Lauren Arcuri

Paxlovid does not significantly alleviate symptoms of COVID-19 compared with placebo among nonhospitalized adults, a new study published April 3 in The New England Journal of Medicine found. 

The results suggest that the drug, a combination of nirmatrelvir and ritonavir, may not be particularly helpful for patients who are not at high risk for severe COVID-19. However, although the rate of hospitalization and death from any cause was low overall, the group that received Paxlovid had a reduced rate compared with people in the placebo group, according to the researchers. 

“Clearly, the benefit observed among unvaccinated high-risk persons does not extend to those at lower risk for severe COVID-19,” Rajesh T. Gandhi, MD, and Martin Hirsch, MD, of Massachusetts General Hospital in Boston, wrote in an editorial accompanying the journal article. “This result supports guidelines that recommend nirmatrelvir–ritonavir only for persons who are at high risk for disease progression.”

The time from onset to relief of COVID-19 symptoms — including cough, shortness of breath, body aches, and chills — did not differ significantly between the two study groups, the researchers reported. The median time to sustained alleviation of symptoms was 12 days for the Paxlovid group compared with 13 days in the placebo group (P = .60).

However, the phase 2/3 trial found a 57.6% relative reduction in the risk for hospitalizations or death among people who took Paxlovid and were vaccinated but were at high risk for poor outcomes, according to Jennifer Hammond, PhD, head of antiviral development for Pfizer, which makes the drug, and the corresponding author on the study.

Paxlovid has “an increasing body of evidence supporting the strong clinical value of the treatment in preventing hospitalization and death among eligible patients across age groups, vaccination status, and predominant variants,” Dr. Hammond said. 

She and her colleagues analyzed data from 1250 adults with symptomatic COVID-19. Participants were fully vaccinated and had a high risk for progression to severe disease or were never vaccinated or had not been in the previous year and had no risk factors for progression to severe disease.

More than half of participants were women, 78.5% were White and 41.4% identified as Hispanic or Latinx. Almost three quarters underwent randomization within 3 days of the start of symptoms, and a little over half had previously received a COVID-19 vaccination. Almost half had one risk factor for severe illness, the most common of these being hypertension (12.3%). 

In a subgroup analysis of high-risk participants, hospitalization or death occurred in 0.9% of patients in the Paxlovid group and 2.2% in the placebo group (95% CI, -3.3 to 0.7). 

The study’s limitations include that the statistical analysis of COVID-19–related hospitalizations or death from any cause was only descriptive, “because the results for the primary efficacy end point were not significant,” the authors wrote. 

Participants who were vaccinated and at high risk were also enrolled regardless of when they had last had a vaccine dose. Furthermore, Paxlovid has a telltale taste, which may have affected the blinding. Finally, the trial was started when the B.1.617.2 (Delta) variant was predominant.

Dr. Gandhi and Dr. Hirsch pointed out that only 5% of participants in the trial were older than 65 years and that other than risk factors such as obesity and smoking, just 2% of people had heart or lung disease. 

“As with many medical interventions, there is likely to be a gradient of benefit for nirmatrelvir–ritonavir, with the patients at highest risk for progression most likely to derive the greatest benefit,” Dr. Gandhi and Dr. Hirsch wrote in the editorial. “Thus, it appears reasonable to recommend nirmatrelvir–ritonavir primarily for the treatment of COVID-19 in older patients (particularly those ≥ 65 years of age), those who are immunocompromised, and those who have conditions that substantially increase the risk of severe COVID-19, regardless of previous vaccination or infection status.”

The study was supported by Pfizer. 

A version of this article appeared on Medscape.com .

Paxlovid does not significantly alleviate symptoms of COVID-19 compared with placebo among nonhospitalized adults, a new study published April 3 in The New England Journal of Medicine found. 

The results suggest that the drug, a combination of nirmatrelvir and ritonavir, may not be particularly helpful for patients who are not at high risk for severe COVID-19. However, although the rate of hospitalization and death from any cause was low overall, the group that received Paxlovid had a reduced rate compared with people in the placebo group, according to the researchers. 

