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Analysis finds little proof that testosterone treatment increases the risk of cardiovascular events

Analysis finds little proof that testosterone treatment increases the risk of cardiovascular events

Testosterone replacement therapy appears safe in the short-to-medium term to treat a condition caused by deficiency of the male sex hormone, according to the most comprehensive analysis of the treatment to date, published in The Lancet Healthy Longevity journal.

The findings suggest that men given testosterone to treat hypogonadism are at no greater risk of heart attack, stroke, and other cardiovascular events in the short-to-medium term than men who do not receive testosterone treatment.

Testosterone replacement therapy is the standard treatment for hypogonadism, which can cause sexual dysfunction, weakening of bones and muscles, and reduced quality of life. Risk factors for the condition include aging (as testosterone levels decline with age), obesity (BMI of 30 kg/m2 or above), and diabetes.

Despite being widely used, the cardiovascular safety of testosterone treatment has until now remained unclear due to inconsistent findings. This is because most previous clinical studies have relied on aggregate data, rather than individual participant data and have not published details of individual adverse events.

Prescribing of testosterone for hypogonadism is increasing globally, but conflicting messages about its safety may have led to many patients not receiving the treatment. Ongoing studies should help to determine the longer-term safety of testosterone but, in the meantime, our results provide much-needed reassurance about its short-to-medium term safety. Our findings could have important implications for the treatment of men with hypogonadism worldwide.”


Jemma Hudson, Study Lead Author, University of Aberdeen

The authors conducted a systematic review identifying 35 eligible clinical trials published since 1992, of which 17 provided individual participant data. A blinded analysis by two independent clinicians enabled the classification of every cardiovascular event, allowing for a more robust analysis of the cardiovascular safety of testosterone treatment.

A meta-analysis using individual participant data from 17 studies and a further meta-analysis integrating these data with the aggregate data provided by the 18 trials that did not provide individual participant data were performed.

Among the 17 trials with individual patient data, 1,750 participants received testosterone and 1,681 were given a placebo. The average length of testosterone treatment was 9.5 months. The average age of participants was 65 years, and most were white and did not smoke. Participants’ average BMI was 30 kg/m2, which is considered obese.

A meta-analysis showed there were 120/1,601 (7.5%) cardiovascular events in the testosterone group and 110/1,519 (7.2%) in the placebo group across 13 trials that provided this information. Patient age, smoking or diabetes status did not affect cardiovascular risk. Similarly, there was no significant difference in mortality rate between the testosterone group (6/1,621 deaths, 0.4%) and the placebo group (12/1,537 deaths, 0.8%) across the 14 trials that provided individual patient data on mortality, but only limited data were available.

The researchers also found that testosterone significantly reduced serum total cholesterol, high-density lipoprotein (HDL), and triglycerides compared with placebo. However, there were no significant differences in serum low-density lipoprotein (LDL), blood pressure, glycaemic parameters, diabetes incidence, and prostate adverse outcomes between the testosterone and placebo groups.

The meta-analysis that integrated individual participant data with aggregate data showed similar results.

The authors acknowledge some limitations to their study. There was little available data evaluating the cardiovascular safety of testosterone treatment beyond 12 months, and the very small number of deaths recorded during testosterone trials hampered the authors’ ability to analyze why they occurred.

However, the longer-term safety of testosterone treatment is currently being investigated in another clinical trial. While the meta-analysis of aggregate data showed similar results to the one involving individual patient data only, it cannot be ruled out with certainty that a high number of unreported cardiovascular events in the trials that did not provide individual participant data could alter the current conclusions.

Source:

Journal reference:

Hudson, J., et al. (2022) Adverse cardiovascular events and mortality in men during testosterone treatment: an individual patient and aggregate data meta-analysis. The Lancet Healthy Longevity. doi.org/10.1016/S2666-7568(22)00096-4

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Proof of vaccination no longer required to access B.C. restaurants, theatres, events

Proof of vaccination no longer required to access B.C. restaurants, theatres, events


Proof of immunization against COVID-19 is no longer required to access restaurants, theatres and indoor events in B.C. as the province lifts its vaccine card rules.


As of 12:01 a.m. Friday, the B.C. Vaccine Card, which has been in use since September, is no longer necessary unless an individual business chooses to keep using it. Proof of immunization is still required for federally regulated travel, like on airplanes, however.


