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.

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.

Shingrix: The New Adjuvanted Recombinant Herpes Zoster Vaccine

2018 ◽  
Vol 52 (7) ◽  
pp. 673-680 ◽  
Author(s):  
Stephanie F. James ◽  
Elias B. Chahine ◽  
Allana J. Sucher ◽  
Cassandra Hanna
Keyword(s):  
Herpes Zoster ◽  
Adverse Events ◽  
Literature Search ◽  
Data Extraction ◽  
Safety Data ◽  
Efficacy And Safety ◽  
Virus Infections ◽  
Additional Material ◽  
Varicella Zoster ◽  
Study Selection

Objectives: To review the immunogenicity, efficacy, and safety of the herpes zoster subunit vaccine (HZ/su) for use in adult patients for the prevention of shingles. Data Sources: A literature search through PubMed was conducted (June 2008 to October 2017) using the terms shingles vaccine and varicella zoster virus. References from retrieved articles and the prescribing information were also reviewed for any additional material. Study Selection/Data Extraction: The literature search was limited to human studies published in English. Randomized controlled, multicenter trials were reviewed and included to evaluate the safety and efficacy of HZ/su. Literature on the epidemiology and pathology of herpes zoster virus infections and recommendations from the Advisory Committee on Immunization Practices (ACIP) were also reviewed. Data Synthesis: HZ/su is a new adjuvanted recombinant vaccine approved by the Food and Drug Administration for the prevention of herpes zoster in adults 50 years of age and older. HZ/su significantly reduced the risk of developing herpes zoster by more than 90% as compared with placebo and displayed a comparable adverse effect profile. The most common local adverse events were injection site pain, redness, and swelling, and the most common systemic adverse events were myalgia, fatigue, and headache. The ACIP recommends the routine use of HZ/su as the preferred vaccine for the prevention of herpes zoster in immunocompetent adults 50 years of age and older. Conclusions: Based on published immunogenicity, efficacy, and safety data, as well as the recent recommendations by the ACIP, HZ/su should be included on both hospital and community pharmacy formularies and recommended to all immunocompetent patients older than 50 years to prevent herpes zoster.

Clinical Use of Fluoroquinolones in Children

2000 ◽  
Vol 34 (3) ◽  
pp. 347-359 ◽  
Author(s):  
Abdullah A Alghasham ◽  
Milap C Nahata
Keyword(s):  
Data Extraction ◽  
Cartilage Damage ◽  
Relevant Literature ◽  
Safety Data ◽  
Optimal Dosage ◽  
Efficacy And Safety ◽  
Suppurative Otitis Media ◽  
Medline Search ◽  
Study Selection ◽  
Elimination Half

OBJECTIVE: To review the pharmacokinetics, efficacy, and safety of fluoroquinolones in children. DATA SOURCES: A MEDLINE search (January 1966–March 1998) was conducted for relevant literature. STUDY SELECTION AND DATA EXTRACTION: Data from compassionate use and published studies were reviewed for the assessment of pharmacokinetics, efficacy, and safety of fluoroquinolones in children. DATA SYNTHESIS: Fluoroquinolones have a broad spectrum coverage of gram-positive and gram-negative bacteria, including Pseudomonas aeruginosa and intracellular organisms. Fluoroquinolones are well absorbed from the gastrointestinal tract, have excellent tissue penetration, low protein binding, and long elimination half-lives. These antibiotics are effective in treating various infections and are well tolerated in adults. However, the use of fluoroquinolones in children has been restricted due to potential cartilage damage that occurred in research with immature animals. Fluoroquinolones have been used in children on a compassionate basis. Ciprofloxacin is the most frequently used fluoroquinolone in children, most often in the treatment of pulmonary infection in cystic fibrosis as well as salmonellosis and shigellosis. Other uses include chronic suppurative otitis media, meningitis, septicemia, and urinary tract infection. Safety data of fluoroquinolones in children appear to be similar to those in adults. Fluoroquinolones are associated with tendinitis and reversible arthralgia in adults and children. However, direct association between fluoroquinolones and arthropathy remains uncertain. CONCLUSIONS: Fluoroquinolones have been found to be effective in treating certain infections in children. Additional research is needed to define the optimal dosage regimens in pediatric patients. Although fluoroquinolones appear to be well tolerated, further investigations are needed to determine the risk of arthropathy in children. However, their use in children should not be withheld when the benefits outweigh the risks.

