Abstract:
BACKGROUND AND OBJECTIVE:The degree of cycle control achieved with a hormonal contraceptive method is an important determinant of its acceptance and continuation. This study set out to compare the cycle control and bleeding profile of drospirenone (DRSP) 3 mg/ethinylestradiol (EE) 20 μg in a 24-active pill/4-inert pill (24/4) regimen (YAZ®) with those of desogestrel (DSG) 150 μg/EE 20 μg in a 21/7 regimen (Mercilon®), an established European combined oral contraceptive (COC). METHODS:Bleeding data from women aged 17-36 years who received either DRSP 3 mg/EE 20 μg in a 24/4 regimen (n = 1285) or DSG 150 μg/EE 20 μg in a 21/7 regimen (n = 471) during four clinical studies were pooled and analysed over seven treatment cycles. RESULTS:The maximum intensity of scheduled withdrawal bleeding was 'normal bleeding' for >50% of subjects in cycles 1-6 in both treatment groups. Moreover, the incidence of unscheduled intracyclic bleeding during cycles 2-7 was comparable between treatment types (10.2-14.9% in women treated with DRSP 3 mg/EE 20 μg 24/4 vs 8.6-13.8% in women treated with DSG 150 μg/EE 20 μg 21/7). Overall, similar bleeding patterns were observed with both treatments. CONCLUSION:DRSP 3 mg/EE 20 μg 24/4 is associated with a bleeding profile and cycle control that is comparable to that of an established, low-dose COC formulation.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Anttila L,Neunteufel W,Petraglia F,Marr J,Kunz Mdoi
10.2165/11590260-000000000-00000subject
Has Abstractpub_date
2011-01-01 00:00:00pages
519-525issue
8eissn
1173-2563issn
1179-1918pii
10.2165/11590260-000000000-00000journal_volume
31pub_type
临床试验,杂志文章,meta分析,多中心研究abstract:BACKGROUND AND OBJECTIVE:TZP-101 is a selective, small molecule ghrelin receptor agonist in clinical development for the treatment of gastric motility disorders. The objectives of this study was to assess pharmacokinetic parameters of TZP-101 after multiple- and single-dose administration to healthy subjects and patien...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200929060-00004
更新日期:2009-01-01 00:00:00
abstract:PURPOSE:Deferiprone (DFP), deferasirox (DFX) and deferoxamine (DFO) are used in thalassaemia major (TM) patients to treat chronic iron overload. We evaluated the cost-effectiveness of DFP, compared with DFX and DFO monotherapy, from an Italian healthcare system perspective. METHODS:A Markov model was used over a time ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0496-1
更新日期:2017-05-01 00:00:00
abstract:BACKGROUND:Concomitant chemotherapy with radiotherapy is considered to be the standard of care for patients with head and neck cancer and good performance status. However, published reports on the cost effectiveness of this therapeutic approach are extremely rare. OBJECTIVE:The aim of this study was to estimate the co...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11588980-000000000-00000
更新日期:2011-10-01 00:00:00
abstract:BACKGROUND:To evaluate the efficacy and safety of bronchoalveolar lavage (BAL) with diluted porcine surfactant in mechanically ventilated term infants with severe acute respiratory distress syndrome (ARDS) due to meconium aspiration syndrome (MAS). METHODS:Eight consecutive mechanically ventilated term infants with se...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200626010-00002
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abstract:BACKGROUND:For patients with hypertension, effective 24-hour blood pressure (BP) control is vital to ensure protection against the early morning surge in BP and the associated increased risk of cardiovascular events. The aim of this analysis was to assess the 24-hour antihypertensive efficacy of olmesartan medoxomil (2...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200626040-00002
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Tegoprazan is one of the potassium-competitive acid blockers (P-CABs). It exhibits its anti-secretory effects by competitively and reversibly blocking the availability of K+ of the H+, K+-ATPase. This study was designed to investigate the safety and pharmacokinetics of tegoprazan in healthy Ch...
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abstract:BACKGROUND AND OBJECTIVES:Ultra-long-acting insulin degludec (DEG) has a longer duration of action and less daily variability relative to other basal insulin (BI), and thus may benefit patients with type 1 diabetes mellitus (T1DM). We examined the impact of switching BI to DEG on glycemic control and insulin dose in T1...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0541-0
更新日期:2017-09-01 00:00:00
abstract:BACKGROUND:Multimodal pain therapy including cyclo-oxygenase-2 inhibitors can result in optimal pain management with decreased opioid use and fewer opioid-related adverse events. Patient reported outcomes (PROs) help identify benefits in reduced opioid use and increased pain control. METHODS:In this randomized, double...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/11317570-000000000-00000
更新日期:2009-01-01 00:00:00
abstract:OBJECTIVE:To evaluate the efficacy and safety of the natural platelet-activating factor receptor antagonist, BN 52021 (ginkgolide B) in the treatment of patients with severe sepsis related to Gram-negative and mixed bacterial infection. DESIGN AND SETTING:Prospective, randomised, double-blind, placebo-controlled, mult...