Other provinces ended their vaccine card programs much earlier than B.C. Ontario lifted its requirement in early March while Alberta lifted its passport in February. Quebec’s vaccine passport, which was more strict than B.C.’s and was used to access box stores and liquor shops, was phased out in mid-March.


But earlier this week, B.C. health officials confirmed the end of the vaccine card program locally.


Dr. Bonnie Henry also gave a modelling presentation that suggested there has been a slight increase in COVID-19 cases, as tracked by wastewater testing in the Lower Mainland.


With increases in activity, more travel and a slightly more transmissible variant, Henry said Tuesday officials “know we are likely to see a slight increase over time in the next month to two months and then a gradual decreasing again.”


Even so, Henry said some measure are “no longer necessary all the time,” including the vaccine card, which she said “was very effective at supporting people to get vaccinated.”


Infectious disease expert Dr. Brian Conway agrees.


“You really do need three shots to protect against the Omicron variants. So the meaningfulness of the vaccine passport has decreased. It’s served its purpose now. Let’s move on and deal with endemic COVID,” Conway said.


But Conway stressed the pandemic is not over and said now is the time for British Columbians to take individual responsibility.


“We live in a COVID world,” he said. 


“Get your shots, if you haven’t gotten all of the shots to which you are entitled. Stay home if you’re sick, keep washing your hands, have a mask on your person to use strategically. Mask mandates have transformed into mask etiquette. Let’s learn that etiquette and these should be our priorities.”


Businesses have been preparing for the end of vaccine card requirements, with some choosing to put other safety measures back in place.


“There’ll be enhanced cleaning, sanitizers. A lot of restaurants probably won’t go back to menus. It will be QR codes, much more emphasis on patios,” said Ian Tostenson with the B.C. Restaurant and Food Services Association.


With more than 90 per cent of eligible British Columbians vaccinated against COVID-19, Tostenson said each person would have to assess their own risk, adding it was Dr. Bonnie Henry and not the association that pushed for the change.


“The chances of you being in a restaurant with an unvaccinated person are pretty small in British Columbia,” he said.


The vaccine passport program was designed to safely ease restrictions on gatherings events and encourage people to get vaccinated.


“It gave the public a sense of competence where we had it while we caught up to those high vaccination rates,” Tostenson said.


He said he hasn’t heard of any restaurants that will continue to ask for it, but it’s still a possibility.


“There might be a little community somewhere where they know their customers, and they would like to have that,” he said.


“But I think by and large, the public understands that with or without the vaccination card, it’s not going to change the safety in a restaurant.”


Proof of vaccination is still required to visit those in long-term care and assisted living facilities in B.C.  


With files from CTV News Vancouver’s Bhinder Sajan 

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COVID-19: Province lifts proof of vaccination requirement for events and restaurants; booster shots starting for those over 70

COVID-19: Province lifts proof of vaccination requirement for events and restaurants; booster shots starting for those over 70
Health Minister Adrian Dix. Government of B.C. photo

VICTORIA – As people in B.C. continue to get vaccinated, the province continues with previously announced plans to further lift COVID-19 restrictions, while protecting those most at risk with the launch of the spring booster vaccine program.

“Thanks to the many British Columbians who have stayed up to date on their COVID-19 vaccines, we are seeing high levels of immunity and protection in our communities,” said Adrian Dix, Minister of Health, in a news release. “Boosters are an important part of continuing to protect those who are most at risk as restrictions continue to be lifted, and I encourage everyone to make time in their day to get a booster dose.”

To protect seniors, the province has begun rolling out a spring booster vaccine program for seniors in long-term care and assisted living facilities. Community-dwelling seniors over the age of 70 and Indigenous people over the age of 55 will also begin receiving their invitations for their spring booster dose – a new booster dose for eligible seniors who received their third shot six months ago or more. People can use their invitation to schedule their appointment in health authority clinics or at participating pharmacies. A call centre will also continue to be available for those who are not able to book online.

People who are clinically extremely vulnerable (CEV) continue to be prioritized for their COVID-19 vaccinations. Those who have received their full three-dose primary series are eligible for their first booster dose about six months after their previous dose.

