Weight loss medication tirzepatide may help lower BP in adults with obesity

The new weight loss medication tirzepatide significantly lowered the systolic blood pressure (the top number in a blood pressure reading) for nearly 500 adults with obesity who took the medication for about eight months, according to new research published today in Hypertension, an American Heart Association journal.

Systolic blood pressure, or the top number in the blood pressure reading, is a stronger predictor for cardiovascular death than diastolic, or bottom number, blood pressure. According to the American Heart Association’s 2024 Heart Disease and Stroke Statistics, more than 122 million adults in the United States, or 47% of adults have hypertension, and nearly 42% of adults have obesity.

Tirzepatide works by mimicking two metabolic hormones in the body: it acts as a glucagon-like peptide-1 (GLP-1) receptor agonist and also as a glucose dependent insulinotropic polypeptide (GIP) receptor agonist. These hormones stimulate insulin secretion and sensitivity after a person eats. Together, they have been found so far to help regulate the body’s blood sugar levels, slow down digestion and reduce appetite, which makes a person feel more full and eat less, leading to weight loss. In contrast, semaglutide has only the GLP-1 hormone; it does not contain a GIP receptor agonist.

In 2022, the Food and Drug Administration approved tirzepatide for prescription as a treatment for Type 2 diabetes. In late 2023, the FDA also approved it for chronic weight management for people with obesity (body mass index of 30 kg/m2 or higher) or overweight (body mass index of 27-29 kg/m2) and at least one weight-related health condition, such as high blood pressure, Type 2 diabetes or high cholesterol.

“Our findings indicate treating obesity with the weight loss medication tirzepatide may be an effective strategy for preventing or treatinghigh blood pressure,” said lead study author James A. de Lemos, M.D., FAHA, the Kern Wildenthal, M.D., Ph.D., distinguished chair of cardiology and a professor of medicine at UT Southwestern Medical Center in Dallas. “Although tirzepatide has been studied as a weight loss medication, the blood pressure reduction in our patients in this study was impressive. While it is not known if the impact on blood pressure was due to the medication or the participants’ weight loss, the lower blood pressure measures seen with tirzepatide rivaled what is seen for many hypertension medications.”

The current research was a planned sub-study including 600 of the participants from the SURMOUNT-1 weight loss study to determine if there was an effect on blood pressure. The sub-study was designed to assess the effects of tirzepatide on blood pressure levels as measured by 24-hour ambulatory blood pressure monitoring in people with obesity but without Type 2 diabetes.

Participants received either a placebo or a dose of tirzepatide in one of three strengths (5 mg, 10 mg or 15 mg). About one-third of participants reported they had high blood pressure at the beginning of the study and were taking one or more hypertension medications. When the sub-study began, all of the participants had blood pressure levels that were less than 140/90 mm Hg, and if they used blood pressure medications, they were required to have been taking their blood pressure medications for at least three months. The sub-study included participants who had hypertension and who had normal blood pressure.

The study was conducted from December 2019 to April 2022, and the participant results after 36 weeks of taking tirzepatide indicate:

  • For participants taking 5 mg of tirzepatide, there was an average reduction in systolic blood pressure of 7.4 mm Hg.
  • For participants taking 10 mg of tirzepatide, there was an average reduction in systolic blood pressure of 10.6 mmHg.
  • For participants taking 15 mg of tirzepatide, there was an average reduction in systolic blood pressure of 8.0 mm Hg.
  • The blood-pressure lowering effects of tirzepatide were evident in blood pressure measures taken during both the day and night. Nighttime systolic blood pressure is a stronger predictor for cardiovascular death and all-cause death than daytime blood pressure readings.

The reductions in systolic blood pressure were consistent across subgroups of participants in the study who were categorized by additional factors, including age, sex, body mass index and hypertension-related risk factors.

