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The Senior Care Pharmacist Jun 2023To review the pharmacotherapy of prescription drugs approved for treatment of chronic dry eye disease (DED). A brief background on DED management and the pharmacist's...
To review the pharmacotherapy of prescription drugs approved for treatment of chronic dry eye disease (DED). A brief background on DED management and the pharmacist's role for care is included. Articles indexed in PubMed (National Library of Medicine), Iowa Drug Information Service, Cochrane Reviews and Trials, and Google Scholar in the past 10 years using the key words "dry eye," "dry eye and treatment," "cyclosporine," "lifitegrast," and "varenicline." Current guidelines and manufacturers' prescribing information were reviewed. Primary sources were used to locate additional resources. Sixty-five publications were reviewed, and criteria supporting the objectives identified useful resources. Selected literature included practice guidelines, review articles, research articles, product prescribing information, and drug information databases. Patient education, eliminating causative factors, improving the daily environment for eye health, and using ocular lubricants are the first steps in DED management. A therapeutic mainstay is ocular lubricants; preservative-free formulations are recommended for chronic or repeated daily use. The Food and Drug Administration approved prescription medications for chronic use for DED, cyclosporine ophthalmic emulsion and solution, lifitegrast ophthalmic solution, and varenicline nasal spray, all improve signs and symptoms but do not cure DED. The ophthalmic products all cause ocular discomfort upon instillation. As a nasal spray, varenicline does not cause ocular discomfort, but it can cause sneezing, cough, and throat and nose irritation in some patients. Pharmacists have an opportunity to provide patient education regarding lifestyle modifications to mitigate DED and provide counseling on available products. Emerging therapies may provide advances in DED treatment.
Topics: United States; Humans; Nasal Sprays; Varenicline; Ophthalmic Solutions; Dry Eye Syndromes; Cyclosporins; Prescriptions; Lubricants
PubMed: 37231571
DOI: 10.4140/TCP.n.2023.239 -
Journal of Addiction MedicineAn overview, meta-analysis, and trial sequential analysis were conducted to evaluate the efficacy and safety of varenicline for smoking cessation. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
An overview, meta-analysis, and trial sequential analysis were conducted to evaluate the efficacy and safety of varenicline for smoking cessation.
METHODS
Systematic reviews (SRs) and randomized controlled trials evaluating varenicline versus placebo for smoking cessation were included. A forest plot was used to summarize the effect size of the included SRs. Traditional meta-analysis and trial sequential analysis (TSA) were performed using Stata software and TSA 0.9 software, respectively. Finally, the Grades of Recommendation, Assessment, Development, and Evaluation approach was used to assess the quality of evidence for the abstinence effect.
RESULTS
A total of 13 SRs and 46 randomized controlled trials were included. Twelve review studies showed that varenicline was superior to placebo for smoking cessation. The meta-analysis results showed that, compared with the placebo, varenicline significantly increased the odds of smoking cessation (odds ratio = 2.54, 95% confidence interval = 2.20-2.94, P < 0.05, moderate quality). Subgroup analysis showed that there were significant differences in smokers with disease and general smokers ( P < 0.05). Differences were also found in the follow-up time at 12, 24, and 52 weeks ( P < 0.05). The common adverse events were nausea, vomit, abnormal dreams, sleep disturbances, headache, depression, irritability, indigestion, and nasopharyngitis ( P < 0.05). The TSA results confirmed the evidence for the effect of varenicline on smoking cessation.
CONCLUSIONS
Existing evidence supports the superiority of varenicline over a placebo for smoking cessation. Varenicline had mild to moderate adverse events but was well tolerated. Future trials should investigate varenicline in combination with other smoking cessation approaches and compare it with other interventions.
Topics: Humans; Smoking Cessation; Varenicline
PubMed: 37788606
DOI: 10.1097/ADM.0000000000001171 -
Drug and Alcohol Dependence Dec 2022Based on randomized controlled trials, a network meta-analysis was conducted to compare treatment effects across varenicline and related smoking interventions. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Based on randomized controlled trials, a network meta-analysis was conducted to compare treatment effects across varenicline and related smoking interventions.
