Incorrect use of orlistat and sibutramine in clinical practice.

OBJECTIVE: To investigate how the antiobesity drugs orlistat and sibutramin are prescribed in relation to the approved indications and the Swedish subsidiary rules. METHODS: Anonymous survey to prescribers of a random sample of 2000 out of 20,000 prescription of orlistat and sibutramin. RESULTS: The response rate was around 65%. About half of the patients were not treated in accordance with the approved indications and a fourth of the patients prescribed sibutramin had one or several contraindications to the drug. The subsidiary rules were not followed in the majority of cases. CONCLUSION: Deviation from the approved indications and subsidiary criteria of orlistat and sibutramin is a question of waste of medical and economic resources. Prescribing of sibutramin to patients with contraindications is a serious health hazard.

Press coverage and sales of Xenical in Sweden, 1998-2000.

OBJECTIVE: The anti-obesity drug Xenical (orlistat, Roche) was launched on the Swedish market in February 1999. The sales peaked in May 1999 and then declined. The purpose of this study was to investigate the press coverage of Xenical during the period 1998-2000 and, if possible, relate press attention to Xenical sales during this period. METHODS: We analysed all articles published in Sweden's four biggest-selling newspapers mentioning Xenical during the period 1998-2000. Promotion activities aimed at healthcare professionals were measured by registering the number of advertisements in the Journal of the Swedish Medical Association. Sales figures for Xenical were obtained from the National Corporation of Swedish Pharmacies. RESULTS: Approximately twice as many positive-effect messages were published than negative or neutral messages. Only six out of 42 positive messages referred to results from scientific studies. The initial high peaks for sales and positive-effect articles coincided with the launch of Xenical on the Swedish market. CONCLUSIONS: It is not possible to discern a causal relationship between press coverage and sales; however, it seems safe to say that the large number of positive articles published before and during the launch greatly increased public awareness of Xenical, thus promoting sales.

Treatment with angiotensin converting enzyme inhibitors, angiotensin-II-antagonists and beta-blockers in an unselected group of patients with chronic heart failure.

OBJECTIVES: Modern diagnostics of chronic heart failure (CHF) is based on echocardiography. Angiotensin converting enzyme inhibitors (ACEIs) or angiotensin-II-antagonists (AIIAs) in case of ACEI intolerance, and beta-blockers are recommended as first-line drugs in patients with CHF and left ventricular systolic dysfunction. The aims of this study were to analyse the diagnostics and treatment of patients with CHF and to identify the optimal drug profile (target level) with regard to ACEI/AIIA- and beta-blocker treatment. METHODS: The medical records of all patients (n=635) from a part of a Swedish county who had a diagnosis of CHF in the year 2000 were analysed retrospectively. RESULTS: The prevalence of CHF increased with age, from 0.9% and 1.6% in the age group 60-64 years in women and men, respectively, to 8.8% and 11.5%, respectively, in the age group 80-84 years. Only 17.6% of the patients had been examined by means of echocardiography. Of the patients without any contra-indication for the drugs, 45.9% received treatment with ACEI/AIIAs and 41.8% with beta-blockers. Treatment with ACEI/AIIAs and beta-blockers was given to 21.3%. The corresponding proportions for treatment of patients with CHF verified by echocardiography were 88.0% (ACEI/AIIA), 52.0% (beta-blocker) and 46.7% (the combination). The target level of the combination treatment was estimated to be about 70% in a group of unselected patients with CHF. CONCLUSIONS: CHF was not optimally diagnosed in this cohort of patients. Correct diagnosing seems to be associated with more adequate treatment.

Evidence b(i)ased medicine--selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications.

OBJECTIVES: To investigate the relative impact on publication bias caused by multiple publication, selective publication, and selective reporting in studies sponsored by pharmaceutical companies. DESIGN: 42 placebo controlled studies of five selective serotonin reuptake inhibitors submitted to the Swedish drug regulatory authority as a basis for marketing approval for treating major depression were compared with the studies actually published (between 1983 and 1999). RESULTS: Multiple publication: 21 studies contributed to at least two publications each, and three studies contributed to five publications. Selective publication: studies showing significant effects of drug were published as stand alone publications more often than studies with non-significant results. Selective reporting: many publications ignored the results of intention to treat analyses and reported the more favourable per protocol analyses only. CONCLUSIONS: The degree of multiple publication, selective publication, and selective reporting differed between products. Thus, any attempt to recommend a specific selective serotonin reuptake inhibitor from the publicly available data only is likely to be based on biased evidence.

Changing Primary Care Doctors' Conceptions - A Qualitative Approach to Evaluating an Intervention.

Objective: To describe conceptions of the management of hyperlipidaemia and assess changes in conceptions after an educational intervention.- Setting and subjects: Primary care in Sweden. Twenty doctors at community health centres.- Methods: Within an educational experiment evaluating the effects of 'group detailing' by community pharmacists at 67 health centres, a selected sample of doctors were interviewed on two occasions, one and a half year apart, regarding their views on atherosclerotic cardiovascular disease and hyperlipidaemia. Half of the doctors had, in between the interviews, participated in four educational group sessions, where information was presented and discussed regarding the national recommendations on the management of hyperlipidaemia. Applying a phenomenographic approach, the variation of conceptions was described regarding six domains: general attitude to cardiovascular disease, risk factors, prevention of ischaemic heart disease, role of blood lipids, treatment of hyperlipidaemia, and screening for hypercholesterolaemia.- Outcome measures: Descriptions of categories of conceptions and changes of conceptions to ones in line with the treatment guidelines for individual doctors and for the two groups of doctors.- Results: There was a variation of conceptions in all six domains in both groups of doctors. The doctors' conceptions in the intervention group changed significantly to ones in line with the treatment recommendations (p < 0.01), which was not the case in the control group. A significant number of doctors in the intervention group changed at least one of the six conceptions to ones in concordance with the recommendations (p = 0.011). Although doctors in the control group also changed conceptions, this change was not statistically significant.- Conclusions: The doctors' conceptions changed significantly after 'group detailing' on management of hyperlipidaemia. Qualitative changes of conceptions may be used as outcome measures when evaluating the impact of an information activity directed at health care professionals.