Study background and details:

  • SURMOUNT-1 was a randomized study on the effect of increasing doses of tirzepatide on weight loss. It found that in participants with overweight or obesity (body mass index (BMI) ≥27 kg/m2), once-weekly injections of 5 mg, 10 mg or 15 mg of tirzepatide led to mean weight reductions of 15%, 19.5% and 20.9%, respectively, compared to placebo.
  • The sub-study included 600 adults from SURMOUNT-1: 155 participants received placebo; 145 were taking tirzepatide 5 mg; 152 were taking tirzepatide 10 mg; and 148 were taking tirzepatide 15 mg.
  • Blood pressure measurements were available and analyzed for 494 participants who valid ambulatory blood pressure monitoring data at the beginning of the study and at week 36.
  • Only the study participants with at least 70% valid readings on ambulatory monitoring and a minimum of 20 daytime and seven nighttime readings were included in the data analyses. This was 494 out of 600 initial participants.
  • 69% of study participants self-identified as female, and 31% self-identified as male. 66.8% self-identified as white adults, 11.8% self-identified as Black adults and 25% self-identified as Hispanic ethnicity.
  • The average age of the participants was 45.5 years, and their average BMI was 37.4 kg/m2, which meets the criteria for obesity (obesity is BMI≥30). People with obesity have an increased risk of high blood pressure, heart disease, stroke and Type 2 diabetes, as well as other health conditions.
  • Ambulatory blood pressure monitoring used in this study included blood pressure measurements every 30 minutes during the day and every hour at night, providing a more comprehensive assessment of blood pressure than in office or daily home blood pressure measurements. For ambulatory blood pressure monitoring, study participants wore a blood pressure monitoring device for a 24- to 27-hour period that measured blood pressure throughout waking and sleeping hours. Ambulatory blood pressure monitoring was conducted when participants first began taking tirzepatide at the start of the study and after 36 weeks of being enrolled in the study.

The 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults classifies hypertension, or high blood pressure, as having top and bottom blood pressure measures greater than or equal to 130/80 mm Hg.

Study limitations include that it was only conducted in a subset of the original 2,539 SURMOUNT-1 participants; the ambulatory blood pressure monitoring was only measured at two points in the study-baseline and at 36 weeks; and measurements were only taken once per hour at night to minimize the burden on study participants. In addition, changes in food intake and 24-hour urine sodium excretion were not assessed, meaning the contribution of dietary modifications including salt intake or other changes that may help to reduce blood pressure are unknown and cannot be estimated.

“Overall, these data are encouraging that novel weight-loss medications are effective at reducing body weight and they are also effective at improving many of the cardiometabolic complications of obesity including hypertension, Type 2 diabetes and dyslipidemia, among others. While the impact of each of these beneficial effects is individually important, many of these obesity-related complications act synergistically to increase the risk of cardiovascular disease. Thus, strategies that mitigate multiple obesity-related complications may reduce the risk of cardiovascular events,” said Michael E. Hall, M.D., M.S., FAHA, chair of the writing group for the Association’s 2021 scientific statement on weight-loss strategies for prevention and treatment of hypertension and chair of the department of medicine at the University of Mississippi Medical Center in Jackson, Mississippi.

“Additional studies will be necessary to determine the long-term impact on cardiovascular events such as heart attack and heart failure. Also, studies are needed to investigate what happens to blood pressure when medications like tirzepatide are discontinued – does the blood pressure rebound and go back up, or does it remain lowered?” Hall concluded.

Reference:

James A. de Lemos, Bruno Linetzky, Carel W. le Roux, Luke J. Laffin, Wanpen Vongpatanasin, Ludi Fan, Andrea Hemmingway, Nadia N. Ahmad, Mathijs C. Bunck and Adam Stefanski, Tirzepatide Reduces 24-Hour Ambulatory Blood Pressure in Adults With Body Mass Index ≥27 kg/m2: SURMOUNT-1 Ambulatory Blood Pressure Monitoring Substudy, Hypertension, https://doi.org/10.1161/HYPERTENSIONAHA.123.22022.

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Probiotic Supplementation may Prevent Recurrent Urinary Tract Infections

A recent study published in the Clinical Infectious Diseases explored the alternative strategies such as the effectiveness of probiotic supplementation to combat recurrent urinary tract infections (UTIs).