journal_title:Clinical drug investigation
pub_type: 杂志文章
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abstract:BACKGROUND AND OBJECTIVES:Fentanyl buccal soluble film (FBSF) is a small, bilayered, water-soluble polymer film (BioErodible MucoAdhesive; BEMA™) that adheres to the buccal mucosa and rapidly delivers fentanyl into the systemic circulation. It is approved for the treatment of cancer breakthrough pain in adult opioid-to...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11594670-000000000-00000
更新日期:2012-01-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11317820-000000000-00000
更新日期:2009-01-01 00:00:00
abstract:OBJECTIVE:To compare the bioavailability of two 15mg ambroxol lozenges with a commercial 30mg ambroxol tablet. DESIGN:Open-label, two-way crossover study. METHOD:Each formulation was randomly administered to 20 healthy Thai volunteers (ten male and ten female) with a 1-week washout period between formulations. After ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323040-00007
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Hypertension remains a major global health problem, and evidence suggests that the majority of patients will require two or more antihypertensive agents in order to reach specified BP targets. Combining two drugs from different classes has the potential to target different aspects of hypertensi...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200929070-00001
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Warfarin-related nephropathy is an unexplained acute kidney injury, and may occur in patients with supratherapeutic INR, in the absence of overt bleeding. Similar findings have been observed in rats treated with dabigatran etexilate. We conducted a prospective study in dabigatran etexilate-tre...
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更新日期:2019-04-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-020-00952-0
更新日期:2020-09-01 00:00:00
abstract::This article discusses current practice in the treatment of conjunctivitis and how the use of topical moxifloxacin can increase therapeutic effectiveness, reduce treatment failures and, consequently, be cost effective and reduce the societal burden of the disorder. Current practice and effectiveness data were derived ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11589020-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:OBJECTIVE:Addressing the needs of migraineurs by actively seeking patient feedback on disease-related disability and treatment satisfaction may lead to improved management and treatment outcomes. Patient feedback can be collected in postmarketing surveillance (PMS) studies. The objective of this PMS study was to evalua...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,多中心研究
doi:10.2165/00044011-200727010-00005
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Vedolizumab, a humanized monoclonal antibody against the α4β7 integrin, is indicated for treatment of moderately to severely active ulcerative colitis or Crohn's disease. In this placebo-controlled, double-blind, randomized, single ascending-dose study, the pharmacokinetics, pharmacodynamics, ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
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abstract:BACKGROUND:Recent clinical studies have documented the analgesic, anti-inflammatory, antioxidative and anxiolytic effects of exogenous melatonin. The pharmacokinetic properties of melatonin have primarily been investigated in experimental studies. OBJECTIVE:The aim of this study was to estimate the pharmacokinetics of...
journal_title:Clinical drug investigation
pub_type: 杂志文章
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abstract:BACKGROUND AND OBJECTIVES:First-line treatment of chronic phase (CP) chronic myeloid leukemia (CML) is based on the first-generation tyrosine kinase inhibitor (TKI) imatinib or the second-generation TKIs dasatinib or nilotinib. Thanks to the efficacy of TKIs, CML has switched from a fatal to a 'chronic' pathology, and ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0676-7
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abstract::Early initiation of rational and effective combination therapy consisting of antihypertensive drugs with two different and complementary mechanisms of actions is increasingly becoming accepted in clinical practice and by guidelines as a first-line approach to control blood pressure (BP) and prevent cardiovascular outc...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
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更新日期:2010-01-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.2165/11587400-000000000-00000
更新日期:2011-01-01 00:00:00
abstract::None of the available antiemetics is entirely effective, perhaps because most of them act through the blockade of one receptor. There is a possibility that a combination of antiemetics with different sites of activity would be more effective than one drug alone for prophylaxis against postoperative nausea and vomiting...
journal_title:Clinical drug investigation
pub_type: 杂志文章,收录出版,评审
doi:10.2165/00044011-200222090-00001
更新日期:2002-09-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Cancer pain affects patients at all stages of the disease and there are clear guidelines for its management. Morphine is considered the first-choice strong opioid in the treatment of moderate-to-severe pain; however, numerous studies have shown that oxycodone controlled-release (CR) has a simi...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,多中心研究
doi:10.2165/00044011-200828070-00001
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Bisphosphonates are commonly used to treat and prevent osteoporosis. These compounds have unusual pharmacokinetic characteristics because they bind strongly to bone, and a portion becomes buried under newly formed bone. Once incorporated into bone tissue, the subsequent release during bone remo...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200525020-00003
更新日期:2005-01-01 00:00:00
abstract:OBJECTIVE:To evaluate the cost effectiveness of subcutaneous interferon-beta-1a (IFNbeta-1a) 44mug three times weekly in relapsing-remitting multiple sclerosis (RRMS) using an econometric model. METHODS:Data on RRMS patients treated with IFNbeta-1a 22 or 44mug subcutaneously three times weekly or placebo for up to 4 y...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323090-00003
更新日期:2003-01-01 00:00:00
abstract::Elbasvir/grazoprevir demonstrated high sustained virologic response rates 12 weeks after the end of treatment (SVR12) across five clinical trials in subjects infected with chronic hepatitis C virus (HCV) genotype 1, including those with advanced chronic kidney disease (CKD), and GT4. Despite favorable results overall,...
journal_title:Clinical drug investigation
pub_type: 杂志文章
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更新日期:2017-04-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/BF03256918
更新日期:2011-11-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章
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更新日期:2019-07-01 00:00:00
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pub_type: 杂志文章
doi:10.1007/s40261-020-00981-9
更新日期:2021-01-01 00:00:00