METHODS
English databases were screened for randomized controlled trials reporting the effect of varenicline as treatment for smoking. The risk of bias in included trials was assessed using the Cochrane Handbook tool. Stata 15.1 software was used to perform network meta-analysis, and the GRADE approach was used to assess the evidence credibility on the tobacco treatment effects of different interventions.
RESULTS
Thirty-four studies involving 26,130 smokers were included in the network meta-analysis. Varenicline and 11 other interventions were reported, yielding 66 pairs of comparisons. Network meta-analysis showed that varenicline monotherapy or its combination with other interventions were superior in achieving smoking cessation compared to bupropion, nicotine replacement therapy, counselling, and placebo. Furthermore, compared to the varenicline, evident abstinence superiority was found in varenicline + bupropion (odds ratio = 1.49, 95% confidence interval [1.02, 2.18]). Finally, the surface under the cumulative ranking curve value indicated that varenicline + bupropion has the highest probability to become the best intervention.
CONCLUSIONS
Varenicline monotherapy increased the odds of smoking cessation further than bupropion monotherapy, nicotine replacement therapy, counselling, and placebo, while varenicline combined with other interventions may even achieve a better abstinence effect. More credible evidence has been reported indicating that the combination of varenicline and bupropion is a superior treatment for smoking.
Topics: Humans; Varenicline; Smoking Cessation; Network Meta-Analysis; Nicotinic Agonists; Tobacco Use Cessation Devices; Bupropion; Benzazepines
PubMed: 36332593
DOI: 10.1016/j.drugalcdep.2022.109672 -
Journal of Obstetrics and Gynaecology... Sep 2015Although pregnancy often motivates women to quit smoking, 20% to 25% will continue to smoke. Smoking is associated with adverse obstetric and neonatal outcomes such as... (Review)
Review
Although pregnancy often motivates women to quit smoking, 20% to 25% will continue to smoke. Smoking is associated with adverse obstetric and neonatal outcomes such as placental abruption, stillbirth, preterm birth and sudden infant death syndrome, and it is therefore important to motivate women to quit during pregnancy. In this review, we explore the efficacy and evidence for safety of strategies for smoking cessation in pregnancy, including behavioural and pharmacologic therapies. The PubMed, Medline, EMBASE, and Cochrane databases (1990 to 2014) were accessed to identify relevant studies, using the search terms "smoking cessation," "pregnancy," "medicine, behavioural," "nicotine replacement products," "bupropion," and "varenicline." Studies were selected based on the levels of evidence presented by the Canadian Task Force on Preventative Health Care. Based on our review of the evidence, incentives combined with behavioural therapy appear to show the greatest promise for abstaining from smoking in the pregnant population. Nicotine replacement therapy administered in the form of gum may be better than using transdermal forms to avoid high levels of nicotine in the fetal circulation. One small trial demonstrated that bupropion is an effective aid for smoking cessation and that it does not appear to be associated with an increased risk of major congenital malformations. The currently available studies of varenicline in pregnancy are insufficient to provide evidence for the safety or efficacy of its use.
