A cost-effectiveness analysis of fluvastatin in patients with diabetes after successful percutaneous coronary intervention

Background: The Lescol Intervention Prevention Study (LIPS) was a multinational randomized controlled trial that showed a 47% reduction in the relative risk of cardiac death and a 22% reduction in major adverse cardiac events (MACEs) from the routine use of fluvastatin, compared with controls, in patients undergoing percutaneous coronary intervention (PCI, defined as angioplasty with or without stents). In this study, MACEs included cardiac death, nonfatal myocardial infarction, and subsequent PCI and coronary artery bypass graft. Diabetes was the greatest risk factor for MACEs. Objective: This study estimated the cost-effectiveness of fluvastatin when used for secondary prevention of MACEs after PCI in people with diabetes. Methods: A post hoc subgroup analysis of patients with diabetes from the LIPS was used to estimate the effectiveness of fluvastatin in reducing myocardial infarction, revascularization, and cardiac death. A probabilistic Markov model was developed using United Kingdom resource and cost data to estimate the additional costs and quality-adjusted life-years (QALYs) gained over 10 years from the perspective of the British National Health Service. The model contained 6 health states, and the transition probabilities were derived from the LIPS data. Crossover from fluvastatin to other lipid-lowering drugs, withdrawal from fluvastatin, and the use of lipid-lowering drugs in the control group were included. Results: In the subgroup of 202 patients with diabetes in the LIPS trial, 18 (15.0%) of 120 fluvastatin patients and 21 (25.6%) of 82 control participants were insulin dependent (P = NS). Compared with the control group, patients treated with fluvastatin can expect to gain an additional mean (SD) of 0.196 (0.139) QALY per patient over 10 years (P < 0.001) and will cost the health service an additional mean (SD) of 10 (E448) (P = NS) (mean [SD] US $16 [$689]). The additional cost per QALY gained was;(51 (US $78). The key determinants of cost-effectiveness included the probabilities of repeat interventions, cardiac death, the cost of fluvastatin, and the time horizon used for the evaluation. Conclusion: Fluvastatin was an economically efficient treatment to prevent MACEs in these patients with diabetes undergoing PCI.

Whither the responsibility to protect? Humanitarian intervention and the 2005 World Summit

At the 2005 World Summit, the world's leaders committed themselves to the "responsibility to protect", recognizing both that all states have a responsibility to protect their citizens from genocide, war crimes, ethnic cleansing and crimes against humanity and that the UN should help states to discharge this responsibility using either peaceful means or enforcement action. This declaration ostensibly marks an important milestone in the relationship between sovereignty and human rights but its critics argue that it will make little difference in practice to the world's most threatened people. The purpose of this article is to ask how consensus was reached on the responsibility to protect, given continuing hostility to humanitarian intervention expressed by many (if not most) of the world's states and whether the consensus will contribute to avoiding future Kosovos (cases where the Security Council is deadlocked in the face of a humanitarian crises) and future Rwandas (cases where states lack the political will to intervene). It suggests that four key factors contributed to the consensus: pressure from proponents of the International Commission on Intervention and State Sovereignty, its adoption by Kofi Annan and the UN's High Level Panel, an emerging consensus in the African Union, and the American position. Whilst these four factors contributed to consensus, each altered the meaning of the responsibility to protect in important ways, creating a doctrine that many states can sign up to but that does little to prevent future Kosovos and Rwandas and may actually inhibit attempts to build a consensus around intervention in future cases.