Estradiol Valerate/Dienogest: A Novel Oral Contraceptive

2011 ◽  
Vol 45 (10) ◽  
pp. 1256-1261 ◽  
Author(s):  
Karen L Whalen ◽  
Renee Rose
Keyword(s):  
Oral Contraceptive ◽  
Oral Contraceptives ◽  
Ethinyl Estradiol ◽  
Data Extraction ◽  
Estradiol Valerate ◽  
Efficacy And Safety ◽  
Data Synthesis ◽  
Efficacy Trials ◽  
Study Selection ◽  
Pearl Index

Objective: To review the pharmacology, pharmacokinetics, efficacy, and safety of the new oral contraceptive estradiol valerate/dienogest. Data Sources: Searches of PubMed (1966-July 2011) and International Pharmaceutical Abstracts (1970-July 2011) were conducted using the key words estradiol valerate, dienogest, Natazia, and Olaira. Bibliographies of retrieved articles were reviewed to identify additional références. Study Selection and Data Extraction: All identified studies published in English and involving efficacy and safety of estradiol valerate/dienogest as an oral contraceptive were reviewed. Data Synthesis: Estradiol valerate/dienogest is a 4-phasic oral contraceptive approved for the prevention of pregnancy. The 4-phasic design allows for acceptable cycle control with this hormonal combination. In efficacy trials of estradiol valerate/dienogest in women aged 18–35 years, the Pearl Index ranged from 0.40 to 1.64, a range comparable to that of other combination oral contraceptives. The safety profile was also similar to that of other oral contraceptives, with headache, metrorrhagia, breast tenderness, nausea or vomiting, acne, and weight gain reported as the most common adverse effects. Menstrual bleeding patterns and cycle control with estradiol valerate/dienogest were comparable to those of a monophasic oral contraceptive containing ethinyl estradiol/levonorgestrel. Estradiol valerate/dienogest differs from other oral contraceptives in that il necessitates more stringent dosing guidelines for maximum contraceptive efficacy. New starts should be on the first day of menses only, and a back-up method of contraception is required for the first 9 days, as compared to 7 days with other oral contraceptives. Back-up contraception is usually required for any pill taken more than 12 hours later than scheduled. Conclusions: Estradiol valerate/dienogest is an effective oral contraceptive. Because it has more stringent start times and requires a longer duration of back-up contraception and stricter adherence, estradiol valerate/dienogest should be reserved for patients who are intolerant of other combination oral contraceptives.

Formulary Considerations for Insulins Approved Through the 505(b)(2) “Follow-on” Pathway

2018 ◽  
Vol 53 (2) ◽  
pp. 204-210 ◽  
Author(s):  
Jack T. Rasmussen ◽  
Heather J. Ipema
Keyword(s):  
Insulin Glargine ◽  
Insulin Lispro ◽  
Lower Cost ◽  
Data Extraction ◽  
Safety Data ◽  
Current Data ◽  
Regulatory Change ◽  
Efficacy And Safety ◽  
Data Synthesis ◽  
Study Selection

Objective: To summarize formulary-relevant issues for follow-on insulins approved through the Food and Drug Administration (FDA) 505(b)(2) approval pathway (Basaglar and Admelog). Data Sources: A search of the MEDLINE database was performed for articles pertaining to clinical and formulary considerations for follow-on insulin products through July 2018. Study Selection and Data Extraction: All clinical trials used in the 505(b)(2) approval process for follow-on insulin glargine and insulin lispro products were included and summarized. Data Synthesis: Follow-on insulin glargine and insulin lispro products have been recently approved as the first lower-cost alternatives to innovator insulin products. The follow-on insulins were approved via the 505(b)(2) pathway, making them neither generics nor biosimilars. Current data do not suggest any clinically relevant differences between the follow-on insulins and their respective innovator products. Clinicians should be aware that follow-on insulins will be reclassified as biologic products in the year 2020. Relevance to Patient Care and Clinical Practice: This article provides information about currently available follow-on insulin products that were approved through the 505(b)(2) pathway, including product characteristics and efficacy and safety data. These products will likely be considered for both clinical use and formulary placement because of their potentially lower cost compared with innovator products. Conclusions: Follow-on insulin products approved through the 505(b)(2) pathway are supported by robust efficacy and safety data. As new follow-on insulins are approved and the regulatory change that will occur with these products in 2020 approaches, formulary decisions and clinical policies (eg, substitution) will continue to be revisited.

scholarly journals Antibiotic and Oral Contraceptive Drug Interactions: Is There a Need for Concern?

