Coronary Edema Demonstrated by Cardiovascular Magnetic Resonance in Patients With Peri-Stent Inflammation and Aneurysm Formation After Treatment by Drug-Eluting Stents.
Coronary edema demonstrated by cardiovascular magnetic resonance in patients with peri-stent inflammation and aneurysm formation after treatment by drug-eluting stents.
Circ Cardiovasc Imaging. 2013 Mar 1; 6(2): 352-4
Holm NR, Kim WY, Maeng M, Thrysøe SA, Bøtker HE, Thuesen L, Høyer S, Tu S, Falk E, Lassen JF, Nielsen PH, Christiansen EH
CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products.
AAPS J. 2013 Mar 20;
Cruz CN, Tyner KM, Velazquez L, Hyams KC, Jacobs A, Shaw AB, Jiang W, Lionberger R, Hinderling P, Kong Y, Brown PC, Ghosh T, Strasinger C, Suarez-Sharp S, Henry D, Van Uitert M, Sadrieh N, Morefield E
The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration was established to assess the possible impact of nanotechnology on drug products. The group is in the process of performing risk assessment and management exercises. The task of the working group is to identify areas where CDER may need to optimize its review practices and to develop standards to ensure review consistency for drug applications that may involve the application of nanotechnology. The working group already performed risk management exercises evaluating the potential risks from administering nanomaterial active pharmaceutical ingredients (API) or nanomaterial excipients by various routes of administration. This publication outlines the risk assessment and management process used by the working group, using nanomaterial API by the oral route of administration as an example. HubMed – drug
Inhibitory Effects of Azelnidipine Tablets on Morning Hypertension.
Drugs R D. 2013 Mar 20;
Kario K, Sato Y, Shirayama M, Takahashi M, Shiosakai K, Hiramatsu K, Komiya M, Shimada K
BACKGROUND: Morning hypertension is a risk factor for cardiovascular and cerebrovascular events. Furthermore, it is a useful measure for definitive diagnosis of hypertension, and patients who self-assess their own blood pressure (BP) in the morning tend to exhibit better compliance with antihypertensive medication than those who do not. OBJECTIVE: The objective of this analysis was to determine the BP- and pulse rate-lowering effects of azelnidipine, a long-acting dihydropyridine calcium antagonist administered once daily in the morning. METHODS: We conducted the Azelnidipine Treatment for Hypertension Open-label Monitoring in the Early morning (At-HOME) Study by surveying patients who were taking azelnidipine. According to the study protocol, high systolic BP (SBP) was defined as ?135 mmHg when measured at home in the morning and ?140 mmHg when measured at the clinic during the day. A total of 5,433 hypertensive patients, who were registered at 1,011 medical institutions across Japan, were enrolled in the study. Data obtained from 4,852 of these patients (mean age, 64.8 years; female, 52.9 %; previous medication with other antihypertensive agents used concomitantly with the present study agent, 45.5 %) were used for efficacy analysis. RESULTS: At baseline, the subjects’ mean [± standard deviation] SBP/diastolic BP values at home in the morning, at the clinic during the day, and at home in the evening were 156.9 ± 16.4/89.7 ± 12.0, 157.5 ± 18.7/89.1 ± 13.3, and 150.2 ± 17.6/85.6 ± 12.2 mmHg, respectively. The mean pulse rates were 72.7 ± 10.7, 74.9 ± 11.2, and 72.5 ± 9.6 beats/min, respectively. Patients whose BP was defined as high accounted for 83.4 % of the study population, whereas 9.9 % had ‘masked’ hypertension, defined as SBP of ?135 mmHg at home in the morning and <140 mmHg at the clinic. However, from 4 weeks after initiation of azelnidipine treatment till the end of the study at week 16, all three daily BP determinations were significantly (p < 0.0001) lowered, and pulse rates at home in the morning, at the clinic, and at home in the evening were similarly and significantly reduced (by -3.7 ± 8.0, -3.5 ± 9.5, and -3.5 ± 7.3 beats/min, respectively). Whereas achievement of home SBP of <135 mmHg in the morning was noted in only 6.6 % of patients before the start of azelnidipine treatment, this was noted in 43.3 % after 16 weeks. Meanwhile, achievement of clinic SBP of <140 mmHg was increased from 12.9 % of patients to 56.1 % of patients at the same timepoints. After azelnidipine treatment, 32.2 % of patients had well-controlled hypertension in both the home and clinic settings. Adverse drug reactions occurred in 2.92 % of patients (154/5,265). All adverse drug reactions were as expected for the calcium antagonist class of agents. CONCLUSION: These data suggest that azelnidipine controlled morning hypertension well. Furthermore, azelnidipine reduced pulse rates significantly. HubMed – drug
Persistent use of Analgesic Medications in Mild-to-Moderate Alzheimer’s Disease.
Drugs Aging. 2013 Mar 20;
Gallini A, Gardette V, Vellas B, Lapeyre-Mestre M, Andrieu S, Brefel-Courbon C,
BACKGROUND AND OBJECTIVES: Previous studies have reported a lower use of analgesics in patients with Alzheimer’s disease (AD) than in non-AD elderly. To date, no study has focused on persistent analgesic use in patients with mild-to-moderate AD. METHODS: The “Réseau sur la maladie d’Alzheimer Français” (REAL.FR) cohort study enrolled community-dwelling patients with mild-to-moderate AD. Persistent analgesic use was defined as the consumption of at least one analgesic drug during two consecutive visits (6 months). Associated factors were identified in a nested case-control study. RESULTS: In REAL.FR, 595 patients were present during at least two consecutive visits [mean age = 77.5 ± 6.8 years, mini-mental state examination (MMSE) = 20.1 ± 4.2]. Prevalence of persistent analgesic use was 13.1 % (95 % CI = 10.4-15.9). The incidence of persistent analgesic use was 5.9/100 patient-years (95 % CI = 5.2-6.6). Women (adjusted odds ratio [OR] = 3.1, 95 % CI = 1.2-8.1), patients with musculoskeletal disorders (OR = 3.4, 95 % CI = 1.6-7.3) and patients treated with numerous medications (OR = 3.0, 95 % CI = 1.5-5.8) were more likely to use analgesics persistently. Statistically significant associations were found with disease duration and disease progression but not with AD severity at baseline. CONCLUSIONS: Our results suggest a low use of analgesics in AD patients, which could vary with AD progression. HubMed – drug