is superior to other methods.

Adverse Drug Reaction Reporting Systems↗
PubMed1992

Adverse event monitoring in clinical trials of felodipine and omeprazole.

Although most clinical trials encompass aspects of safety, methods for assessing the safety of a drug by recording adverse events have been poorly studied. It has been suggested that adverse events rather than adverse drug reactions should be monitored, since a reliable determination of which events were caused by the drug and which were not is only possible after analysing data from a substantial number of clinical trials. In the present study adverse events were monitored to see the extent to which events recorded on the case record forms were reported as adverse events. Data from omeprazole and felodipine programmes were used, comprising altogether 143 clinical trials from eight different projects, and encompassing 12,069 patients in whom 11,812 events were recorded. The first project was started in 1982 and the last in 1988. Overall, 74% of recorded events were entered on a special adverse event form used in the trials, and 26% were not. Initially, about 35% of adverse events were not reported as such, as opposed to 13% towards the end of the study period. Serious adverse events were reported less frequently than non-serious events, but in the most recent project all serious adverse events were reported. Adverse events in women were reported more often than adverse events in men, and reporting was more complete for the middle-aged than for the oldest and the youngest persons. Certain types of adverse events were reported more completely than others. In conclusion, the transition from registering adverse reactions to registering adverse events has been a gradual one in spite of intensive educational efforts when the projects were started.(ABSTRACT TRUNCATED AT 250 WORDS)

Adverse Drug Reaction Reporting Systems↗
PubMed1992

Safety experience from long-term treatment with omeprazole.

Omeprazole was administered for up to 6 years in 859 patients for 'prevention of relapse in patients with poorly responsive peptic ulcer or reflux oesophagitis'. The pattern of adverse events reported during long-term treatment was similar to the adverse-event profile in short-term treatment with omeprazole (n = 2,818), ranitidine (n = 1,572) and cimetidine (n = 891). Omeprazole had essentially the same adverse-event profile as the two H2-receptor antagonists. The adverse-event profile for omeprazole during long-term treatment did not differ from that seen during short-term treatment with either omeprazole or the H2-receptor antagonists. The rate of occurrence of any specific adverse event decreased with time, and no previously unidentified adverse event occurred with long-term omeprazole therapy. There were no serious adverse events that were considered to be causally related to omeprazole therapy. Thus, omeprazole has been shown to be well tolerated in both short- and long-term treatment.

Adolescent↗
PubMed1991

Aspects of quality of life on treatment with felodipine.

Quality of life has been assessed in a double-blind four week study comparing felodipine 5, 10, 20 mg and placebo added to metoprolol by adding two self-administered questionnaires to the conventional procedure for the evaluation of adverse events. None of the aspects related to general well-being was affected by felodipine. The subjective symptoms reported were mostly dose-related and so here mainly observed at the highest dose. Some of them, e.g. headache, were transient. It is concluded that felodipine in combination with metoprolol CR did not negatively influence the feeling of well-being of the patients. When the drug was given in low, individually adjusted doses, the symptoms normally associated with Ca antagonists were likely to be minimised.

Adult↗
PubMed1991

Evaluation of three methods of symptom reporting in a clinical trial of felodipine.

251 patients from 23 primary health care centres were recruited to a clinical trial in which either felodipine or placebo was added to baseline metoprolol treatment. Three methods of symptom reporting were used in 191 patients, namely two previously documented self-administered questionnaires and an adverse event monitoring system (spontaneous reports to treating physician). Higher frequencies of symptoms were seen with the questionnaires compared to spontaneous reporting. However, the overlap between the methods was moderate and they were found to complement one another. The questionnaires were completed twice during the study and the adverse event monitoring system was applied on five occasions. The rate of application had consequences for the ability of each method to detect transient, dose-related symptoms, e.g. headache and dizziness. Regardless of method, the possibility of detecting dose-related symptoms was enhanced when symptoms were measured not only during active treatment but also during a run-in or other baseline period, and both phases were considered in the analyses.

Adult↗
PubMed1990

Safety in clinical trials.

Safety deals with the surveillance and detection of possible threats that can arise against a patient. It might not be an obvious one, like an anaphylactic shock, but a bizarre syndrome of late onset preceded by vague signs or symptoms. To be able to conclude about a possible causal relationship between a drug and such a state with as short a delay in time as possible, the collection and analysis of adverse events during the total clinical trial program of a drug is mandatory. To ask investigators for adverse drug reactions instead is to produce an effective filter, which may help in keeping the incidence figures down in the international data sheet but which also may prove to be hazardous for the pharmaceutical industry in the long run.

Animals↗