“Clearly, the benefit observed among unvaccinated high-risk persons does not extend to those at lower risk for severe COVID-19,” Rajesh T. Gandhi, MD, and Martin Hirsch, MD, of Massachusetts General Hospital in Boston, wrote in an editorial accompanying the journal article. “This result supports guidelines that recommend nirmatrelvir–ritonavir only for persons who are at high risk for disease progression.”

The time from onset to relief of COVID-19 symptoms — including cough, shortness of breath, body aches, and chills — did not differ significantly between the two study groups, the researchers reported. The median time to sustained alleviation of symptoms was 12 days for the Paxlovid group compared with 13 days in the placebo group (P = .60).

However, the phase 2/3 trial found a 57.6% relative reduction in the risk for hospitalizations or death among people who took Paxlovid and were vaccinated but were at high risk for poor outcomes, according to Jennifer Hammond, PhD, head of antiviral development for Pfizer, which makes the drug, and the corresponding author on the study.

Paxlovid has “an increasing body of evidence supporting the strong clinical value of the treatment in preventing hospitalization and death among eligible patients across age groups, vaccination status, and predominant variants,” Dr. Hammond said. 

She and her colleagues analyzed data from 1250 adults with symptomatic COVID-19. Participants were fully vaccinated and had a high risk for progression to severe disease or were never vaccinated or had not been in the previous year and had no risk factors for progression to severe disease.

More than half of participants were women, 78.5% were White and 41.4% identified as Hispanic or Latinx. Almost three quarters underwent randomization within 3 days of the start of symptoms, and a little over half had previously received a COVID-19 vaccination. Almost half had one risk factor for severe illness, the most common of these being hypertension (12.3%). 

In a subgroup analysis of high-risk participants, hospitalization or death occurred in 0.9% of patients in the Paxlovid group and 2.2% in the placebo group (95% CI, -3.3 to 0.7). 

The study’s limitations include that the statistical analysis of COVID-19–related hospitalizations or death from any cause was only descriptive, “because the results for the primary efficacy end point were not significant,” the authors wrote. 

Participants who were vaccinated and at high risk were also enrolled regardless of when they had last had a vaccine dose. Furthermore, Paxlovid has a telltale taste, which may have affected the blinding. Finally, the trial was started when the B.1.617.2 (Delta) variant was predominant.

Dr. Gandhi and Dr. Hirsch pointed out that only 5% of participants in the trial were older than 65 years and that other than risk factors such as obesity and smoking, just 2% of people had heart or lung disease. 

“As with many medical interventions, there is likely to be a gradient of benefit for nirmatrelvir–ritonavir, with the patients at highest risk for progression most likely to derive the greatest benefit,” Dr. Gandhi and Dr. Hirsch wrote in the editorial. “Thus, it appears reasonable to recommend nirmatrelvir–ritonavir primarily for the treatment of COVID-19 in older patients (particularly those ≥ 65 years of age), those who are immunocompromised, and those who have conditions that substantially increase the risk of severe COVID-19, regardless of previous vaccination or infection status.”

The study was supported by Pfizer. 

A version of this article appeared on Medscape.com .

Paxlovid does not significantly alleviate symptoms of COVID-19 compared with placebo among nonhospitalized adults, a new study published April 3 in The New England Journal of Medicine found. 

The results suggest that the drug, a combination of nirmatrelvir and ritonavir, may not be particularly helpful for patients who are not at high risk for severe COVID-19. However, although the rate of hospitalization and death from any cause was low overall, the group that received Paxlovid had a reduced rate compared with people in the placebo group, according to the researchers. 

“Clearly, the benefit observed among unvaccinated high-risk persons does not extend to those at lower risk for severe COVID-19,” Rajesh T. Gandhi, MD, and Martin Hirsch, MD, of Massachusetts General Hospital in Boston, wrote in an editorial accompanying the journal article. “This result supports guidelines that recommend nirmatrelvir–ritonavir only for persons who are at high risk for disease progression.”

The time from onset to relief of COVID-19 symptoms — including cough, shortness of breath, body aches, and chills — did not differ significantly between the two study groups, the researchers reported. The median time to sustained alleviation of symptoms was 12 days for the Paxlovid group compared with 13 days in the placebo group (P = .60).