1999 ◽  
Vol 10 (6) ◽  
pp. 429-433 ◽  
Author(s):  
George G Zhanel ◽  
Shannon Siemens ◽  
Kathryn Slayter ◽  
Lionell Mandell
Keyword(s):  
Oral Contraceptive ◽  
Drug Interactions ◽  
Birth Control ◽  
Oral Contraceptives ◽  
Data Extraction ◽  
Data Synthesis ◽  
Contraceptive Failure ◽  
Medline Search ◽  
Search Terms ◽  
Clinical Consequences

OBJECTIVE: To assess the clinical significant of antibiotic and oral contraceptive drug interactions.DATA SELECTION: MEDLINE search from 1975 to 1998 (September) inclusive. Search terms ‘antitiobic’, ‘oral contraceptive’ and ‘pregnancy’ were included. Published papers as well as references from these papers were reviewed. Papers documenting mechanistic interactions between antibiotics and oral contraceptives were included.DATA EXTRACTION: Studies reporting oral contraceptive pharmacokinetics, mechanisms, incidence, implicated antibiotics and clinical consequences of antibiotic/oral contraceptive drug interactions.DATA SYNTHESIS: Reports of oral contraceptive failure seem to be most numerous in women using preparations containing 30 μg of ethinylestradiol and 150 μ g of levonorgestrel. Rifampin is the only antibiotic that has been reported to reduce plasma estrogen concentrations. When taking rifampin, oral contraceptives cannot be relied upon and a second method of contraception is mandatory. Amoxicillin, ampicillin, griseofulvin, metronidazole and tetracycline have been associated with contraceptive failure in three or more clinical cases. When these agents are used, the clinician should discuss the available data with the patient and suggest a second form of birth control. Other antibiotics are most likely safe to use concomitantly with oral contraceptives.CONCLUSIONS: Rifampin is the only antibiotic to date that has been reported to reduce plasma estrogen concentrations. Oral contraceptives cannot be relied upon for birth control while taking rifampin.

Aripiprazole: A New Atypical Antipsychotic Drug

2003 ◽  
Vol 37 (5) ◽  
pp. 687-694 ◽  
Author(s):  
Toya M Bowles ◽  
Gary M Levin
Keyword(s):  
Partial Agonist ◽  
Data Extraction ◽  
Comparable Efficacy ◽  
Efficacy And Safety ◽  
Data Synthesis ◽  
Study Selection ◽  
Acute Exacerbations ◽  
Serotonin 2A ◽  
Long Term Studies

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical efficacy, and safety profile of aripiprazole for the treatment of schizophrenia. DATA SOURCES: Information was selected from MEDLINE (1995–August 2002). Abstracts, scientific posters, and presentations were also used. STUDY SELECTION/DATA EXTRACTION: All published information regarding the pharmacokinetic, pharmacodynamic, and clinical characteristics of aripiprazole was considered. Studies providing a comprehensive description of aripiprazole were selected. DATA SYNTHESIS: Aripiprazole is a dopamine partial agonist and a serotonin-2A antagonist; it is dosed 10–30 mg/d, with no initial titration necessary. Short-term clinical trials demonstrated efficacy in acute exacerbations, and long-term studies showed that aripiprazole can maintain remission of schizophrenia. Most adverse events were mild. The incidence of extrapyramidal symptoms was low, with akathisia being the most common. CONCLUSIONS: Aripiprazole currently demonstrates comparable efficacy and safety for use in schizophrenia.

scholarly journals Prioritising recommendations following analyses of adverse events in healthcare: a systematic review

2020 ◽  
Vol 9 (4) ◽  
pp. e000843
Author(s):  
Kelly Bos ◽  
Maarten J van der Laan ◽  
Dave A Dongelmans
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Data Extraction ◽  
Data Sources ◽  
Cochrane Library ◽  
High Quality ◽  
Data Synthesis ◽  
Study Selection ◽  
Personal Opinion ◽  
User Friendly