The spring booster vaccine program will provide a new boost of immunity for eligible seniors, as public health has indicated immunity in older people can wane in that time. The new booster will help to maintain and lengthen protection against severe outcomes of COVID-19, especially hospitalization and death.

The first booster shot provides protection in all ages and anyone who has not yet received their first booster dose are strongly encouraged to do so as soon as possible. Booster doses will be either the Moderna or Pfizer (mRNA) vaccine. Both vaccines are effective, interchangeable and you may receive either.

“Today, as we continue our progress managing COVID-19, we are easing restrictions and, at the same time, taking important steps to boost our immunity and keep people safe,” said Dr. Bonnie Henry, B.C.’s provincial health officer. “As we all do our part – to get vaccinated, use our layers of protection and stay home when we are ill, we will continue to adjust our response as the pandemic evolves.”

Starting on Friday, April 8, 2022, at 12:01 a.m., the following changes will take place:

  • Showing the BC Vaccine Card proof of vaccination to access events, services and businesses will no longer be required. Individual businesses and organizations can choose to continue requiring the BC Vaccine Card on their premises.
  • The remainder of the Workplace Safety Order will expire, which means that businesses are transitioning back to communicable disease plans to reduce risk of all communicable disease.
  • The requirement for students residing in residence to be fully vaccinated under the Post-secondary Institution Housing COVID-19 Preventative Measures Order will be repealed.

The easing of restrictions is based on ongoing and careful review of data by the provincial health officer and the BC Centre for Disease Control (BCCDC). Everyone will adjust to the changes in restrictions at their own pace, and it is important to be respectful of other people’s comfort levels.

Vaccinations remain the primary layer of protection that have limited severe health outcomes from COVID-19. Of all eligible adults in B.C., 93.8 per cent (4,057,726 people) have received their first dose, 91.5% (3,957,573 people) received their second dose and 59.5 per cent (2,571,726 people) have received a third dose.

B.C. has also increased the supply of rapid tests, helping people monitor and manage mild COVID-19 symptoms at home. Currently, rapid antigen tests, in kits of five tests, are available to people aged 18 years and older through community pharmacies. As of Monday, April 11, 2022, citizens can pick up rapid tests without needing to show their B.C. personal health number.

As of Monday, April 4, 2022, nine million tests have been shipped to pharmacy distributors with more than 4.3 million rapid tests dispensed through more than 1,300 participating pharmacies. Across all priority populations and pharmacies, more than 40 million tests have been distributed.

The province, provincial health officer and BC Centre for Disease Control will continue to monitor COVID-19 cases, hospitalization, critical care and death rates very closely in the weeks and months ahead.

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UConn changes fan policy for athletics events: Masks optional, proof of vaccination removed

UConn changes fan policy for athletics events: Masks optional, proof of vaccination removed

Fans attending UConn home athletic events, including games at the XL Center in Hartford and Gampel Pavilion on campus, no longer must show proof of vaccination or negative COVID-19 test results for entry, according to a shift in policy announced Thursday by the university.

Also, fans at home athletic events at all facilities are no longer required to wear masks.

The changes go into effect Friday.

UConn began requiring fans attending home athletic events to show proof of vaccination or a negative test, performed within 72 hours, on Jan. 15.

As part of the reasoning for changes announced Thursday, the university cited low positive rates and high vaccination rates on campus, low state positivity rates, and seven of eight counties in Connecticut being classified as “low risk” by the U.S. Center for Disease Control and Prevention. Also, the state no longer requires masks to enter state buildings.

UConn’s policy on mask wearing has changed from required to recommended in most campus settings. Masking will remain required in all instructional settings (classrooms, labs, studios, rehearsal rooms, clinics) through at least April 1, at which point the policy will be reevaluated.

“While this change means masks will not be required in most settings, the university still recommends wearing them on our campuses,” UConn’s announcement read. “We also strongly encourage each member of the UConn community to continue to be flexible and courteous when it comes to masking. Please always carry a mask with you in the event you are asked to wear it in certain close settings, such as individual or small group meetings. Members of the community will be at varying stages of comfort with mask wearing and we want to be respectful of others.”

The UConn men’s basketball team plays its final regular Saturday at Gampel Pavilion against DePaul.