The safety of valsartan: results of a postmarketing surveillance study on 12 881 patients in England

Biswas, Pipasha; Wilton, Lynda V.; Shakir, Saad

doi:10.1038/sj.jhh.1001490

Cited by 48 publications

(30 citation statements)

References 10 publications

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“…This is not the first time such conclusions have been reached [18], but it is striking how little the therapeutic area, vaccines or drugs, influences differences between solicited and unsolicited rates of AEs. Solicited rates of headache in the current study are extremely similar to studies with placebo [5] and antihypertensive medications [19]. Regardless of differences in study design, indications, patient populations and therapies, 10-15% of patients typically report headache when prompted.…”

Section: Discussionsupporting

confidence: 59%

Real-life versus package insert: A post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal® in healthy travellers

Hatz

Beck

Steffen

et al. 2011

Vaccine

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Section: Discussionsupporting

confidence: 59%

Real-life versus package insert: A post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal® in healthy travellers

Hatz

Beck

Steffen

et al. 2011

Vaccine

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“…Six articles were excluded from the analysis because the listed cases were not described in detail [76][77][78][79][80][81] ; however, these reports were further explored for the description of the prevalence and general aspects of fetal RAS-blockade syndrome (see the online-only Data Supplement Expanded Results section with Figure S2) and the analysis of the prevalence of major congenital malformations.…”

Section: Search Resultsmentioning

confidence: 99%

Pregnancy Outcome Following Exposure to Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor Antagonists

Bullo

Tschumi²,

Bucher³

et al. 2012

Hypertension

273

151

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Abstract-The objective was to analyze the outcome following prenatal exposure to angiotensin-converting enzyme inhibitors (ACE-Is) or angiotensin receptor antagonists (ARBs). For this purpose, a systematic review of published case reports and case series dealing with intrauterine exposure to ACE-Is or to ARBs using Medline as the source of data was performed. The publications retained for analysis included patients who were described individually, revealing, at minimum, the gestational age, substance used, period of medication intake, and the outcome. In total, 72 reports were included; 37 articles (118 well-documented cases) described the prenatal exposure to ACE-Is; and 35 articles (68 cases) described the prenatal exposure to ARBs. Overall, 52% of the newborns exposed to ACE-Is and 13% of the newborns exposed to ARBs did not exhibit any complications (PϽ0.0001). Neonatal complications were more frequent following exposure to ARBs and included renal failure, oligohydramnios, death, arterial hypotension, intrauterine growth retardation, respiratory distress syndrome, pulmonary hypoplasia, hypocalvaria, limb defects, persistent patent ductus arteriosus, or cerebral complications. The long-term outcome is described as positive in only 50% of the exposed children. Fetopathy caused by exposure to ACE-Is or ARBs has relevant neonatal and long-term complications. The outcome is poorer following exposure to ARBs. We propose the term "fetal renin-angiotensin system blockade syndrome" to describe the related clinical findings. Thirty years after the first description of ACE-I fetopathy, relevant complications are, at present, regularly described, indicating that the awareness of the deleterious effect of prenatal exposure to drugs inhibiting the renin-angiotensin system should be improved. A n undamaged renin-angiotensin system (RAS) is a prerequisite for normal prenatal renal development. Loss of function mutations in the genes encoding the RAS present with a disturbed renal development, characterized by reduced fetal diuresis, leading to oligohydramnios and, occasionally, skull-ossification defects. At birth, blood pressure is low, and death occurs in most cases.1 This clinical scenario resembles the findings, first reported by Guignard et al 2 and Duminy et al 3 in 1981, in infants exposed during pregnancy to drugs that block the RAS. This condition, which occurs following maternal treatment with either angiotensinconverting enzyme inhibitors (ACE-Is) or angiotensin receptor antagonists (ARBs), is usually termed fetal reninangiotensin system blockade syndrome (fetal RAS-blockade syndrome). Some data also indicate a possible association between the use of these drugs during the first trimester of pregnancy and congenital malformations.Because the adverse effects of drugs that block the RAS in the unborn child have been described only in single-case reports or in small case series, we performed a formal systematic analysis of the literature that addresses the intrauterine exposure to ACE-Is or ARBs. Our purposes in con...

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“…Furthermore, there is a tendency for ARBs to increase plasma potassium levels. 27 Therefore, post-treatment difference between treatment groups regarding circulating potassium levels may reflect a fall in the V --H group and a small rise in the V --A group. Also, despite good correlation with the hyperinsulinemic euglycemic clamp (the 'gold standard' for assessing insulin resistance) it is not clear whether HOMA-IR can detect minimal changes in insulin resistance.…”

Section: Antihypertensive Combinations and Lipoprotein Subfractionsmentioning

confidence: 99%

Distinct effects of fixed combinations of valsartan with either amlodipine or hydrochlorothiazide on lipoprotein subfraction profile in patients with hypertension

et al. 2011

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The effect of antihypertensive drugs on lipoprotein subfraction profile is still under investigation. In this study the effects of fixed combination of valsartan with either amlodipine (V --A) or hydrochlorothiazide (V --H) on low-density-lipoprotein (LDL) and high-density-lipoprotein (HDL) subfraction profile of patients with stage 2 or 3 hypertension were assessed. A total of 60 drug-naive patients were randomized to either V --A (160/5 mg, n ¼ 30) or V --H (160/12.5 mg, n ¼ 30). At baseline as well as 16 weeks post-treatment analysis of the LDL and HDL subfraction profile was conducted by using LDL Lipoprint System. Both V --A and V --H effectively reduced blood pressure (BP) to similar levels. An increase in the cholesterol concentration of small-dense LDL subfractions (by 18.2%, Po0.05) was observed in the V --H group, whereas this parameter remained unchanged in the V --A group. Therefore, mean LDL particle size was decreased in the V --H group (from 267 ± 5 to 266 ± 5Å, Po0.05). HDL-Cholesterol (HDL-C) levels were reduced by 4.7% (Po0.05) in the V --H group, mirrored by a reduction in the cholesterol mass of small and intermediate HDL particles. In conclusion, despite similar reductions in BP, V --H combination may adversely affect serum lipids as well as LDL and HDL subfraction profile as compared with V --A.

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The safety of valsartan: results of a postmarketing surveillance study on 12 881 patients in England

Cited by 48 publications

References 10 publications

Real-life versus package insert: A post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal® in healthy travellers

Real-life versus package insert: A post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal® in healthy travellers

Pregnancy Outcome Following Exposure to Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor Antagonists

Distinct effects of fixed combinations of valsartan with either amlodipine or hydrochlorothiazide on lipoprotein subfraction profile in patients with hypertension

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