This double-blind, placebo-controlled trial enrolled a total of 174 premenopausal women with a history of recurrent UTIs. The participants were divided into four groups and administered either oral probiotics, vaginal probiotics, a combination of both or placebos over a span of four months.

The results revealed that at the four-month mark, the incidence of UTIs in participants who received vaginal probiotics or the combination of oral and vaginal probiotics was significantly lower when compared to those in the placebo group. Also, the mean number of symptomatic UTI recurrences was significantly reduced in these groups which indicate the benefits of probiotic supplementation.

The time to the first symptomatic UTI was significantly prolonged in the groups receiving vaginal probiotics or the combination regimen, underscoring the potential for these interventions to provide long-term protection against recurrent UTIs. The probiotic supplements were well tolerated by participants and no serious adverse events were observed. This suggests that probiotic supplementation could offer a safe and effective alternative or adjunctive therapy for individuals prone to recurrent UTIs.

The study highlighted the importance of these findings in the context of growing antibiotic resistance which emphasize the benefits of probiotics as a nonantibiotic strategy in preventing recurrent UTIs. Probiotics offers promise for reducing the burden of UTIs while minimizing the risk of antibiotic resistance by promoting a healthy balance of bacteria in the urinary and vaginal tracts. Further research on the role of probiotics in urinary tract health may inform clinical guidelines for the prevention and management of recurrent UTIs.

Reference:

Gupta, V., Mastromarino, P., & Garg, R. (2023). Effectiveness of Prophylactic Oral and/or Vaginal Probiotic Supplementation in the Prevention of Recurrent Urinary Tract Infections: A Randomized, Double-Blind, Placebo-Controlled Trial. In Clinical Infectious Diseases. Oxford University Press (OUP). https://doi.org/10.1093/cid/ciad766

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Physical activity insufficient to counter CV risk associated with sugar-sweetened beverage consumption

Contrary to popular belief, the benefits of physical activity do not outweigh the risks of cardiovascular disease associated with drinking sugar-sweetened beverages, according to a new study led by Harvard T. H. Chan School of Public Health. Jean-Philippe Drouin-Chartier, professor at Université Laval’s Faculty of Pharmacy, was a co-author.

Sugar-sweetened beverages are the largest source of added sugars in the North American diet. Their consumption is associated with a higher risk of cardiovascular disease, the world’s leading cause of death.

“The marketing strategies for these drinks often show active people drinking these beverages. It suggests that sugary drink consumption has no negative effects on health if you’re physically active. Our research aimed to assess this hypothesis,” says Drouin-Chartier.

For the study, the scientists used two cohorts totalling around 100,000 adults, followed for about 30 years. The data show that those who consumed sugar-sweetened beverages more than twice a week had a higher risk of cardiovascular disease, regardless of physical activity levels.

The study found that even if the recommended 150 minutes of weekly physical activity protects against cardiovascular disease, it’s not enough to counter the adverse effects of sugar-sweetened beverages. “Physical activity reduces the risk of cardiovascular disease associated with sugar-sweetened beverages by half, but it does not fully eliminate it,” says Drouin-Chartier.

The frequency of consumption considered in the study-twice a week-is relatively low but still is significantly associated with cardiovascular disease risk. With daily consumption, the risk of cardiovascular disease is even higher.

For this reason, Drouin-Chartier underlines the importance of targeting the omnipresence of sugar-sweetened beverages in the food environment. This category includes soft and carbonated drinks (with or without caffeine), lemonade, and fruit cocktails. The study did not specifically consider energy drinks, but they also tend to be sugar-sweetened.

For artificially sweetened drinks, often presented as an alternative solution to sugar-sweetened beverages, their consumption was not associated with higher risk of cardiovascular diseases. “Replacing sugar-sweetened beverages by diet drinks is good, because it reduces the amount of sugar. But the best drink option remains water,” explains Drouin-Chartier.

“Our findings provide further support for public health recommendations and policies to limit people’s intake of sugar-sweetened beverages, as well as to encourage people to meet and maintain adequate physical activity levels,” added lead author Lorena Pacheco, a research scientist in the Department of Nutrition at Harvard Chan School. 

