PubMed Health⌕ Search

Biomedical subjects

R D Mann

Publications and source records attributed to R D Mann.

At least 19 recordsLinked to original sources
PubMed1997

A comparison of two cohort studies evaluating the safety of cisapride: Prescription-Event Monitoring and a large phase IV study.

OBJECTIVE: The results of Prescription-Event Monitoring (PEM) from over 13,000 patients receiving cisapride are compared with safety data from a large-scale clinical study involving nearly 10,000 patients. RESULTS: The clinical study population showed a significantly younger age profile than the PEM population and excluded patients with serious disease; however, both studies showed similar patterns of adverse events. The most common adverse events reported in association with cisapride in both studies were diarrhoea, headache, abdominal pain, constipation and nausea. Some of these may be attributed to the underlying condition rather than the action of the drug. Prompting patients about adverse events during a clinical trial assessment appeared to increase the reporting of some conditions: for example, diarrhoea was reported more frequently in the clinical trial than in the PEM study. CONCLUSION: Both studies showed cisapride to be generally safe and well tolerated.

Adolescent↗
PubMed1996

Salmeterol: a study by prescription-event monitoring in a UK cohort of 15,407 patients.

OBJECTIVE: To examine the safety of the long-acting beta2-agonist, salmeterol, in general medical practice in the U.K. DESIGN: In Prescription-Event Monitoring (PEM) the exposure data are derived from prescriptions confidentially provided by the Prescription Pricing Authority. Outcome data are obtained by questionnaires (green forms) on which prescribing medical practitioners recorded event (safety) data. Additional information is obtained from the patients' lifetime clinical records, from follow-up of all pregnancies, and from death certificates. SETTING: PEM provides an observational cohort study in which there is no interference with the medical decision on which drug is prescribed for individual patients. SUBJECTS: A total of 15,407 patients were given salmeterol and observed for a minimum of 1 year. RESULTS: Headache, tremor, and palpitations were associated with the use of salmeterol. No unexpected major adverse events were noted, although in this study there was a total of 1022 deaths. Of these, 73 were due to asthma, but only 39 of these patients were taking salmeterol in the last month of life. All of these deaths appear on careful examination of the clinical records to have been due to natural causes, although in a minority (four, 10%) of the group of 39 subjects, a temporal relationship between death and the use of salmeterol makes it difficult to exclude a possible association. The study suggests that advanced age and severity of disease were the most likely factors contributing to asthma mortality in the population studied. CONCLUSION: Headache, tremor, and palpitations occur as adverse effects of salmeterol and lead to withdrawal of the drug in some subjects. No unexpected adverse reaction has been noted and paradoxical bronchospasm was reported in only three subjects. The study has produced no evidence that salmeterol contributed to death in any of the patients examined.

Adolescent↗
PubMed1996

A comparison of ciprofloxacin, norfloxacin, ofloxacin, azithromycin and cefixime examined by observational cohort studies.

1. The safety in everyday clinical usage of three 4-quinolone antibiotics, (ciprofloxacin, norfloxacin and ofloxacin), was compared with similar data for azithromycin and cefixime, each agent being examined by Prescription-Event Monitoring (PEM) during the early post-marketing period. 2. In PEM the exposure data are derived from general practitioner prescriptions confidentially provided by the Prescription Pricing Authority. Outcome data are provided by questionnaires (green forms) on which the prescribing medical practitioner records event data. When necessary, further information is obtained from a number of sources which include follow-up of all pregnancies and the patients' life-time medical record. 3. The main outcome measures were demographic information, including the patient's date of birth and sex; the indication for prescribing the drug being monitored; the reason for stopping treatment; the start and stop dates of treatment and the events recorded during and after treatment. 4. The final cohort for each of the five antibiotics exceeded 11000 patients. The only event significantly related to the use of all five antibiotics was nausea/vomiting. This was also the most frequent adverse event causing treatment to be discontinued with norfloxacin, ofloxacin and azithromycin (relevant information was not requested in the studies of ciprofloxacin and cefixime). Vaginal candidiasis was significantly more frequently associated with the use of the three 4-quinolones than with azithromycin and cefixime but it was frequently delayed until the week or two after the cessation of therapy. Within each event, as recorded in these studies, the highest event rates (the number of events per 1000 patients) in the week following the start of therapy were: 9.2 for diarrhoea with cefixime; 4.9 for nausea/vomiting with ofloxacin; 2.4 for rash with azithromycin; 2.2 for abdominal pain with norfloxacin; 1.5 for headache/migraine with ofloxacin; 1.4 for malaise/lassitude with ofloxacin; 1.2 for dizziness with norfloxacin. Uncommon events (reported in less than 1:1000 patients) included rare cases of allergic phenomena, convulsions and pseudomembranous colitis. There were no reports of tendinitis, tenosynovitis or tendon rupture in children but tendon disorders were reported in the two months following the start of treatment in 20 adults. A total of 307 pregnancies were reported. Thirty-eight of the 55 women who received these drugs during the first trimester of pregnancy gave birth to healthy babies. No congenital abnormalities were reported. Apart from one case of unconfirmed pseudomembranous colitis, none of the other 2468 deaths that occurred in these studies was attributed to the antibiotics. 5. These five antibiotics are acceptably safe antimicrobial agents when used in general medical practice. PEM is an effective method for monitoring the safety of recently introduced antimicrobial agents.