However, the phase 2/3 trial found a 57.6% relative reduction in the risk for hospitalizations or death among people who took Paxlovid and were vaccinated but were at high risk for poor outcomes, according to Jennifer Hammond, PhD, head of antiviral development for Pfizer, which makes the drug, and the corresponding author on the study.

Paxlovid has “an increasing body of evidence supporting the strong clinical value of the treatment in preventing hospitalization and death among eligible patients across age groups, vaccination status, and predominant variants,” Dr. Hammond said. 

She and her colleagues analyzed data from 1250 adults with symptomatic COVID-19. Participants were fully vaccinated and had a high risk for progression to severe disease or were never vaccinated or had not been in the previous year and had no risk factors for progression to severe disease.

More than half of participants were women, 78.5% were White and 41.4% identified as Hispanic or Latinx. Almost three quarters underwent randomization within 3 days of the start of symptoms, and a little over half had previously received a COVID-19 vaccination. Almost half had one risk factor for severe illness, the most common of these being hypertension (12.3%). 

In a subgroup analysis of high-risk participants, hospitalization or death occurred in 0.9% of patients in the Paxlovid group and 2.2% in the placebo group (95% CI, -3.3 to 0.7). 

The study’s limitations include that the statistical analysis of COVID-19–related hospitalizations or death from any cause was only descriptive, “because the results for the primary efficacy end point were not significant,” the authors wrote. 

Participants who were vaccinated and at high risk were also enrolled regardless of when they had last had a vaccine dose. Furthermore, Paxlovid has a telltale taste, which may have affected the blinding. Finally, the trial was started when the B.1.617.2 (Delta) variant was predominant.

Dr. Gandhi and Dr. Hirsch pointed out that only 5% of participants in the trial were older than 65 years and that other than risk factors such as obesity and smoking, just 2% of people had heart or lung disease. 

“As with many medical interventions, there is likely to be a gradient of benefit for nirmatrelvir–ritonavir, with the patients at highest risk for progression most likely to derive the greatest benefit,” Dr. Gandhi and Dr. Hirsch wrote in the editorial. “Thus, it appears reasonable to recommend nirmatrelvir–ritonavir primarily for the treatment of COVID-19 in older patients (particularly those ≥ 65 years of age), those who are immunocompromised, and those who have conditions that substantially increase the risk of severe COVID-19, regardless of previous vaccination or infection status.”

The study was supported by Pfizer. 

A version of this article appeared on Medscape.com .

TOPLINE:

A clinical trial of preterm infants with inguinal hernia found that performing repair after discharge from the neonatal intensive care unit (NICU) resulted in fewer adverse events than procedures prior to discharge.

METHODOLOGY:

• The study compared the safety of repair before discharge from the NICU with repair after discharge and post-55 weeks gestational plus chronological age (postmenstrual age).
• The study randomized 338 infants from 39 US hospitals to early or late repair; of the 320 infants who had the surgery, 86% were male, 30% were Black, and 59% were White.
• The primary outcome was the occurrence of at least one serious adverse event over the 10-month observation period, including apnea requiring respiratory intervention, intubation for more than 2 days, bradycardia requiring pharmacological intervention, or death.
• Secondary outcomes included a total number of days in the hospital, including the initial NICU stay after randomization, postoperative hospitalization, and any inpatient days due to hospital readmission over the course of the following 10-month period.

TAKEAWAY:

• Infants who underwent late repair had a lower probability of having at least one serious adverse event: 28% had at least one adverse event in the early group vs 18% in the late group.
• Infants in the late repair group had shorter stays in the NICU after randomization, as well as fewer hospital days following surgery.
• Late repair provided the greatest benefit to infants with a gestational age younger than 28 weeks and those who had bronchopulmonary dysplasia.
• Hernias resolved spontaneously in 4% of infants in the early repair group and 11% in the late group, which the authors said supports delaying hernia repair.

IN PRACTICE:

“The decision to treat the inguinal hernia with an early or late repair strategy likely does not influence the overall duration of the neonatal intensive care unit stay but may hasten the discharge by several days if later repair is chosen, which is likely important to parents and neonatologists.”

SOURCE:

The study was published online in JAMA. It was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Martin L. Blakely, MD, MS, from the Department of Surgery at the University of Texas Health Science Center, Houston, Texas, is the corresponding author.