Topics: Bupropion; Dopamine Uptake Inhibitors; Female; Humans; Nicotinic Agonists; Pregnancy; Smoking Cessation; Tobacco Use Cessation Devices; Varenicline
PubMed: 26605448
DOI: 10.1016/S1701-2163(15)30149-3 -
Addiction (Abingdon, England) Apr 2017
Topics: Drug Labeling; Health Communication; Humans; Nicotinic Agonists; Risk; United States; United States Food and Drug Administration; Varenicline
PubMed: 27558015
DOI: 10.1111/add.13592 -
Expert Opinion on Drug Discovery Jul 2018Tobacco use causes one premature death every six seconds. Current smoking cessation aids include nicotine replacement therapies, bupropion, and varenicline. Although... (Comparative Study)
Comparative Study Review
Tobacco use causes one premature death every six seconds. Current smoking cessation aids include nicotine replacement therapies, bupropion, and varenicline. Although more than 70% of smokers express a desire to quit, fewer than 3% remain abstinent for more than one year, highlighting a critical need for more efficacious smoking cessation treatments. Areas covered: The authors discuss the rationale, preclinical and clinical development of varenicline for smoking cessation. They cover the development of varenicline as a partial agonist at αβ receptors, the primary neural substrate for nicotine reward. Then, they discuss evidence from preclinical studies indicating varenicline's efficacy in blocking nicotine reward, followed by clinical trials demonstrating safety and efficacy in sustaining abstinence in smokers. Finally, they cover post-market surveillance, including caution in heavy machine operators, putative cardiovascular risk, and the repealed warning for adverse neuropsychiatric events. Expert opinion: Varenicline development was based on strong theoretical rationale and preclinical evidence. Clinical studies indicate that varenicline is safe and more effective in sustaining abstinence than placebo, bupropion or nicotine replacement therapies. However, given that continuous abstinence rates across studies remain low (18 ~ 30% with varenicline; 4 ~ 10% with placebo), novel and more effective medications targeting other nicotinic or glutamate receptors for smoking cessation are required.
Topics: Animals; Bupropion; Drug Development; Drug Discovery; Humans; Smoking; Smoking Cessation; Smoking Cessation Agents; Varenicline
PubMed: 29587555
DOI: 10.1080/17460441.2018.1458090 -
Expert Opinion on Drug Safety 2016Tobacco continues to be a leading cause of preventable morbidity and mortality in the world. First-line pharmacotherapies for the treatment of tobacco use disorder... (Review)
Review
INTRODUCTION
Tobacco continues to be a leading cause of preventable morbidity and mortality in the world. First-line pharmacotherapies for the treatment of tobacco use disorder include nicotine replacement therapy, bupropion sustained-release (SR), and varenicline. We provide an overview of current evidence on the safety of first-line pharmacotherapies for the treatment of tobacco use disorder.
AREAS COVERED
Randomized clinical trials published in English up to July 2015 were identified and reviewed through searches of PUBMED using the terms nicotine replacement therapy, bupropion SR, varenicline, smoking, and tobacco cessation.
EXPERT OPINION
Nicotine replacement has few contraindications and side effects and can be recommended to almost all tobacco users. Bupropion SR should be used with caution in patients with bipolar disorder or liver or kidney disease, and alternative treatments should be considered for patients with a history of seizures or who are at risk for seizures. The only contraindication for varenicline is an allergy to the medication, and nausea is the most common side effect. Varenicline can be used safely in patients with cardiovascular disease. Varenicline can be used in patients with stable psychiatric disease and safety can be ensured through close clinical monitoring.
Topics: Bupropion; Delayed-Action Preparations; Humans; Randomized Controlled Trials as Topic; Smoking Cessation; Smoking Prevention; Tobacco Use Cessation Devices; Tobacco Use Disorder; Varenicline
PubMed: 26715118
DOI: 10.1517/14740338.2016.1131817 -
Journal of the American Heart... Feb 2016Varenicline is an efficacious smoking-cessation drug. However, previous meta-analyses provide conflicting results regarding its cardiovascular safety. The publication of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Varenicline is an efficacious smoking-cessation drug. However, previous meta-analyses provide conflicting results regarding its cardiovascular safety. The publication of several new randomized controlled trials (RCTs) provides an opportunity to reassess this potential adverse drug reaction.