PurposeThe purpose of this systematic review was to identify an appropriate method—a user-friendly and validated method—that prioritises recommendations following analyses of adverse events (AEs) based on objective features.Data sourcesThe electronic databases PubMed/MEDLINE, Embase (Ovid), Cochrane Library, PsycINFO (Ovid) and ERIC (Ovid) were searched.Study selectionStudies were considered eligible when reporting on methods to prioritise recommendations.Data extractionTwo teams of reviewers performed the data extraction which was defined prior to this phase.Results of data synthesisEleven methods were identified that are designed to prioritise recommendations. After completing the data extraction, none of the methods met all the predefined criteria. Nine methods were considered user-friendly. One study validated the developed method. Five methods prioritised recommendations based on objective features, not affected by personal opinion or knowledge and expected to be reproducible by different users.ConclusionThere are several methods available to prioritise recommendations following analyses of AEs. All these methods can be used to discuss and select recommendations for implementation. None of the methods is a user-friendly and validated method that prioritises recommendations based on objective features. Although there are possibilities to further improve their features, the ‘Typology of safety functions’ by de Dianous and Fiévez, and the ‘Hierarchy of hazard controls’ by McCaughan have the most potential to select high-quality recommendations as they have only a few clearly defined categories in a well-arranged ordinal sequence.

Pegfilgrastim-Induced Bone Pain: A Review on Incidence, Risk Factors, and Evidence-Based Management

2017 ◽  
Vol 51 (9) ◽  
pp. 797-803 ◽  
Author(s):  
Donald C. Moore ◽  
Annie E. Pellegrino
Keyword(s):  
Risk Factors ◽  
Bone Pain ◽  
English Language ◽  
Data Extraction ◽  
Treatment Modalities ◽  
Management Options ◽  
Data Synthesis ◽  
Pharmacological Management ◽  
Study Selection ◽  
Incidence Risk

Objective: To review the incidence, risk factors, and management of pegfilgrastim-induced bone pain (PIBP). Data Sources: PubMed was searched from 1980 to March 31, 2017, using the terms pegfilgrastim and bone pain. Study Selection and Data Extraction: English-language, human studies and reviews assessing the incidence, risk factors, and management of PIBP were incorporated. Data Synthesis: A total of 3 randomized, prospective studies and 2 retrospective studies evaluated pharmacological management of PIBP. Naproxen compared with placebo demonstrated a reduction in the degree, incidence, and duration of bone pain secondary to pegfilgrastim. Loratadine was not effective in reducing the incidence of bone pain prophylactically, but a retrospective study evaluating dual antihistamine blockade with loratadine and famotidine demonstrated a decreased incidence in bone pain when administered before pegfilgrastim. Conclusion: Naproxen is effective at managing PIBP. Although commonly used, antihistamines have a paucity of data supporting their use. Dose reductions of pegfilgrastim and opioids may also be potential management options; however, data supporting these treatment modalities are scarce.

Recovery and Return to Activity Following Exertional Heat Stroke: Considerations for the Sports Medicine Staff

2007 ◽  
Vol 16 (3) ◽  
pp. 163-181 ◽  
Author(s):  
Brendon P. McDermott ◽  
Douglas J. Casa ◽  
Susan W. Yeargin ◽  
Matthew S. Ganio ◽  
Lawrence E. Armstrong ◽  
...  
Keyword(s):  
Data Extraction ◽  
Heat Stroke ◽  
Data Sources ◽  
Exertional Heat Stroke ◽  
Data Synthesis ◽  
Residual Symptoms ◽  
Study Selection ◽  
Initial Care ◽  
Type Data ◽  
Return To Activity

Objective:To describe the current scientific evidence of recovery and return to activity following exertional heat stroke (EHS).Data Sources:Information was collected using MEDLINE and SPORTDiscus databases in English using combinations of key words, exertional heat stroke, recovery, rehabilitation, residual symptoms, heat tolerance, return to activity, and heat illness.Study Selection:Relevant peer-reviewed, military, and published text materials were reviewed.Data Extraction:Inclusion criteria were based on the article’s coverage of return to activity, residual symptoms, or testing for long-term treatment. Fifty-two out of the original 554 sources met these criteria and were included in data synthesis.Data Synthesis:The recovery time following EHS is dependent on numerous factors, and recovery length is individually based and largely dependent on the initial care provided.Conclusion:Future research should focus on developing a structured return-to-activity strategy following EHS.