Reference:

Lorena S Pacheco, Deirdre K Tobias, Yanping Li, Shilpa N Bhupathiraju, Walter C Willett, David S Ludwig, Cara B Ebbeling, Danielle E Haslam, Jean-Philippe Drouin-Chartier, Frank B Hu, Marta Guasch-Ferré, Sugar-sweetened or artificially-sweetened beverage consumption, physical activity, and risk of cardiovascular disease in adults: a prospective cohort study, The American Journal of Clinical Nutrition, 2024, https://doi.org/10.1016/j.ajcnut.2024.01.001.

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Superior Trunk Block Effective Phrenic-Sparing Alternative to Interscalene Block for Shoulder Arthroscopy

Recently published research study reviewed the use of superior trunk block (STB) as an alternative to interscalene block (ISB) for postoperative pain management in patients undergoing shoulder arthroscopy. The study aimed to compare the incidence and degree of hemidiaphragmatic paralysis and the block efficacy of these techniques. The findings were based on a systematic review and meta-analysis of randomized controlled trials (RCTs) that included 359 patients.

Findings and Conclusion of STB versus ISB

The study found that the STB group showed a significantly lower incidence of total hemidiaphragmatic paralysis, subjective dyspnea, and Horner’s syndrome compared to the ISB group. Furthermore, the duration of the block and block efficacy showed no significant difference between the groups. The researchers concluded that STB has a better safety profile than ISB, resulting in lower rates of hemidiaphragmatic paralysis and dyspnea while providing a similar block. They suggested that STB could be preferred over ISB, especially in patients susceptible to phrenic nerve paralysis complications.

Significance of Meta-Analysis and Study Outcome

This meta-analysis is the first to pool the results of RCTs comparing STB with ISB in patients undergoing shoulder arthroscopy. The study included 359 patients and found that STB demonstrated equal effectiveness as ISB in providing analgesia while also showing a higher safety profile with lower incidence of hemidiaphragmatic paralysis and minor complications. The study highlighted that STB may offer advantages over ISB, particularly in patients at increased risk of respiratory insufficiency.

Study Limitations and Implications for Clinical Practice

The researchers acknowledged some limitations, such as the relatively small sample size and heterogeneity in some outcomes among the included studies. They also noted that the publication bias analysis suggested some degree of asymmetry in the data, indicating the possibility of small study effects. However, the study’s findings have significant implications for clinical practice, and the researchers recommended STB as a preferred alternative to ISB, especially for patients at increased risk of respiratory insufficiency.

In conclusion, this meta-analysis of RCTs comparing STB and ISB in patients undergoing shoulder arthroscopy indicates that STB may be a safer alternative with equivalent analgesic efficacy compared to ISB. The study suggests that STB should be considered as a preferred option, particularly for patients at increased risk of respiratory insufficiency.

Reference –

Amaral S, Arsky Lombardi R, Medeiros H, et al. (November 03, 2023) Superior Trunk Block Is an Effective Phrenic-Sparing Alternative to Interscalene Block for Shoulder Arthroscopy: A Systematic Review and Meta-Analysis. Cureus 15(11): e48217. doi:10.7759/cureus.48217.

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Organic compound found in trees could prevent contact lens eye infections

A new study suggests a naturally-occurring material is an effective disinfectant for contact lenses, worn by millions of people worldwide.

Microbial keratitis is one of the most serious potential complications for contact lens wearers. It’s an infection of the cornea that is caused by bacteria; the most common being Pseudomonas aeruginosa.

Previous studies have found that existing disinfecting solutions are not effective for preventing biofilm, which are clusters of bacteria that attach to the surface of lenses.

Hydroquinine, an organic compound found in the bark of some trees, is known to have bacterial killing activity against Pseudomonas aeruginosa and several other clinically important germs, including Staphylococcus aureus, Escherichia coli, and Klebsiella pneumoniae.

The team behind the discovery, from the University of Portsmouth in England and Naresuan and Pibulsongkram Rajabhat universities in Thailand, has now explored the potential use of multipurpose formulas containing hydroquinine as a disinfectant for contact lenses.

