Alirocumab Reduces Total Hospitalizations and Increases Days Alive and Out of Hospital in the ODYSSEY OUTCOMES Trial

In ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), alirocumab was compared with placebo, added to high-intensity or maximum tolerated statin treatment after acute coronary syndrome in 18 924 patients. Alirocumab reduced first occurrence of the primary composite end point-coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina-as well as total nonfatal cardiovascular events and all-cause deaths. The present analysis determined whether alirocumab reduced total (first and subsequent) hospitalizations and death and increased days alive and out of hospital (DAOH) and percent DAOH in ODYSSEY OUTCOMES.In prespecified analyses, hazard functions for total hospitalizations and death were jointly estimated by a semiparametric model, while in post hoc analyses, DAOH and percent DAOH were compared between treatment groups with Poisson regression and one-inflated beta regression, respectively. With 16 629 total hospitalizations and 726 deaths, 331 fewer hospitalizations, and 58 fewer deaths were observed with alirocumab compared with placebo, translating to 15.6 total hospitalizations or deaths avoided with alirocumab per 1000 patient-years of assigned treatment. Alirocumab reduced total hospitalizations (hazard ratio, 0.96 [95% CI, 0.92-1.00]; P=0.04) and increased DAOH relative to placebo (rate ratio, 1.003 [95% CI, 1.000-1.007]; P=0.05), primarily through a reduction in days dead (rate ratio, 0.847 [95% CI, 0.728-0.986]; P=0.03). Patients randomized to alirocumab were also more likely to survive to the end of the study without hospitalization (odds ratio, 1.06 [95% CI, 1.00-1.13]; P=0.03).Alirocumab reduced total hospitalizations with corresponding small increases in DAOH and percent DAOH. These outcomes provide alternative patient-centered metrics to capture the totality of alirocumab clinical efficacy after acute coronary syndrome.URL: http://www.clinicaltrials.gov. Unique identifier: NCT01663402

Prelude to a merger: Predicting a merger with financial characteristics

This dissertation utilizes survival analysis methods to describe time-to-event data, where the event is a merger executed by a publicly traded pharmaceutical firm with a current market capitalization of $10 billion or more. The Cox proportional hazards model, the analytical method used to summarize relationships between characteristics of the acquiring firms—including financial, balance sheet and operational measures and indices of efficiency—and the likelihood of a merger event, has never been previously utilized in the merger and acquisition (M&A) literature. Furthermore, the majority of the existing M&A literature examines the characteristics of the target firms at a fixed point in time whereas the current analysis examines characteristics of the acquiring firms both at a fixed point of time and as time-varying measures and accounts for the interval of time until a first merger or the interval of time between mergers. Additional analyses summarize short-term changes in commonly used measures of efficiency in the period immediately preceding and immediately following a merger event and long-term changes in these measures among the firms that engaged in mergers over time. Univariate Cox regression models find statistically significant relationships between net income, operating income, SG&A, and total shareholder equity. Multivariate Cox regression models reveal total shareholder equity as the main driver of merger activity. This finding is consistent with one popular theory found in the literature that firms seek to maximize their shareholder\u27s wealth. The analyses of short-term and long-term changes in measures of efficiency did not reveal any notable changes, suggesting that the mergers did not have a substantial negative or positive effect on efficiency over time. These analyses extend on the existing literature that has examined the characteristics of firms that engage in mergers and the short- and long-term impact of mergers on the acquiring companies