METHODS AND RESULTS
We searched MEDLINE, EMBASE, and the Cochrane Library for RCTs that compare varenicline with placebo for smoking cessation. RCTs reporting cardiovascular serious adverse events and/or all-cause mortality during the treatment period or within 30 days of treatment discontinuation were eligible for inclusion. Relative risks (RRs) with 95% CIs were generated by using DerSimonian-Laird random-effects models. Thirty-eight RCTs met our inclusion criteria (N=12 706). Events were rare in both varenicline (57/7213) and placebo (43/5493) arms. No difference was observed for cardiovascular serious adverse events when comparing varenicline with placebo (RR 1.03, 95% CI 0.72-1.49). Similar findings were obtained when examining cardiovascular (RR 1.04, 95% CI 0.57-1.89) and noncardiovascular patients (RR 1.03, 95% CI 0.64-1.64). Deaths were rare in both varenicline (11/7213) and placebo (9/5493) arms. Although 95% CIs were wide, pooling of all-cause mortality found no difference between groups (RR 0.88, 95% CI 0.50-1.52), including when stratified by participants with (RR 1.24, 95% CI 0.40-3.83) and without (RR 0.77, 95% CI 0.40-1.48) cardiovascular disease.
CONCLUSIONS
We found no evidence that varenicline increases the rate of cardiovascular serious adverse events. Results were similar among those with and without cardiovascular disease. Given varenicline's efficacy as a smoking cessation drug and the long-term cardiovascular benefits of cessation, it should continue to be prescribed for smoking cessation.
Topics: Adolescent; Adult; Aged; Cardiovascular Diseases; Female; Humans; Male; Middle Aged; Nicotinic Agonists; Odds Ratio; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Smoking Prevention; Tobacco Use Cessation Devices; Tobacco Use Disorder; Varenicline; Young Adult
PubMed: 26903004
DOI: 10.1161/JAHA.115.002849 -
Drugs Sep 2022Increasing endogenous tear film production via pharmacological neuroactivation of the nasolacrimal reflex [NLR; also known as the trigeminal parasympathetic pathway... (Review)
Review
Increasing endogenous tear film production via pharmacological neuroactivation of the nasolacrimal reflex [NLR; also known as the trigeminal parasympathetic pathway (TPP)] is a novel therapeutic approach to treating dry eye disease (DED). An intranasal formulation of the water-soluble, small-molecule, nicotinic acetylcholine receptor (nAChR) agonist varenicline (Tyrvaya™) has been approved in the USA for the treatment of DED. Twice-daily administration of varenicline solution nasal spray resulted in rapid, statistically significant and clinically meaningful improvements in the signs and symptoms of DED over a period of 4 weeks in two pivotal studies (ONSET-1 and -2). The efficacy of varenicline solution was maintained over a longer-term period of 12 weeks in a third study (MYSTIC). Consistent with the nasal route of delivery, the most common adverse events reported by varenicline solution recipients were non-ocular in nature (mild and transient sneezing and cough). Thus, varenicline solution nasal spray is a rapidly-acting, effective and generally well tolerated treatment for DED that offers several potentially useful advantages over existing topical ocular therapies in terms of increasing endogenous tear secretion and reducing ophthalmic treatment burden.
Topics: Humans; Tears; Varenicline; Nasal Sprays; Dry Eye Syndromes; Administration, Ophthalmic
PubMed: 36197638
DOI: 10.1007/s40265-022-01782-4 -
Cleveland Clinic Journal of Medicine Jul 2021Nicotine addiction and dependence is a chronic relapsing disease driven by addiction to nicotine. Proactive treatment for all tobacco users, regardless of their... (Review)
Review
Nicotine addiction and dependence is a chronic relapsing disease driven by addiction to nicotine. Proactive treatment for all tobacco users, regardless of their readiness to quit, is recommended. First-line tobacco cessation medications include nicotine replacement therapy, bupropion, and varenicline. Comprehensive treatment with behavioral interventions and pharmacologic therapy increases success rates of smoking cessation. Although there are many popular alternative treatments, they should not replace or delay the use of known effective therapies.
Topics: Humans; Smoking; Smoking Cessation; Tobacco Use Cessation; Tobacco Use Cessation Devices; Varenicline
PubMed: 34210714
DOI: 10.3949/ccjm.88a.20099