They examined the antibacterial, anti-adhesion, and anti-biofilm properties of hydroquinine-formulated multi-purpose solutions (MPSs), and then compared it to two commercial MPSs; Opti-free Replenish and Q-eye. The natural compound killed 99.9 per cent of bacteria at the time of disinfection.

The paper, published in Antibiotics, says these findings may aid in the development of novel disinfectants aimed at combating the P. aeruginosa bacteria.

Dr Robert Baldock from the School of Pharmacy and Biomedical Sciences at the University of Portsmouth, said: “Commercially available disinfecting solutions, which are made up of a number of chemicals, can sometimes cause reactions with painful side-effects.

“We hoped to demonstrate that new agents made from natural products may be an excellent option to limit or reduce the risk of contact lens contamination.

“It is exciting to see how this research has progressed; from discovery to exploring potential applications.”

There are up to 3.5 million reports of corneal infections annually, and in extreme cases it can result in permanent eye damage and vision loss. The risk of microbial keratitis doubles when someone wears contact lenses overnight and or longer than the recommended daily amount.

Corneal blindness resulting from microbial keratitis is emerging as a prominent cause of visual disability, according to the World Health Organisation (WHO). The World Health Organisation (WHO) has also classified multidrug-resistant P. aeruginosa as one of the most concerning pathogens.

Drug-resistant bacteria occur in more than 2.8 million infections and are responsible for 35,000 deaths per year. Antimicrobial resistance happens when germs change over time and no longer respond to medicines, making it difficult to treat infections.

Amoxicillin and Trimethoprim are commonly prescribed antibiotics that certain strains of P. aeruginosa have become resistant to.

Hydroquinine is already known to be an effective agent against malaria in humans, and it is also being used in the Netherlands to treat nocturnal muscle cramps. Until now, there has been little investigation into its drug-resistant properties.

Lead author, Sattaporn Weawsiangsang from the Faculty Of Allied Health Sciences at Naresuan University, is currently a visiting researcher at the University of Portsmouth.

She said: “Our initial findings suggest that soaking contact lenses in a multi-purpose solution containing hydroquinine is possibly helpful to prevent contamination and infection.

“However, further investigation is needed to determine whether hydroquinine itself also has adverse reactions or toxicity.

“We are continuing to test the compound on a number of cells, and so far, the results are really promising. This potential development could contribute to the creation of new disinfectants from natural products, effectively combating P. aeruginosa infections and reducing cases of corneal infections.”

The paper concludes by recommending further research examining the effectiveness of hydroquinine with several different contact lens materials, and against other pathogenic microorganisms. 

Reference:

Weawsiangsang S, Rattanachak N, Ross S, Ross GM, Baldock RA, Jongjitvimol T, Jongjitwimol J. Hydroquinine Enhances the Efficacy of Contact Lens Solutions for Inhibiting Pseudomonas aeruginosa Adhesion and Biofilm Formation. Antibiotics. 2024; 13(1):56. https://doi.org/10.3390/antibiotics13010056.

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Drugs used for treating erectile dysfunction tied to reduced risk of Alzheimer’s disease: Study

UK: Erectile dysfunction drugs, which work by dilating blood vessels to allow more blood to flow through, were first developed to treat high blood pressure. A new study published in Neurology suggests that the drugs may be tied to a reduced risk of Alzheimer’s disease. 

According to the study, the drugs used to treat erectile dysfunction may also be associated with a reduced risk of Alzheimer’s disease. The study does not prove that erectile dysfunction drugs reduce the risk of Alzheimer’s disease. It only shows an association.

“Although we’re making progress with the new treatments for Alzheimer’s disease that work to clear amyloid plaques in the brain for people with early stages of the disease, we desperately need treatments that can prevent or delay the development of Alzheimer’s disease,” said study author Ruth Brauer, PhD, of the University College London in the United Kingdom. “These results are encouraging and warrant further research.”