LIMITATIONS:

This study had a modest sample size, an issue compounded by some subjects withdrawing from the trial. The randomization rate was lower than expected. The trial was also discontinued early due to meeting a prespecified stopping rule for effectiveness.

DISCLOSURES:

Study authors report grant support from the US Department of Defense, personal fees, author royalties, and institutional contracts with various companies including Medicem, Fresenius Kabi, Baxter, and Mead Johnson.

A version of this article appeared on Medscape.com.

TOPLINE:

A clinical trial of preterm infants with inguinal hernia found that performing repair after discharge from the neonatal intensive care unit (NICU) resulted in fewer adverse events than procedures prior to discharge.

METHODOLOGY:

• The study compared the safety of repair before discharge from the NICU with repair after discharge and post-55 weeks gestational plus chronological age (postmenstrual age).
• The study randomized 338 infants from 39 US hospitals to early or late repair; of the 320 infants who had the surgery, 86% were male, 30% were Black, and 59% were White.
• The primary outcome was the occurrence of at least one serious adverse event over the 10-month observation period, including apnea requiring respiratory intervention, intubation for more than 2 days, bradycardia requiring pharmacological intervention, or death.
• Secondary outcomes included a total number of days in the hospital, including the initial NICU stay after randomization, postoperative hospitalization, and any inpatient days due to hospital readmission over the course of the following 10-month period.

TAKEAWAY:

• Infants who underwent late repair had a lower probability of having at least one serious adverse event: 28% had at least one adverse event in the early group vs 18% in the late group.
• Infants in the late repair group had shorter stays in the NICU after randomization, as well as fewer hospital days following surgery.
• Late repair provided the greatest benefit to infants with a gestational age younger than 28 weeks and those who had bronchopulmonary dysplasia.
• Hernias resolved spontaneously in 4% of infants in the early repair group and 11% in the late group, which the authors said supports delaying hernia repair.

IN PRACTICE:

“The decision to treat the inguinal hernia with an early or late repair strategy likely does not influence the overall duration of the neonatal intensive care unit stay but may hasten the discharge by several days if later repair is chosen, which is likely important to parents and neonatologists.”

SOURCE:

The study was published online in JAMA. It was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Martin L. Blakely, MD, MS, from the Department of Surgery at the University of Texas Health Science Center, Houston, Texas, is the corresponding author.

LIMITATIONS:

This study had a modest sample size, an issue compounded by some subjects withdrawing from the trial. The randomization rate was lower than expected. The trial was also discontinued early due to meeting a prespecified stopping rule for effectiveness.

DISCLOSURES:

Study authors report grant support from the US Department of Defense, personal fees, author royalties, and institutional contracts with various companies including Medicem, Fresenius Kabi, Baxter, and Mead Johnson.

A version of this article appeared on Medscape.com.

TOPLINE:

A clinical trial of preterm infants with inguinal hernia found that performing repair after discharge from the neonatal intensive care unit (NICU) resulted in fewer adverse events than procedures prior to discharge.

METHODOLOGY:

• The study compared the safety of repair before discharge from the NICU with repair after discharge and post-55 weeks gestational plus chronological age (postmenstrual age).
• The study randomized 338 infants from 39 US hospitals to early or late repair; of the 320 infants who had the surgery, 86% were male, 30% were Black, and 59% were White.
• The primary outcome was the occurrence of at least one serious adverse event over the 10-month observation period, including apnea requiring respiratory intervention, intubation for more than 2 days, bradycardia requiring pharmacological intervention, or death.
• Secondary outcomes included a total number of days in the hospital, including the initial NICU stay after randomization, postoperative hospitalization, and any inpatient days due to hospital readmission over the course of the following 10-month period.

TAKEAWAY:

• Infants who underwent late repair had a lower probability of having at least one serious adverse event: 28% had at least one adverse event in the early group vs 18% in the late group.
• Infants in the late repair group had shorter stays in the NICU after randomization, as well as fewer hospital days following surgery.
• Late repair provided the greatest benefit to infants with a gestational age younger than 28 weeks and those who had bronchopulmonary dysplasia.
• Hernias resolved spontaneously in 4% of infants in the early repair group and 11% in the late group, which the authors said supports delaying hernia repair.