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.

Role of Topical Oxymetazoline for Management of Erythematotelangiectatic Rosacea

2017 ◽  
Vol 52 (3) ◽  
pp. 263-267 ◽  
Author(s):  
Rebecca M. Hoover ◽  
John Erramouspe
Keyword(s):  
English Language ◽  
Human Subjects ◽  
Data Extraction ◽  
Drug Approval ◽  
Current Data ◽  
Patient Response ◽  
Study Selection ◽  
Cochrane Database ◽  
Drug Approval Process ◽  
Individual Patient Response

Objective: To review and summarize topical oxymetazoline’s pharmacology, pharmacokinetics, efficacy, safety, cost, and place in therapy for persistent redness associated with erythematotelangiectatic rosacea. Data Sources: Literature searches of MEDLINE (1975 to September 2017), International Pharmaceutical Abstracts (1975 to September 2017), and Cochrane Database (publications through September 2017) using the terms rosacea, persistent redness, α -agonist, and oxymetazoline. Study Selection and Data Extraction: Results were limited to studies of human subjects, English-language publications, and topical use of oxymetazoline. Relevant materials from government sources, industry, and reviews were also included. Data Synthesis: Data support the efficacy of oxymetazoline for persistent facial redness. Little study beyond clinical trials cited in the drug approval process has been conducted. Current data suggest that oxymetazoline is similar in safety and efficacy to brimonidine. Head-to-head comparisons of topical α-agonists for erythema caused by rosacea are needed. Conclusion: The topical α-agonist, oxymetazoline, is safe and effective for reducing persistent facial redness associated with erythematotelangiectatic subtype of rosacea. Health care practitioners selecting among treatments should consider not only the subtype of rosacea but also individual patient response, preference, and cost.

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.

iGlarLixi: A Fixed-Ratio Combination of Insulin Glargine 100 U/mL and Lixisenatide for the Treatment of Type 2 Diabetes

2017 ◽  
Vol 51 (11) ◽  
pp. 990-999 ◽  
Author(s):  
Jennifer Goldman ◽  
Jennifer M. Trujillo
Keyword(s):  
Type 2 Diabetes ◽  
Insulin Glargine ◽  
English Language ◽  
Data Extraction ◽  
Safety Data ◽  
Fixed Ratio ◽  
Postprandial Glucose ◽  
The United States ◽  
Glucagon Like Peptide 1

Objective: To review the safety and efficacy of iGlarLixi, a titratable fixed-ratio combination of insulin glargine 100 U/mL (iGlar) and lixisenatide, a glucagon-like peptide-1 receptor agonist. Data Sources: A literature search of MEDLINE for all English-language primary articles through June 2016, using the terms LixiLan, iGlarLixi and insulin glargine and lixisenatide, and a search of abstracts presented at the 2016 Scientific Sessions of the American Diabetes Association were performed. Study Selection and Data Extraction: All studies assessing the efficacy and/or safety of iGlarLixi were evaluated. Data Synthesis: iGlarLixi has been approved in the United States for glycemic control in people with type 2 diabetes (T2D) inadequately controlled with basal insulin (<60 U/d) or lixisenatide. In clinical trials, iGlarLixi was associated with significantly greater reductions from baseline in glycated hemoglobin A1C (A1C) than iGlar or lixisenatide alone. Reductions in postprandial glucose were also greater with iGlarLixi than with iGlar or lixisenatide. iGlarLixi was weight neutral compared with the weight gain with iGlar and loss with lixisenatide alone, and there was no increase in hypoglycemia with iGlarLixi compared with iGlar despite the greater A1C reduction. Gastrointestinal events, frequently associated with lixisenatide, were less common with iGlarLixi. Potential drawbacks of iGlarLixi include reduced flexibility in dosing and the absence of long-term efficacy and safety data. Conclusions: iGlarLixi is a titratable fixed-ratio combination that shows improved efficacy and comparable or improved safety outcomes relative to its separate constituents, offering an alternative approach to intensification of therapy in T2D.

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.

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