The study involved 269,725 male participants with an average age of 59 who were newly diagnosed with erectile dysfunction. Participants did not have any memory or thinking problems at the start of the study. They were then followed for an average of five years. The study compared the 55% of the participants who had prescriptions for erectile dysfunction drugs to the 45% who did not have prescriptions.

During the study, 1,119 people developed Alzheimer’s disease.

Among the participants taking erectile dysfunction drugs, 749 developed Alzheimer’s disease, which corresponds to a rate of 8.1 cases per 10,000 person-years. Person-years represent both the number of people in the study and the amount of time each person spends in the study. Among those who did not take the drugs, 370 developed Alzheimer’s disease, which corresponds to a rate of 9.7 cases per 10,000 person-years.

Once researchers adjusted for other factors that could affect the rate of Alzheimer’s disease, such as age, smoking status and alcohol consumption, they found that people who took erectile dysfunction drugs were 18% less likely to develop Alzheimer’s than people who did not take the drugs.

The association was strongest in those who were issued the most prescriptions over the study period.

“More research is needed to confirm these findings, learn more about the potential benefits and mechanisms of these drugs and look into the optimal dosage,” Brauer said. “A randomized, controlled trial with both male and female participants is warranted to determine whether these findings would apply to women as well.”

The study was based on prescription records. A limitation of the study is that researchers did not have information on whether participants actually filled the prescriptions and used the drugs.  

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Intra arterial tirofiban as rescue therapy during mechanical thrombectomy in stroke may improve recanalization rates

Tamil Nadu: Use of intra-arterial (IA) tirofiban with or without adjunct techniques as rescue therapy during mechanical thrombectomy (MT) in large vessel occlusion (LVO) improves recanalization rates without raising the risk of symptomatic haemorrhage, a recent study has shown. The findings were published online in the Journal of Clinical Interventional Radiology.

Stroke is an important cause of disability and morbidity affecting the productive life of an individual with a substantial socioeconomic impact. Acute ischemic stroke (AIS) due to LVO can be in situ occlusion due to underlying intracranial atherosclerotic disease (ICAD) or thromboembolism (cardiac-embolism/artery-to-artery embolism). Recanalizing the acutely occluded vessel as early as possible is the strongest predictor of good clinical outcomes.

Mechanical thrombectomy has become the standard of care in acute LVO since 2015. In the event of unsuccessful recanalization during MT, there are no established guidelines for rescue therapy. MT can cause plaque disruption and endothelial damage, resulting in subsequent platelet activation and occlusion of the initially recanalized vessel.

Tirofiban is approved for use in acute coronary syndrome by the U.S. Food and Drug Administration (FDA), a short-acting inhibitor of the glycoprotein IIb/IIIa receptor (GpIIb/IIIa). Tirofiban blocks platelet aggregation and subsequent thrombus formation. Karthikeyan Muthugounder Athiyappan, Department of Interventional Radiology, Kovai Medical Center and Hospital, Coimbatore, Tami Nadu, India, and colleagues aimed to investigate the safety profile and role of intra-arterial (IA) tirofiban as a rescue therapy in acute ischemic stroke (AIS) patients undergoing MT.

For this purpose, they conducted a retrospective study among AIS patients with LVO eligible for endovascular revascularization and in whom IA tirofiban is given as rescue therapy.

IA tirofiban at a dose of 0.4 μg/kg/min was administered through the microcatheter in the target vessel followed by intravenous (IV) infusion of 0.1 μg/kg/min if the target vessel shows reocclusion following initial recanalization, flow limiting or significant residual stenosis after thrombectomy, or requires balloon angioplasty or stenting. The study’s primary safety measure was the incidence of symptomatic haemorrhage.

There were 82 patients in the study; 36 were in the tirofiban group, and 46 were in the non-tirofiban group.

The study led to the following findings:

  • Immediate successful reperfusion was achieved in 86.1% of patients and 89% of patients in the tirofiban and non-tirofiban groups, respectively.
  • 19.4 and 25% of patients in the tirofiban group required adjunct techniques of angioplasty and stenting, respectively.
  • 2.7% of patients in the tirofiban group had a symptomatic haemorrhage, while 8.7% in the non-tirofiban group had symptomatic intracranial haemorrhage.
  • On multinomial logistic regression, a history of transient ischemic attack, watershed infarct pattern, and truncal occlusion predicted the usage of IA tirofiban during mechanical thrombectomy.