IN PRACTICE:

“The decision to treat the inguinal hernia with an early or late repair strategy likely does not influence the overall duration of the neonatal intensive care unit stay but may hasten the discharge by several days if later repair is chosen, which is likely important to parents and neonatologists.”

SOURCE:

The study was published online in JAMA. It was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Martin L. Blakely, MD, MS, from the Department of Surgery at the University of Texas Health Science Center, Houston, Texas, is the corresponding author.

LIMITATIONS:

This study had a modest sample size, an issue compounded by some subjects withdrawing from the trial. The randomization rate was lower than expected. The trial was also discontinued early due to meeting a prespecified stopping rule for effectiveness.

DISCLOSURES:

Study authors report grant support from the US Department of Defense, personal fees, author royalties, and institutional contracts with various companies including Medicem, Fresenius Kabi, Baxter, and Mead Johnson.

A version of this article appeared on Medscape.com.

TOPLINE:

A new study published in JAMA Network Open showed that an intervention including cognitive behavioral therapy improved the quality of life for women with overactive bladder (OAB).

METHODOLOGY:

• A total of 79 women with moderate to severe OAB were randomized to the control group or the intervention, which was composed of four 30-minute sessions using strategies including cognitive behavioral therapy (CBT).
• The first and second sessions provided education on OAB and CBT, lifestyle modifications such as limiting coffee intake, pelvic floor muscle training, and introduced exposure training.
• The third and fourth sessions continued exposure and pelvic floor muscle training and education on relapse prevention.
• Researchers assessed outcomes using the health-related quality of life (HRQOL), in which participants answered questions regarding their degree of distress, emotions, and physical and social limitations related to OAB symptoms.

TAKEAWAY:

• Participants who received the intervention on average improved in their HRQOL score by 12.6 points higher than those in the control group (usual care) from baseline to week 13 (between-group difference estimate, 12.6 [95% CI, 6.6-18.6] points; P < .001).
• The average age of participants was 63.5 years, and more than 87% of women in each group had moderate OAB.
• Patient-reported improvement and satisfaction scores were also more improved in the intervention group than in the control group; most participants in both groups had no change in the pharmacotherapy during the trial.

IN PRACTICE:

Urologists and other primary care clinicians who treat women with OAB may consider a multicomponent intervention that includes cognitive components and exposure-based bladder training or could refer to a cognitive behavioral therapist or pelvic floor physical therapist experienced in these techniques.

SOURCE:

Satoshi Funada, MD, PhD, and Takashi Kobayashi, MD, PhD, both with the Department of Urology at Kyoto University Graduate School of Medicine in Kyoto, Japan, are the corresponding authors. The study was published online in JAMA Network Open.

LIMITATIONS:

The trial was open label, and the use of a waiting list control group is known to produce greater differences between the two groups. The trial included patients both taking and not taking medication for OAB. The sample size was also relatively small, and the intervention was performed by a single clinician, possibly limiting the generalizability of results.

DISCLOSURES:

The study was funded by the Japan Society for the Promotion of Science (JSPS). Various study authors reported receiving grants from the Pfizer Health Research Foundation, AstraZeneca, and JSPS. Other study authors reported receiving personal fees from Eisai, Sawai Pharmaceutical, Statcom, and others. One author reported pending patents for intellectual properties for the Kokoro app licensed to Mitsubishi Tanabe Pharma.

A version of this article appeared on Medscape.com.

TOPLINE:

A new study published in JAMA Network Open showed that an intervention including cognitive behavioral therapy improved the quality of life for women with overactive bladder (OAB).

METHODOLOGY:

• A total of 79 women with moderate to severe OAB were randomized to the control group or the intervention, which was composed of four 30-minute sessions using strategies including cognitive behavioral therapy (CBT).
• The first and second sessions provided education on OAB and CBT, lifestyle modifications such as limiting coffee intake, pelvic floor muscle training, and introduced exposure training.
• The third and fourth sessions continued exposure and pelvic floor muscle training and education on relapse prevention.
• Researchers assessed outcomes using the health-related quality of life (HRQOL), in which participants answered questions regarding their degree of distress, emotions, and physical and social limitations related to OAB symptoms.

