Orlistat and the risk of acute liver injury: self controlled case series study in UK Clinical Practice Research Datalink

Douglas, Ian; Langham, Julia; Bhaskaran, Krishnan; Brauer, Ruth; Smeeth, Liam

doi:10.1136/bmj.f1936

Cited by 57 publications

(55 citation statements)

References 8 publications

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“…A similar phenomenon had also been reported in previous literature. 24 The findings of this study do not support a causal relationship between the use of oral FQs and the development of seizure. In addition, the crude absolute risk estimated in this study was very low in both databases.…”

contrasting

confidence: 49%

“…This study method has been used frequently in pharmacoepidemiologic studies. 24,26 However, to apply SCCS correctly, several assumptions should be met. First, the occurrence of the event should not affect the occurrence of subsequent events.…”

Section: Data Sources Clinical Data Analysis and Reporting Systemmentioning

confidence: 99%

“…22 Numerous high-quality studies have been published using data from CPRD, which affirms the validity and credibility of this database. 23,24 Study design. The SCCS method conducts within-person comparisons of individuals who have both the exposure and outcome of interest.…”

Section: Data Sources Clinical Data Analysis and Reporting Systemmentioning

confidence: 99%

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Association between oral fluoroquinolones and seizures

Chui¹,

Chan²,

Wong³

et al. 2016

Neurology

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Objectives: The aim of this study was to investigate the association and to estimate the crude absolute risk of seizure among patients exposed to fluoroquinolones (FQs) in Hong Kong and the United Kingdom.Methods: A self-controlled case series study was conducted. Data were collected from the Hong Kong Clinical Data Analysis and Reporting System database and the Clinical Practice Research Datalink. Patients who were prescribed any oral FQ and had an incident seizure diagnosis from 2001 to 2013 were included. The risk windows were defined as pre-FQ start, FQ-exposed, and post-FQ completion. Incidence rate ratios were estimated in all risk windows and compared with baseline periods. A post hoc subgroup analysis was conducted to examine the effect of patients with a history of seizure.Results: An increased incidence rate ratio was found in the pre-FQ start periods and no association was found in the post-FQ completion periods in both databases. The crude absolute risk of an incident seizure in 10,000 oral FQ prescriptions was 0.72 (95% confidence interval 0.47-1.10) in the Clinical Data Analysis and Reporting System and 0.40 (95% confidence interval 0.30-0.54) in the Clinical Practice Research Datalink. The rate ratio during treatment was not higher than pre-FQ start periods among patients with a history of seizure, therefore the results did not raise serious concerns.Conclusions: This study does not support a causal association between the use of oral FQs and the subsequent occurrence of seizure. An increased risk before the FQ exposure period suggests that the clinical indication for which FQ was prescribed may have contributed to the development of seizure rather than the drug itself.

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contrasting

confidence: 49%

Section: Data Sources Clinical Data Analysis and Reporting Systemmentioning

confidence: 99%

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Association between oral fluoroquinolones and seizures

Chui¹,

Chan²,

Wong³

et al. 2016

Neurology

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“…In a self-control study, recruited patients act as their own control, thus limiting the effect of confounding. In fact, study outcomes may be influenced by relevant characteristics that may differ between patients [19]. In addition, overoptimistic results should have been avoided, as patient satisfaction was assessed including all dropouts as dissatisfied.…”

Section: Discussionmentioning

confidence: 99%

“…A prospective, self-controlled study design was adopted because it allows within-person comparisons avoiding the potential confounding caused by differences between patients [19]. The investigation was performed in an academic department specializing in the management of endometriosis, and the competent Institutional Review Board approved the study.…”

Section: Methodsmentioning

confidence: 99%

Shifting from Oral Contraceptives to Norethisterone Acetate, or Vice Versa, because of Drug Intolerance: Does the Change Benefit Women with Endometriosis?

Vercellini

Ottolini

Frattaruolo

et al. 2018

Gynecol Obstet Invest

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Background/Aims: Oral contraceptives (OC) and norethisterone acetate (NETA) are among first-line medical therapies for symptomatic endometriosis, but their use is sometimes associated with intolerable side effects. We investigated whether shifting from low-dose OC to NETA (2.5 mg/day), or vice versa, improved tolerability. Methods: Sixty-seven women willing to discontinue their treatment because of intolerable side effects despite good pain relief, were enrolled in a self-controlled study, and shifted from OC to NETA (n = 35) or from NETA to OC (n = 32). The main study outcome was satisfaction with treatment 12 months after the change. Tolerability, pain symptoms, health-related quality of life, psychological status, and sexual functioning were also evaluated. Results: After treatment change, good tolerability was reported by 37% of participants who shifted to NETA, and by 52% of those who shifted to OC. At 12-month assessment, 51% of women intolerant to OC were satisfied with NETA, and 65% of those intolerant to NETA were satisfied with OC (intention-to-treat analysis). Other study variables did not vary substantially. Conclusions: In selected endometriosis patients, shifting from OC to NETA, or vice versa, because of side effects, improved tolerability. Better results were observed when substituting NETA with OC rather than the other way round.

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