“The findings revealed that using IA tirofiban with or without other adjunct techniques as rescue therapy during MT in LVO improved recanalization rates without raising symptomatic haemorrhage risk,” the researchers concluded.

Reference:

The study titled, “Safety Profile of Intra-Arterial Tirofiban as a Rescue Therapy during Mechanical Thrombectomy in Acute Ischemic Stroke,” was published online in the Journal of Clinical Interventional Radiology. DOI: 10.1055/s-0043-1775981

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Cariprazine Shows High Tolerability and Completion Rates in Major Depressive Disorder Patients

Cariprazine, approved by the FDA as an adjunctive treatment for MDD, has demonstrated positive outcomes in various trials. The analysis focused on its safety profile, leveraging data from five randomized, double-blind, placebo-controlled trials involving patients with inadequate responses to monotherapy antidepressant treatment.

A recent pooled analysis of phase 3 trials has shed light on the safety and tolerability of cariprazine, an adjunctive treatment for major depressive disorder (MDD). This study was published in the International Clinical Psychopharmacology journal. Led by Michael E. Thase, MD, from the Perelman School of Medicine at the University of Pennsylvania, the study aimed to assess the outcomes of patients with MDD receiving cariprazine in conjunction with antidepressant therapy.

A total of 16,825 patients were included in the analysis. 62% of patients were at intermediate or high risk of frailty. In-hospital mortality and any complication rates were primary outcomes. Length of hospital stay and total charges were secondary outcomes. Frailty was assessed using the Hospital Frailty Risk Score, stratified into low, intermediate, and high risk.

  • Patients with high or intermediate frailty had higher in-hospital mortality rates (6.37 and 5.15 times, respectively) compared to those with low frailty.

  • Patients undergoing leadless pacemaker implantation had a 90% completion rate.

  • Only 4.3% discontinued treatment due to mild or moderate treatment-emergent adverse events.

  • PANDO patients showed significant associations with ocular surface, eyelid, upper airway, and systemic inflammatory-related diseases.

  • The Butantan–Dengue Vaccine demonstrated an overall 2-year vaccine efficacy of 79.6% against symptomatic, virologically confirmed dengue.

The pooled analysis underscores the high tolerability and completion rates in MDD patients treated with cariprazine. Despite mild to moderate adverse events, the study supports the safety of cariprazine as an adjunctive therapy for MDD.

Reference:

Thase ME, Yeung PP, Rekeda L, Liu M, Varughese S. Safety and tolerability of cariprazine for the adjunctive treatment of major depressive disorder: a pooled analysis of phase 2b/phase 3 clinical trials. Int Clin Psychopharmacol. Published online January 25, 2024. doi:10.1097/YIC.0000000000000528

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Indiscreet prescribing of antibiotics is key contributor to microbial resistance nationwide: MoS Health

New Delhi: The Union Health Ministry has initiated several initiatives to promote judicious use of antimicrobials, as indiscreet prescribing of antibiotics is one of the major causes of microbial resistance in the country, the Parliament was recently informed.

Concerns related to overprescription of antibiotics in the country were raised during a Rajya Sabha Session by Minister A D Singh, who inquired whether a survey of nearly 10 thousand hospitals by the National Centre for Diseases Control (NCDC), has found that more than half of the patients were given antibiotics to prevent rather than treat the infection.

In response to the question raised, Prof. Satya Pal Singh Baghel, the Minister of State in the Ministry of Health and Family Welfare confirmed that National Centre for Disease Control (NCDC) conducted Point Prevalence Survey (PPS) on antibiotic use at 20 tertiary care government hospitals (NAC-NET sites). This study was conducted amongst 9653 eligible patients admitted in these 20 hospitals. 71.9% of the patients received antibiotics. Of those who were prescribed antibiotics, 54.8% received antibiotics for prophylactic indications (Surgical Prophylaxis 37.3% and Medical prophylaxis 17.5%).