TAKEAWAY:

• Participants who received the intervention on average improved in their HRQOL score by 12.6 points higher than those in the control group (usual care) from baseline to week 13 (between-group difference estimate, 12.6 [95% CI, 6.6-18.6] points; P < .001).
• The average age of participants was 63.5 years, and more than 87% of women in each group had moderate OAB.
• Patient-reported improvement and satisfaction scores were also more improved in the intervention group than in the control group; most participants in both groups had no change in the pharmacotherapy during the trial.

IN PRACTICE:

Urologists and other primary care clinicians who treat women with OAB may consider a multicomponent intervention that includes cognitive components and exposure-based bladder training or could refer to a cognitive behavioral therapist or pelvic floor physical therapist experienced in these techniques.

SOURCE:

Satoshi Funada, MD, PhD, and Takashi Kobayashi, MD, PhD, both with the Department of Urology at Kyoto University Graduate School of Medicine in Kyoto, Japan, are the corresponding authors. The study was published online in JAMA Network Open.

LIMITATIONS:

The trial was open label, and the use of a waiting list control group is known to produce greater differences between the two groups. The trial included patients both taking and not taking medication for OAB. The sample size was also relatively small, and the intervention was performed by a single clinician, possibly limiting the generalizability of results.

DISCLOSURES:

The study was funded by the Japan Society for the Promotion of Science (JSPS). Various study authors reported receiving grants from the Pfizer Health Research Foundation, AstraZeneca, and JSPS. Other study authors reported receiving personal fees from Eisai, Sawai Pharmaceutical, Statcom, and others. One author reported pending patents for intellectual properties for the Kokoro app licensed to Mitsubishi Tanabe Pharma.

A version of this article appeared on Medscape.com.

TOPLINE:

A new study published in JAMA Network Open showed that an intervention including cognitive behavioral therapy improved the quality of life for women with overactive bladder (OAB).

METHODOLOGY:

• A total of 79 women with moderate to severe OAB were randomized to the control group or the intervention, which was composed of four 30-minute sessions using strategies including cognitive behavioral therapy (CBT).
• The first and second sessions provided education on OAB and CBT, lifestyle modifications such as limiting coffee intake, pelvic floor muscle training, and introduced exposure training.
• The third and fourth sessions continued exposure and pelvic floor muscle training and education on relapse prevention.
• Researchers assessed outcomes using the health-related quality of life (HRQOL), in which participants answered questions regarding their degree of distress, emotions, and physical and social limitations related to OAB symptoms.

TAKEAWAY:

• Participants who received the intervention on average improved in their HRQOL score by 12.6 points higher than those in the control group (usual care) from baseline to week 13 (between-group difference estimate, 12.6 [95% CI, 6.6-18.6] points; P < .001).
• The average age of participants was 63.5 years, and more than 87% of women in each group had moderate OAB.
• Patient-reported improvement and satisfaction scores were also more improved in the intervention group than in the control group; most participants in both groups had no change in the pharmacotherapy during the trial.

IN PRACTICE:

Urologists and other primary care clinicians who treat women with OAB may consider a multicomponent intervention that includes cognitive components and exposure-based bladder training or could refer to a cognitive behavioral therapist or pelvic floor physical therapist experienced in these techniques.

SOURCE:

Satoshi Funada, MD, PhD, and Takashi Kobayashi, MD, PhD, both with the Department of Urology at Kyoto University Graduate School of Medicine in Kyoto, Japan, are the corresponding authors. The study was published online in JAMA Network Open.

LIMITATIONS:

The trial was open label, and the use of a waiting list control group is known to produce greater differences between the two groups. The trial included patients both taking and not taking medication for OAB. The sample size was also relatively small, and the intervention was performed by a single clinician, possibly limiting the generalizability of results.

DISCLOSURES:

The study was funded by the Japan Society for the Promotion of Science (JSPS). Various study authors reported receiving grants from the Pfizer Health Research Foundation, AstraZeneca, and JSPS. Other study authors reported receiving personal fees from Eisai, Sawai Pharmaceutical, Statcom, and others. One author reported pending patents for intellectual properties for the Kokoro app licensed to Mitsubishi Tanabe Pharma.

A version of this article appeared on Medscape.com.