High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management

2021 ◽  
pp. 106002802110538
Author(s):  
Courtney L. Bradley ◽  
Sara M. McMillin ◽  
Andrew Y. Hwang ◽  
Christina H. Sherrill
Keyword(s):  
Weight Loss ◽  
Adverse Effects ◽  
Data Extraction ◽  
High Dose ◽  
Lifestyle Interventions ◽  
Double Blind ◽  
Study Selection ◽  
Patients With Diabetes ◽  
Glycemic Indices ◽  
Overweight Or Obesity

Objective To review the pharmacology, efficacy, and safety of high-dose once-weekly semaglutide for chronic weight management. Data Sources PubMed/MEDLINE and ClinicalTrials.gov were searched (inception to September 8, 2021) using keywords “semaglutide” and “obesity,” “weight,” “high dose,” “high-dose,” or “2.4.” Study Selection and Data Extraction Clinical trials with published results were included. Publications studying the oral or <2.4 mg formulation of semaglutide were excluded. Data Synthesis Four phase 3, multicenter, randomized, double-blind trials demonstrated efficacy of high-dose once-weekly semaglutide compared with placebo for weight loss. Study populations included patients with overweight or obesity (STEP 1, STEP 3, and STEP 4) or patients with diabetes and with overweight or obesity (STEP 2). Lifestyle interventions for diet and exercise were included for all participants. Weight loss from baseline was significant for all studies, and secondary outcomes demonstrated cardiometabolic improvements including waist circumference, systolic blood pressure, and lipid profiles. Gastrointestinal adverse effects were common, but the medication was otherwise well tolerated. Relevance to Patient Care and Clinical Practice High-dose semaglutide offers significant weight-lowering potential and favorable effects on cardiometabolic risk factors and glycemic indices. Clinicians and patients should consider the route and frequency of administration, adverse effect profile, and cost when choosing an antiobesity medication. The importance of concomitant lifestyle interventions should be emphasized. Conclusions High-dose once-weekly semaglutide can significantly reduce weight, and although gastrointestinal adverse effects were common, it is generally well tolerated.

Pharmacotherapeutic Options for the Treatment of Patients with Obesity

2012 ◽  
Vol 28 (5) ◽  
pp. 211-218
Author(s):  
Lindsay R Debellis ◽  
Mark J Wrobel
Keyword(s):  
Weight Loss ◽  
Adverse Effects ◽  
English Language ◽  
Data Extraction ◽  
Double Blind ◽  
Obesity Epidemic ◽  
Safety Risks ◽  
Study Selection ◽  
Study Results ◽  
Antiobesity Agents

Objective: To assess the safety and efficacy of FDA-approved and in-development antiobesity agents. Data Sources: Literature was accessed through MEDLINE (1950-current) and EMBASE using the terms antiobesity agent, diethylpropion, phentermine, orlistat, topiramate, lorcaserin, bupropion, and naltrexone. In addition, reference citations from publications identified were reviewed. Files related to FDA expert panel hearings were retrieved from the FDA website. Study Selection and Data Extraction: Randomized double-blind trials assessing the efficacy and safety of antiobesity agents compared with placebo in the treatment of overweight and obese adults were reviewed. Only English-language or English-translated literature was reviewed. Medications were selected based on FDA approval status. Data Synthesis: Ten double-blind clinical trials were reviewed. There are currently 5 FDA-approved antiobesity agents and 1 agent recently rejected by the FDA. Study results for all agents showed statistically significant weight loss compared with placebo, but with varying adverse effects. The combination of phentermine and topiramate is the most efficacious antiobesity agent approved by the FDA. However, this combination has various neurologic, cardiovascular, and teratogenic safety risks that may limit its use. Based on its safety profile, orlistat is the preferred antiobesity medication, despite the lesser extent to which it induces weight loss versus newer agents. The incidence of unwanted gastrointestinal adverse effects limits its use. Conclusions: Despite a glaring medical need for options to treat obesity, available medications are limited. No current drug option is ideal; each has either safety risks or efficacy concerns. Safe agents that meet FDA efficacy standards are needed to help treat the obesity epidemic.