Combined oral contraceptives and treatment of new coronavirus infection (COVID-19): aspects of drug interactions

2021 ◽  
Vol 19 (1) ◽  
pp. 149-158
Author(s):  
O.A. Limanova ◽  
◽  
L.E. Fedotova ◽  
O.A. Gromova ◽  
◽  
...  
Keyword(s):  
Drug Interactions ◽  
Oral Contraceptives ◽  
Ethinyl Estradiol ◽  
Antihypertensive Drugs ◽  
Efficacy And Safety ◽  
Antiinflammatory Drugs ◽  
Combined Oral Contraceptives ◽  
Chlormadinone Acetate ◽  
Coronavirus Infection ◽  
Oral Hypoglycemic Drugs

This article discusses the problem of drug interactions between combined oral contraceptives on the example of Belara® (30 μg of ethinyl estradiol + 2 mg of chlormadinone acetate; Gedeon Richter, Hungary) and medications recommended for the treatment of new coronavirus infection (COVID-19) and concomitant disorders at the pharmacodynamic and pharmacokinetic levels with an assessment of the efficacy and safety of therapy for females. We described safe, potentially dangerous, and dangerous combinations of these drugs. Key words: new coronavirus infection (CAVID-19), combined oral contraceptives, antiviral drugs, antibacterial drugs, antiinflammatory drugs, anticoagulants, migraine drugs, antihypertensive drugs, oral hypoglycemic drugs, essential micronutrients, pharmacodynamic and pharmacokinetic interactions

Lactulose in the Management of Constipation: A Current Review

1992 ◽  
Vol 26 (10) ◽  
pp. 1277-1282 ◽  
Author(s):  
Theresa V. Kot ◽  
Ngaire A. Pettit-Young
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Clinical Studies ◽  
Data Extraction ◽  
Point Of View ◽  
Data Synthesis ◽  
Study Selection ◽  
Beneficial Response ◽  
A Current

OBJECTIVE: To review the current published clinical studies evaluating the clinical efficacy and safety of lactulose compared with other laxatives or placebo. Adverse effects associated with lactulose are also reported. DATA SOURCES: Information was retrieved by searching the MEDLINE and EMBASE databases for clinical trials, abstracts, conference proceedings, and review articles dealing with lactulose. STUDY SELECTION: Emphasis was placed on clinical trials where lactulose was compared with other laxatives or placebo in patient populations where the diagnosis of constipation was reasonably established. DATA EXTRACTION: The methodology and results from clinical studies were evaluated. Assessment of the studies was made based on diagnosis of constipation, prior management of patients, follow-up of patients, dosage, and adverse effects. DATA SYNTHESIS: Clinical trials in geriatric patients, terminally ill patients, children, and normal and constipated subjects were reviewed. In most instances, lactulose was compared with a placebo, without incorporating the current education on dietary techniques for improving defecation. CONCLUSIONS: Generally, clinical trials have demonstrated a beneficial response compared with placebo, although sometimes that response has been only marginally better, from a clinical point of view.

Assessment of Sweat-Testing Practices for the Diagnosis of Cystic Fibrosis

2001 ◽  
Vol 125 (11) ◽  
pp. 1420-1424 ◽  
Author(s):  
Vicky A. LeGrys
Keyword(s):  
Clinical Laboratory ◽  
Data Extraction ◽  
National Committee ◽  
Data Synthesis ◽  
Study Selection ◽  
Erroneous Result ◽  
Sweat Testing ◽  
Data Source ◽  
Areas Of Concern ◽  
Sweat Tests

Abstract Objective.—To describe the results of the College of American Pathologists survey questions assessing the current practice of sweat testing in North America and to identify areas in which improvement is needed. Data Source.—Results of the supplemental questions to the SW-B 2000 survey. Study Selection.—Supplemental questions were designed to assess variation in sweat collection, analysis, and interpretation. Data Extraction.—Extractions of the data were made based on the relevance of the data to the objectives of the review. Data Synthesis.—The majority of laboratories surveyed performed sweat testing according to the procedures described in the National Committee for Clinical Laboratory Standards' document. The study revealed that a number of laboratories have adopted poor practice standards and are potentially compromising patient care. Areas of concern include the number of laboratories performing few sweat tests per year, the persistence of unreliable methodology, misunderstanding of collection parameters, lack of patient education, and erroneous result reporting. Conclusions.—The study identified areas of concern toward which educational efforts can be directed. Such efforts include the development of a College of American Pathologists accreditation checklist for sweat testing and targeted responses in the sweat analysis participant summary report.

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