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Although dapagliflozin may reduce death or worsening heart failure (HF) in patients with aortic stenosis (AS) undergoing TAVI, it showed limited improvement in patients’ health status post TAVI, according to a prespecified subanalysis of the DapaTAVI trial published Oct. 6 in JACC. Dapagliflozin may be most relevant in patients with a residual symptomatic burden.

A total of 964 patients from the DapaTAVI study group enrolled between January 2021 and December 2023 were included in this independent, investigator-initiated trial. Clara Bonanad-Lozano, MD, PhD, et al., used the Kansas City Cardiomyopathy Questionnaire (KCCQ) to assess the effect of dapagliflozin on health status post TAVI. Of note, the primary endpoint was the change in KCCQ score from baseline to one year. The mean baseline KCCQ score was 39.9 in the dapagliflozin group and 39.1 in the control arm (p=0.404).

Using an ordinal logistic regression model to analyze the primary endpoint, the authors assessed the change in KCCQ score from baseline to three and 12 months, as well as the effect of dapagliflozin on the composite of death or worsening HF by baseline KCCQ score.

Researchers found no significant differences in change of KCCQ score at three months (odds ratio [OR ], 0.96; p=0.745) or 12 months (OR, 1.03; p=0.819) between the two groups. Additionally, at 12-month follow-up, similar proportions of patients in the dapagliflozin and control groups showed clinically meaningful improvements, with 43.4% vs. 45.4%, respectively, improving by >50 points, highlighting that the clinical benefits of dapagliflozin after TAVI appeared to be similar across the full range of baseline KCCQ scores.

“…Our findings suggest that future trials should consider targeted inclusion criteria, such as patients with persistent congestion, elevated biomarkers or low KCCQ scores after TAVI, to better identify those patients who may benefit symptomatically from SGLT2 inhibition,” write the authors.

In an accompanying editorial comment, Chetan Prakash Huded, MD, FACC, et al., express their belief that “future studies should focus on patients who remain symptomatic after successful TAVR.” “…Only through such a multidisciplinary approach are we likely to fully achieve the fundamental goals of treatment in valvular heart disease – increasing longevity and optimizing health status,” they write.

Ramon Laguarta was not widely known when he became PepsiCo’s chief executive in 2018, a veteran operator who had spent most of his career in Europe. His low profile stood in contrast to his former boss Indra Nooyi, one of few immigrant women atop corporate America and a regular at Davos with a keen eye for public relations.

Laguarta is now in the spotlight, willingly or not. Like Nooyi before him, he is staring down an activist investor agitating for a shake-up of the drinks and snacks powerhouse that owns brands such as Gatorade, Doritos and its namesake Pepsi cola.

The 29-year PepsiCo veteran on Thursday will face investors for the first time since hedge fund Elliott Management went public with a $4bn stake in the company last month, one of its biggest investments.

Thursday’s third-quarter results will be scrutinised for signs of how Laguarta will respond to Elliott’s demands. The earnings presentation is expected to be Laguarta’s last before the deadline for Elliott to wage a proxy contest at the end of November. How he rises to the challenge may determine whether the hedge fund takes that path.

The activist’s 75-page slide presentation asserts that weakening sales and profit margins in PepsiCo’s North American businesses and an unwieldy product portfolio have put it at a disadvantage to rival Coca-Cola and other competitors, wiping away more than $40bn in market capitalisation over the past three years.

“I think he’s going to get a real test here on his leadership and his resolve,” said Kevin Grundy, a senior consumer goods analyst at BNP Paribas.

Elliott’s case against PepsiCo is less dramatic than Nelson Peltz’s demands for Nooyi to engineer a full break-up more than a decade ago. Nooyi, who promoted a lofty agenda of “performance with purpose”, resisted those calls, but after a two-year stand-off agreed to give Peltz’s hedge fund Trian Management a board seat in 2015. A few years later, she left the top job.