Pharmacotherapeutic Options for Overweight Adolescents

2007 ◽  
Vol 41 (9) ◽  
pp. 1445-1455 ◽  
Author(s):  
Kaelen C Dunican ◽  
Alicia R Desilets ◽  
Julie K Montalbano
Keyword(s):  
Weight Loss ◽  
Adverse Effects ◽  
Weight Reduction ◽  
English Language ◽  
Data Extraction ◽  
Short Term ◽  
Data Synthesis ◽  
Study Selection ◽  
Overweight Adolescents ◽  
Fat Soluble Vitamins

Objective: To evaluate the safety and efficacy of current pharmacotherapeutic options for weight loss in overweight adolescents. Data Sources: Literature was obtained through MEDLINE Ovid (1996–April 2007) and EMBASE Drugs and Pharmacology (1991–2nd quarter 2007) searches and a bibliographic review of published articles. Key words included adolescents, overweight, obesity, anti-obesity agents, drug therapy, orlistat, sibutramine, and metformin. Study Selection and Data Extraction: All studies published in the English language that evaluated the use of pharmacotherapy for the treatment of overweight adolescents were critically analyzed; pertinent articles were selected for this review. Data Synthesis: Orlistat has been approved for use in adolescents between the ages of 12 and 16 years. The most frequently reported adverse effects of orlistat were gastrointestinal; reduced concentrations of fat-soluble vitamins were also observed. Of the 6 clinical trials published, 5 have shown statistically significant reductions in body mass index {BMI) from baseline, ranging from 0.55 to 4.09 kg/m2; one small trial failed to demonstrate significant weight reduction compared with placebo. Sibutramine has also been evaluated for use in overweight adolescents in 6 trials. Trials demonstrated a statistically significant reduction in BMI up to 5.6 kg/m2 (from baseline). Of concern is evidence indicating that sibutramine therapy may be associated with elevated blood pressure, increased pulse rate, depression, and suicidal ideations. Lastly, metformin has recently been evaluated for weight loss in overweight adolescents; small, short-term trials demonstrate modest reductions in weight and BMI. Conclusions: Orlistat has been proven both safe and effective for weight reduction in overweight adolescents. Sibutramine has also been proven effective in reducing weight in this population; however, the potential for severe adverse effects requires further investigation. Metformin has demonstrated promising results in small trials; its role in the treatment of overweight adolescents will remain investigational until further research is conducted.

Rifaximin: A New Treatment for Travelers' Diarrhea

2005 ◽  
Vol 39 (2) ◽  
pp. 284-289 ◽  
Author(s):  
Amy L Pakyz
Keyword(s):  
Adverse Effects ◽  
Drug Interactions ◽  
English Language ◽  
Data Extraction ◽  
Cross Resistance ◽  
Double Blind ◽  
Data Synthesis ◽  
Medline Search ◽  
Study Selection ◽  
New Treatment

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical efficacy, adverse effects, drug interactions and precautions, and dosing recommendations of rifaximin, a new nonabsorbed antimicrobial agent for travelers' diarrhea. DATA SOURCES: A MEDLINE search (1966–July 2004) was conducted to extract human and animal research data in the English language on rifaximin. STUDY SELECTION AND DATA EXTRACTION: Randomized, double-blind, placebo-controlled trials were reviewed and included to evaluate the efficacy of rifaximin in the treatment of travelers' diarrhea. DATA SYNTHESIS: Rifaximin is approved for the treatment of travelers' diarrhea in patients ≥12 years of age with diarrhea caused by noninvasive strains of Escherichia coli. Rifaximin was superior to placebo and trimethoprim/sulfamethoxazole and equivalent to ciprofloxacin in the primary clinical endpoint of the time to the last unformed stool passed. CONCLUSIONS: Rifaximin is a viable alternative to ciprofloxacin for the treatment of travelers' diarrhea. As rifaximin is not systemically absorbed, it offers the advantage of leading to the development of less resistance compared with systemically absorbed antibiotics, in addition to fewer systemic adverse effects and drug interactions. However, the potential for cross-resistance between rifaximin and rifampin, as well as with other classes of antibiotics, is of concern and needs to be elucidated.

Maximizing Pharmacodynamics with High-Dose Levofloxacin

2005 ◽  
Vol 40 (9) ◽  
pp. 777-788 ◽  
Author(s):  
Kurt A. Wargo ◽  
Nichole A. Wargo ◽  
Edward H. Eiland
Keyword(s):  
Adverse Effects ◽  
Data Extraction ◽  
Community Acquired Pneumonia ◽  
High Dose ◽  
Data Synthesis ◽  
Search Terms ◽  
Short Course ◽  
Study Selection ◽  
Dosage Formulation