Adult↗
PubMed1996

The safety of finasteride used in benign prostatic hypertrophy: a non-interventional observational cohort study in 14,772 patients.

OBJECTIVE: To examine the safety of finasteride as used in general medical practice to treat benign prostatic hypertrophy (BPH). PATIENTS AND METHODS: Information was collected on 14,772 patients who were included in an observational cohort study conducted using Prescription-Event Monitoring. RESULTS: Finasteride was reported to have been effective in 60% of the patients in whom an opinion on efficacy was recorded. Impotence or ejaculatory failure was reported in 2.1% of the patients, decreased libido in 1% and gynaecomastia and related conditions in 0.4%. Impotence was the most frequent reason for stopping treatment with finasteride and was the most commonly reported adverse reaction to the drug. Of the patients included in the elderly cohort involved in this study, 819 (5.5%) died; none of these deaths was attributed to finasteride. CONCLUSION: Impotence or ejaculatory failure, decreased libido and gynaecomastia in a small proportion of patients were associated with the use of finasteride. The results of this study strongly suggest that this drug is acceptably safe when used in accordance with the current prescribing information.

Adolescent↗
PubMed1995

Signalling drug-induced rash with 36 drugs recently marketed in the United Kingdom and studied by Prescription-Event Monitoring.

This study examines skin rash, as a reported event, in the patients who used one of the 36 drugs recently released to the UK market and studied by Prescription-Event Monitoring between 1985 and 1992. The results are also compared to the voluntary reports on rash as a possible adverse drug reaction sent to the Committee on Safety of Medicines (CSM). Specific types of skin rash (e.g. exfoliative dermatitis) are excluded. The rate of rash has been calculated for 2 periods, the first month (T1) and the subsequent 5 months (T2) after the first prescription for the drug. Despite the heterogeneity of the patient groups, the rate for rash between the 2nd and 6th months was consistent in the 36 drugs and probably represented the baseline rate of rash due to a variety of nonspecific causes. This rate (T2) was around 1 per 1,000 patients per month (ranging from 0.5 to 2 per 1,000 patients per month). On the other hand, in the first month after the first prescription for the drug, the rate (T1) varied substantially from 0.9 to 6.4 per 1,000 patients per month. Diltiazem had the highest first monthly rate. These rates are listed for the 36 drugs. The difference of the rates was tested by 2 methods: a standard statistical test assuming a Poisson model and a method based on the ratio of the rates for the 2 periods. When the 2 rates (T1 and T2) were similar to each other, drug induced rash was considered to be rare.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1994

A study of the association between hormone replacement therapy, smoking and the occurrence of myocardial infarction in women.

The initial results are reported of a case-control study undertaken on the VAMP multi-purpose database and designed to estimate the risk for first-time occurrence of myocardial infarction in users of hormone replacement therapy (HRT). The findings currently available relate to the computerized data and show 2- to 5-fold increases in risk in smokers and those with diabetes mellitus, hypertension or hyperlipidaemia. With any form of HRT, a non-significant protective effect [adjusted odds ratio = 0.83 with 95% CI (confidence intervals) of 0.66-1.03, p = 0.089] has been shown. However, the protective effect of HRT in the data available to date appears to be confined to non-smokers in whom the odds ratio in the absence of other risk factors is 0.70 (95% CI of 0.49-1.00). The comparable odds ratio in smokers is 1.05 (95% CI of 0.71-1.53). These results should be interpreted with caution as smoking status was unknown for about half of the subjects and was more complete among the cases than controls.

Case-Control Studies↗