Whether Laguarta decides to play peace broker or dig in may yet define the tactics that Elliott decides to deploy. Marc Steinberg, the Elliott portfolio manager leading the PepsiCo investment, last year masterminded one of the most conciliatory campaigns in Elliott’s history, reaching a speedy détente with industrials giant Honeywell after taking a $5bn position. The company has since added Steinberg to its board.

Laguarta, a cheerful 61-year-old Catalan, oversaw the company’s international growth before taking the reins at its headquarters in the New York City suburbs. Since he became chief executive, PepsiCo’s revenue has increased by nearly 40 per cent. He has divested poorly performing brands such as Tropicana and Naked Juice while making more than $10bn in acquisitions, according to data from S&P Capital IQ.

But over the course of his tenure he became overly focused on quarterly earnings, according to several former executives. He has struggled to sell colleagues and investors on his vision of how to respond to changing consumer habits, such as the impact of weight-loss drugs on taste preferences, rattling the wider consumer sector, the executives said.

He has rankled some of his senior colleagues, in particular by involving his wife Maria in corporate affairs, including strategy meetings and retreats on several occasions, according to people familiar with the matter. His wife also played a role in promoting PepsiCo’s culinary initiatives, which explained how its products could be used in home recipes.

Laguarta has acknowledged a need for a turnaround and has taken steps that include shuttering two snack manufacturing plants to adjust to shrinking US demand.

“Under Ramon’s leadership, PepsiCo has taken a series of steps to best position the company for the long term,” the company said in a statement, pointing to cost-cutting efforts, investments in core brands such as Gatorade and Walkers crisps and the growth of the international business, which has averaged 10 per cent annual growth over the past five years.

“Maria is passionate about PepsiCo and our products, and is an advocate for the culinary aspects of our portfolio,” the company added.

Elliott expressed its “deep respect for the company and its leaders” in a letter to PepsiCo’s board last month, but said investors were sceptical of the company’s prospects. Charts in Elliott’s presentation show how PepsiCo has been outpaced by rivals Coca-Cola and Procter & Gamble, set roughly over the timeline of Laguarta’s seven-year tenure.

The hedge fund also called for better corporate oversight and accountability, hinting at the appetite for a board refresh. Elliott declined to comment.

The first part of Laguarta’s reign looked good. Consumers binged on PepsiCo’s fizzy drinks and snacks while locked down during the Covid-19 pandemic, and the soaring price inflation that followed drove its market capitalisation to an all-time high of more than $260bn in 2023 — tantalisingly close to surpassing Coca-Cola’s market value.

But by the end of 2023 the momentum came out of the business as snack and drinks sales in North America began to decline, as higher prices finally drove away some consumers.

Now PepsiCo is valued at $90bn less than its rival. Elliott draws brutal comparisons to Coca-Cola, highlighting PepsiCo’s relentless soda sales declines. Elliott pinpoints Coca-Cola’s decision to farm out beverage bottling to independent companies as key to its continued success, and argues PepsiCo should do the same with its mostly in-house North American bottling system.

Elliott also called for PepsiCo to sell off legacy food brands that it contends no longer fit its snack-heavy portfolio, such as Pearl Milling baking mixes and syrups, and breakfast cereals such as Cap’n Crunch. Proceeds could be reinvested in acquisitions of high-end or healthy snacking brands, Elliott added.

PepsiCo added in its statement that Laguarta has “repositioned the portfolio” through acquisitions, including of prebiotic soda company Poppi and healthy tortilla chips brand Siete Foods.

Some PepsiCo investors have endorsed Elliott’s ideas, but questioned whether they differ from changes already under way inside the company. “I appreciate Elliott’s suggestions as they correspond with many of the ideas the current management has,” said Kai Lehmann of Flossbach von Storch, a large PepsiCo shareholder. Still, he said the company “needs a greater sense of urgency as PepsiCo risks falling behind”.

In a statement last month, the company said it was reviewing Elliott’s proposals as it “maintains an active and productive dialogue with our shareholders”. A former executive close to Laguarta said the company’s previous experience with activism may mean it is better prepared this time around. “They didn’t pick an easy target,” said the person.