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Pharmacotherapy

Observational cohort study to monitor the use and safety of carvedilol in the treatment of heart failure in clinical practice in England – 1st interim report

N.V. Acharya, L.V. Wilton, and S.A.W. Shakir

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Volume 43 p. 1 - 6

Abstract

N.V. Acharya¹, L.V. Wilton¹,² and S.A.W. Shakir¹,²

¹Drug Safety Research Unit, Southampton, and ²University of Portsmouth, UK
Aims: This is an interim report of a prospective observational cohort study to monitor the safety and tolerability of carvedilol in clinical practice when prescribed for heart failure in England. The utilization of carvedilol, management of adverse events in the community and the symptomatic progression of heart failure were examined. It is a non-interventional, observational cohort surveillance study using questionnaires sent to the patients’ general practitioners. Methods: The general practitioners (GPs) of the patients identified by the Prescription Pricing Authority were sent an eligibility questionnaire if the patient had been newly prescribed carvedilol between September 1999 and July 2001. Further questionnaires requesting baseline clinical information about eligible patients (carvedilol indicated for cardiac failure) and subsequent event data were sent to consenting GPs at 12 months. The questionnaires also requested specific information about initiation and supervision of treatment, including severity of heart failure and treatment withdrawal. The data were analyzed by using descriptive statistics. In addition, the incidence densities (ID) of each event (per 1000 person-months of treatment) were calculated, ranked and the difference between the ID of each event in the first (ID1) and subsequent 5 months of exposure (ID2) was tested by constructing 99% confidence intervals (CI). Selected events of clinical interest would be followed-up for further information to enable causal association with carvedilol to be assessed. Results: In this interim report we have data on a cohort of 847 eligible patients for whom we have received information from the first follow-up questionnaire. The treatment of carvedilol was initiated in a majority of cases by hospital specialists (87%, n = 735), however, for most of them, further supervision of treatment was done under shared care between GPs and hospitals (70%, n = 595). More than 90% of the patients were started on carvedilol in the recommended dose range for the management of cardiac failure. Amongst the patients where NYHA grade of cardiac failure was expressed, the majority of patients treated with carvedilol had NYHA II (37%, n = 281) and III (40%, n = 297) symptoms at the start of carvedilol treatment. On treatment with carvedilol, improvement in NYHA status was reported for 43% (n = 364) of this cohort, whilst less than 2.5% (n = 20) of the patients deteriorated. The events reported with the highest ID1 were malaise/lassitude (14.6), dizziness (12.2), cardiac failure (9.7), dyspnea (9.7) and hypotension (8.5). The most common events reported as reasons for stopping carvedilol were “drug not effective”, “dyspnea”, “dizziness” and “lassitude”. No events were identified as new signals (according to the ID1 – ID2 statistic) of adverse events associated with carvedilol. There have been no events identified in this cohort that have required specific follow-up at the time of writing this paper. Conclusions: In summary, the interim results show that there is effective cooperation between hospital specialists and GPs in the use of carvedilol in the management of patients with heart failure. It also shows that carvedilol was well-tolerated and that patients with mild and moderate heart failure benefit symptomatically when treated with carvedilol in routine clinical practice.Correspondence to:
Prof. S.A.W. Shakir

Drug Safety Research Unit

Bursledon Hall, Blundell Lane

Southampton, SO31 1AA, UK
Email: [email protected]

Therapeutics

Prospective observational cohort safety study to monitor the introduction of a non-CFC formulation of salbutamol with HFA134a in England

P.M. Craig-McFeely, L.V. Wilton, J.B. Soriano, W.C. Maier and S. A.W. Shakir

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Volume 41 p. 67 - 76

Abstract

P.M. Craig-McFeely, L.V. Wilton, J.B. Soriano, W.C. Maier and S. A.W. Shakir

¹Drug Safety Research Unit, Southampton, ²Hillbrow Surgery, Liss, ³GlaxoSmithKline, Greenford, and ⁴London School of Hygiene and Tropical Medicine, London, UK
Objective: To monitor the safety of a salbutamol MDI with a hydrofluoroalkane propellant (Ventolin Evohaler) during its introduction into primary care use in England. Methods: Prospective observational cohort study. 1,365 GPs in England submitted data on 10,472 regular users of Ventolin MDI, over five 3-month periods of observation between October 1, 1998 and December 31, 1999. The primary aim was to compare event rates occurring before and after the introduction of Ventolin Evohaler. The secondary aim was a comparison of event rates between users of Ventolin Evohaler and Ventolin MDI. The main outcome measures were: indication for use of Ventolin MDI, assessment of disease severity, event rates during each period of observation; deaths, pregnancies, reported adverse drug reactions and reasons for discontinuation of MDI. Event rates were adjusted using a ratio for under-reporting derived from a validation study on 4.6% of the study population and stratified by severity of indication. Results: The primary indication was asthma in 94%, distributed by severity as 47% mild, 44% moderate and 9% severe; 13% were children. By October 1999, 52.7% of the 8,973 remaining patients had transitioned to Ventolin Evohaler. There was no increase in major or minor events observed following the introduction of Ventolin Evohaler. No serious adverse events, abnormal pregnancy outcomes or deaths have been related to Ventolin MDI or Ventolin Evohaler. The validation study showed a degree of under-reporting. Conclusion: These results on a large cohort of community patients in England indicate that Ventolin Evohaler is well tolerated among asthmatics.