Objective To review published literature of levofloxacin 750 mg for the treatment of community-acquired pneumonia (CAP), nosocomial-acquired pneumonia (NAP), and skin and skin-structure infections (SSSI) focusing on microbiology, pharmacokinetic, and pharmacodynamic parameters. Data Sources MEDLINE was searched for clinical trials and review articles (1966 to September 2004). Also included were data from the manufacturer. Search terms utilized were levofloxacin, pneumonia, skin infections, adverse effects, pharmacokinetics, pharmacodynamics, and resistance. Study Selection and Data Extraction All articles and product labeling regarding levofloxacin for the treatment of CAP, NAP, and SSSI were included for review. Data Synthesis Compared with the other currently marketed fluoroquinolones, levofloxacin demonstrates similar in vitro activity to a number of commonly identified microorganisms. Levofloxacin 750 mg has shown equivalency to various non-fluoroquinolone regimens for the treatment of NAP and SSSI. Furthermore, a short, 5-day course of levofloxacin 750 mg was similar in efficacy to a longer, 10-day course of levofloxacin 500 mg for the treatment of CAP. Adverse events associated with levofloxacin therapy are dose independent; therefore, the adverse effects seen with high-dose levofloxacin are comparable to lower doses. Conclusions The levofloxacin 750 mg dosage formulation is a logical option when evaluating the antimicrobial armamentarium commonly utilized for the empiric treatment of CAP, NAP, and SSSI. Pharmacodynamic parameters are optimized and resistance is minimized when high-dose, short-course therapy is implemented.

Lumateperone: A Novel Antipsychotic for Schizophrenia

2020 ◽  
Vol 55 (1) ◽  
pp. 98-104
Author(s):  
Jessica Greenwood ◽  
Rucha B. Acharya ◽  
Valerie Marcellus ◽  
Jose A. Rey
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
English Language ◽  
Partial Agonist ◽  
Data Extraction ◽  
Double Blind ◽  
Study Selection ◽  
Syndrome Scale ◽  
Negative Syndrome ◽  
Key Terms

Objective: To provide a concise review of the new Food and Drug Administration (FDA)-approved antipsychotic, lumateperone, for use in schizophrenia. Data Sources: A literature search of PubMed was performed (January 2000 to May 2020) using the following key terms: lumateperone, Caplyta, and ITI-007. Abstracts from conferences, review articles, clinical trials, and drug monographs were reviewed. Study Selection and Data Extraction: Relevant English-language monographs and studies conducted in humans were considered. Data Synthesis: Lumateperone was FDA approved for the treatment of schizophrenia in December 2019 based on 2 published randomized, double-blind, placebo-controlled trials. Lumateperone’s pharmacology is consistent with that of other second-generation antipsychotics in that it has a higher affinity for the serotonin (5-HT2A) receptors compared with dopamine (D2) receptors but with lower affinities for α-1 and histaminergic receptors. In addition, it serves as a presynaptic dopamine partial agonist, serotonin reuptake inhibitor, and an indirect modulator of glutamatergic systems. Based on the 4-week clinical trials, lumateperone was well tolerated. Most common treatment-emergent adverse events were headache, somnolence, and dizziness. Relevance to Patient Care and Clinical Practice: At this time, lumateperone had a statistically significant reduction in Positive and Negative Syndrome Scale when compared with placebo and was not significantly associated with the extrapyramidal symptoms (EPS) and metabolic adverse effects commonly seen with other antipsychotics. Conclusions: Lumateperone has the potential to benefit individuals with schizophrenia who are intolerant to the EPSs or metabolic adverse effects of other antipsychotics. However, further head-to-head trials with commercially available antipsychotics are still required to assist in establishing its role in treatment.

scholarly journals Impact of maternal supplementation with probiotics during pregnancy on atopic eczema in childhood – a meta-analysis

2011 ◽  
Vol 107 (1) ◽  
pp. 1-6 ◽  
Author(s):  
Katja Doege ◽  
Donata Grajecki ◽  
Birgit-Christiane Zyriax ◽  
Elena Detinkina ◽  
Christine zu Eulenburg ◽  
...  
Keyword(s):  
Atopic Eczema ◽  
Data Extraction ◽  
Meta Analysis ◽  
Significant Risk ◽  
Controlled Trials ◽  
Bacterial Strains ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Study Selection ◽  
The Impact

In the present study, we sought to conduct a literature review of randomised, double-blind, placebo-controlled trials, which assessed the impact of probiotics intake during pregnancy on the development of eczema in children. A meta-analysis was conducted for comparison of the development of atopic eczema in children whose mothers took probiotics during pregnancyv.placebo. Study selection, quality appraisal and data extraction were performed independently and in duplicate. The studies were rated according to their size in order to calculate the influence of individual studies on the meta-analysis. A total of seven randomised, double-blind, placebo-controlled trials, published between 2001 and 2009, were selected from the PubMed and Ovid databases for the meta-analysis. The meta-analysis was performed with statistical software Stata/SE11.0. The completed meta-analysis of the seven studies shows a significant risk reduction for atopic eczema in children aged 2–7 years by the administration of probiotics during pregnancy (reduction 5·7 %;P = 0·022). However, this effect was only significant for lactobacilli (reduction 10·6 %;P = 0·045), but not for a mixture of various bacterial strains as probiotics (difference 3·06 %,P = 0·204). In conclusion, the meta-analysis shows that the administration of lactobacilli during pregnancy prevents atopic eczema in children aged from 2 to 7 years. However, a mixture of various bacterial strains does not affect the development of atopic eczema, independent of whether they contain lactobacilli or not.

