BACKGROUND Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk. OBJECTIVES In a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels. METHODS ODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was <70 mg/dL (median 69.4 mg/dL; interquartile range: 64.3–74.0 mg/dL); in 14,573 patients (77.0%), both determinations were ≥70 mg/dL (median 94.0 mg/dL; interquartile range: 83.2–111.0 mg/dL). RESULTS In the lower LDL-C subgroup, MACE rates were 4.2 and 3.1 per 100 patient-years among placebo-treated patients with baseline lipoprotein(a) greater than or less than or equal to the median (13.7 mg/dL). Corresponding adjusted treatment hazard ratios were 0.68 (95% confidence interval [Cl]: 0.52–0.90) and 1.11 (95% Cl: 0.83–1.49), with treatment-lipoprotein(a) interaction on MACE ( P interaction = 0.017). In the higher LDL-C subgroup, MACE rates were 4.7 and 3.8 per 100 patient-years among placebo-treated patients with lipoprotein(a) >13.7 mg/dL or ≤13.7 mg/dL; corresponding adjusted treatment hazard ratios were 0.82 (95% Cl: 0.72–0.92) and 0.89 (95% Cl: 0.75–1.06), with P interaction = 0.43. CONCLUSIONS In patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402 )
The costs and benefits of a planned patient education programme for patients with asthma were evaluated in a controlled trial. The patient education group received a planned patient education programme, performed by a physician, a pharmacist and a nurse over a 6-month period. Changes in the use of resources, productive output and in health status were measured for the patient education group and the control group. The total cost for planning, implementation and evaluation of the programme was 14074 British pounds sterling. The patient education group increased its contacts to general practitioners and the extra costs totalled 252 British pounds sterling. The increased costs of drugs used by the patient education group in the 6-month period was 2313 British pounds sterling compared with costs in the control group. The number of days lost through sickness decreased in the patient education group, corresponding to a 4528 British pounds sterling saving of otherwise lost earnings. The quality of life increased in the patient education group by 3.2 points on the Psychosomatic Discomfort Scale (2.9%). Health status increased by 38.9%. The study shows that the patient education programme has a positive clinical effect on the patient's quality of life and health status. The economic consequences of the implementation programme depend on the specific setup of the local healthcare system, where the programme is applied.
426 consecutive patients admitted to a Danish University Department of Cardiology have been studied. Drug intake prior to admission by each patient was ascertained from medical records and personal interviews. Adverse drug reactions (ADR) were the primary cause of admission in 49 patients (11.5%), and 16 patients (3.8%) were admitted due to drug non-compliance (DNC). Thiazide diuretics, beta-adrenoceptor blocking agents and calcium antagonists accounted for almost 60% of all the ADR-related admissions. Patients admitted for ADR took significantly more drugs than patients admitted for other reasons. DNC was not correlated with the number of prescribed drugs. It is concluded that drug-related hospital admissions are an important medical and economic problem. Most of the ADRs were well-known and predictable actions of the drugs, and could have been avoided by more careful clinical and laboratory monitoring of the patients. Most of the DNC, too, could have been avoided by giving better information to the patients.
The kinetics at a single oral dose (400 mg) of quinidine were studied in four extensive metabolizers (EM) and four poor metabolizers (PM) of sparteine. The clearance of quinidine by 3-hydroxylation was significantly lower in PM than in EM, but the difference was small (25-30%). This finding suggests that 3-hydroxylation, in part, is catalyzed by the same isoenzyme of cytochrome P450, P450dbl which oxidizes sparteine. Otherwise, no significant phenotypic differences in total or metabolic clearance were found and it is concluded that the metabolism of quinidine is largely carried out by P450 isoenzymes different from P450dbl. A biexponential decline in the log plasma quinidine concentration vs time curves was observed in all subjects, and the mean elimination half-life was 11-12 h. This is about twice as long as generally reported in the literature.
Patients with mild to moderate HF may benefit from long-term follow-up in a HF clinic in terms of pharmacological therapy and functional status, but we found no significant impact on unplanned hospitalisations or death.
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