Statistics in Medicine — Reporting of Subgroup Analyses in Clinical Trials

Wang, Rui; Lagakos, Stephen W.; Ware, James H.; Hunter, David J.; Drazen, Jeffrey M.

doi:10.1056/nejmsr077003

Cited by 1,210 publications

(985 citation statements)

References 17 publications

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“…Nonetheless, our analyses focused on differences in sex groups but the interaction between treatment and sex was not significant, 11,12 similar to previous studies. 13,14 Therefore, the effect of treatment cannot be explained exclusively by sex.…”

Section: Discussionsupporting

confidence: 52%

Sex differences in response to angiotensin II receptor blocker-based therapy in elderly, high-risk, hypertensive Japanese patients: a subanalysis of the OSCAR study

et al. 2014

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for the OlmeSartan Calcium Antagonists Randomized (OSCAR) Study GroupThe OlmeSartan Calcium Antagonists Randomized (OSCAR) study is a multicenter, prospective, randomized, open-label, blinded, end point study of elderly hypertensive Japanese patients that compared the efficacy of a high-dose angiotensin II receptor blocker (ARB) treatment to an ARB plus calcium channel blocker (CCB) combination. In this pre-specified subgroup analysis, we compared the response to such therapy according to sex. A total of 1164 patients (515 (44%) men and 649 (56%) women) were included, and each gender was split into two nearly equal treatment groups. The primary end point was a composite of cardiovascular events and non-cardiovascular death. The baseline characteristics between the two treatment groups in each sex were similar, except for some variables. Male patients had lower systolic and higher diastolic blood pressure than female patients (156.8/85.7 vs. 158.5/84.2 mm Hg). At the end of the study, the mean systolic pressure was higher in the ARB group (134.4 mm Hg) than in the ARB plus CCB group (131.5 mm Hg; P ¼ 0.03) for men but not for women (135.4 vs. 133.4 mm Hg; P ¼ 0.12). For men, the primary outcome events tended to be higher in the ARB group than in the ARB plus CCB group (hazard ratio (HR) ¼ 1.66; P ¼ 0.055) but not for women (HR ¼ 0.97; P ¼ 0.92). This difference in men was due to cardiovascular events (HR ¼ 1.86; P ¼ 0.03). The interaction between sex and treatment group was not significant (P ¼ 0.17). These findings suggest that, in addition to blood pressure control, appropriate patient risk assessment is important for the treatment of hypertension, especially in male patients, as opposed to possible sex differences in treatment effects.

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Section: Discussionsupporting

confidence: 52%

Sex differences in response to angiotensin II receptor blocker-based therapy in elderly, high-risk, hypertensive Japanese patients: a subanalysis of the OSCAR study

et al. 2014

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“…In accordance with recommendations of the reviewers of the report and specifi c reporting guidelines, 20 we did separate post-hoc unadjusted tests for interaction between the treatment and each minimisation factor on the basis of Cochran's Q statistic. For the safety analysis, patients were classed as treated.…”

Section: Discussionmentioning

confidence: 99%

Citicoline in the treatment of acute ischaemic stroke: an international, randomised, multicentre, placebo-controlled study (ICTUS trial)

Dávalos¹,

Álvarez-Sabín²,

Castillo³

et al. 2012

The Lancet

241

157

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“…No adjustments for multiplicity were made. As recommended by guidelines (16) for subgroup analyses, we prespecified the number of subgroup analyses examined and calculated the potential magnitude of the false-positive rate.…”

Section: Discussionmentioning

confidence: 99%

“…(16) Subgroup analyses inherently have limited power to detect interactions in small subgroups with few events. In this study, the subgroups in which a significant effect was not observed were either small or had a low risk of fracture (nonwhites, North and Latin America, higher BMD and BMI, prevalent vertebral fractures, and prior nonvertebral fractures).…”

Section: Discussionmentioning

confidence: 99%

Effect of denosumab treatment on the risk of fractures in subgroups of women with postmenopausal osteoporosis

McClung

Boonen

Törring

et al. 2011

Journal of Bone and Mineral Research

136

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Denosumab reduces the risk of new vertebral and nonvertebral fractures. Previous trials suggest that the efficacy of antiresorptives on fractures might differ by patients' characteristics, such as age, bone mineral density (BMD), and fracture history. In the FREEDOM study, 7808 women aged 60 to 90 years with osteoporosis were randomly assigned to receive subcutaneous injections of denosumab (60 mg) or placebo every 6 months for 3 years. New vertebral and nonvertebral fractures were radiologically confirmed. Subgroup analyses described in this article were prospectively planned before study unblinding to evaluate the effect of denosumab on new vertebral and nonvertebral fractures across various subgroups. Compared with placebo, denosumab decreased the risk of new vertebral fractures in the overall study population over 3 years. This effect did not significantly differ for any of the nine subgroups analyzed ( p > 0.09 for all potential interactions). Denosumab also reduced all nonvertebral fractures by 20% in the full study cohort over 3 years. This risk reduction was statistically significant in women with a baseline femoral neck BMD T-score À2.5 but not in those with a T-score > À2.5; in those with a body mass index (BMI) < 25 kg/m 2 but not ! 25 kg/m 2 ; and in those without but not with a prevalent vertebral fracture. These differential treatment effects were not explained by differences in BMD responses to denosumab. Denosumab 60 mg administered every 6 months for 3 years in women with osteoporosis reduced the risk of new vertebral fractures to a similar degree in all subgroups. The effect of denosumab on nonvertebral fracture risk differed by femoral neck BMD, BMI, and prevalent vertebral fracture at baseline. ß

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Statistics in Medicine — Reporting of Subgroup Analyses in Clinical Trials

Cited by 1,210 publications

References 17 publications

Sex differences in response to angiotensin II receptor blocker-based therapy in elderly, high-risk, hypertensive Japanese patients: a subanalysis of the OSCAR study

Sex differences in response to angiotensin II receptor blocker-based therapy in elderly, high-risk, hypertensive Japanese patients: a subanalysis of the OSCAR study

Citicoline in the treatment of acute ischaemic stroke: an international, randomised, multicentre, placebo-controlled study (ICTUS trial)

Effect of denosumab treatment on the risk of fractures in subgroups of women with postmenopausal osteoporosis

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