Adverse events densities

All the patients took supplementary calcium and vitamin D. The primary end-point was the mean percentage change in lumbar spine bone mineral density from baseline to 2 years. In those who took alendronate 5, 10, and 2.5/10 mg/day, bone mineral density increased significantly by 2.8, 3.9, and 3.7% respectively, and fell by -0.8% with placebo. There were significantly fewer patients with new vertebral fractures in the alendronate group compared with placebo (0.7 versus 6.8%). Adverse events were similar across the groups. 

The impact of a new formulation of low-dose micronized medroxyprogesterone plus 17-beta-estradiol on lipid profiles in menopausal women has been studied for 12 months. Total cholesterol concentrations fell 8.4%, low-density lipoprotein cholesterol fell 18%, and high-density lipoprotein cholesterol increased 6.9% total triglycerides increased 12%. The most frequently reported adverse events were menorrhagia, breast tenderness, cervical polyps or cysts, bloating, fatigue or lethargy, influenza or a flu-like syndrome, back pain, headaches, irritability, and depression (34). 

An extensive literature review has provided a useful assessment of the benefit to harm balance of raloxifene (20). The findings were reassuring. One large fracture prevention trial provided the best evidence that raloxifene 60 mg/day for 3 years reduced the relative risk of vertebral fractures by 30-50% in women with prevalent fractures or osteoporosis. The extraskeletal effects of raloxifene include a reduction in total cholesterol and low density lipoprotein cholesterol concentrations. Raloxifene was not associated with endometrial hyperplasia, and there was a 72% reduction in the incidence of invasive breast cancer. Adverse events associated with raloxifene included an increase in the absolute risk of venous thromboembolism and increased risks of hot... 

In postmenopausal osteoporosis treatment with calcitriol plus etidronate or calcitonin produced improvement in spinal bone mineral density, but a high rate of nephrotoxic adverse events (17). 

In a small (81 patients) retrospective analysis, patients on lipidlowering medication (statins, fibrates, or niacin derivatives) at the time of PCI had a significantly lower incidence of adverse events during the procedure, such as emboli and dissections, as compared to those not taking such agents (57). A high-total cholesterol, low-density lipoprotein, or ratio of low to high-density lipoprotein were also associated with increased adverse events,... 

In the TITAN and POWER series of studies [174, 175, 176, the following adverse reactions were reported nasopharyngitis, increases in triglycerides, low density lipoprotein, total cholesterol, and blood glucose, neutropenia, nausea and diarrhea, often a cause of withdrawal, rashes, and raised aminotransferase, pancreatic lipase, and amylase activities. There was an increase in adverse events affecting the... 

An exploratory study in Japan treated 15 patients with chronic hepatitis C (genotype lb) infection with telaprevir alone [77=]. They were treatment naive and received telaprevir 750 mg eight hourly for 24 weeks. 93% (n=14) of the patients experienced adverse events (AEs) with a total of 80 AEs. The most common events were rash (53.3%, n=8), anaemia (46.7%, n=7), raised low-density lipoprotein (40%, n=6), increased blood uric acid (26.7%, n=4), and pruritus (26.7%, n=4). There was a decrease in haemoglobin in all 15 patients, described as anaemia in seven patients. 

Randomised trials A randomised, controlled trial of 6 months of parathyroid hormone treatment in combination with either concurrent or sequential ibandronate over 2 years [67 ] found that both treatment regimens were efficacious in increasing bone mineral density in postmenopausal women (N = 44). Seven women met the criteria for hypercalcaemia, with only one requiring reduction in treatment. Three women met the criteria for hypercalciuria. The most commonly reported adverse events were nausea (32%) and injection-site reactions (32%). 

To control risk factors and prevent major adverse cardiac events, statin therapy should be considered in all patients with ischemic heart disease, particularly in those with elevated low-density lipoprotein cholesterol. In the absence of contraindications, angiotensin-converting enzyme inhibitors should be considered in ischemic heart disease patients who also have diabetes melli-tus, left ventricular dysfunction, history of myocardial infarction, or any combination of these. Angiotensin receptor blockers... 

Skin rashes are relatively common with flnoroqninolones. A retrospective cohort stndy in patients in general practice in the Netherlands focused on the nse of antibacterial agents and the occnrrence of adverse cntaneons events covered 469 505 consnltations with 87 475 patients, of whom 13 679 received prescriptions for antibiotics (57). After adjnstment for age, sex, and co-medications, the incidence density ratio (incidence density per 1000 exposed days) for varions gronps of antibacterial agents was as follows tetracyclines 1.0, macrohdes 1.1, flnoroqninolones 2.8, penicillins 2.9, and co-trimoxazole 4.4 (57). No details of the types of skin reactions were given, and it is therefore possible that phototoxic events were inclnded. Compared with other stndies, the reported rate of antibiotic-associated adverse cntaneons events in this ontpatient popnlation was rather low. 

Using the method of prescription event monitoring (PEM), the incidence densities of adverse effects per 1000 patient-months of exposure have been measured in 14 522 patients (2). Most were hypertensive (63%). During treatment months 2-6, the commonest adverse... 

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