Pharmacovigilance

A post-marketing observational study to assess the safety of mibefradil in the community in England

J. Riley, L.V. Wilton, and S.A.W. Shakir

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Volume 40 p. 241 - 248

Abstract

J. Riley¹, L.V. Wilton¹,² and S.A.W. Shakir¹,³

¹Drug Safety Research Unit, Bursledon Hall, Southampton, ²School of Medicine, University of Southampton, and ³London School of Hygiene and Tropical Medicine, London, UK
Objectives: To conduct a post-marketing observational cohort study to assess the safety of mibefradil in the community, using Prescription-Event Monitoring (PEM). Method: Data were collected and analyzed on patients prescribed mibefradil by 1,996 General Practitioners (GPs) throughout England. Incidence densities were calculated for all reported events and selected events were followed-up by means of further questionnaires. Results: The study was terminated early due to the voluntary withdrawal of mibefradil from the market because of potential drug interactions. A cohort of 3,085 patients was recruited, with a mean age of 64.5 years. The major indication for use was hypertension (55% of the cohort), the indication was not specified in 33% of patients. 80% of GPs expressing an opinion rated mibefradil as effective. The major reason for stopping was withdrawal from the market (2,342 patients). The commonest reported adverse events and reasons for stopping were malaise/lassitude, dizziness, edema and headache. Seven clinically serious reports of bradycardia/collapse were considered to be possible adverse drug reactions (ADRs) to mibefradil. All were in the elderly (> 65 years), 6 were considered to be a result of possible drug interactions. In total, 11 possible drug interactions occurred. Nine (8 reports of bradycardia and 1 of syncope) involved b-blockers. Another, a report of collapse and severe bradycardia, occurred in a patient who had started a dihydropyridine calcium channel blocker within 24 hours of stopping mibefradil and the other was a report of palpitations and dyspnea in a patient on concomitant digoxin and sotalol. None of the 53 deaths occurring during the study was attributed to mibefradil. Conclusion: Mibefradil was only available on the UK market for 6 months before it was withdrawn from the market because of potential drug interactions. With respect to the reasons leading to its withdrawal, in this cohort of 3,085 patients, 11 possible drug interactions were detected (6 clinically significant) involving b-blockers, a dihydropyridine calcium channel blocker and digoxin and/or sotalol. PEM can contribute to the understanding of ADRs caused by drug interactions occurring in real-life settings.Correspondence to:
Dr. L. Wilton; Drug Safety Research Unit, Bursledon Hall, Blundell Lane, Southampton SO31 1AA, UK
Email: [email protected]

Immunopharmacology

Montelukast and improvement of eczema: observations from a prescription event monitoring study in England

P. Biswas, L.V. Wilton and S.A.W. Shakir

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Volume 39 p. 529 - 533

Abstract

P. Biswas, L.V. Wilton and S.A.W. Shakir

Drug Safety Research Unit, Burseldon Hall, Southampton and School of Medicine, University of Southampton, UK
Objective: Montelukast is an orally administered cysteinyl receptor antagonist, approved for the treatment of asthma. There is pharmacological plausibility of its effectiveness in the treatment of other immunologically mediated conditions such as eczema and urticaria. The objective of this study was to determine whether there are any beneficial effects of montelukast on eczema and urticaria. Method: A non-interventional observational cohort study was conducted between February 1998 and December 1998 using Prescription-Event Monitoring (PEM). During PEM studies, patients are systematically identified from dispensed prescription data and questionnaires are sent to the prescribing general practitioner (GP) asking them to report events occurring during and after treatment. In this study, events reported as eczema or urticaria improved were identified. A simple questionnaire was sent to the GPs for additional information. Results: The cohort comprised 15,612 patients, in which 16 reports of eczema or urticaria improved were identified. Questionnaires were sent to the GPs for additional information. Fifteen of the 16 questionnaires were returned. In 5 cases the GPs thought that there was an improvement of eczema or urticaria with montelukast treatment in patients who had history of long-standing eczema or urticaria. Of the remaining 11 cases there was an alternative explanation for the improvement of eczema or urticaria in 10 cases and one was unassessable. Conclusion: PEM is conducted to monitor the safety of medicines, and doctors report events including improvement in pre-existing conditions. Although the number of cases of improvement of eczema or urticaria in this cohort is small, there is a possibility that leukotriene inhibitors may be helpful in the treatment of these diseases. Further studies are needed to provide evidence as to whether montelukast will have a role in the treatment of these conditions.Correspondence to:
Dr. P. Biswas Drug Safety Research Unit, Burseldon Hall, Blundell Lane, Southampton, SO31 1AA, Hants, UK
Email: [email protected]

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