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.

Pharmacological Treatment for Obesity in Adults: An Umbrella Review

2020 ◽  
Vol 54 (7) ◽  
pp. 691-705 ◽  
Author(s):  
Hanan Khalil ◽  
Laura Ellwood ◽  
Heidi Lord ◽  
Ritin Fernandez
Keyword(s):  
Weight Loss ◽  
Systematic Reviews ◽  
Data Extraction ◽  
Fasting Blood Glucose ◽  
Pharmacological Therapy ◽  
Umbrella Review ◽  
Data Synthesis ◽  
Study Selection ◽  
The Us ◽  
Key Terms

Objective: To synthesize the evidence from systematic reviews of clinical trials investigating the effectiveness of pharmacological therapies approved by the Australian Therapeutic Goods Administration and the US Food and Drug Administration for the management of obesity in adults. Data Sources: A 3-step literature search of the MEDLINE, EMBASE, CINAHL, and PubMed databases was conducted between March and May 2019. The key terms used were obesity, pharmacological therapy, antiobesity agent, antiobesity medication, weight loss, and systematic review. Study Selection and Data Extraction: Systematic reviews that evaluated the effectiveness of pharmacological therapies for the management of obesity in patients with a body mass index of or greater than 25 kg/m2. Data Synthesis: Nine systematic reviews involving three pharmacotherapies, liraglutide, orlistat, and naltrexone-bupropion were identified. The results indicate that the pharmacotherapies reduced weight when compared with placebo. Orlistat was effective in significantly reducing fasting blood glucose, HbA1c, total cholesterol, triglycerides, and systolic and diastolic blood pressure. All reviews discussed the presence or risk of gastrointestinal adverse effects including diarrhea, vomiting, and nausea related to orlistat and liraglutide. Relevance to Patient Care and Clinical Practice: This umbrella review compares the efficacy and safety of antiobesity medications for reducing weight and a discussion on their weight loss and metabolic control to guide clinicians when prescribing medications for obesity. Conclusions: All pharmacological therapies included in this review are superior to placebo in reducing weight. Clinicians should consider patient comorbidities and risk of adverse events when recommending medications for weight loss.

Intranasal Glucagon: A New Way to Treat Hypoglycemic Emergencies

2020 ◽  
Vol 54 (8) ◽  
pp. 780-787
Author(s):  
Rachel N. Lowe ◽  
Jennifer M. Trujillo
Keyword(s):  
Adverse Events ◽  
English Language ◽  
Data Extraction ◽  
Severe Hypoglycemia ◽  
Data Synthesis ◽  
Language Studies ◽  
Study Selection ◽  
Free Treatment ◽  
Patients With Diabetes ◽  
Data Source

Objective: To review the safety, efficacy, and administration of intranasal (IN) glucagon for the management of hypoglycemia. Data Source: A literature search of PubMed/MEDLINE (1995 to November 2019) using the terms intranasal glucagon, nasal glucagon, glucagon, hypoglycemia treatment, and hypoglycemia management was completed. Study Selection and Data Extraction: English-language studies evaluating IN glucagon were evaluated. Data Synthesis: IN glucagon is a newly approved product for the treatment of hypoglycemia in patients with diabetes, 4 years and older. Administered as a 3-mg dose, it was shown to be noninferior to intramuscular (IM) glucagon. In comparison trials, more than 98% of hypoglycemic events were treated successfully with IN glucagon in both pediatric and adult patients. In simulated and real-world studies, IN glucagon was administered in less than a minute for the majority of scenarios. IM glucagon took longer to administer, ranging from 1 to 4 minutes, and often, patients did not receive the intended full dose. Nausea and vomiting, known adverse events for glucagon, as well as local adverse events were most commonly reported with IN glucagon. Relevance to Patient Care and Clinical Practice: IN glucagon is safe, effective, easy to use, and does not require reconstitution prior to use, which can lead to faster delivery in a severe hypoglycemic event. It does not require age- or weight-based dosing. This delivery method offers an option for someone who fears needles or is uncomfortable with injections. Conclusion: IN glucagon is a safe, effective, easy to use, needle-free treatment option for severe hypoglycemia.

Sign in / Sign up

Export Citation Format

Share Document