The Minister further said that indiscreet prescribing of antibiotics is one of the major causes of microbial resistance in the country. He further shed light on the efforts being made by Government to control the tendency of overprescription of antibiotics. He said that the Health Ministry has taken steps to promote judicious use of antimicrobials which includes launch of Red Line awareness campaign on Antimicrobials Resistance, urging people not to use medicines marked with a red vertical line, including antibiotics, without a doctor’s prescription.

Furthermore, the Indian Council of Medical Research (ICMR) has released treatment guidelines for antimicrobial use in common syndromes, which contain guidelines for the use of antibiotics for viral bronchitis and low-grade fever antibiotics are included in Schedule H and H1 of the Drugs Rules, 1945. These drugs have specific caution labeling requirements and are sold only under the prescription of a Registered Medical Practitioner.

“The supply of a drug specified in Schedule H1 are recorded in a separate register at the time of the supply and such records are maintained for three years and are open for inspection. Central Drugs Standard Control Organisation (CDSCO) has placed 24 hi-end antimicrobials under schedule H1 by issuing notification,” the Minister added.

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Inhaled antibiotics may reduce exacerbations and improve QoL in bronchiectasis patients

Inhaled antibiotics  may reduce exacerbations and improve QoL in bronchiectasis patients suggests a new study published in the Chest. 

Inhaled antibiotics are conditionally recommended by international bronchiectasis guidelines for the treatment of patients with bronchiectasis but results of individual studies are inconsistent. A previous meta-analysis demonstrated promising results regarding the efficacy and safety of inhaled antibiotics in bronchiectasis. Subsequent publications have further supplemented the existing body of evidence in this area. Systematic review and meta-analysis of randomised controlled trials of inhaled antibiotics in adult patients with bronchiectasis. We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, and ClinicalTrials.gov for eligible studies. Studies were included if they enrolled adults with bronchiectasis diagnosed by CT and trials had a treatment duration of at least 4 weeks. The primary endpoint was exacerbation frequency, with additional key efficacy endpoints including severe exacerbations, bacterial load, symptoms, quality of life and FEV1. Data were pooled through random-effects meta-analysis.Results: 20 studies involving 3468 patients were included. Inhaled antibiotics were associated with reduced number of subjects with exacerbations (risk ratio 0.85 95%CI 0.75-0.96), a slight reduction in exacerbation frequency (rate ratio 0.78 95%CI 0.68-0.91), a probable reduction in the frequency of severe exacerbations (rate ratio 0.48 95%CI 0.31-0.74) and a likely slight increase in time to first exacerbation (hazard ratio 0.80 95%CI 0.68-0.94). Inhaled antibiotics likely lead to a slight increase in the Quality of Life-Bronchiectasis Respiratory Symptom Score (2.51, 95%CI 0.44 to 4.31) and may reduce scores on the St. George’s Respiratory Questionnaire (-3.13, 95%CI -5.93 to -0.32). Bacterial load was consistently reduced but FEV1 was not changed with treatment. Evidence suggests little to no difference in adverse effects between groups (odds ratio 0.99 95%CI 0.75-1.30). Antibiotic resistant organisms were likely increased by treatment. Inhaled antibiotics result in a slight reduction in exacerbations, a probable reduction in severe exacerbations and a likely slight improvement in symptoms and quality of life in adults with bronchiectasis.

Reference:

Ricardo Cordeiro, Hayoung Choi, Charles S. Haworth, James D. Chalmers. The efficacy and safety of inhaled antibiotics for the treatment of bronchiectasis in adults: Updated systematic review and meta-analysis, CHEST, 2024,ISSN 0012-3692. https://doi.org/10.1016/j.chest.2024.01.045.

(https://www.sciencedirect.com/science/article/pii/S0012369224001399)

Keywords:

Inhaled antibiotics, exacerbations, improve QoL, bronchiectasis patients, bronchiectasis; therapeutics; antibiotics; inhalation; meta-analysis, CHEST, Ricardo Cordeiro, Hayoung Choi, Charles S. Haworth, James D. Chalmers

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