Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere®) in patients with neovascular age-related macular degeneration.

The present study was an open-label, prospective, uncontrolled and multicenter clinical trial to investigate the safety and effectiveness of bevacizumab (Lumiere®) administered by the intravitreal route for the treatment of neovascular age-related macular degeneration (nAMD). A total of 22 patients without previous treatment with anti-vascular endothelial growth factor were recruited. Monthly therapy with 1.25 mg intravitreal bevacizumab was applied. Adverse events (AE), visual acuity (VA) and central retinal thickness (CRT) were assessed at baseline, day 1 and day 28 after each injection. A total of 87 AEs were reported; most of them were not serious (96.6%), expected (65.5%) and occurred after the third injection (56.3%). The most frequent AE was 'conjunctival hemorrhage' (29.9% of AEs), attributed to the injection procedure. Treatment was not suspended due to safety reasons in any case. After six months, a statistically significant gain of +8.2 (SD±8.8) letters and a CRT reduction of -75.50 µm (SD±120.3) were achieved with unilateral therapy. VA improvement and CRT reduction were also achieved with bilateral therapy, although to a lesser extent. The results of the present study suggested that therapy with a minimum of 3 doses of bevacizumab over a 6-month period was well tolerated and resulted in a sustained response regarding VA improvement and CRT reduction from the beginning of therapy compared with the baseline value. The study protocol was registered at clinicaltrials.gov (ref. no. NCT03668054).

Evaluation of cortical bone by peripheral quantitative computed tomography in continuous ambulatory peritoneal dialysis patients.

Several studies have suggested an increased prevalence of osteopenia in dialysis. Peripheral quantitative computed tomography (pQCT) is a new technique that allows the noninvasive evaluation of trabecular and cortical bone separately. The aim of the study was: (1) to evaluate cortical bone by pQCT in continuous ambulatory peritoneal dialysis (CAPD) patients and compare the data with that obtained in healthy controls; and (2) to correlate cortical bone parameters with bone mineral density (BMD) of the lumbar spine and femoral neck and total bone mineral content (TBMC). Cortical bone parameters were obtained in 22 CAPD patients and 27 healthy individuals at the distal radius using a Stratec XCT 960 pQCT machine. In the dialysis patients, we also determined BMD and TBMC by bone densitometry. Dialysis patients, compared with controls, showed a significant reduction in volumetric cortical BMD (VcBMD) (p = 0.04) and cortical thickness (cThk) (p < 0.0001) with a significant increase in radial total cross-sectional area (TA) (p = 0.006), endosteal circumference (p < 0.0001), and buckling ratio (p < 0.0001). In CAPD patients, total time on dialysis correlated negatively with radial total BMD (p < 0.01) and VcBMD (p < 0.01). Age correlated positively with TA (p < 0.01), endosteal (p < 0.01), and periosteal circumferences (p < 0.01). Serum intact parathyroid hormone (PTH) levels correlated positively with endosteal (p = 0.04) and periosteal perimeter (p = 0.01). Total alkaline phosphatase correlated negatively with VcBMD (p < 0.01), and positively with endosteal perimeter (p = 0.02). Total bone mineral content correlated significantly with radial cortical content (p < 0.001), cross-sectional cortical area (cA; p < 0.001), and cThk (p < 0.01) but not with total radial BMD, VcBMD, or buckling ratio. No correlations were found between radial cortical parameters and BMD measured at the lumbar spine or femoral neck. We conclude that dialysis patients show cortical osteopenia with marked cortical thinning partially mediated by PTH action on bone. Total bone mineral content correlated with various radial cortical parameters (content, area, and thickness) but not with others. No correlations were found between cortical bone parameters measured at the peripheral skeleton with areal bone density measured at the axial skeleton. These findings suggest that pQCT may be a new tool in the assessment of bone fragility in dialysis patients.

Observational study of compliance and continuance rates of raloxifene in the prevention and treatment of osteoporosis.

UNLABELLED: Abstract. BACKGROUND: Medical practitioners face the challenge of noncompliance with prescriptions, particularly in chronic, asymptomatic, diseases such as osteoporosis. OBJECTIVE: The aim of this study was to assess the raloxifene compliance and continuance rates and adverse effects over 24 months in clinical practice. METHODS: Using a retrospective study of clinical histories obtained from a database at the Metabolic Research Institute, University of El Salvador School of Medicine, Buenos Aires, Argentina, as well as telephone interviews, we assessed compliance and continuance with raloxifene therapy in post-menopausal patients who had received prescriptions for raloxifene to prevent or treat osteoporosis. Patients were contacted by telephone 24 months after they had received a prescription for raloxifene. Compliance and continuance rates were calculated based on the data provided by the patients. RESULTS: Data from 419 patients (mean [SD] age, 61.4 [7.4] years [range, 42-90 years]) were included in the study. At the time of the telephone interview, 225 (53.7%) were still receiving raloxifene, 105 (25.1%) had stopped treatment at their own discretion, 59 (14.1%) had not started treatment, and 30 (7.2%) had discontinued treatment as a result of advice from a physician. The reasons for not starting treatment were fear of thrombolytic events (21 patients [35.6%]); lack of interest in starting treatment (12 [20.3%]); other physician's advice (11 [18.6%]); family problems (3 [5.1%]); dissatisfaction with the prescribing physician, treatment cost, health problems unrelated to osteoporosis, and mistrust in the prescription (each, 2 [3.4%]); and advice from family/friends, fear of breast cancer, belief that raloxifene is hormonal, and that the patient was already polymedicated (each, 1 [1.7%]). Eleven of the 59 patients (18.6%) who had not started therapy were advised by a physician other than the prescribing physician not to start treatment and were excluded from the compliance analysis. Thus, the compliance analysis included 408 patients. The 2 most common reasons for discontinuing treatment at the patient's own discretion were health problems unrelated to osteoporosis (25 [23.8%]) and digestive problems not considered treatment related (16 [15.2%]). The compliance rates were 75.0%, 71.1%, 65.0%, 57.1%, and 52.0% at 3, 6, 12, 18, and 24 months, respectively. In patients who started raloxifene treatment, the continuance rates were 85.0%, 80.6%, 73.6%, 64.7%, and 58.9% at 3, 6, 12, 18, and 24 months, respectively. Sixty-two of the 135 patients who discontinued treatment did so within 3 months of receiving the prescription, accounting for 45.9% of all discontinuations. CONCLUSIONS: In the present study of raloxifene compliance and continuance in clinical practice, the compliance rate appeared to be relatively high compared with those of hormone-replacement therapy (HRT) and other non-HRT treatments. Almost half of patients who discontinued treatment did so in the first 3 months.